Bio-Technology : news and updates

What is the News?

The government of India has concluded that there have been lapses in the conduct and protocols followed for the filovirus study of bats in Nagaland.

What was the filovirus study about?

• Researchers from India, China and the US had conducted a study in Nagaland on bats and humans carrying antibodies to deadly viruses like Ebola.
  • From India, the National Centre for Biological Sciences(NCBS) and the Tata Institute of Fundamental Research(TIFR) participated in the study.
• Findings: The study found the presence of filovirus reactive antibodies in human and bat populations in northeast India. Hence, the study suggested that Bats in South Asia act as reservoir hosts of a diverse range of filoviruses.

Note:

• Filoviruses belong to a virus family called Filoviridae and can cause severe hemorrhagic fever in humans and nonhuman primates.
• So far, three varieties of this virus family have been identified: Cuevavirus, Marburgvirus and Ebolavirus.

Significance of this filovirus study:

• The findings of the study became significant given the debate over the origins of COVID-19 worldwide and the handling of bat samples at the Wuhan Institute laboratory.
• However, scientific experts and officials have made it clear that the Nagaland bat study on filoviruses (Ebola and Marburg) was in no way related to the coronavirus(SARS) studies at Wuhan.

Government of India’s inquiry into filovirus study:

• The Government of India had ordered an inquiry in 2020 into this study. The inquiry investigated how the scientists were allowed to access live samples of bats and bat hunters (humans) without due permission.
• The inquiry concluded that there have been lapses in the conduct and the protocols followed by the study. The lapses include:
  • Firstly, the study did not have the approval of the Indian Council of Medical Research(ICMR)
  • Secondly, the Bangalore based National Centre for Biological Sciences (NCBS) is not equipped in terms of Biosafety and Biosecurity for testing samples.

Source: The Hindu

Read Also :-Most pollution linked deaths occurs in India

Synopsis: Synthetic biology is a double-edged sword. It is highly prone to misuse, thus there is an urgent need for international measures for monitoring and verification.

Background:

• Synthetic biology is a revolutionary technology. It can help us manipulate biological organisms and processes for human betterment, especially in treating diseases, by re-engineering cells.
• Till now there is no clarity over the origin of Coronavirus, but it is clear that bio-weapons can be made in labs.

However, the preparedness of nation-states and weak global security arrangements are not sufficient in dealing with the misuse of synthetic biology.

What are the concerns associated with the misuse of synthetic biology?

1. Firstly, its misuse has national and global security implications.
   • In 2014, for instance, the U.S. Department of Defense categorised synthetic biology as one of the six disruptive basic research areas.
2. Secondly, there is always a chance of accidental leaks of experimental pathogens.
   • Various factors such as insufficiently trained staff, inadequately safeguarded facilities, and lack of proper protocols followed during experiments might trigger the leak in the future.
3. Thirdly, poor regulation of bio-weapons even after growing military interest in synthetic biology.
   • Bio-weapons are recognised as the ‘weapon of mass destruction’ (WMD) but nothing is done by the international community.
   • Nuclear weapons have received maximum safety and security due to attention given by the institutional arrangements.
4. Fourthly, the attack through bioweapons takes time to show its impact. In that case, it is difficult to ensure accountability.
   • For example, in case of attacks carried out by state actors against the enemy, it would be difficult to pin responsibility as the incubation period is high, and the pathogen can be modified to hide its origin.

Why Biological and Toxin Weapons Convention is not effective in dealing with the misuse of synthetic biology?

1. Firstly, the Biological and Toxin Weapons Convention (BTWC) of 1972 has no implementing body and does not have a verification clause.
   • Also, it has not clearly laid down rules and procedures to guide research.
2. Secondly, the dilemma in Article 1 of the BTWC.
   • Bio-weapons are banned, but research for medical and bio-defence purposes is allowed for peaceful purposes.
   • But the issue is that there is a thin line between bio-defense research and bio-weapons research.
3. Thirdly, the report of an ad-hoc group to negotiate a protocol to ensure transparency was not accepted by the member states of BTWC. The Ad Hoc Group was set up in 1994 at the Fifth BTWC Review Conference in 2001.
4. Lastly, the traditional distinction at the international institutional level between biological weapons (BTWC) and diseases (domain under the World Health Organization) is not useful anymore.

Why India is more vulnerable to bio-weapon attack?

• Firstly, lack of preparation and poor infrastructure.
  • India is not having a strong disease surveillance system.
  • The poor state of the healthcare system was visible during a pandemic.
• Secondly, there is a multiplicity of bodies and the absence of an empowered coordinating body, which makes coordination difficult.
  • For instance, the implementation of biosafety guidelines is the responsibility of the Science and Technology Ministry and the Environment Ministry.
  • However, labs dealing with biological research are set up under the Indian Council of Medical Research and the Indian Council of Agricultural Research, which are under the Ministries of Health and Agriculture, respectively.
• Thirdly, the traditional ministry-wise separation is not useful in the case of zoonotic diseases as it requires “one health approach”.
• Lastly, India has porous borders with ill-trained border control institutions, and they are not prepared for defending against pathogens.

Way forward:

• There is a need for cooperation between health specialists and bio-weapons/defence specialists.
• The November 2021 BTWC review conference must review advances in the field and address the thinning line between biotechnology research and bio-weapons research.

Source: The Hindu

More Related Articles :

Synopsis:

The data from clinical trials and post-vaccination study on vaccines shows that the Dominant delta variant of Covid-19 can’t be easily controlled by a single dose of vaccine. The countries must administer two doses of vaccine and should reduce the time gap between them.

Background:

• The WHO has recently given a new classification to SARS-CoV-2 variants of interest (VOI) and variants of concern (VOC) on the basis of Greek letters. The objective was to create easy-to-pronounce and non-stigmatising labels for VOI and VOC.
• However, the established nomenclature systems for naming and tracking of SARS-CoV-2 genetic lineages by GISAID, Nextstrain and Pango will remain in use for scientific research.
• The new classification is as follows:
  • VOC B.1.1.7 will be called Alpha Variant. It was the earliest documented in the United Kingdom (September 2020).
  • VOC B.1.351 will be called Beta Variant. It was the earliest documented in South Africa (May 2020).
  • VOC P.1 will be called Gamma Variant. It was the earliest documented in Brazil (November 2020).
  • VOC B.1.617.2 will be called Delta Variant. It was the earliest documented in India (October 2020).

About the Delta Variant:

• It was first identified in Maharashtra and is believed to be responsible for the severe second wave in India.
• It has now spread to most parts of India and also been identified in many other countries.
• The rapid expansion has induced the WHO to graduate it from a “variant of interest” (VOI) to a “variant of concern” (VOC) category.

Scientists have undertaken various studies to address 3 major questions surrounding the delta VOC – 

1. Is it more infectious than the prevalent virus?
2. Is it more lethal than the previous virus?
3. Does the delta variant is more resistant to the effect of vaccines? 

Data shown by various studies on vaccines:

Read Also :-What are “Variants of Concern” (VoC)?

• Results of Study conducted by Indian SARS-CoV-2 Genomic Consortia (INSACOG) and the National Centre for Disease Control (NCDC):
  • The Delta variant is the “prime reason” behind the second wave, though the wave may have been initiated by the Alpha variant.
  • The Delta Variant has become dominant even in Britain, where scientists have recently noted that it is 50% more infectious than the Alpha variant.
• Results of study on vaccines conducted by Public Health England:
  • A single dose of the AstraZeneca vaccine provided 33% efficacy against the Delta variant, while it was 51% against the Alpha variant.
  • The second dose improved the efficacy to 60% against the Delta variant and to 66% against the Alpha variant.
  • Further, two doses of Pfizer-BioNtech vaccine provided much higher levels of protection than two doses of the AstraZeneca vaccine.
• Results of a British study on vaccines published in Lancet Journal:
  • Merely 32%of the vaccinated individuals had adequate antibody levels against the Delta variant after the first dose of the Pfizer vaccine. It was 25% against the beta variant.
  • The antibody levels rose after the second dose. However, they were far below the levels obtained against the initial variant of the Covid-19 virus.
• Results of a study on vaccines conducted by the Pasteur Institute, France:
  • The Delta variant showed reduced response to both the vaccines (Pfizer and Astrazeneca). It was resistant to neutralisation by some monoclonal antibodies targeting the Spike protein.
  • The study concluded that a single dose of the Astrazeneca vaccine will not display optimal protection against the delta variant.

Lessons learnt from the various study on vaccines:

• First, the Delta variant is the most infectious variant in circulation. However, there is not much convincing evidence to prove it is more deadlier than the previous variants.
• Second, vaccines have diminished efficacy against the delta variant. Further, a single dose of either the AstraZeneca or the Pfizer-BioNTech vaccine does not provide adequate protection against the Delta variant.
• Third, a shortened dosing interval is recommended to deal with the Delta variant. Britain has already reduced the interval to 8 weeks from earlier 12 weeks.

Source: The Indian Express

What is the news?

India plans to conduct research on Mixing Covid-19 vaccines. This is to investigate if it can immunize people using a “mix and match” of different Covid-19 vaccines.

What does mixing of vaccines mean?

• Mixing of vaccines means following up one dose of a particular vaccine with a second dose of a different vaccine. In scientific terms, this is called “heterologous” immunization.

Have vaccines been mixed before Covid-19?

• Mixing and matching of vaccines have been tested for decades, especially for viruses like Ebola. However, most combinations had initially been restricted to vaccines that use the same technology.
• In India, combinations of rotavirus vaccines have also been used and tested out.

Reasons for mixing Covid-19 vaccines:

• Better Immune Response: Several scientists believe that using a different vaccine for the second dose could potentially boost the immune response against the virus.
  • Example: Viral vector vaccines like Covishield use a modified and weakened chimpanzee ‘adenovirus’ (common cold virus). But using the same adenovirus could make the vaccine less effective the second or third time around. That is why Sputnik V uses two different adenoviruses to deliver the spike protein’s code to our bodies.
• Protection against mutations and variants: Mixing and matching vaccines of different technologies such as a viral vector vaccine followed up with an mRNA vaccine-like Pfizer’s might encourage our immune system to build a wider response.
  • Such combinations could also potentially provide wider protection against certain mutations or variants of the SARS-CoV-2 virus.
• Can cover up the shortages of Vaccines: Current Covid-19 vaccine production cannot sufficiently cater to the existing demand, resulting in stock-outs. Hence, in the short term, mixing solves the shortage of vaccines problem.
• Safety Concerns: Countries like Germany, UK have halted the use of the AstraZeneca vaccine in younger age groups due to concerns of rare blood clots. Here, mixing and matching will allow the completion of immunization while ensuring safety.

Also Read: India needs an effective vaccine policy

Concerns:

• Many unknowns: The Covid-19 vaccines in use have received restricted emergency use permissions. Hence, questions about how safe it is to mix and match and whether the approach can prompt a better immune response are still being answered.
• Untested Combinations: Some vaccines like Covaxin have not even been administered in a mix and match scenario. Hence, more research needs to be conducted.
• Differences in Vaccines: There are complexities in mixing vaccines which includes
  • differences in the shelf life of these vaccines
  • shipment and storage conditions
  • Some vaccines may have more side effects or may not work.
• Side effects: Studies such as the Com-COV trials have shown that some combinations like AstraZeneca with Pfizer vaccines could lead to an increase in side effects.

Source: Indian Express

Synopsis: There is a need for rapidly expanding genomic sequencing and sharing related data in a timely & transparent manner. This will help in understanding the impact of new variants on transmissibility, severity and vaccine effectiveness.

Background

• An effective COVID-19 pandemic response requires tracking of emerging variants, conducting studies about their transmissibility, immune escape and its potential to cause severe disease.
• In this context, genomic sequencing becomes important. Genomic sequencing helps to track the emerging variants and use the evidence for timely actions.
• Unfortunately, Genomic sequencing in India is not being paid much attention.
• Despite, the establishment of SARS-CoV2 Genomic Consortia, or INSACOG the sequencing has remained very low.
  • INSACOG: It is a grouping of 10 National Laboratories involved in carrying out genomic sequencing and analysis of circulating COVID-19 viruses. It was established by the Ministry of Health and Family Welfare.

What is Genome Sequencing?

Genome sequencing is a process of determining the complete DNA/RNA sequence of an organism’s genome. It has the potential to benefit mankind especially in healthcare, disease prevention etc.

Significance of Genome Sequencing

The data from genomic sequencing has both policy and operational implications.

• First, the genome sequencing of SARS CoV-2 conducted by premier research institutes provides very useful insight into the behaviour and impact of Delta variant. For instance, consider the recent findings in India based on genome sequencing.
  • Recently, the Council of Scientific and Industrial Research – Institute of Genomics along with two other institutes, analysed nearly 3,600 genomic sequence samples from Delhi.
  • The genome sequencing of SARS CoV-2 led to the following findings,
    • The Delta variant had become the most circulating variant in Delhi and was found in nearly 60% of the samples analysed.
    • The Delta variant was found to be 50% more transmissible than the Alpha variant.
    • Also, the Delta variant was found to be associated with a high viral load and resulted in a higher proportion of breakthrough infection.
  • Based on their analysis, they were able to conclude that the Delta variant was responsible for the pandemic wave in Delhi.
• Second, Genome sequencing was also helpful to find out the efficacy of the vaccine against different strains. For instance,
  • Based on the findings from genome sequencing in U.K, The Public Health England reported that the effectiveness of a single dose of vaccine was lower against the Delta strain.

Read Also :-What is genome sequencing?

What needs to be done for an effective COVID-19 pandemic response?

• First, to scale up genomic sequencing in India, across all States, adequate samples should be collected for national-level analysis of collated genomic sequencing data on a regular basis and findings should be shared publicly.
• Second, the Indian government needs to invest and support more scientific and operational research on vaccine effectiveness. The data should be analysed on various stratifies such as age, gender and comorbid conditions, etc.
• Third, experts need to deliberate and find solutions to the issues posed by Covid-19 variants, such as immune escape and reduced vaccine effectiveness against the Delta variant.

The only assured way to fight the pandemic is to use scientific evidence to decide policies, modify strategies and take corrective actions. In this regard, increasing genomic sequencing is not a choice but an absolute essential.

Source: The Hindu

What is the news?

As per a study carried out by INSACOG (the consortium of labs undertaking genome sequencing in India), Delta variant of Covid-19 is the primary cause of the second Covid-19 wave gripping the country presently.

What is the Delta Variant of Covid-19?

• The World Health Organization (WHO) has named B.1.617.1 variant as ‘Kappa‘ and B.1.617.2 variant as ‘Delta‘
  • These variants are sub-lineages of B.1.617 which was detected in India in 2021.
• This new nomenclature for the various variants of the coronavirus using Greek alphabets was introduced to simplify public discussions and also help remove the stigma from the names.
• Moreover, WHO has also categorized the Delta variant as a Variant of Concern (VOC).

What is Variant of Concern (VOC)? 

WHO classifies a variant as a VOC when it is associated with

• An increase in transmissibility or detrimental change in Covid-19 epidemiology or
• Increase in virulence (Ability to cause severe/life-threatening disease)
• Decrease in the effectiveness of public health measures or available diagnostics, vaccines and therapeutics.

Why is Delta Variant more dangerous than other variants?

• This variant has multiple mutations that appear to give it an advantage over other strains.
• The most important advantage is that the mutations may make the strain more transmissible.This will make the delta variant the most dangerous variant yet.
• One study indicated that the Delta variant may be up to 50% more transmissible than the B.1.1.7 (U.K./Alpha) variant.

What is a mutation?

• A mutation means a change in the genetic sequence of the virus.
• In the case of Covid-19, which is a Ribonucleic acid (RNA) virus, a mutation means a change in the sequence in which its molecules are arranged.
• A mutation in an RNA virus often happens when the virus makes a mistake while it is making copies of itself.

Source: Indian Express

What is the News?

India has placed an advance order to block 300 million doses of a new Covid-19 vaccine, Corbevax from Hyderabad-based company Biological E.

About Corbevax Vaccine:

• Corbevax is a recombinant protein subunit vaccine. The vaccine is being indigenously produced by Biological E, Hyderabad-based Pharmaceutical company.
• Made up of: The Corbevax vaccine is made up of a specific part of SARS-CoV-2 — the spike protein on the virus’s surface.
• Administration of Vaccine: The vaccine will be administered in two doses. It is expected to be among the cheapest available in the country.

What are Spike Proteins?

• The members of the coronavirus family have sharp bumps that protrude from the surface of their outer envelopes. Those bumps are known as spike proteins.
• These spike proteins allow the virus to enter the cells in the body so that it can replicate and cause disease.
• However, in Corbevax Vaccine the spike protein alone is given to the body. So, it is not expected to be harmful as the rest of the virus is absent. The body is expected to develop an immune response against the injected spike protein.
• Therefore, when the real virus attempts to infect the body, it will already have an immune response ready that will make it unlikely for the person to fall severely ill.

Note: The technology to inject spike protein to develop immunity against a disease is not new. It has been used previously in making hepatitis B vaccines. However, Corbevax is the first vaccine made for COVID-19 to use this technology.

Different types of Covid-19 vaccines:

Vaccines are categorised on the basis of the development process adopted by scientists. For example:

• Pfizer and Moderna vaccines developed in the US are mRNA vaccines. In this type, vaccines will carry the molecular instructions to make the protein in the body through a synthetic RNA of the virus. The host body uses this to produce the viral protein that is recognized and thereby making the body mount an immune response against the disease.
• Johnson & Johnson, Sputnik V and AstraZeneca-Oxford University vaccine is a kind of viral vector vaccine. In this type, a modified version of other viruses (for example, adenovirus) is used. The virus can enter human cells but not replicate inside. A gene for the coronavirus vaccine was added into the adenovirus DNA, allowing the vaccine to target the spike proteins that SARS-CoV-2 uses to enter human cells.
• Bharat Biotech’s Covaxin and Sinovac-CoronaVac is categorised as an inactivated vaccine. In this type, an inactivated live virus is used to create an immune response against the disease.

How is the Corbevax Vaccine different from these vaccines?

• Inactivated vaccines attempt to target the entire structure of the virus.
  • On the other hand, Corbevax like the mRNA and viral vector Covid-19 vaccines targets only the spike protein but in a different way.
• Viral vectors and mRNA vaccines use a code to induce our cells to make the spike proteins against which the body has to build immunity.
  • On the other hand, in the case of Corbevax is actually giving the spike protein alone.

Source: Indian Express

What is the News?

The World Health Organization(WHO) and the Swiss Confederation have signed a Memorandum of Understanding (MoU) to launch the first WHO BioHub Facility.

About WHO BioHub Facility:

• BioHub Facility has been launched to enhance the rapid sharing of viruses and other pathogens between laboratories and partners globally.
• Based in: Spiez, Switzerland.

Key Features of the WHO BioHub Facility:

• Firstly, the facility will help in the safe reception, storage, and preparation of biological materials for distribution to other laboratories. It will help in global preparedness against these pathogens.
• Secondly, the facility will enable member states to share biological materials with and via the BioHub. However, its sharing will take place under pre-agreed conditions, including biosafety, biosecurity, and other applicable regulations.
  • Currently, most pathogen sharing is done bilaterally between countries and on an ad hoc basis. It can be slow and leave some countries without access to the benefits and tools.
• Lastly, WHO will broaden the use of biological materials by qualified entities – such as manufacturers – for the development of medical by-products for fair allocation to countries.

What are Pathogens?

• A Pathogen is usually defined as a microorganism that causes or can cause disease.

Types of Pathogens:

• Viruses: Viruses are made up of a piece of genetic code such as DNA or RNA, and protected by a coating of protein. Once you’re infected, viruses invade host cells within your body. They then use the components of the host cell to replicate, producing more viruses.
• Bacteria: Bacteria are microorganisms made of a single cell. They have the ability to live in just about any environment including in and on your body. Not all bacteria cause infections. Those that can are called pathogenic bacteria. Antibiotics are used to treat bacterial infections.
• Fungi: Fungi can be found just about everywhere in the environment, including indoors, outdoors, and on human skin. They cause infection when they overgrow.
• Parasites: Parasites are organisms that behave like tiny animals, living in or on a host and feeding from or at the expense of the host. Though parasitic infections are more common in tropical and subtropical regions, they can occur anywhere.

Source: Down To Earth

What is the News?

A new point-of-care test has been developed for the rapid diagnosis of Kyasanur Forest Disease (KFD).

About Point-of-Care Test:

• Firstly, the Point-of-Care Test has been developed by the Indian Council of Medical Research (ICMR)-National Institute of Virology.
• Secondly, the test kit includes a battery-operated Polymerase Chain Reaction (PCR). The analyser is portable and lightweight. The kit also has a universal cartridge-based sample pre-treatment kit and nucleic acid extraction device that aid in sample processing at the point of care.

Significance of Point of Care Test:

• The Point of Care tests would be beneficial for the diagnosis of KFD. It is because the outbreaks mainly happen in remote areas where there is a lack of well-equipped sample handling and laboratory testing facilities.
• The test kit would also be useful in quick patient management and controlling the further spread of the virus.

About Kyasanur Forest disease:

• Firstly, the Kyasanur Forest disease is caused by a Kyasanur Forest disease virus. The disease primarily affects humans and monkeys.
• Secondly, India: The disease was first identified in the Kyasanur forest of Shimoga district in Karnataka during an investigation of monkey mortalities in 1957.
• Thirdly, Symptoms: The disease is characterized by chills, frontal headache, body ache, and high fever for five to 12 days with a case fatality rate of 3 to 5%.
• Fourthly, Transmission:
  • Rodents, shrews, and monkeys are common hosts for KFDV after being bitten by an infected tick.
  • Transmission to humans may occur after a tick bite or contact with an infected animal, most importantly a sick or recently dead monkey.
• Fifthly, Diagnosis: Diagnosis can be made in the early stage of illness. It can be done by molecular detection by PCR or virus isolation from blood.
• Sixthly, Treatment: There is no specific treatment for KFD. A vaccine (Formalin inactivated KFDV vaccine) does exist for KFD and is used in endemic areas of India.

Source: Indian Express

What is the News?

Defense Research and Development Organisation(DRDO) has developed a Covid-19 antibody detection kit named Dipcovan.

About Dipcovan Kit:

• Firstly, Dipcovan kit is a Covid-19 antibody detection kit. Defence Institute of Physiology and Allied Sciences lab of DRDO developed it in association with Delhi’s Vanguard Diagnostics Pvt Ltd.
• Secondly, Purpose: Its primary purpose is to detect antibodies. It will also be used in Covid-19 epidemiology studies such as serosurveys.
  • Antibodies are protective proteins produced by the immune system to attack antigens. The antigen is a toxin or other foreign substance that induces an immune response in the body.
• Thirdly, How does it work? DIPCOVAN is a DIPAS-VDx Covid-19 IgG antibody microwell ELISA. The kit can detect both spikes and nucleocapsid (S&N) proteins of the SARS-CoV-2 virus with a high sensitivity of 97% and specificity of 99%.
• Fourthly, the Indian Council of Medical Research(ICMR) has approved the detection kit .
• Fifthly, Significance: The kit offers a significantly faster turn-around time. It requires just 75 minutes to conduct the test without any cross-reactivity with other diseases. It also has a shelf life of 18 months.

About ELISA:

• Enzyme-Linked Immunosorbent Assay(ELISA) is a test that detects and measures antibodies in the blood.
• The usage of the test includes determining antibodies related to certain infectious conditions.
• Some examples include HIV which causes AIDS, Rotavirus, Zika virus, Lyme disease among others.

Source: Indian Express

What is the News?

The World Health Organization(WHO) has announced that it would unveil a new naming system for Virus Variants. The system would be similar to the way tropical storms are named.

What is the current method of naming Virus Strains?

• Currently, WHO and other agencies across the world refer to viruses and their variants by formal lineage names. It is a combination of letters and names that point to the relationships between different variants.
  • Example: Variants such as B.1.1.7 and B.1.617 are named after mutations in common and as well clues to their evolutionary history.
• Geographical tag: The virus names and their associated diseases have also been frequently named after geographical places where outbreaks were first reported or samples first isolated.
  • Example: West Nile virus, Ebola, U.K Strain(B.1.1.7) and South African Strain(B.1.351).

What is the problem with this method of naming strains?

• The current method is stigmatizing and disincentivizing countries from making their sequencing results public as the virus strains are associated with the geographical tag.
• Moreover, the current naming of virus variants is also difficult to remember for the public due to complicated lineage numbers.

What will the new method be like?

• The new method of naming virus strains would be similar to the way tropical storms are named.
• For the naming of tropical storms, the World Meteorological Organisation (WMO) leaves it to countries that surround a particular ocean basin to come up with names.

Source: The Hindu

What is the News?

A team of researchers at the University of Massachusetts Amherst’s Institute for Applied Life Sciences has developed a nanoparticle. This nanoparticle has the potential to revolutionize disease treatment including for cancer. The research is based on a method known as Protein–Antibody Conjugates or PACs.

What are Protein–Antibody Conjugates or PACs?

• This is a new concept of combining two different approaches to drug delivery. Namely, Biological drugs and Antibody-Drug Conjugates(ADC).  Both these methods combined to produce Protein–Antibody Conjugate or PACs. This PAC can be used for targeted drug delivery.
• Protein‐antibody conjugates(PACs) are used for antibody‐directed delivery of protein to specific cells.
• This method ensures the precise and effective delivery of drugs to specific cells. Hence, this method could have an impact on treating diseases like pancreatic cancer.

What are biological drugs(biologics)?

• A biologic drug (biologics) is a product that is produced from living organisms or contains components of living organisms. The composition may include sugars, proteins, or nucleic acids or complex combinations of these substances.
• The biological drug works by targeting a defective protein in the system by delivering proteins to it.
  • For example in case of insulin treatment. If a person is short of insulin, (which is a protein), then s/he will get an insulin shot to balance the system.

How are Biologics different from conventional drugs?

• Conventional Drugs are made from chemical processes to create the active ingredient compound in a traditional lab.
  • On the other hand, a biologics drug is defined as a drug derived from living cells. They are not chemically manufactured.
• Conventional Drugs generally have well-defined chemical structures. On the other hand, biologics are complex mixtures that are not easily identified or characterized.

What are Antibody Drug Conjugates?

• Antibody-drug conjugates or ADCs are a class of biopharmaceutical drugs designed as a targeted therapy for treating diseases like cancer.
• Unlike chemotherapy, ADCs are intended to target and kill tumour cells while sparing healthy cells.

Note: Antibodies is a protective protein produced by the immune system in order to attack antigens. The antigen is a toxin or other foreign substances that induces an immune response in the body.

Source: The Hindu

Pneumococcal Conjugate Vaccines are effective against pneumonia

What is the News?

Six young girls from Assam have developed a biodegradable and compostable yoga mat called ‘Moorhen Yoga Mat’.

Note: The Mat was developed with the support of the North East Centre for Technology Application and Reach(NECTAR). NECTAR is an autonomous body under the Department of Science & Technology(DST).

About Moorhen Yoga Mat:

• Firstly, the ‘Moorhen Yoga mat’ is named after Kam Sorai or Purple moorhen (a resident bird of Deepor Beel Wildlife sanctuary).
• Secondly, the mat has been developed from Water Hyacinth. The mat is 100% biodegradable and 100% compostable mat.
• Thirdly, the mat comes in a cotton canvas cloth bag. So that no zip or metal closures are used.
• Benefits of the Mat: The Moorhen Yoga mat has the following benefits:
  • The Mat can improve the aquatic ecosystem of the wetland through the removal of water hyacinth
  • It can provide sustainable production of utility products with community engagement
  • The mat can generate livelihood for indigenous communities to become completely ‘Atma Nirbhar’.

About Water Hyacinth:

• Water hyacinth is a free-floating and flowering invasive aquatic plant that originated from Amazon Basin, South America.

Why is Water Hyacinth considered invasive?

• It grows rapidly and can form thick layers over the water. So Water hyacinth is considered invasive throughout the world.
• These mats shade out the other aquatic plants. Eventually, these shaded plants die and decay.
• The decaying process depletes the amount of dissolved oxygen in the water. As oxygen levels decline, many fish are unable to survive.
• Hence, often the waters below water hyacinth masses witness the absence of life.

Other Effects of Water Hyacinth:

• Water Hyacinth interferes with boat navigation and prevents fishing, swimming and other recreational activities.
• The water hyacinth may also clog intake pipes used for drinking water, hydropower or irrigation.
• Moreover, it creates a prime habitat for mosquitoes that carry a variety of infectious diseases. So, water hyacinth is also considered a serious threat to biodiversity and human health.

Water Hyacinth in India:

• States like Assam and Kerala are highly affected by the Water Hyacinth.
• Water Hyacinth is also referred to as the Bengal terror. This is because of its effect on the local ecology and lives of the people.

Source: PIB

Yoga as a hobby

What is the News?

The World Health Organization(WHO) has recommended against the use of ‘ivermectin‘ drug for the treatment of COVID-19 patients.

Despite this, Ivermectin is still listed in India as a possible treatment option for mild COVID-19 patients under home isolation.

About Ivermectin Drug:

• Ivermectin is an orally administered drug used to treat parasitic infections. These include parasitic infections of the intestinal tract, skin, and eyes.
• How does it work? Ivermectin works by binding to parts inside the parasite. It eventually paralyses and kills off the parasite. Or it stops adult parasites from making larvae for a while. This provides relief to the parasitic infection.
• Why is it used for Covid-19 patients? Ivermectin was found to be effective in reducing the multiplication of certain RNA viruses. Such as SARS and Covid-19 RNA. Hence, it is used for the treatment of COVID-19 in mild to moderate cases.

What has WHO said? WHO has recommended against the use of Ivermectin drug  for Covid-19 patients on following grounds:

• No scientific basis for a potential healing effect against Covid-19 especially from pre-clinical studies;
• No meaningful evidence for clinical activity or clinical efficacy in patients with Covid-19 disease,
• A concerning lack of safety data in the majority of studies.

Source: The Hindu

“Harlequin Ichthyosis” – Odisha’s First Case

What is the News?

Recently, the Drugs Controller General of India(DCGI) has approved an anti-COVID drug named 2-deoxy-D-glucose(2-DG). The Defence Research and Development Organization(DRDO) developed this medicine for emergency use.

However, independent experts have raised questions about the efficacy of the drug.

About 2-deoxy-D-glucose (2-DG):

• 2-DG drug has been developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS)- a lab of DRDO in collaboration with Dr. Reddy’s Laboratories(DRL).
• The drug comes in powder form in the sachet. One has to take it orally by dissolving the powder in water.

Working Mechanism of the drug:

• The basic mechanism of the drug involves inhibiting glycolysis or one of the ways in which cells break down glucose for energy.
• This approach can starve and kill cancer cells, but in theory, work in inhibiting virus cells too, that are almost entirely dependent on glycolysis for replication.

Questions over 2-deoxy-D-glucose: Independent experts have raised questions over the utility of the drug based on the following reasons:

• Firstly, lack of published data on its performance in human trials,
• Secondly, questions on whether the phase-3 trial objectively evaluated the benefits of the drug and its side effects
• Thirdly, the drug’s history of being an unapproved anti-cancer drug.

Source: The Hindu

Zydus Cadila’s antiviral drug “Virafin” gets emergency use nod

What is the News?

The World Health Organization has classified the B.1.617 (variant first identified in India in 2020) as a Variant of Concern(VoC).

Variant Classifications: Variants of a virus have one or more mutations that differentiate it from the other variants that are in circulation.

Types: US Centers for Disease Control and Prevention (CDC) classifies variants into three categories:

Variant of Interest(VOI):

A variant is classified as Variant of Interest, based on the following possible attributes:

• Firstly, Associated with changes to receptor binding
• Secondly, Reduced neutralization by antibodies generated against previous infection or vaccination
• Thirdly, Reduced efficacy of treatments
• Fourthly, Potential diagnostic impact
• Lastly, A predicted increase in transmissibility or disease severity.

Variant of Concern(VoC):

A variant is classified as Variant of Concern if there is any evidence of:

• Increase in transmissibility
• More severe disease (e.g. increased hospitalizations or deaths)
• Significant reduction in neutralization by antibodies generated during previous infection or vaccination
• Reduced effectiveness of treatments or vaccines or diagnostic detection failures.

Note: The most frequent Variant of Concern(VOC) named by WHO by their geography of origin are

• ‘U.K. variant’ for B.1.1.7;
• ‘South Africa variant’ for B.1.351;
• ‘Brazil variant’ for P.1. and
• ‘Indian Variant’ for B.1.617

Variants of High Consequence

• This is classified when there is clear evidence that prevention measures or medical countermeasures do not work on curbing the virus compared to other variants.
• Currently, there are no SARS-CoV-2 variants that rise to the level of high consequence.

Source: The Hindu

What are “Variants of Concern” (VoC)?

What is the News?

Defence Research and Development Organization(DRDO) has developed an anti-COVID drug named 2-deoxy-D-glucose(2-DG). Recently, the Drugs Controller General of India(DCGI) has approved this drug for emergency use.

About 2-deoxy-D-glucose (2-DG):

• 2-deoxy-D-glucose (2-DG) is an anti-Covid oral drug. It has been developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of DRDO in collaboration with Dr Reddy’s Laboratories(DRL).

How does a 2-DG drug work?

• The 2-DG comes in powder form in the sachet. One has to take it orally by dissolving the powder in water.
• The drug accumulates in the virus-infected cells. It, thereby, prevents virus growth by stopping viral synthesis and energy production.
• The selective accumulation of the drug in virally infected cells makes this drug unique.

Significance of this drug:

• The drug helps in the faster recovery of hospitalised patients. Further, it also reduces supplemental oxygen dependence.
• A higher proportion of patients treated with 2-DG also showed RT-PCR negative conversion in Covid-19 patients.

Source: Indian Express

Inequality in education system

What is the News?

Biotech firm Oxitec has released its Genetically Modified Mosquitoes(GMM) in Florida, USA.

What are Genetically Modified Mosquitoes(GMM)?

• These are the mosquitoes whose genome has been altered using recombinant DNA technology. Their genome is altered in a way to favour the few desired physiological traits and the generation of desired biological products.
• The desired trait of these GMM is to reduce the transmission of mosquito-borne human diseases.

How does GMM work?

• Firstly, Aedes aegypti mosquitoes are known to spread deadly diseases to humans such as dengue, Zika, chikungunya and yellow fever.
• Secondly, among them, only female mosquitoes will bite humans because they need blood to produce eggs.
• Thirdly, the researchers have bioengineered male Aedes aegypti mosquitoes. These male mosquitoes will mate with wild female mosquitoes.
• Fourthly, the genetically engineered males carry a specific gene that prevents the female from producing essential protein for survival.
• Fifthly, as the gene passes to their offspring, it will kill the female descendant at the early larval stages. 
• Sixthly, the gene does not affect the males’ survival. Further, the male will continue to possess the gene that will pass on to future generations.
• Seventhly, over time, the GMM will reduce the population of Aedes aegypti mosquitoes. Thereby reduce the spread of disease to humans.

Note: Oxitec had previously released its modified Aedes aegypti mosquitoes in Brazil, the Cayman Islands, Panama and Malaysia. The company had reported that local A. aegypti populations fell by at least 90% in those locations.

Source: IndiaTimes

Synopsis:

Phase 2b clinical trials of R21/Matrix M (a new malaria vaccine) have shown the efficacy of 77%. It is a new version of RTS, S — another candidate against malaria. Experts believe that this new version could be a game-changer in curtailing the spread of malaria across the globe, especially during pandemic times. 

Background:

• The results of phase 2b clinical trials of R21/Matrix M were published recently in the Lancet Journal.
• The new malaria vaccine showed an efficacy of 77%, much higher than its previous version named RTS,S.

About the Previous Version:

• RTS, S has been in development for more than 30 years. It is a joint work of Walter Reed Institute of Research, GlaxoSmithKline, and Bill and Melinda Gates Foundation with the PATH Malaria Vaccine Initiative.
• It targets the liver stage protein of the Plasmodium falciparum life cycle.
• Thus, it stops the Plasmodium falciparum malaria parasite from entering the liver thereby preventing the subsequent deadly blood stages.
• To date, it is the only vaccine to reduce malaria in children. However, it doesn’t have high efficacy. 

About the new version:

• R21/Matrix M is a modified version of RTS, S.
• Scientists at the University of Oxford have been developing it for the last 6-7years. Serum Institute of India is manufacturing it.
• The vaccine trial began in 2014-15 on 450 children in Burkina Faso. 
• The result of the phase 2b trial showed a 77% efficacy. This made it the first vaccine to reach WHO’s goal of at least 75% efficacy.

Need of New Malaria Vaccine:

• High Incidence of Malaria: In 2019, there were an estimated 229 million cases of malaria and 409 000 malaria-related deaths in 87 countries. In the same year, India witnessed 5.6 million cases.
  • Under 5 children in sub-saharan Africa accounted for approximately two-thirds of global deaths. 
• Greater Hardships posed by Pandemic: As per a WHO survey, approximately one-third of countries around the world reported disruptions in malaria prevention, diagnosis and treatment services during the first quarter of 2021.
  • Disruptions occurred as people were unable or unwilling to seek care in health facilities.
  • Further lockdowns and restrictions on the movement led to delays in the delivery of insecticide-treated mosquito nets.

What’s next?

• Serum Institute of India and US vaccine maker Novavax have begun the process of phase 3 trials in 4 African countries.
  • This would assess large-scale safety and efficacy in 4,800 children aged five to 36 months.
• The success of the trial would enable bulk production of the vaccine that would help curtail malaria across the globe.

Source: Indian Express 

What is the News?

CSIR-Central Leather Research Institute (CLRI), Chennai has inaugurated the Integrated Solar Dryer and Pyrolysis pilot plant. This plant and dryer focus on urban waste management. Also, this pyrolysis plant is the part of Indo-German project Pyrasol.

About Indo-German Science & Technology Centre (IGSTC):

• The Government of India (DST) and the Government of Germany(BMBF) jointly established the Indo-German Science & Technology Centre.
• Aim To facilitate bilateral science and technology networking. Further, the IGSTC also play a proactive role in catalysing institute-industry cross-border partnerships through joint R&D efforts.

What is the 2+2 Project?

• The 2+2 project is the flagship programme of the Indo-German Science & Technology Centre(IGSTC).
• Aim: The aim is to catalyse innovation-centric R&D projects. This is achieved by synergizing the strength of research/academic institutions and public/private industry from India and Germany.
• Under the scheme, R&D projects will be supported through “2+2 Mode of Partnership” i.e. involvement of at least one research/academic institute and one public/private industry from both India and Germany.

About Pyrolysis:

• Pyrolysis is a process of chemically decomposing organic materials at elevated temperatures in the absence of oxygen.
• The process typically occurs at temperatures above 430 °C (800 °F) and under pressure.
• It simultaneously involves the change of physical phase and chemical composition of organic material. Pyrolysis is an irreversible process.

Source: PIB

What is the News? 

The Variants of concern(VOC) together with widespread relaxation of COVID-19 appropriate behavior resulted in the 2nd wave of Covid-19 in India.

 What is a Variant of Concern?

• The term variant of concern(VOC) is a category assigned to a newly emerged variant of a virus with an increased ability of transmission.

Properties of VOC: The VOC is characterized by three sinister properties:

1. Firstly, Increased Transmission Efficiency: In many countries, including India the VOC, by virtue of increased transmissibility, has started off a new wave(s) of epidemic transmission.
2. Secondly, Virulence: It is the ability to cause severe/life-threatening disease. The UK variant has the worse virulence. The South Africa and Brazil variants do not seem to have higher virulence.
3. Thirdly, Immune to antibodies generated by previous vaccination or infection: Most vaccines were made using antigens made from D614G variant. However, these vaccines show low efficacy on the South African, Brazil and UK variants. Hence, reinfection can occur in spite of immunity provided by earlier D614G infection or vaccination.

How does a new variant emerge?

• If a manuscript is copied by hand repeatedly, there are high chances of spelling errors.
• Similarly, when ‘genetic scripts’ encoded in DNA or RNA are copied repeatedly in virus replication, errors do occur.
• Further, RNA viruses are more error-prone than DNA viruses.SARS-CoV-2 genome is single-stranded RNA and mutations or different variants of a virus occur frequently.

Who detects these variants?

• The ability to detect and track new variants is on the laboratory capacity in whole genome sequencing of viruses.
• In India, the Indian SARS CoV-2 Genomic Consortium (INSACOG), a network of ten competent public-sector laboratories for genomic surveillance was established to detect and track variants.

Nomenclature of SARS-CoV-2 Variants:

• There are three different schemes of nomenclature of SARS-CoV-2 variants.
• The widely used one is the ‘Phylogenetic Assignment of Global Outbreak Lineages’(PANGOLIN) that uses a hierarchical system based on genetic relatedness – an invaluable tool for genomic surveillance.
• It uses alphabets (A, B, C, P) and numerals starting with 1. Variant lineages are at the emerging edge of the pandemic in different geographies. Lineage B is the most prolific.

SARS Cov-2 Variants:

• The three most frequent Variant of Concern(VOC) are named by their geography of origin:
  • ‘U.K. variant’ for B.1.1.7;
  • ‘South Africa variant’ for B.1.351;
  • and ‘Brazil variant’ for P.1.

Note: The original pandemic virus (founder variant) was Wu.Hu.1 (Wuhan virus). In a few months, variant D614G emerged and became globally dominant.

Source: The Hindu

What is the News?

Scientists from MACS- Agharkar Research Institute (ARI) Pune in collaboration with the Indian Council of Agricultural Research(ICAR) have developed a variety of Soybean called MACS 1407. The MACS-ARI is an autonomous institute of the Department of Science & Technology.

 About MACS 1407:

• MACS 1407 is a high-yielding and pest-resistant variety of soybean.
• Cultivation: It is suitable for cultivation in the states of Assam, West Bengal, Jharkhand, Chhattisgarh and North-Eastern states.

Key Features:

• MACS 1407 requires an average of 43 days for 50 % flowering. Further, it takes 104 days to mature from the date of sowing.
• It has white coloured flowers, yellow seeds and black hilum (a scar on a seed marking the point of attachment to its seed vessel). Its seeds have 19.81 % oil content, 41 % protein content and show good germinability (the ability of a seed to germinate).

Advantages:

• High Yielding: It gives 39 quantal per hectare making it a high yielding variety
• Pest Resistant: It is resistant to major insect pests like girdle beetle, leaf miner, leaf roller, stem fly, aphids, whitefly and defoliators.
• It has certain characters suitable for mechanical harvesting. Such as,
  • It has a thick stem that makes it stronger to harvest using machines.
  • This variety has higher pod insertion (7 cm) from the ground
  • It is resistant to pod shattering.

Significance of this development:

• Firstly, in 2019, India produced around 90 million tons of soybean. This is widely cultivated as oilseeds and a cheap source of protein for animal feed and many packaged meals.
• Secondly, India also has a target to be among the world’s major producers of soybean.
• Hence, MACS 1407 having high yielding, disease-resistant characteristics can help India to achieve this target.

Source: PIB

Synopsis:

The challenges posed by Antimicrobial resistance (AMR) demands a comprehensive and collaborative approach by all the countries. They must come together to tackle the silent pandemic.

Background:

• Covid 19 exposed the vulnerabilities of health systems across the globe. It took away the lives of more than 3 million people since January 2020.
• Experts believe that greater destruction would be caused by AMR in the coming years. This calls for taking strong steps at the national and global levels.

What is AMR?

• It is a phenomenon by which bacteria, fungi, parasites, and viruses evolve and become resistant to presently available Antimicrobial resistance treatment.
• The infections persist in the body, increasing the risk of spread to others.

Reasons behind the development of AMR:

Primary reasons:

• Misuse of antimicrobials in medicine – This happens when the proper course of medication is not done or the person indulges in self-medication.
• Inappropriate use in agriculture – Antibiotics are used to boost the productivity of livestock.
• Contamination around pharmaceutical manufacturing sites –  The untreated waste releases large amounts of active antimicrobials into the environment.

Secondary Reasons:

• No new antimicrobial developments: No new classes of antibiotics have made it to the market in the last three decades. This is a result of inadequate incentives for their development and production.
  • A recent report from the non-profit PEW Trusts found that over 95% of antibiotics in development today are from small companies.
• Easily Availability: Antimicrobials are easily available as ‘over the counter drugs’ in many countries. This ease facilitates more consumption and development of AMR.

Challenges posed by AMR development:

• Threat to the health care system: Antimicrobials prevent infections post a routine surgery or cancer treatment. Their ineffectiveness would impair the modern health system. 
  • The problem is more grave for low- and middle-income countries (LMICs) of Asia and Africa where cheap antimicrobials have significantly reduced the mortality rates.
• Loss of Human Lives: It is responsible for up to 7 lakh deaths a year. It is estimated that 10 million annual deaths would be caused by it post 2050.
• Economic Brunt: The countries would require abundant capital to manage the AMR crisis in the future. As per an estimate, it may cost up to $100 trillion by 2050.

Way Forward:

• Accessibility: There is a need to ensure better accessibility of antimicrobials. Globally, 5.7 million people die every year because they cannot access drugs for infections that are treatable.
• Incentivisation: The companies must be encouraged to develop new antimicrobial drugs. In this regard, a multi-sectoral $1 billion AMR Action Fund was launched in 2020 to support the development of new antibiotics.
• Judicious Use: There must be appropriate and judicious use of antimicrobial drugs. Countries can learn from:
  • Peru’s efforts on patient education to reduce unnecessary antibiotic prescriptions
  • EU-supported VALUE-Dx programme that has increased the use of point-of-care diagnostics. This has resulted in prudent drug intake.
• Tracking the spread of AMR: Surveillance measures to identify these organisms need to expand beyond hospitals. They should encompass livestock, wastewater, and farm run-offs.
  • For instance, Denmark’s efforts to prevent the use of antibiotics in livestock had reduced AMR prevalence and boosted agricultural productivity.
  • Similarly, countries must formulate a dedicated and holistic plan to deal with AMR like India’s National Action Plan for antimicrobial resistance.
• Global Coordination: International alignment and coordination are paramount in both policymaking and its implementation. The countries can use the Paris Agreement as a blueprint for developing a similar global approach to tackling AMR.

Source: The Hindu 

What is the News?

ICAR-Indian Veterinary Research Institute has transferred the Technology for the Classical swine fever(CSF) & Sheep Pox Vaccines to M/s Hester Biosciences through Agrinnovate India Limited.

About the technology transfer:

ICAR-IVRI has developed both the CSF vaccine and Sheep pox vaccine. But to provide commercialisation and build sustainable public-private partnerships ICAR-IVRI decided to perform technology transfer. Further, the technology transfer will also help in the following,

• It will provide the Vaccine at a cheaper price and ensure longer immunity of livestock.
• It is a great game-changer for the farmers or people involved in animal husbandry practices

 About Classical swine fever(CSF):

• Classical swine fever(CSF) also known as hog cholera. It is a contagious viral disease of domestic and wild swine(pigs).
• Caused by: It is caused by a virus of the genus Pestivirus of the family Flaviviridae.
• Transmission: The most common method of transmission is through direct contact between healthy swine and those infected with the CSF virus.
• Humans are not affected by this virus. Swine are the only species known to be susceptible.
• Treatment: The disease has a 100% mortality. However, Vaccination can prevent the spread of the disease.

Vaccine for CSF:

• In India, the disease is controlled by a lapinized CSF vaccine. This vaccine is produced by killing large numbers of rabbits.
• To avoid this, the ICAR-IVRI developed a Cell Culture CSF Vaccine (live attenuated). This is developed using the Lapinized Vaccine Virus from a foreign strain.
  • Live attenuated vaccines use a weakened (or attenuated) form of the germ that causes a disease.
• The new vaccine has been extensively tested for safety and potency. It has been found to induce protective immunity from the 14th day of the Vaccination till 18 Months.

About Sheep Pox Disease:

• Sheep Pox is a highly contagious viral disease of sheep caused by a poxvirus.
• The disease is the most severe of all the animal pox diseases. It can result in some of the most significant economic consequences due to poor wool and leather quality.
• Transmission: The sheep pox virus is an aerosol. So it can be transmitted via contact with an infected animal.
• Treatment: There is no treatment for the sheep pox virus, thus efforts are directed towards prevention.

Vaccine for Sheep Pox:

• A live attenuated Sheep Pox Vaccine using indigenous strain was developed by the Institute for preventive vaccination in the sheep population.
• The Vaccine is safe, potent and immunogenic [efficacious] for sheep aged more than six months of age. Also, it protects the Vaccinated animals for a period of 40 months.

Agrinnovate India Limited:

It is a registered Company under the Companies Act, 1956. The Government of India in the Department of Agricultural Research and Education (DARE) owns it.

Functions:

• Firstly, it aims to work on the strengths of DARE’s Indian Council of Agricultural Research (ICAR)
• Secondly, Agrinnovate India also promotes the development and spread of R&D and its outcomes through IPR protection, commercialization and forging partnerships for the public benefit.

Source: PIB

What is the News? The union health ministry has said that the breakthrough infection rate is low for both Covaxin and Covishield vaccines.

What is it?

• Breakthrough infection is a case of illness in which a vaccinated individual becomes sick from the same disease for which the vaccine was administered.
• Simply, it occurs when vaccines fail to provide immunity against the pathogen they are designed to target.

Possible Reasons for Breakthrough Infections:

• India’s healthcare and frontline workers were on the priority list for vaccination during the first phase. They were always prone to more occupational exposure to the coronavirus disease.
• The second wave of Covid-19 is highly transmissible, it might also have contributed to the breakthrough infection rates.

India’s Breakthrough Infections Data:

• Covishield: After the first dose two per 10,000 people get reinfected and after the second dose, three per 10,000 people get reinfected.
• Covaxin: After the first dose four per 10,000 people get reinfected after the number remains the same for the second dose too.
• This type of Infections are mostly mild or asymptomatic because the individuals still have partial protection.

Concerns:

• According to a US study, people with no symptoms transmit more than half of all cases. This means that controlling this silent transmission from persons without symptoms is very important for controlling the pandemic.
• Hence, it is very possible that an asymptomatic breakthrough infection can result in the further spread of the disease in the community.
• This happens especially because people may become careless following vaccination and many such infections are asymptomatic.

Source: The Hindu

What is the News?

The National Centre for Disease Control(NCDC) has released data obtained from the ‘Genome Sequencing of SARS-CoV-19’ Samples in India. UK Variant is the cause of the Current COVID-19 surge in Delhi.

Who conducted the study?

• Indian SARS-CoV-2 Consortium on Genomics(INSACOG) has conducted Genome Sequencing of around 15,000 samples. It is about 1% of India’s coronavirus caseload.

Key Findings from the study:

• Firstly, Variants of Concern(VoC): The relative proportion of known Variants of Concern or VoC (the U.K., South Africa, Brazil variants) is around 11% of the sequenced samples.
  • VoC is a category used during the initial assessment of a newly emerged variant of a virus. Before this, an emerging variant may have been labeled a “variant of interest”.
• Secondly, The proportion of the UK. variant (B.1.1.7) in the samples sequenced from Delhi increased to 50% from 28% in the 2nd week of March.
  • The UK variant has a mutation N501Y. It increases the transmission of the virus leading to increased disease severity and mortality.
• Thirdly, there was also a rise in the Indian variant (B.1.617). The Indian Variant possesses two mutations “E484K and L245R” that are associated with increased efficacy and decreasing the potency of vaccines.
• Fourthly, Vaccines Effectiveness: According to a Preliminary report by the CSIR-Centre for Cellular and Molecular Biology, Hyderabad, Covaxin and Covishield appeared to be effective against the Indian variant.

Source: The Hindu

What is the News? Drug Controller General of India(DCGI) has granted emergency use approval for pharma major Zydus Cadila’s antiviral drug ‘Virafin’ to treat moderate COVID-19 in adults.

About Virafin Drug:

• Virafin is an antiviral drug. It is administered subcutaneously, i.e., it is injected under the skin. “Zydus Cadila”, a pharma major, manufactured. The drug was originally approved for the treatment of liver disease caused by the hepatitis B and C virus.
• The drug has now been repurposed for treating the moderate COVID-19 disease.
• It has been found that when the drug was given to Covid patients in the early stage, it showed significant improvement in moderate Covid cases.
• The drug was also found to reduce hours of supplemental oxygen required by patients.
• Moreover, patients who were treated with the drug ‘Virafin’ were tested Covid negative within 7 days.
• Hence, after the emergency approval, the drug will now be available on the prescription of a medical specialist for use in hospital/institutional setup.

Source: The Hindu

What is the News?

Researchers at the Salk Institute for Biological Studies in the US have for the first time created the first monkey embryo containing human cells. This particular field of research is called “chimera research”.

About the Chimera Research:

• Research: Scientists have injected human stem cells(cells that have the ability to develop into many different body tissues) into the macaque monkey embryos. This integration created a chimeric tool.
  • Chimeras are organisms that comprise the cells of two distinct species. In this case, it was humans and monkeys.
  • For instance, if this hybrid embryo is placed in the womb of a monkey, it could possibly grow into a new kind of animal (however this was not the aim of this study).
• Outcome: This human-monkey chimeric embryo was monitored in the lab for 19 days, before being destroyed. Researchers found that the human stem cells survived and integrated with better relative efficiency than in the previous experiments.

Purpose of Chimera Research: Researchers believe that the ability to grow cells of two different species together helps scientists in research and Medicine such as:

• Advancing current understanding about early human development,
• Understanding disease onset and progression
• Drug evaluation and
• Also, it can address the critical need for organ transplantation.

Concerns Regarding Chimera Research:

• Moral Dilemma: Humans are widely (but not universally) thought to have a higher moral status than other animals. But human-animal chimeras blur this line. These Chimeras are not fully human nor fully non-human.
• Survival Issues: Some rare hybrid animals exist naturally probably as a result of unintentional cross-breeding between animals of different species.
  • However, generally different species don’t cross-breed. But if they do, their offspring don’t survive for long and are prone to infertility.
• Issue of Infertility: Mules are an example of a hybrid animal that is the result of mating between a female horse and a male donkey.
  • Mules can live a long healthy life. But they are infertile which means that they cannot have offspring of their own.
• Injustice Against Animals for Human Needs: Chimera research has the potential to worsen injustice against animals. This is because it is being done to meet human needs.

Source: Indian Express

What is the News? Researchers have come closer to identify the reason behind the post-Vaccine blood clotting cases following the Covid-19 vaccination.

Background:

• The US pauses the use of Johnson and Johnson’s Covid-19 vaccine. It was followed by adverse reactions in a few vaccinated persons.
• A similar adverse reaction to AstraZeneca’s vaccine has also been observed in some rare cases.

About the Research:

• Researchers show how the adverse reaction due to the Covid-19 vaccine resembles a reaction to heparin — a blood thinner.
  • Usage of Heparin is normally to prevent clotting. But in very rare cases, it can trigger a syndrome called heparin-induced thrombocytopenia (HIT) which causes blood clots and low platelet levels.

Adverse Reaction after vaccination:

• After vaccination, the person develops specific antibodies which can bind to the platelets or thrombocytes. Antibodies activate them to form clots which could eventually block the blood vessel (thrombosis). There is also an accompanying decrease in the free platelets (thrombocytopenia).
• The researchers are not sure whether it is the vaccine that is causing the reaction. Or it is due to some internal body mechanism.

Method Proposed by Researchers:

• Researchers have differentiated the blood clots arising from vaccination from HIT. Also, they have outlined a way to test patients with worrying symptoms.
• They have also developed a screening assay to determine whether the person has developed these particular antibodies.
• They have advised to first rule out heparin-induced thrombocytopenia. After that testing for vaccine-induced immune thrombotic thrombocytopenia (VITT) followed by specific treatment of the condition with immunoglobulin should take place.

Source: The Hindu

Synopsis: Clinical Trials have been instrumental in the development of treatment for Covid-19 so far.

Introduction

The World Health Organization (WHO) declared the SARS-CoV-2 pandemic on March 11, 2020. Doctors did not know how to treat patients with COVID-19 in the beginning. Clinical care was dominated by opinion, narratives, and code of belief in the first few months.

• For example, it was believed that hydroxychloroquine could cure COVID-19. The truth is hydroxychloroquine does not benefit COVID-19 patients. 
• After one year, many medicines which do not cure Covid-19 are still in use, such as steam inhalation, multivitamins, mineral supplements, ivermectin, and chloroquine, etc.

How the clinical trials helped in finding the best treatment?

Clinical trials are important for finding the best treatment. Doctors treated symptoms and provided life support until these trials produced results.

1. Firstly, many COVID-19 patients developed blood clots and treated with blood-thinning medications. Other treatments included oxygen, breathing support ventilators for severely ill patients, kidney dialysis, and supporting heart with blood pressure medications.
2. Secondly, COVID-19 demanded for producing high-quality evidence quickly. There was a requirement for designing trials to test many treatments at once with innovative designs such as platform trials and adaptive trials.
   • For example, The RECOVERY trial network in the U.K., the REMAP-CAP trial globally focusing on critically ill patients, and the WHO-led SOLIDARITY trial.
   • RECOVERY verified that there was no benefit of using hydroxychloroquine, azithromycin, lopinavir-ritonavir, colchicine, and convalescent plasma.
   • REMAP-CAP found that hydroxychloroquine and lopinavir-ritonavir were harmful to use. It proved that there is no benefit with convalescent plasma.
   • SOLIDARITY highlighted the lack of benefit of Remdesivir. It is an antiviral drug that possibly shortens the illness duration.
3. Thirdly, it is important that the results of these clinical trials should be interpreted into clinical practice by healthcare professionals managing COVID-19 patients.

What are the drugs that have been proven to benefit COVID-19 patients?

1. Firstly, Corticosteroid (dexamethasone) is effective in COVID-19 patients who require oxygen and in severely ill patients (hydrocortisone). 
2. Secondly, two interleukin-6 receptor blocking drugs (tocilizumab and sarilumab) benefit COVID-19 patients. They show enhanced results used in combination with corticosteroids, specifically in patients with moderate and severe COVID-19.

What should be done? 

• Thus, clinical trials show that apart from supportive care (oxygen, ventilatory support), the only drugs that reduce mortality are steroids and interleukin-6 receptor blocking drugs. Thus, random drugs without proper clinical trial, need to be avoided 

Source: click here

What is the News?

The World Health Organization(WHO), World Organization for Animal Health and United Nations Environment Programme jointly released guidelines to control “Zoonotic Diseases” for governments. Guidelines ask to reduce the risk of transmission of zoonotic pathogens to humans in food production and marketing chains.

What are Zoonotic Diseases?

• Zoonosis is an infectious disease that jumps from a non-human animal to humans.
• Zoonotic pathogens may be bacterial, viral, or parasitic. They can spread to humans through direct contact or through food, water, and the environment.

Key Guidelines issued by WHO:

• Firstly, Countries should suspend the sale of live animals captured from the wild in food markets. This is an emergency measure as they are the leading source of emerging infectious diseases like the coronavirus.
• Secondly, strengthening the regulatory base for improving standards of hygiene and sanitation in traditional food markets. This will reduce the risk of transmission of zoonotic diseases.
• Thirdly, Adequately training food inspectors to ensure businesses comply with regulations to protect consumers’ health.
• Fourthly, Strengthening animal health surveillance systems for zoonotic pathogens. This includes both domestic and wild animals. This will provide an early warning for pathogen emergence. Further, it will also help in developing the control measures.
• Fifthly, Developing and implementing food safety information campaigns. The campaign should create awareness to market traders, stallholders, consumers, and the wide public. These campaigns should communicate the principles of food safety and the risks of transmission of zoonotic pathogens.

Source: The Hindu

[Answered]Discuss the problems faced by the power sector in India. Suggest some measures to tackle these problems.

What is the News?

Indian SARS-CoV-2 Consortium on Genomics (INSACOG) has been doing genome sequencing of Covid-19 Variants. It has found a unique “double mutant” virus variant in India. This variant has a unique combination of mutations, not seen anywhere else in the world.

What is Double Mutation?

• Double Mutation is when two mutated strains of a virus come together and form a third strain.
• The one reported in India is the result of the combination of E484Q, and L452R strains. The L452R strain is found in California in the United States, while, the E484Q strain is indigenous.

Is this double Mutant COVID Variant Harmful?

• Mutation in the virus is a normal process. But some mutations help the virus in defending itself from vaccines or antibodies or linking to a spike in cases.
• However, the capability of double mutant coronavirus variant in increased infectivity or in making COVID-19 more severe is still uncertain.
• Hence, INSACOG will submit details of this variant to a global repository called GISAID. If it qualifies, it will be classified as a “variant of concern”(VOC).
• Variant of concerns requires appropriate public health actions, such as
  • Notification to WHO under the International Health Regulations,
  • reporting to CDC,
  • local or regional efforts to control spread,
  • increased testing, or research to determine the effectiveness of vaccines and treatments against the variant

Note: So far, only three global Variants of Concern (VOCs) have been identified: the U.K. variant (B.1.1.7), the South African (B.1.351) and the Brazilian (P.1) lineage.

About INSACOG:

• Indian SARS-CoV-2 Consortium on Genomics(INSACOG) is a grouping of 10 National Laboratories. It was established by the Ministry of Health and Family Welfare(MoH&FW).
• Aim:
  • Firstly, to monitor the genomic variations in the SARS-CoV-2 on a regular basis through a multi-laboratory network.
  • Secondly, to ascertain the status of a new variant of SARS-CoV-2 in the country.
  • Furthermore, to establish a surveillance system for early detection of genomic variants and determine the genomic variants in the unusual events/trends.
• Coordinated by: The Department of Biotechnology (DBT) along with MoH&FW, ICMR, and CSIR coordinate it.
• Significance: The knowledge generated through this vital research consortium assists in developing diagnostics and potential therapeutics and vaccines in the future.

Global Initiative on Sharing All Influenza Data(GISAID) Initiative

• The GISAID Initiative was launched on the occasion of the 61st World Health Assembly in 2008.
• In 2010, Germany became the official host of the GISAID Initiative through a public-private partnership.
• Aim: It aims to promote rapid sharing of data of all influenza and COVID virus sequences globally. Moreover, it helps to understand, how the viruses evolve, spread, and potentially become pandemics.
• Headquarters: Munich, Germany.

Source: The Hindu

What is the News?

Candida Auris (deadly hospital pathogen) identified for the first time in the Andaman and Nicobar Islands.

About Candida Auris:

• Candida Auris or C.auris is a multidrug-resistant fungus. It presents a serious global threat to human health.

Origin of Candida Auris:

• Candida Auris was first identified in 2009 in a patient in Japan. The fungus emerged in more than 40 countries across five continents in the last decade.
• The fungus is mostly found in tropical marshes and marine environments, outside hospital environments.
• However, it is an emerging pathogen, thus very little is known about the Candida Auris so far.

Symptoms of C.Auris:

• C.Auris infections can show no symptoms before turning into a fever and chills. These symptoms don’t go away despite the use of medicines and can lead to death.
• C.auris survives on the skin before entering the body through wounds. Once in the bloodstream, it causes severe illness and can lead to death.

Why  C.Auris is harmful? C.Auris is considered dangerous because of three reasons:

• Fisrtly, C.Auris is often multidrug-resistant. It means that it is resistant to multiple antifungal drugs commonly used to treat Candida infections.
• Secondly, it can survive and persist within the hospital environment for prolonged periods. It is capable to survive on dry environmental surfaces for prolonged periods. It means that it adapts well to survival outside human host settings as well.
• Lastly, C.Auris is difficult to identify with standard laboratory methods, and it can be misidentified in labs without specific technology. Misidentification may lead to inappropriate management.

Vulnerable Population:

• C.Auris can get deadly for immunocompromised patients. The incidence of deaths from this fungal infection is high in countries such as the US and the UK, but its prevalence is less in Indian hospitals.

Treatment:

• Echinocandins, a class of antifungal drugs, can treat most of the C.auris infections. However, some C. auris infections have been resistant to antifungal medications making them more difficult to treat.

Source: Indian Express

What is the news?

The European Commission has unveiled a “digital green certificate” for the European Union(EU) Citizens.

About Digital Green Certificate:

• Firstly, Digital Green Certificate is a type of vaccine passport. It will be available to the citizens who are Covid-19 vaccinated or tested negative against Covid-19. It is also available to the persons recovered from Covid-19.
• After the issue of the the Digital Green Certificate, they can travel freely within the European Union(EU) bloc.
• Secondly, Features: The Digital Green certificate will be in digital or paper format with a QR code. The certificates will be provided free of charge.
• Thirdly, Issuance of Certificate: Authorities, such as, hospitals, testing centres, and health authorities can issue the certificates.
• Fourthly, Who can use it? All EU citizens or third-country nationals who are legally staying in the EU. These persons will get exemption from movement restrictions due to COVID-19.

About Vaccine Passports:

• Firstly, a vaccine passport is an e-certificate that stores and records the Covid-19 test status. One can save it on a smartphone app or in other digital formats.
• Secondly, it functions as proof that the holder has been vaccinated against Covid-19 and is safe to travel.

Source: Indian Express

What is the News?
National Institute of Oceanography(NIO) has launched its first-of-its-kind project of Genome Mapping in the Indian Ocean.

About the Genome Mapping in the Indian Ocean Project:

• Aim of the Project:
  • To reveal the internal working of the body of the ocean at a cellular level.
  • To understand the biochemistry and the response of the ocean to climate change, nutrient stress and increasing pollution.
• Duration of the Project: The project will take three years to complete.

How will the Project be conducted?

• The NIO research team onboard its research vessel Sindhu Sadhana will travel from India’s east coast, all the way to Australia, then onward towards Port Louis in Mauritius and up to the border of Pakistan.
• During this journey, they will gather samples for genome mapping of microorganisms at an average depth of 5 km.
• They will then map the DNA and RNA of these microorganisms just like gene mapping on human blood samples.

Significance of the Project:

• The genome mapping will enable scientists to identify the factors controlling the changes in RNA, DNA in the oceans and various stressors impacting them.
• The project will also help in identifying which part of the ocean has a greater concentration of which mineral or element.Scientists will then use these as tracers to tackle the causative factors for excess or lack of a certain mineral or element and suggest possible solutions for their mitigation.
• Further, the genome mapping of oceans will enable commercial biotechnology applications from anticancer treatments and industrial enzymes to antiviral molecules.

What is Genome Mapping?

• Genome refers to an organism’s complete set of DNA which includes all its genes and mapping these genes simply means finding out the location of these genes in a chromosome.
• Therefore, Genome mapping essentially means figuring out the location of a specific gene on a particular region of the chromosome and also determining the location of and relative distances between other genes on that chromosome.

About National Institute of Oceanography(NIO):

• NIO is an autonomous research organization established in 1966.It is one of the 37 constituent laboratories of the Council of Scientific & Industrial Research (CSIR), New Delhi.
• Focus: The principal focus of research has been on observing and understanding special oceanographic characteristics of the Indian Ocean.
• Headquarters: Goa

Source: Indian Express

What is the News?

AstraZeneca and Johnson & Johnson vaccines, produced from harmless adenovirus have low efficacy. On the other hand, Pfizer and Moderna vaccines which are produced from mRNAs have higher efficacy.

About Adenovirus:

• Adenoviruses are common viruses that cause a range of illnesses. They can cause cold-like symptoms, sore throat, bronchitis, pneumonia, diarrhoea and pink eye(conjunctivitis).

When was adenovirus discovered?

• Adenoviruses are non-enveloped, double-stranded DNA viruses. They were first discovered in the human adenoid tissue in 1953 by Rowe and his colleagues.

How are Adenoviruses Transmitted? Adenoviruses are usually spread from an infected person to others in the following ways.

• Close personal contact, such as touching or shaking hands
• Air transmission through coughing and sneezing
• Touching an object or surface with adenoviruses on it, then touching mouth, nose or eyes before washing hands.

How is adenovirus infection treated?

• There is no specific treatment for people with adenovirus infection. Most adenovirus infections are mild. So these infections may require only to relieve symptoms, such as over-the-counter pain medicines or fever reducers.

Source: The Hindu

What is the News?

The 2nd edition of Global Bio-India is being organised on a digital platform.

About Global Bio India 2021:

• Organized by: It is organised by the Department of Biotechnology, Ministry of Science & Technology along with BIRAC in partnership with the Confederation of Indian Industry(CII), Association of Biotechnology Led Enterprises(ABLE) and Invest India.
• Purpose: To showcase the strength and opportunities of India’s biotechnology sector at national and global level.
• Inaugural Edition: The first edition of Global Bio-India was held in 2019.
• Theme for 2021: The theme is “Transforming lives” and the tagline is “Biosciences to Bioeconomy”.

India’s Biotechnology Sector:

• Biotechnology is an industry that focuses on novel drug development and clinical research aimed at treating diseases and medical conditions.
• India is among the first countries to set up a department of biotechnology under the Ministry of Science and Technology in 1986.
• India is among the top 12 destinations for biotechnology in the world. It accounts for approximately 3% share in the global Biotechnology industry.
• Valu of the Indian Biotechnology industry was at $62 bn in 2019. It will reach a $150 bn target by 2025.

About Biotechnology Industry Research Assistance Council(BIRAC)

• It is a not-for-profit Public Sector Enterprise set up by the Department of Biotechnology(DBT).
• It is an industry-academia interface. Likewise, it aims to strengthen and empower the emerging Biotech enterprise to undertake strategic research and innovation, addressing nationally relevant product development needs.

Source: PIB

[Answered] Examine how Biotechnology sector can emerge as engine of economic growth and societal change?

What is the News?

Ghana has become the first country in the world to receive a shipment of coronavirus vaccines under the COVAX program.

What is the COVAX program?

• The COVAX program is led by the vaccine alliance GAVI, the World Health Organisation(WHO) and the Coalition for Epidemic Preparedness Innovations(CEPI). The COVAX program is in partnership with UNICEF, vaccine manufacturers and the World Bank.
• Aim: The COVAX program aims to ensure rapid, fair and equitable access to COVID-19 vaccines for all the countries around the world.
• The COVAX program forms a key part of the Access to COVID-19 Tools(ACT) Accelerator.
• Target: To vaccinate roughly 20% of the population in the 92 Advance Market Commitment (AMC) countries. This includes middle and lower-income nations that cannot afford to pay for COVID-19 vaccines.
• Process of Vaccination: Once the vaccines receive approval, the vaccines will be bought by the COVAX facility. The COVAX facility will then try to provide it to the 20% population of each of the eligible countries at free of cost.
• Funding: The funding target for this program for 2021 is about the US $6.8 billion. The funding is partly coming from high and middle-income countries that will also receive a share of the vaccines produced for COVAX.

ACT Accelerator

• It is a framework that was set up in response to a call from G20 Leaders in 2020. ACT Accelerator was launched by the WHO, European Commission, France and The Bill & Melinda Gates Foundation in April 2020.
• Goal: To end the COVID-19 pandemic as quickly as possible. The ACT Accelerator aim to achieve this by reducing COVID-19 mortality and controlling the severe disease spread. This will be targeted through the accelerated development, equitable allocation and scaled-up delivery of vaccines, therapeutics and diagnostics.
• Pillars of ACT Accelerator: The Accelerator comprises four pillars:
  • Diagnostics
  • Treatment
  • Vaccines (also known as COVAX)
  • Health system strengthening.
• Significance: ACT accelerator is not a legal or decision-making entity. Instead, it has been set up as a support structure. It will help in the working of the delivery partners and facilitate knowledge sharing among them.

Source: Indian Express

What is the News?

The University of Cambridge has found out new genes emerging in the genome of living organisms. They have called them novel Open Reading Frames or as nORFs.

Human Genome Project:

• Human Genome Project(HGP) was an international, collaborative research program conducted from 1990 to 2003. The main goal was to completely map and understand all the genes of human beings.
• Apart from that it also strengthened the study of human diseases and aided new drug discovery.
• But even after the research, the number of ‘known’ genes has remained constant for two decades.
• Hence, a team from the University of Cambridge has set out to find whether new genes emerge in the genome of living organisms and if they do, how they do so.

About the research:

Novel Regions:

• These novel regions were explored and cannot be defined by our current ‘definition’ of a gene. Hence, these novel regions are called novel Open Reading Frames or as nORFs.
• These regions are also broadly involved in diseases. They were seen as dysregulated (poor ability to manage) in 22 cancer types.
  • Dysregulated means that they could either be mutated, upregulated, or downregulated or could be uniquely present.
• Further, these regions can form structures. They can undergo biochemical regulation like known proteins. They can also be targeted by drugs in case they are disrupted in diseases.

Significance of the research:

• This research shows that there is an urgent need to redesign our existing drugs. Because they currently target only the known proteins and not target the novel regions.

Source: The Hindu

What is the News?
Scientists have unveiled the detailed genome of the Asian malaria vector mosquito Anopheles stephensi.

Click Here to Read about Malaria

Who conducted the research?

• The research was conducted by the Tata Institute for Genetics and Society (TIGS) and Institute of Bioinformatics and Applied Biotechnology both in Bengaluru.

What was the need for the research?

• There is a need for intricate knowledge of the genomes of vector mosquitoes. It will be helpful in order to find an advanced form of defence against malaria transmission including targeted CRISPR and gene drive-based strategies.
  • CRISPR technology: It is a gene-editing tool. It allows researchers to easily alter DNA sequences and modify gene function.

Key Finding of the research:

• It unearthed more than 3,000 genes of the Anopheles stephensi genome that previously evaded scrutiny.
• These newly discovered genes play key roles in the metabolism of ingested blood meal, reproduction, and immunity against microbial parasites.

Significance of this research:

• This detailed genome of the malaria mosquito vector is vital for the development of genetic control strategies of disease transmission, It would help malaria biologists in India and the rest of the world towards the goal of malaria elimination.
• The newly discovered genes can also help address the issue of growing insecticide-resistant mutations in Asian and African An. stephensi populations.

National Framework for Malaria Elimination(NFME) 2016-2030

• The framework has been developed with a vision to eliminate malaria from the country. It will contribute to improved health and quality of life and alleviation of poverty by 2030.
• Goals:
  • Eliminate malaria (zero indigenous cases) throughout the entire country by 2030; and
  • Maintain malaria–free status in areas where malaria transmission has been interrupted and prevent re-introduction of malaria.

Source: The Hindu

What is the News?

Indian drug regulator approved Serum Institute to conduct a phase-2/3 trial of CovoVax COVID-19 vaccine that was originally developed by Novavax Inc. In this case, the regulator allowed the vaccine manufacturer to use a placebo in the control group.

What is a Placebo?

• It is a substance or treatment which is designed to have no therapeutic value. All placebos have one common feature, that they do not contain an active substance meant to affect health.
• Common placebos include inert tablets (like sugar pills), inert injections (like saline), sham surgery, and other procedures.

How Are Placebos Used?

• Researchers use placebos during research. It helps them understand the effect, a new drug or some other treatment might have on a person with a particular condition.
• For instance, some people in a study might be given a new drug to lower cholesterol. Others would get a placebo. None of the people in the study will know if they got the real treatment or the placebo.
• Researchers then compare the effects of the drug and the placebo on the people under the study. That way, they can determine the effectiveness of the new drug and check for its side effects.

What is the Placebo effect?

• Sometimes a person can respond to a placebo. The response can be positive or negative. For instance, the person’s symptoms may improve. Or the person may have what appears to be side effects from the treatment. These responses are known as the “placebo effect”.

Source: The Hindu

What is the News?

A study by NIMHANS, Bengaluru has rejected the assumption that if one stops drinking, the damage to health from excessive consumption of alcohol can be reversed.

About the study:

• The study has been published online in the American Journal of Medical Genetics.
• It tracked patients at NIMHANS Centre for Addiction Medicine outpatient clinic from March 2015 to April 2016.
• It analysed the DNA chemistry of the individuals who had been drinking on an average of 10 drinks/day.

Key Findings of the study:

• Excessive alcohol consumption can cause irreversible changes to the DNA. It will continue even when alcohol is no longer consumed.
• The effects of alcohol are more noticeable in those who had started drinking at an early age. This suggests that starting to drink early may physically alter many genes including those of the brain.

Source: The Hindu

What is the News?

The Government of India has decided to waive off some GST amount against the import of gene therapy — Zolgensma. This therapy is required to treat a child who is suffering from Spinal Muscular Atrophy.

Spinal Muscular Atrophy

• Spinal muscular atrophy is a rare genetic disease. The person suffering from this disease cannot control the movement of their muscles.
• Caused By: It is caused by the loss of nerve cells that carry electrical signals from the brain to the muscles. The protein needed for this signaling is coded by a gene. Everyone has two copies of this gene- one from the mother and the other from the father. A child develops this disorder only if both the copies are faulty.
• Vulnerable Group: The disease most often affects babies and children. With time, it progresses and makes it extremely difficult for the babies to carry out basic activities like sitting up, lifting their head, or swallowing milk.

Zolgensma Gene therapy

• Gene Therapy Treatment: There is also a gene therapy treatment named Zolgensma which replaces the faulty gene. US regulators approved this therapy in May 2019.
• Zolgensma works by supplying a healthy copy of the faulty gene. It allows nerve cells to then start producing the needed protein. This halts the deterioration of the nerve cells and allows the baby to grow more normally.

Source: The Hindu

What is the News?
The Food Safety and Standards Authority of India(FSSAI) has amended its rules. Under new rules, it put a cap on trans fatty acids(TFAs) in food products. Previously, it tightened the norms for oils and fats in the food.

What are the new rules?

• According to FSSAI, Food products contain edible oils and fats. The use of industrial trans fatty acids in these products shall not be more than 2% by mass of the total oils/fats. These rules are effective from 1st January 2022.
• The allowed limit of TFA was at 5%. In December 2020, the FSSAI had capped TFAs in oils and fats to 3% by 2021, and 2% by 2022.
• The present amendment has been introduced to achieve the 2022 target.
• It is in line with the WHO’s call for the elimination of industrially-produced trans-fatty acids from the global food supply by 2023.
• Achievement of the 2% limit is equal to elimination of TFAs.

About Trans Fatty Acids:

• They are created in an industrial process.  It adds hydrogen to liquid vegetable oils to make them more solid. It increases the shelf life of food items and can be used as an adulterant as they are cheap.
• Present in: They are present in baked, fried, and processed foods as well as adulterated ghee. They become solid at room temperature.
• Harmful Effects: They are the most harmful form of fats. They clog arteries and cause hypertension, heart attacks, and other cardiovascular diseases.
• As per the WHO, intake of industrially-produced trans-fatty acids results in approx. 5.4 lakh deaths each year globally.

Initiatives against Trans Fats:

• Heart Attack Rewind Campaign: It is a mass media campaign launched by FSSAI. It calls for the elimination of industrially-produced trans fat in the food supply by 2022.
• REPLACE campaign: REPLACE stands for Review, Promote, Legislate, Assess, Create awareness and Enforce. It is a WHO campaign to eliminate industrially-produced artificial trans-fats from the global food supply by 2023.
• Eat Right India Movement: It was launched by FSSAI in 2018. It is a preventive healthcare measure to trigger social and behavioural change among people. The movement aims to improve public health in India and combat negative nutritional trends to fight lifestyle diseases.

Click Here for Further Reading on Trans Fats

 Source: The Hindu

What is the News?

The Prime Minister mentioned the garbage to power Plant (Waste to power) plant in his speech. The plant is being commissioned inside the Dr. B.R. Ambedkar Agriculture Market.

About the Garbage-to-power plant:

• Developed by:  CSIR-Indian Institute of Chemical Technology(IICT)
• Technology: It is based on a biomethanation technology-based Anaerobic Gas lift Reactor(AGR). CSIR-Indian Institute of Chemical Technology (IICT) has patented the reactor.
  • Biomethanation: It is a process by which organic material is microbiologically converted to biogas, under anaerobic conditions.
• How does the plant work?
  • To initiate the process of biomethanation, conveyor belts carry tonnes of vegetable waste to shredders.
  • The shredded waste is then converted into a semi-liquid mixture. It is then put into large containers or pits to start the process of anaerobic digestion. Organic waste is eventually converted into biofuel which has two major components, methane and carbon dioxide.
  • The fuel is then put into ‘100 percent biogas generators’ that converts the fuel into electricity and reaches the market’s electricity bulbs.

Source: The Hindu

Why in News?
Verbio AG, a German company is setting up compressed biogas(CBG) plant in  Bhutal Kalan village in Punjab. Increasing CBG production is much more beneficial compared to the Production of CNG.

Facts:

• Compressed Biogas(CBG): It is a purified form of biogas. It can be produced from waste including municipal solid waste, sludge from wastewater treatment plants, market residues, agricultural residues, cattle dung, sugarcane press mud among others.

Process of Producing CBG: CBG from biomass involves a two-pronged approach.

1. First Step: Biogas is produced through the anaerobic decomposition of biomass.
   • Anaerobic Process: In this process, microorganisms break down biodegradable material in the absence of oxygen. The process is used for industrial or domestic purposes to manage waste or to produce fuels.
2. Second Step: Biogas contains 55 to 60% methane, 40 to 45% carbon dioxide (CO2) and trace amounts of hydrogen sulphide. The second process involves purifying the gas to remove carbon dioxide and hydrogen sulphide gases to prepare CBG.

How is CBG different from Compressed Natural Gas(CNG)?

1. Chemically, CBG is the same as CNG — both are compressed methane — and have the same calorific value.
2. But, CNG is a by-product of petroleum, and CBG can be produced from any biomass, be it crop residue, cattle dung, sugarcane press mud, municipal wet waste, or effluents from a sewage treatment plant.
3. Hence, this makes CBG a commercially viable option as it can be directly used to replace CNG in transportation fuel. Just like CNG, CBG too can be transported through cylinders or pipelines to retail outlets.

Other advantages of CBG:

1. Compressed biogas has the potential to minimize India’s need to import fuel.
2. The solid by-products of CBG can be used as bio-manure. According to experts, bio-manure produced using paddy straw can result in a 20% increase in crop yield.
3. The other by-product from CBG is CO2. It is used to produce a liquid or solid CO2. It has a high demand for food preservation or to be used in fire extinguishers.

Government Initiative to promote CBG:

1. Sustainable Alternative to Affordable Transport(SATAT) Initiative: It was launched in October 2018 to promote the Compressed Biogas (CBG)
2. The scheme targeted the production of 15 million metric tonnes (MMT) of CBG by 2023.
3. Public sector undertakings oil marketing companies(OMCs) including IOCL partnered with potential entrepreneurs under this initiative to set up plants and supply CBG to them for sale as automotive and industrial fuels.

Source: Down To Earth

Source: click here

Syllabus: GS 3

Synopsis: Mutation of the coronavirus has become a new threat for the world. India must take precautionary measures to deal with it.

Introduction 

New SARS-CoV-2 variants have emerged independently in several countries and the virus is changing very quickly.  If it continues to change, currently available vaccines will become ineffective.

Why do viruses mutate?

All the viruses carry a genetic code in the form of RNA or DNA. The DNA is replicated as the cells multiply and this process may cause random errors in the new DNA.

Errors in DNA can be corrected by the enzymes present in the cell. However, RNA doesn’t contain enzymes, thus errors caused in RNA cannot be corrected. It causes more genetic changes (mutations)in RNA than DNA viruses.

How are vaccines tested for efficiency against emerging variants?

• Indirect tests are conducted in labs. It will find if variant virus escapes antibodies developed after natural infection or vaccination.
• Antibodies that neutralize the original virus are tested on the variant viruses. 

Are the emerging variants vulnerable to vaccines?

• The emerging variants from South Africa could pose a challenge to current vaccines. Not enough information is available yet for the Brazil variant.
• However, the studies have only tested antibody responses. Vaccines also increase cellular immunity to eliminate infection which has not been tested.

The evidence currently does not suggest that vaccines are failing. 

• However, Moderna and Pfizer/BioNTech have agreed that their vaccines have had reduced protection against the South African variant. Both the companies are now working on developing new vaccines to fight these variants.

What steps should India take in this situation?

There is no local transmission of the new variants in India until now. Only the UK variant viruses have been found in travellers coming to India. 

1. Firstly, India should strictly implement masks and limit crowds. It should also do the contact tracing of people infected with the new UK variant. 
2. Secondly, India should also put a ban on travel from South Africa and Brazil just like the US did. India must also be cautious of people with a history of travel to South Africa since October 2020, and Brazil since December 2020.
3. Thirdly, the most efficient way to catch emerging variants is increased genomic surveillance. So far, there are only about 5,000 SARS-CoV-2 sequences from India in public databases, which accounts for only 0.05 percent of confirmed cases. 

The setting up of an inter-ministerial group -Indian SARS-CoV-2 Genomics Consortium (INSACOG) to increase genomic surveillance is a step in the right direction. India should take more such steps. 

What is the news?
An expert body is looking into Bharat Biotech’s application for testing its  Covid-19 vaccine, BBV154. This is an Intranasal Vaccine.

What is Intranasal Vaccine?

• Vaccines are administered as injectable shots into the muscles(intramuscular). Or the tissue just between the skin and the muscles(subcutaneous).
• However, with intranasal vaccines, the solution is sprayed into the nostrils and inhaled instead of injecting it.

Benefits of Intranasal Vaccine:

• The nasal route has excellent potential for vaccination due to the organized immune systems of the nasal mucosa.
  • It is non-invasive, Needle-free.
  • Ease of administration – does not require trained health care workers.
  • Elimination of needle-associated risks (injuries and infections).
  • High compliance (Ideally suits for children and adults).
  • Reduces the overall cost of a vaccination drive as for example BBV154 requires a single-dose regimen.

Potential Setbacks of Intranasal Vaccine:

• Past attempts to develop intranasal vaccines, including for measles flu, have not been very successful.
• These vaccines use live, weakened viruses, but have never cleared clinical trials.
• Only a live attenuated influenza flu vaccine has been licensed through this route of delivery.

Source: Indian Express

What is the News?
Indian Council of Medical Research (ICMR) and the National Institute of Virology(NIV) study found Covaxin effective against the new UK variant of Covid-19.

About the Study:

• The study has found that Covaxin has a good neutralization capacity against the U.K variant of the COVID-19 virus. This capacity was the same against the strain used for making the vaccine.

How were the neutralization studies carried out?

• Under this study, the virus isolated from people is grown in the lab using cell lines. When viruses successfully grow in them, the pathogenic effects of the viruses are observed in the cells.
• The sera (the protein-rich liquid separated from blood after it is clotted) taken from vaccinated people are then added to the cell line culture system and its ability to prevent the virus from causing pathogenic effects is observed.
• In this case, the sera taken from vaccinated people were able to neutralize the virus and hence prevent pathogenic effects being produced in the cell lines containing the virus.

Further Reading on Vaccines

Source: The Hindu

Why in News? 

WHO, UNICEF, IFRC and MSF announced the establishment of a Global Ebola Vaccine Stockpile to ensure response to outbreak.  

 Facts: 

• • Global Ebola Vaccine Stockpile: The stockpile is led by International Coordinating Group(ICG) on Vaccine Provision which includes the WHO, UNICEF, the International Federation of Red Cross and Red Crescent Societies(IFRC), and Médecins Sans Frontieres (MSF) with financial support from Gavi, the Vaccine Alliance.  
  • Purpose: The stockpile will ensure timely access to vaccines for countries at risk during outbreaks. 
  • Ebola Vaccine: The injectable single-dose Ebola vaccine rVSV-ZEBOV is manufactured by Merck, Sharp & Dohme(MSD) Corp and developed with financial support from the government of the United States of America (USA). 
  • Based in: The stockpile will be based in Switzerland. 

 To Read About Ebola: http://bit.ly/3bWL96g

News: Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) has entered into Technology Transfer Agreements with Pune based Biorad Medisys for flow Diverter Stents.

The cost of the Chitra Flow Diverter stent is expected to be priced significantly lower than the currently imported ones.

Facts:

What are Flow Diverter Stents?

• It is a endovascular technique used for diverting blood flow away from an intracranial aneurysm or localized ballooning of arteries in the brain, helping reduce chances of its rupture and related stroke. Currently, India does not manufacture flow diverters stents,
• Flow diverters have the advantages of being flexible and adaptable to the shape and course of the vessel. Also, flow diverters promote healing of the vessel wall by removing the constant stress of blood flow on it.

What are Technology Transfer Agreements?

• Technology transfer is the process by which a technology, expertise, know-how or facilities developed by one individual, enterprise or organization is transferred to another individual, enterprise or organization.
• It may happen from country to country, from industry to industry or from research laboratory to an existing or new business.

Article source

Synopsis: Government has released a Vaccine Fact sheet that contains guidelines for administering both vaccines (Covaxin and Covishield). 

Background 

• Union Health Ministry has sent a comprehensive fact sheet for both vaccines (Covaxin and Covishield) to all states and immunisation officer.  
• The Centre has also asked the states and immunisation officers to disseminate the fact sheet to all programme managers, cold chain handlers, and vaccinators before the rollout. 

What is this fact sheet? 

The fact sheet contains the general guidelines that should be followed during the initial phase of the Covid-19 vaccination drive, while vaccinating the priority group (3 crore people). 

The fact sheet contains the guidelines on the following aspects,  

• • Physical specifications such as dosage, cold chain storage requirements. 
  • Specific guidelines on contraindications (a factor due to which the vaccine is to be withheld to certain categories of people)  
  • Guidelines on adverse events   
  • Details on special precautions. 

Now we will examine in detail, the exceptions, precautions, and possible adverse events that are mentioned in the fact sheet. 

First, the general guidelines in the fact sheet contain the following directives to ensure that proper care is taken while administering the vaccine. 

• • Only people over the age of 18 years are eligible for vaccination. 
  • Since 2 doses of vaccines are required per person, every Person should be administered the same vaccine in both the dosage. It is to deal with the issue of possible interchangeability. 
  • While administering the vaccine to a person with a history of any bleeding or coagulation disorder, platelet disorder, clotting factor deficiency, or coagulopathy, it should be done with caution. 
  • Both Vaccines have to be stored at +2°C to +8°C and needed to be protected from light. If it is found frozen it has to be discarded. 

Second, the specific guidelines on contraindications. The three categories of people for whom the vaccine should not be administered. They are, 

• • Persons who have shown a history of an allergic reaction. 
  • People who show an immediate or delayed onset of an allergic reaction to vaccines or injectable therapies, pharmaceutical products, and food items. 
  • Pregnant and lactating women.  

Third, guidelines on temporary contraindications. 3 categories of persons for whom vaccination is to be deferred for four-eight weeks. They are, 

• • Persons showing active symptoms of SARS-CoV-2 infection. 
  • Covid-19 patients who have been treated with anti-SARS-Cov-2 monoclonal antibodies or convalescent plasma. 
  • Acutely unwell and hospitalised patients (with or without intensive care) due to any illness. 

Fourth, the fact sheet under not contraindicated, specifically mentions that persons suffering from following health conditions can get vaccinated. However, the response to the Covid-19 vaccine may be less in these individuals. They are; 

• • Persons with a past history of Covid-19 infection. 
  • Persons with a history of chronic diseases and comorbidities (cardiac, neurological, pulmonary, metabolic, and malignancies). 
  • Persons with immunodeficiency or HIV, and patients on immune suppression due to “any condition” can be administered with the Covid-19 vaccine.  

Fifth, the fact sheet has also separately mentioned the Possible Adverse Reactions for both the vaccines along with the required precautions to be taken during the adverse reaction. 

Guidelines provide the list of mild adverse events and rare adverse events that may follow the vaccination from both Covishield and Covaxin. It also provides for the precautions and medication that will be required in the above cases.  

For example; In case of Mild adverse events for Covishield like myalgia (deep muscle pain), malaise (a feeling of overall discomfort), common painkiller paracetamol may be used. 

How Covid-19 vaccines administered in other countries have performed till now? 

Though the overall performance is found to be safe so far, there were few adverse events recorded in a small section of the population. For example, in the case of the US,  

• The US Centers for Disease Control (CDC), monitoring by the Vaccine Adverse Event Reporting System detected 21 cases of anaphylaxis (a severe, life-threatening allergic reaction that occurs rarely after vaccination) out of a reported 1,893,360 first doses of the Pfizer-BioNTech vaccine. 
• Whereas in the case of Modern’s mRNA vaccine, which was authorized for emergency use in the US, the CDC said data is still limited.

Synopsis: Government has issued strategic guidelines for the effective rollout of COVID vaccine program. There are challenges in the way of the Vaccine program that should be tackled as soon possible. 

Strategic guidelines for COVID vaccine programme 

With limitations of Vaccine related to efficiency and efficacy in mind, government has framed strategic guidelines for COVID vaccine programme 

• Guidelines were framed using the knowledge acquired over three decades of implementing the Universal Immunisation Programme. It aims to aims to cover 30 crore people by July 2021. 
• It has specified involvement of 19 departments, donor organisations and NGOs at the national, state, district and block level in the roll out of COVID vaccine programme. 
• The guidelines have also clearly mentioned the priority criteria. Citizens eligible for the first round of COVID vaccine programme includes the following, 

• • • The caregivers and front-line workers working under the department of health, defense, municipalities, and transportation. 
    • Persons above the age of 50.  
    • And persons below the age of 50 who suffers from comorbidities such as diabetes, hypertension, cancers, and lung diseases are all included. 

• The strategic guidelines have also clearly stated in detail, 
  • • The skills, roles, and responsibilities of the required human resources. 
    • The quantum of logistics required for delivering vaccines at point of use.  
    • The requirement of physical infrastructure, monitoring systems based on digital platforms, and feedback systems for reporting adverse events. 

However, it has been criticised that the guidelines are ideal and have failed to provide solutions for real-time issues of our health system.  

What are the challenges involved in effective rollout of COVID vaccine programme? 

There are many challenges to roll out COVID vaccine programme. They are, 

• First, unequal distribution of cold storage facilities among states. For example, out of the 28,932 cold chain points, half are in the five southern states, Maharashtra and Gujarat. 

• • Whereas the eight states in the North and Odisha that account for over 40 per cent of the country’s population have only 28 per cent of the cold chain points.  

• Second, pertaining issues in our health care sector such as poor human resources, a weak private sector, poor safety and hygiene standards, frequent power outages, poor infrastructure will reduce the capacity to implement the vaccine programme with speed, quality, and accuracy. 
• Third, a massive immunization programme for 30 crore people can distort the routine health service delivery and affect other immunisation drives, and can lead to exhaustion of health care workers. 
• Fourth, acquiring the data for under the 50s with comorbidities will be challenging though we have data for the above-50-year-olds in the electoral rolls. 

• Fifth, there are also challenge of tackling Fudging, false certification, and siphoning off vaccines to private facilities in the event of vast price differences between private hospitals and public hospitals. 
• Sixth, the non-availability of efficacy data could result in huge wastage and gives scope for errors and duplication during the procurement and supply of vaccines. 
• Seventh, the trust among the people on COVID vaccines are decreasing leading to suspicions and fears due to various reasons such as  

• • • Non-transparency of data on either of the two vaccines proposed for use in the program. 
    • Opacity with which the licenses were given etc. For example, have not completed the Phase 3 trials that confirm the safety and efficacy of the vaccine.  
    • Above all, India hasn’t signed the advance purchase agreements for vaccines that have completed Phase 3 trials from other countries. 

What is the way forward? 

• First, avoid the complexity of listing the priority groups throughout our country. It should be replaced by covering the complete area in one go, instead of sequencing them into different groups.  

• • • The areas could be ranked on the basis of a vulnerability index based on disease burden, caseload of COVID infections, demographic profile, health-seeking behavior and availability of infrastructure, etc. 

• Second, to create confidence in the community we need to establish an independent team of experts under the aegis of the WHO to ensure adherence to recruitment standards, consent conditions, adverse event record management, compensation standards. 
• Third, to build trust about vaccination programme we need to plan for large–scale public education and information programme through State- and local-level networks where people are informed, sensitised and their feedback was taken.  
• Fourth, People should be involved in decision-making. For this Local leader from public figures, religious leaders, self-help groups, the media, and even educational institutions need to participate to help citizens understand its importance and build trust 
• Fifth, Science, evidence, and data analytics need to be extensively used for effective policymaking. 
• Finally, vaccination is not a complete solution to end the epidemic. We need to adopt safe behavior through a communication strategy. For this, the government can use its experience of controlling the HIV/AIDS epidemic.  

The need of the hour is a winning strategy against epidemic that has drained us economically, socially and psychologically.  Government needs to understand that the effective way of improving uptake of the vaccine while reducing costs is by creating participatory frameworks of engaging experts and communities and building effective and reliable public information, and transparency.

Synopsis: Many issues have been highlighted in the Phase-3 trial of Bharat Biotech’s COVID-19 vaccines. Those issues could have been avoided after HPV vaccine trial controversy. 

Introduction 

In a previous case, Human papilloma virus (HPV) vaccine trial was carried out on nearly 23,500 girls in the 10-14 age group in Vadodara, Gujarat and Khammam without proper consent. Almost eight years later the Supreme Court of India criticized the government for its inability to take action on illegal clinical trials carried out in India by multinational countries. 

Present situation of the approval process in India suggests nothing much has changed. 

• The phase-3 clinical trial of Bharat Biotech’s COVID-19 vaccine resembles the HPV vaccine because it seems that the trial is suffering from serious violations. 
• The ICMR which has assigned the task of promulgating research ethics guidelines is also the cosponsor of the Covaxin trial. 

What are the problems in the Covaxin phase 3 trial? 

After the 2013 SC order, The Indian regulator made audio-video recording of the informed consent of each individual participant mandatory in 2019. Written consent from the participant had to certainly be taken before the audio-video recording. 

However, the process was not followed properly; 

• Firstly, no efforts were made to explain and inform the participants about the pros and cons of taking part in the trial instead; they were deceived by the trial site to think they were getting a COVID-19 vaccine for free. 
• Secondly, many participants didn’t know about their rights to get free medical care in case of any adverse events. 

• • Many aware participants sought medical help from private practitioners whereas some of the participants don’t possess mobile phones, thus medical follow-up was not possible.  

• Thirdly, not enough time was given to discuss with the family before signing the consent form. At least in a few instances, the consent was taken after vaccination, which is a serious violation.  

• • Participants were not given a copy of the consent form and other documents to prove their participation. 

• Fourthly, 700 participants in the trial were illiterate and there is no evidence that an impartial witness was present during the entire informed consent process to attach his/her signatures to the consent form.   
• Fifthly, communities living close to the hospital have told the media that they were offered ₹750, and luring people in trial for money is unethical.  

• Although the company maintained that the amount was the reimbursement for the transportation and loss of wages, an open announcement of remuneration was unethical.   

• Lastly, it is not yet confirmed that institutional ethics committee approved the advertisement for inviting people to the trial, in lieu of money.   

Way forward 

• India has already approved 2 vaccines for restricted use and the virus spread slowing down, so enrolling participants will be more challenging. Therefore, a thorough and impartial inquiry will bring back confidence in clinical trials. 

Introduction  

The permission of two COVID-19 vaccinats for emergency use is nearing. There is now hope of an end to the pandemic. But for the administration of vaccination and treatment properly and skillfully, a trained and effective workforce is required. 

Present strength of healthcare workers in India 

• In India, over 4,00,000 frontline workers have been trained to respond to COVID-19. 
• However, this includes people with no prior experience also. Thousands have been trained for (1) contact tracing, (2) quarantine strategies, (3) ventilator management, (4) personal protective equipment, and (5) psychological issues. 

In this context, Project Echo provides a cost effective way if ncreasing our workforce – both number wise and qualitywise.

What is project ECHO? 

India was a recipient of an effective global innovation called Project ECHO.  

• ECHO is a low-cost way out for growing the size of health workers in underserved communities to offer patients with the best possible care and facilities.  
• ECHO was utilised as a strategy for treating Hepatitis C in the beginning but now is being used for newly trained experts in HIV, malaria, tuberculosis, addiction, mental health, and many other conditions. 
• Under this project, health workers, nurses and doctors are trained through video conferencing technology. They learn speciality care from subject matter experts and from each other’s community informed knowledge.  
• ECHO provides the ability to spread healthcare workers in the most remote areas of the country and give them training similar to what a healthcare worker in one of our largest cities would receive. 

What needs to be done before the vaccine arrives? 

India is led by the Serum Institute of India which has the largest manufacturing capacity in the world. However, certain aspects need to be figured out and planned before the COVID-19 vaccine becomes widely available: 

• Firstly, real skills need to be cultivated for planning out the following: 

• • Delivery system of these vaccines needs to be figured out. 
  • Storage and handling of the vaccines. 
  • India needs to overcome cultural and religious obstacles for those who are unwilling to accept a vaccine. 
  • People need to be counselled about the side-effects of the vaccine. 

• Secondly, more trained health experts are required to support vaccine treatment. 
• Thirdly, further preparation of the ECHO model can be done to identify new healthcare workers who can be trained to be COVID-19 experts.

News: A command and control centre has been set up at Airports Authority of India Cargo Logistics and Allied Services Company Limited(AAICLAS) to monitor the movement of COVID-19 vaccines.

Facts:

Source: The Hindu

• What will AAICLAS do? It will be the nodal body for coordinating air transportation of the vaccines across a network of 41 airports with Pune — where vaccine manufacturer Serum Institute of India is located — as the hub.
• Process of Vaccine Transportation:
  • • The 41 airports or cities where transportation efforts will be focused include Karnal, Mumbai, Chennai and Kolkata, each of which has a Government Medical Stores Depot (GMSD) of the Central government’s Ministry of Health and Family Welfare.
    • Once vaccines dispatched by the manufacturers arrive at these four big depots, they will be further distributed across 37 State depots.
    • Thereafter, they will be sent to district depots and finally to the primary health care centres.
    • Each of these centres has a temperature tracker which will upload temperature data on a central server for real time monitoring.

Article Source

News: Scientists at the CSIR-National Institute for Interdisciplinary Science and Technology(NIIST) in Kerala have come up with a new product called banana grit or granules.

Facts:

• Banana Grit or Granules: It has been developed from raw Nendran bananas. The product resembles ‘rava’ and broken wheat.
• Purpose: The product has been labelled as an ideal ingredient for a healthy diet as it utilises the presence of resistant starch in bananas which is reported to improve gut health. Hence, the dishes prepared with banana grit and its byproduct improves gut health.
• Significance: Developing new uses for Nendran Banana comes as a boon to farmers who have often been struggling against falling prices.

Additional Facts:

• Nendran Banana or famously known as Chengalikodan is a banana variety originated and cultivated in Chengazhikodu village of Thrissur District in Kerala
• Where is it cultivated? It is now cultivated on the banks of the Bharathapuzha river.It has got the Geographical indication registration from the Geographical Indications Registry, Chennai.
• Uses: Generally consumed ripe, it also finds use in typical Kerala dishes such as avial and thoran.

Article source

News: Government of India has launched the Indian SARS-CoV-2 Genomic Consortia Group(INSACOG).

Facts:

• INSACOG: It has been established to monitor the genomic variations in the SARS-CoV-2 on a regular basis through a multi-laboratory network.
• Composition: It comprises 10 labs (NIBMG Kolkata, ILS Bhubaneswar, NIV Pune, CCS Pune, CCMB Hyderabad, CDFD Hyderabad, InSTEM Bengaluru, NIMHANS Bengaluru, IGIB Delhi and NCDC Delhi).
• Coordinated by: The group is coordinated by the Department of Biotechnology (DBT) along with the Ministry of Health and Family Welfare(MoH&FW), ICMR and CSIR.
• Nodal Unit for Maintaining Database: National Centre for Disease Control(NCDC) will be the nodal unit for maintaining a database of all samples of the new variants of public health significance. The data will be epidemiologically analysed, interpreted, and shared with states for investigation, contact tracing and planning response strategies.
• Other key Functions of the INSACOG:
  • It will establish sentinel surveillance for early detection of genomic variants with public health implications and to determine genomic variants in unusual events or trends such as super-spreader events.
  • Knowledge generated through this vital research consortium will also assist in developing diagnostics and potential therapeutics and vaccines in the future.
  • The group will also closely work with NCDC on activities like SOPs, data annotation, data analysis, data release among others.

Synopsis- There is need for more genome sequencing from samples from all over the world in order to come up with effective approaches to control and prevent COVID-19 infections.  

Background- 

• A new variant of the pandemic SARS-CoV-2 coronavirus is spreading rapidly in Britain and prompting high levels of concern. 
• Six samples of the recent U.K. returnees have been found to be positive with a variant of SARS- CoV-2 virus.
• From 25 Nov-23 Dec, about 33,000 passengers landed at various Indian airports from the U.K. So far, only 114 have been found positive and samples have been sent to 10 INSACOG (Indian SARS-CoV-2 Genomics Consortium) labs for genome sequencing.

Thus, only through detailed epidemiological studies combined with genome sequencing data can we confirm the presence and spread of the variant in India.  

What are the findings related to new stain of coronavirus and will it cause concern in India? 

The genomic analysis undertaken by the COVID-19 Genomics U.K. Consortium found that- 

• First. The new variant of coronavirus is named “VUI 202012/01” and is defined by a set of 23 changes or mutations. Among the 23 mutations, the two of which are particularly worrisome and specifically N501Y makes is more transmissible. 
  • • It includes a genetic mutation in the “spike” protein that can lead to an easy and immediate spread of the virus, making it deadlier. This new variant has 17 mutations that affect the shape of the virus.
• Second, It is about 70% more transmissible- The variant has the potential to increase the number of people a person can infect by over 0.4 

However, it might not be able to spread wildly in India as a sizeable percentage of people are already infected.  

Read more – Mutation in Coronavirus 

Why it is important to undertake more genome sequencing of the virus? 

The genome sequencing study would determine if the COVID patients are carrying the existing strain of SARS-CoV-2 or the mutant strain.  

• First, to understand the evolving nature of the virus–So far, we are doing very less frequent genomic sequencing compared to western nations. For instance, in England, around 10 percent of the infected virus samples are sequenced to study the nature of the virus. 
• Second, to find an immune escape variant of the SARS-CoV-2, [which means a mutation in the virus that allows it to evade the immune system]  
  • • One of the immune escape variants found in genomes from India, known as N440K variant — was found to be in 2.1 percent of the gene sequences in India.
• Third, The N501Y mutation can arise independently here in India. Hence more genome sequencing and genomic epidemiology is needed. 

Steps were taken by the Indian Government regarding this-  

• The genomic surveillance consortium (INSACOG) has been recommended for laboratory and epidemiological surveillance of circulating strains of the SARS-CoV-2 in India. 
• Under this initiative, 5 percent of the positive cases will be tested for Whole Genome Sequencing, from all the States and UT. 

Read Also : Current affairs for upsc

What is the way forward? 

Genome sequencing is very much important of the higher percentage of the samples to understand the evolving nature of the virus. 

Source: PIB

News: Union Health Minister of India has been nominated by the Global Alliance for Vaccines and Immunisation(GAVI) as a member of the GAVI Board.

Facts:

• Union Health Minister will be representing the South East Area Regional Office(SEARO)/ Western Pacific Regional Office (WPRO) constituency on the GAVI Board from 1st January,2021 until 31st,December 2023.

What is GAVI?

• Gavi is an international organisation – a global Vaccine Alliance created in 2000.
• It brings together public and private sectors with the shared goal of creating equal access to new and underused vaccines for children living in the world’s poorest countries.
• GAVI has observer status at the World Health Assembly.
• As part of its mission to save lives, reduce poverty and protect the world against the threat of epidemics, GAVI has helped vaccinate more than 822 million children in the world’s poorest countries preventing more than 14 million future deaths.

GAVI Board:

• The GAVI Board normally meets twice a year in June and November/ December and holds an annual retreat, normally in March or April.
• The board is responsible for strategic direction and policy-making, oversees the operations of the Vaccine Alliance and monitors programme implementation.
• With membership drawn from a range of partner organisations, as well as experts from the private sector, the Board provides a forum for balanced strategic decision making, innovation and partner collaboration.

Synopsis: Indian is one of the world’s leading vaccine manufacturer, thus will have better access to vaccines, but the distribution of manufactured vaccine will prove to be a formidable task.

Dry run to test preparedness for the nationwide roll-out of a COVID-19 vaccine kicked off in four States — Assam, Andhra Pradesh, Gujarat and Punjab.

What is dry run of Vaccines?

• A dry run is aimed at testing the planned operations and the laid out mechanisms for Covid-19 vaccination in the state. It will provide insights into any gaps or bottlenecks so that those could be addressed before the commencement of the actual drive.
• Intended beneficiaries of each State, registered on Co-WIN’ app, have been sent text messages, containing info about the time and place of their “COVID-19 vaccination”.

Read – About Co-Win app and platform

• All the beneficiaries will have to register themselves compulsorily on Co-Win platform and provide a photo ID proof upon asking.
• Authorities will prepare a report for the STF, after conducting this dry run. STF will review the report and provide feedback and guidance to the authorities on further actions.
• The report will also be submitted to the Union Ministry of health and Family Welfare.

India’s vaccine distribution infrastructure

India has created a network of Cold Chain Infrastructure for vaccines at various levels. Presently, Vaccine distribution takes place through following process and infrastructures;

1. Vaccines are produced by Manufacturers or procured by suppliers through agreements and arrangements.
2. These vaccines are then delivered to 4 Government Medical Store Depots (GMSDs) in Karnal, Mumbai, Chennai and Kolkata.
3. From these GMSDs vaccines are delivered to state, divisional and regional vaccine stores.
4. They further distribute these vaccines to District Vaccine stores (DVCs). DVCs then deliver vaccines to PHCs, CHCs and Private facilities.
5. From these centers beneficiaries can get themselves vaccinated.

All these distributions take place through insulated Vans and Vaccine carriers.

Some of the important facts and figures

• In Phase-1, Government is aiming at vaccinating 300 million most vulnerable people by August 2021 i.e.  600 million doses till August.
• At present India is having About 27000 cold chain points across the country.
• India’s present distribution capacity is 360 million doses in 8 months for both government and private facilities. It includes the Capacity of Private Cold Chain infrastructure at 200 million and government capacity at 160 million.
• The above capacity includes the infrastructure of the current immunization program, if leveraged for the covid vaccination.
• Due to the electronic vaccine intelligence network (eVIN) system, a real-time supply chain management system, India’s vaccine management has improved

What are the challenges in vaccine distribution in India?

1. Firstly, to complete the aims of the first phase of the covid vaccination drive, the public sector distribution capacity will need to be expanded 2-3 times.
2. Secondly, there are gaps in the vaccine distribution system. As per the Audit of health ministry in 2017-18, 26% of eVIN cold chain points reported instances of stock out during the period of assessment. More than a fifth of facilities reported wastage of vaccines.
3. Third, Interstate disparity in the distribution of cold chain infrastructure across the country. For instance, roughly 4 cold chain points serve 100,000 population in Gujarat, whereas there is just one cold chain for the same number of people in Jharkhand. 
4. Fourth, unique requirements of the COVID-19 Pandemic such as Identifying beneficiaries, ensuring they show up on the day of vaccination, and administering a second dose after a month, provide vaccine across age groups instead of current programmes focus on particularly vulnerable sections, etc. All these require micro-level planning with a proper collaboration from the top.
5. Fifth, Post-vaccination challenges such as documentation of vaccination and the tracking and investigation of vaccine safety events, all are equally important to create positive public opinion about vaccination.
6. Sixth, India has performed poorly on the analysis by WHO-UNICEF in 2018, it ranked among 89 countries in 51-75 percentile range on effective vaccine management.
7. Seventh, If the present infrastructure of universal immunization programme is used as planned, what will happen to the regular immunization drive, is also a big challenge in front of government.

India is one of the biggest producers of vaccines in the world. Serum Institute of India (SII) alone is a producer of more than 1.5 billion vaccine doses every year and is expected to produce 1 billion doses of the Novavax vaccine by 2021.

As now, the vaccine is being authorized by Emergency Use Authorisation method, Need is to augment the capacity of vaccine distribution on an urgent basis.

Source: The Indian Express

News: A team of scientists from IIT Delhi won an innovation contest (Innovate 4 SDG) organised by the United Nation Development Programme (UNDP) Accelerator Lab India for their innovation of a “plant based mock egg”.

Facts:

• Mock Egg: It has been developed from very simple farm based crop proteins, which not only looks and tastes like an egg but is also very close in nutritional profile to poultry eggs.
• Significance: The development of the mock egg meets the protein needs of the diet-specific, health conscious, vegan and vegetarian people and will also help in addressing the longstanding battle for malnutrition and clean protein food for people.

Additional Facts:

• UNDP’s Accelerator Lab: It is an innovative initiative by UNDP, State of Qatar and the Federal Republic of Germany to find 21st century solutions to today’s complex new challenges.
• UNDP Accelerator Lab India: It is a part of a network of 60 global labs covering 78 nations that tests and scales new solutions to global challenges like climate change and inequality.
  • Objective: It seeks to address some of the most pressing issues facing India, such as air pollution, sustainable water management and client-resilient livelihoods through innovation.

Source: The Indian Express

News: Union Minister for Health and Family Welfare has inaugurated India’s first pneumococcal conjugate vaccine(PCV) named “Pneumosil”.

Facts:

• Pneumosil: It has been developed by the Serum Institute of India Private Limited (SIIPL) in collaboration with partners like the Bill and Melinda Gates Foundation.
• Pneumosil was licensed by the Drugs Controller General (India) in July 2020.

What is Pneumococcal conjugate vaccine(PCV)?

• It is a pneumococcal and a conjugate vaccine used to protect infants, young children and adults against disease caused by the bacterium Streptococcus pneumoniae (pneumococcus).
  • Conjugate: It is a type of vaccine that joins a protein to an antigen in order to improve the protection the vaccine provides.
• It contains purified capsular polysaccharide of pneumococcal serotypes conjugated to a carrier protein to improve antibody response.
• The unique feature of the PCV is its composition which is specially tailored to the prevailing serotype prevalence of S Pneumoniae in India and other regions of the world.

What is Pneumococcal disease?

• Pneumococcal disease is the name given to a group of diseases caused by a bacterium called Streptococcus pneumoniae, (also known as pneumococcus).
• Diseases caused by pneumococcus include 1) severe diseases such as pneumonia, meningitis and bacteraemia (presence of bacteria in the blood) and 2) milder diseases such as middle ear infection (otitis media), sinusitis and bronchitis.
• Cases: Pneumococcal disease is a significant contributor to the under-five mortality rate worldwide.Annually India witnesses an estimated 71% of pneumonia deaths and 57% of severe pneumonia cases.Every year, nearly 67,800 children under five years of age die from pneumococcal diseases.
• Vaccine: Hence, recognising its widespread fatality, WHO recommended the inclusion of PCV in routine childhood immunisation programmes in all countries.

Source: The Hindu

News: Researchers at the Indian Institute of Science Education and Research (IISER) have identified a gene called “BBX11”.

Facts:

• BBX11: It is a gene that facilitates in the greening of plants by playing a crucial role in regulating the levels of protochlorophyllide — an intermediate in the biosynthesis of the green pigment chlorophyll.

What is Chlorophyll? It is a pigment that gives plants their green color and it helps plants create their own food through photosynthesis ( a process by which light energy is converted to chemical energy through the synthesis of organic compounds).

Role of BBX11 in the Synthesis of Chlorophyll: The synthesis of chlorophyll in plants is a lengthy, multi-step process:

• When a seedling emerges from under the soil it must quickly synthesize chlorophyll to start supporting its own growth.
• In order to facilitate quick synthesis of chlorophyll, plants make a precursor of chlorophyll called ‘protochlorophyllide’ in the dark which glows red when blue light is shone on the plant.
• As soon as the plant comes out into the light from under the soil, light-dependent enzymes convert protochlorophyllide to chlorophyll.
• However, if there is excess of free protochlorophyllide, then exposure to light converts it into molecules that cause ‘photobleaching’.
• Thus, it is very important to regulate the amount of protochlorophyllide synthesized by the plant and here comes the vital plant played by the ‘BBX11’
• If it is less, plants are unable to efficiently ‘green’ in order to harvest sunlight. If the amount of protochlorophyllide is more, then plants bleach under the light.

Significance of the study: This study could have tremendous implications in the agriculture sector in tropical countries like India and can help provide leads to optimise plant growth under stressful and rapidly changing climatic conditions.

Source: The Indian Express

News: US Food and Drug Administration(FDA) has approved a first-of-its-kind intentional genomic alteration(IGA) in a line of domestic pigs referred to as GalSafe pigs.These pigs may be used for food and human therapeutics.

Facts:

• What is intentional genomic alteration in animals? It means making specific changes to the genome of the organism using modern molecular technologies that are popularly referred to as “genome editing” or “genetic engineering”.
• Purpose: Such changes in the DNA sequence of an animal may be carried out for research purposes to produce healthier meat for human consumption and to study disease resistance in animals among other reasons.
• Difference: The FDA maintains that the only difference between an animal with an IGA and one that does not have an IGA is that the IGA gives them a new trait or characteristic such as faster growth or resistance to certain diseases.

Additional Facts:

• Genome editing: It is a type of genetic engineering in which DNA is inserted, deleted, modified or replaced in the genome of a living organism.Editing DNA can lead to changes in physical traits like eye color and disease risk.

News: India’s first indigenous mRNA vaccine candidate HGCO19 has received approval from Indian Drug regulators to initiate Phase I/II human clinical trial.

Facts:

• HGCO19: It is a novel mRNA vaccine candidate developed by Gennova, Pune and supported with seed grant under the Ind-CEPI mission of Department of Biotechnology of Ministry of Science & Technology.

Additional Facts:

• mRNA vaccines: It is a new type of vaccine to protect against infectious diseases.It does not use the conventional model to produce immune response.mRNA vaccine carries the molecular instructions to make the protein in the body through a synthetic RNA of the virus.The host body uses this to produce the viral protein that is recognized and thereby making the body mount an immune response against the disease.
  • Advantages: mRNA-based vaccines are scientifically the ideal choice to address a pandemic because of their rapid developmental timeline.The mRNA vaccine is considered safe as is non-infectious, non-integrating in nature and degraded by standard cellular mechanisms.
• Ind-CEPI mission: It is a Department of Biotechnology mission that aims to strengthen the development of vaccines for the diseases of epidemic potential in India as well as build coordinated preparedness in the Indian public health system and vaccine industry to address existing and emerging infectious threats in India.The mission is implemented by Biotechnology Industry Research Assistance Council(BIRAC).

Source : Click here

News: A new drug called Molnupiravir has been shown to stop the transmission of SARS-CoV-2 (COVID-19) in 24 hours.

Facts:

• Molnupiravir: It is an experimental antiviral drug which is orally active (can be taken orally) and was developed for the treatment of influenza.
• Developed by: The drug is being developed by the biotechnology firm Ridgeback Biotherapeutics in collaboration with pharmaceutical firm Merck.
• Significance: This is the first demonstration of an orally available drug to rapidly block SARS-CoV-2 transmission and it can be a game-changer

Emergency Use Authorisation (EUA)

This article explains the process of Emergency Use authorization, based on The Indian Express Article “Three Covid-19 vaccine developers seek emergency use approval in India” 

Central Drug Standard Control Organisation (CDSCO) has received applications from 3 vaccine developers seeking Emergency Use Authorisation/Approval (EUA) for their candidate Covid-19 vaccines which are still under trial. These Vaccines are COVISHIELD, COVAXIN, and BNT162b2.

None of the Vaccine developers has yet generated data about the effectiveness of their vaccine from phase-III trials conducted in India.

What is the normal process of Vaccine Development?

In normal circumstances, a Vaccines has to go through several phases, with each phase taking many months to get completed, but in the case of COVID, it is expected that vaccines would be in the market within a year from its start, after seeking Emergency Use Approval (EUA) from their respective governments.

After Pre-clinical testing of Vaccines, it is tested on the human under clinical trials before its mass production.

Clinical trials: It involves testing on humans. There are 3 phases of clinical trials;

1. Phase I of a clinical trial is conducted on a small group of healthy individuals. It only indicates what is the ideal dose required to administer in the next stage, it provides evidence of the vaccine’s ability to generate an immune response and its safety.
   1. The vaccine is not considered safe if it develops any major complication, however little headache and fevers are expected.
2. In phase II, the range of participants is expanded to a few hundred healthy participants to check the immune response system in the body and it also assesses the time period for which antibodies last to provide immunity against the virus.
3. Phase-III involves a very large group of people (Thousands of individuals) to investigate its efficiency among large population groups. Half of the population is administered the actual Vaccine and the other half are administered dummy vaccines.
   1. Individuals administered Vaccines are checked on fixed intervals which can be months in normal conditions to see whether their immune system is responding to the virus or not.

After the Vaccine is successfully tested, it would require regulatory approval before it can be produced in bulk quantity.

Emergency Use Authorisation (EUA)

The term “Emergency Use Authorisation (EUA)” has been used mainly by the regulatory agencies like FDA in the US and some other countries with the following guidelines;

FDA has specified that it would consider an application for EUA only if phase 3 data showed

• it was at least 50% effective in preventing the disease.
• This data needed to be generated from “well over” 3,000 trial participants, “representing a high proportion of participants” enrolled.
• These participants needed to be followed up for any serious adverse effects for at least one month after all dosages had been given.
• EUA can be granted only in a declared public health emergency.

Accelerated Approval Process in India

In India, New Drugs and Clinical Trials Rules, 2019 governs Clinical trials of new drugs and vaccines and their approvals.

But the term Emergency Use Authorisation (EUA) has not been used anywhere in rules in India. However, 2019 rules provide for an “Accelerated Approval Process” for granting approval to a drug that is still in clinical trials. The definition of a new drug in the 2019 Rules includes a vaccine.

Conditions for Accelerated Approval Process

• There should be a prima facia case that the drug is of Therapeutic benefits.
• “Accelerated approval may also be granted to a new drug if it is intended for the treatment of a serious, or life-threatening condition, or disease of special relevance to the country, and addresses unmet medical needs,”.
• Approval can be granted even if “remarkable” effectiveness is reported even from phase-II trials.

Approval granted to drugs or vaccines that are still in clinical trials is temporary, and valid only for one year. 

Examples of granting EUA

• FDA granted its first EUA for use of Tamiflu drug for infants and young children for the treatment of H1N1 infection for the civilian population in 2009.
• Remdesivir or faviparir, are existing drugs approved for other ailments received EUA for treatment of Covid-19, including in India.

Issues in EUA of Vaccines

• Due to tolls or public sentiments, Governments are putting pressure on regulatory bodies to fast-track the entire process of Vaccine development. 
• Lack of transparency about vaccine safety and efficacy may negatively impact people’s confidence and willingness to get vaccinated.
• Some surveys have shown that there is vaccine hesitancy among a certain section of people due to the hastening of the vaccine development process.
• Whereas FDA has formulated its guidelines 50% effectiveness and no. of participants, the Indian regulator has not formulated any such guidelines.
• Another issue with EUA-approved drugs and treatments is that they can reflect and exacerbate already existing inequities in the health system if the vaccine administered is found out to be ineffective. It might create a huge burden on the pocket of poor people.
• There are examples of granting EUA to certain drugs like hydroxychloroquine, a malaria drug in haste, which later proved to be ineffective treatment, and the risks of taking it outweighed any benefits.
• If a drug proved to be ineffective later on, after its administration to a huge population, it would be very harmful to the people’s confidence, economy, and health system of the country.

Way forward

Concerns regarding use of Vaccines can be addressed when all stakeholders are transparent at every stage of development and not by merely sharing guidelines regarding vaccine safety with the States. It is important that those seeking emergency-use authorisation share the safety and efficacy data with the authorities and public immediately.

Context: Safety and efficacy data for the new vaccine must be known before emergency-use authorisation for vaccines.

Why in news?

• The Pune-based Serum Institute of India has approached the regulator for nod for its vaccine, Covishield, developed by Oxford University.
• AstraZeneca, which is carrying out the phase-3 trials of the Oxford vaccine in four countries, is yet to secure a nod from any of the regulatory agencies.
• AstraZeneca recently gave details of the interim safety and efficacy data involving 131 COVID-19 cases in the phase-3 trials in the U.K. and Brazil. But details of the trials in India are not out yet.

Why fast tracking of vaccine authorization is needed?

• The unprecedented speed in taking the vaccine from the development stage to approval process in less than a year is remarkable but also necessitated by the toll the virus has taken on lives and livelihoods.
• To reduce mortality and morbidity.

What are the concerns associated with authorization of vaccines?

• Regulatory bodies under pressure: to fast-track the entire process.
• Lack of transparency: Opaqueness about vaccine safety and efficacy does no good in gaining people’s confidence and willingness to get vaccinated.
  • For example, Moderna, Pfizer and AstraZeneca took the extraordinary step of publicly sharing the trial protocol, the time points at which interim analysis of phase-3 trial in India will be carried out for safety and efficacy is unclear.
• No checks: the U.S. FDA has clearly spelt out at least 50% efficacy and stipulated a median follow-up duration of at least two months after completion of the full vaccination regimen to assess a vaccine’s benefit-risk profile for emergency-use approval. However, no such conditions have been mentioned by the Indian regulatory agency. The phase-3 trial of Covishield began on September 21 and completed the enrolment on November 12.
• Fear of side effects and vaccine hesitancy: ineffective or unsafe vaccine is worse than not having one.A survey by the London-based Vaccine Confidence Project revealed that though the intent to get vaccinated was 87% in India, 34% respondents were worried about side-effects while 16% were concerned about fast-moving trials.

What needs to be done?

• Need to engage all stakeholders in a transparent manner at every stage and not by merely sharing guidelines regarding vaccine safety with the States.
• It is also important that those seeking emergency-use authorisation share the safety and efficacy data immediately.

For further read about Emergency Use Authorisation : Click here

Source: Click here

News: Singapore Food Agency(SFA) has approved the sale of a lab-grown meat product.This is the first time cultured meat has been cleared for sale anywhere in the world.

Facts:

• What is Lab Grown Meat? Lab Grown Meat or Cultured meat is meat produced by in vitro cell culture of animal cells instead of from slaughtered animals.
• How is lab-grown different from plant-based meat?
  • The plant based meat is made from plant sources such as soy or pea protein while cultured meat is grown directly from cells in a laboratory.
  • In terms of cellular structure, cultured or cultivated meat is the same as conventional meat — except that cultured meat does not come directly from animals.
• Advantages of Lab Grown Meat:
  • The lab grown meat could reduce land use by more than 95%, climate change emissions by 74-87% and nutrient pollution by 94%.
  • As meat is created in clean facilities, the risk of contamination by pathogens such as salmonella and E coli is significantly reduced thereby reducing the threat posed to public health by growing antibiotic resistance.

Context:  Antimicrobial resistance (AMR), a silent pandemic, is growing at an alarming rate.

Why is AMR growing at an alarming rate?

• AMR:  Globally, about 35% of common human infections have become resistant to available medicines.
• About 700,000 people die every year because available antimicrobial drugs (antibiotics, antivirals, anti-parasitic and antifungals) have become less effective at combating pathogens.
• Resistance to second- and third-line antibiotics the last lines of defence against some common diseases are projected to almost double between 2005 and 2030.
• According to a study published in The Lancet, an estimated 58,000 new-born children die annually from sepsis in India alone because antibiotics can no longer treat certain bacterial infections.
• Reasons for AMR:
• Microorganisms develop resistance to antimicrobial agents as a natural defence mechanism. Human activity has significantly accelerated the process.
• The misuse and overuse of antimicrobials for humans, livestock and agriculture is probably the biggest reason for this.
• Research points to the role of environment and pollution in AMR.
  • Once consumed, up to 80% of antibiotic drugs are excreted un-metabolised, along with resistant bacteria.
• Release of effluents from households and health and pharmaceutical facilities, and agricultural run-off, is propagating resistant microorganisms. Wastewater treatment facilities are unable to remove all antibiotics and resistant bacteria.

What are the problems faced?

• Issues faced: In India, there is capacity to treat only about 37% of the sewage generated annually. The rest is discharged into natural water bodies without treatment.
• An analysis of single wastewater discharge from a treatment facility in India catering to drug manufacturers found concentrations of antibiotics high enough to treat over 40,000 people daily.
• Mode of spread: Water may be a major mode for the spread of AMR, especially in places with inadequate water supply, sanitation and hygiene.
• Wildlife that comes into contact with discharge containing antimicrobials can also become colonised with drug-resistant organisms.

What are the key initiatives to tackle AMR?

• UNEP: The United Nations Environment Programme (UNEP) identified antimicrobial resistance as one of six emerging issues of environmental concern in its 2017 Frontiers Report.
• The UN Environment Assembly pressed the need to further understand the role of environmental pollution in spreading AMR.
• GAP: UN agencies are working together to develop the One Health AMR Global Action Plan (GAP) that addresses the issue in human, animal, and plant health and food and environment sectors.
• MoEF&CC: The Ministry of Environment, Forest and Climate Change (MoEF&CC) issued draft standards which set limits for residues of 121 antibiotics in treated effluents from drug production units.
• The Ministry of Health and Family Welfare and MoEF&CC constituted the inter-ministerial Steering Committee on Environment and Health, with representation from WHO and UNEP.

Way forward

• The Centre and State governments in India can strengthen the environmental dimensions of their plans to tackle antimicrobial resistance.
• It is particularly important to promote measures that address known hotspots such as hospitals and manufacturing and waste treatment facilities.

Context: Aspects of vaccine distribution.

Background

• The World Health Organisation (WHO) declared the COVID-19 a pandemic in march 2020 and the most optimistic prediction for a vaccine to be available was by the middle of 2021.
• Now, the labs around the world are working faster than anticipated and the first vials of a vaccine are likely to roll out in the next two months.

Why stakes in a vaccine against COVID-19 are unprecedented?

• Though, Economies have gradually opened up after lockdowns, festivals have been celebrated in a subdued manner, and polls have been conducted in several countries.
• But it’s the vaccine that can set us free, can give back the human freedom of association, and most importantly, it can relieve the anxiety and worry that has become the part of life in large parts of the planet.

How early research in Corona virus family is helping now?

• The epidemics caused by pathogens of the coronavirus family in the past 20 years, SARS and MERS, have pushed scientists to study the varied interactions between the human immune system and contagions.
• These studies have illustrated that, unlike other flu viruses, coronaviruses make use of various biological pathways in the human body. For example-opting enzymes of the host’s cells.
• Knowledge of the spike protein has made the scientific community to understand the ways in which the immune system behaves when a person contracts the novel coronavirus.
• The recent approaches targeting the spike protein whether through genetic material as in the case of the vaccines developed by Moderna and Pfizer or through a viral vector from chimpanzees as in the Oxford-AstraZeneca vaccine, have benefitted from earlier research with coronaviruses.

What are the challenges to vaccine distribution?

• India, produces 60 per cent of the world’s vaccines and is home to the largest manufacturer, the Pune-based Serum Institute.
• Yet, the country also has the largest number of unvaccinated children in the world.
• NSO data shows that less than 60 per cent children receive the entire basket of vaccines.
• Delay in acceptance or refusal of vaccines despite availability of vaccination services in more than 90 per cent countries in the world is another hurdle in immunisation programmes.

What is the Way forward?

• Securing 1.3 billion people will require a massive public policy effort at improving the country’s public health infrastructure.
• Partnership with the private sector in immunisation programme.
• Controlling the growth of black markets.
• Checking the diversion of resources from regular immunisation programmes.
• Institute transparent mechanisms at points where science and research meet public policy.

The novel coronavirus forces us to do things differently, it demands a different conception of herd from science and public policy.

Context: India’s COVID-19 control plan of actions can be the basis for building a much-needed public health infrastructure.

How can vaccine help in eradicating a disease?

• Preventive medicines: Vaccines play a major role in human mastery over infectious diseases by inducing immunity in individuals.
• Herd immunity: When a vaccine is rolled out as a national programme and increasing proportions of people are vaccinated, ‘herd immunity’ level increases and disease frequency decreases in the vaccinated population.
• The ‘herd effect’ of vaccination: That decelerates transmission of the microbe in the whole community, resulting in decreasing disease frequency even in the unvaccinated segment of population.
  • Herd immunity plus herd effect reduces the overall disease burden in the community.
• Control: In epidemiology, the common word ‘control’ has a specific meaning: ‘deliberate reduction of disease frequency to a desired level, validated with evidence’.
  • • For evidence, disease frequencies must be documented both at baseline and on an ongoing basis, through systematic surveillance. So, control interventions include vaccination programme and disease surveillance.
• Elimination: The extreme form of control is ‘elimination’ of transmission of the microbe in a whole country.
  • • For example, measles and rubella have been eliminated in Sri Lanka through sustained vaccination achieving high coverage.
• Diseases eradicated using vaccine: Eradication is global elimination of an infectious disease. So far, smallpox and cattle plague have been eradicated using their respective vaccines.
  • • Severe Acute Respiratory Syndrome (SARS) was eradicated in 2003 without a vaccine, using ‘non-pharmacological interventions’, or NPI, systematic case detection, contact tracing and quarantine.

What are the statuses of vaccine candidates in India?

• Protective efficacies: Three COVID-19 vaccines have claims of about 90-95% protective efficacy are BNT162b2 (Pfizer-BioNTech), mRNA-1273 (Moderna) and Sputnik-V (Gamaleya Institute).
• Trial phases: Sputnik-V is under phase 2-phase 3 vaccine trials in India, by Dr. Reddy’s Laboratories. Another vaccine, ChAdOx1 nCoV-19 (OxfordAstraZeneca), manufactured under licence by Serum Institute of India as Covishield, is undergoing phase 2-phase 3 trials in India.
• An indigenous vaccine candidate, Covaxin (Bharat Biotech), found safe and immunogenic in phase 1 and phase 2 trials, is now under phase 3 trial.
• Policy development: In India’s national Universal Immunisation Programme (UIP), vaccines are procured and supplied by the Union government and vaccination is implemented by State governments.
  • • States have the freedom to surpass policy limits if no fund is sought.
    • For example, Delhi used the Measles Mumps-Rubella vaccine when the central government policy was only for Measles vaccine and Sikkim unilaterally used human papillomavirus vaccine to prevent cervical cancer in women.

What can be done to tackle the issues?

• Policy issue: An important policy issue is whether vaccination should be confined to only uninfected individuals or should it be for all people. All test results of infected subjects are available on a computer data base and that is one way to identify those who were already infected.
• Trained staff: The vaccination stations should be staffed with trained personnel and supervised by medical doctors.
• Infrastructure: The site must have a waiting area and a post-vaccination staying area to manage any untoward reaction during the first hour.
• Digital list: A computerised master list with details and mobile numbers of all vaccinated subjects needs to be maintained for the purpose of post-vaccination follow up to document rare side-effects.
• Data management: Data management has to be meticulously planned and executed.

Way forward

• This is a huge opportunity to eliminate the novel coronavirus from India, setting an example to the rest of the world. With will and wisdom we can, and should, accomplish this.

Context- Problems posed by vaccine nationalism and the possible solutions.

What is vaccine nationalism the problems posed by vaccine nationalism?

Vaccine nationalism occurs when a country manages to secure doses of vaccine for its own citizens or residents before they are made available in other countries.

• This is done through pre-purchase agreements between a government and a vaccine manufacturer.

The problems posed by vaccine nationalism-

• It undermines equitable access to vaccines.
• Issue for countries with fewer resources-The most immediate effect of vaccine nationalism is that it further disadvantages countries with fewer resources and bargaining power.
• Deprives access to public health- It deprives populations from timely access to vital public health goods.

What needs to be done? 

1. Global framework for equitable access– International institutions, including the WHO, should coordinate negotiations to produce a framework for equitable access to vaccines during public health crises.
2. Governments should be the custodian of public goods– Governments must step in to regulate vaccine development, innovation, manufacture, sale, and supply ultimately to the public.
3. Prioritization for high risk groups– The first batch of the vaccines should be made available to all frontline, health and social care workers, police and others who are at high risk of getting the infection.
4. Ensuring equity-Equitable distribution and access should be ensured. Equity entails both affordability of vaccines and access opportunities for populations across the world, irrespective of geography and geopolitics.
5. Pre-purchase agreements and contracts should not trump equitable access to global public health goods
6. It was important for WTO members to work together to ensure that intellectual property rights such as patents, industrial designs, copyright and protection of undisclosed information did not create barriers to timely access to affordable medical products.

Way forward-

• Countries around the world should stop engaging in overly nationalistic behaviors.  Failure to do so will harm patient populations across the globe.
• The WTO has a role in getting pharmaceutical firms and countries to treat vaccines and life-saving medicines as a public good.

Context: The pandemic has given the country an opportunity to evolve from being the pharmacy of the world to being the centre of a revolutionary research.

How has India performed in the field of biotechnology over the years?

• Change overtime: India has seen an immense improvement in the number and quality of its healthcare facilities, reduction in pregnancy-related deaths, improvement in sanitation and immunisation coverage and has successfully averted several preventable disease epidemics.
• Department of biotechnology: The Government of India recognised the enormous potential of biotechnology and established a separate department in 1986.
• Contribution of innovators: The researchers and innovators have shown the way forward by introducing low-cost diagnostics and testing kits, manufacturing PPE kits, masks & therapeutics and now conducting clinical trials for COVID-19 vaccine.
• The clinical trial for the vaccine developed by the Oxford University and produced by the Pune-based Serum Institute of India (SII), Bharat Biotech’s Covaxin and Zydus Cadila’s ZyCoV-D, has entered the final phase.
• Tackling the pandemic: The immediate need was to have our indigenous production of masks, PPE’s, ventilators and most importantly diagnostic kits.
• In less than 60 days from 100 per cent import we attained self-sufficiency with a potential to export.
• A vibrant innovation ecosystem: Prime Minister launched the Startup India, Make in India and similar other programmes which have today established a very strong foundation of an ecosystem that has been enabling policy initiatives.
• The Biotechnology Industry Research Assistance Council (BIRAC): BIRAC brings innovators and funders on to a common table, enabling ideas to become a reality and facilitate technological advances that make human progress possible.
• Achievements in biotechnology: the sector employs the best of minds and contributes to the development of generic and affordable medicare.
• The country accounts for approximately 3 per cent of the global biotech industry.
• Industry enterprise, a highly-skilled research force backed by government support, has led the biotechnology sector to grow from $1.1 billion in 2003 to a mammoth $64 billion sector in 2019.
• India has over 2,700 biotech start-ups and are expected to touch the 10,000-mark by 2024.
• Over 3,500 biotech companies generate employment, contribute to the country’s economy and facilitate a sustainable environment.
• By 2025, we aim to be worth a $150 billion industry.

Way forward

• Atma nirbhar: we must motivate our young scientists to continue this path of research and generate new ideas and solutions. “Atma Nirbhar Bharat” will lead to an entrepreneur-friendly ecosystem in the country wherein our energetic youth and their innovations will thrive.
• The pandemic has provided the country with an opportunity to play the lead role in a global biotech ecosystem. It is time to build on our existing strengths and enter the next stage i.e. from being the pharmacy of the world to being the hub of cutting-edge innovation and research.
  

  ---

India’s potential as a Global investment hub

Context: India must improve its cold chain infrastructure to avail benefits of new vaccines

Elaborate about the potential covid-19 vaccine by Pfizer?

• Potential covid vaccine: Multinational drug company Pfizer has announced promising results from its ongoing phase-3 trial of a potential COVID-19 vaccine.
• Effectiveness in trials: Pfizer, which is using a vaccine candidate by German firm BioNTech, had disclosed in September that for a vaccine to be judged 60% effective, 164 volunteers would have to contract COVID-19.
• Sample size: The claim of 90% is based on a sample of 94 volunteers but it is not known how many belonged to either group. It is also unclear if those who were eventually infected, manifested mild or moderate severity of disease.
• Awaited result: There is still time to be reliably sure that the results actually hold up in a wider population.
• There are no large phase-3 trials of the ‘Covishield’ by the Serum Institute or ‘Covaxin’ by Bharat Biotech Ltd vaccine in India.
• India’s access to vaccine: While there were early discussions with Pfizer, there is as yet no confirmation on whether India can be assured of early access to even a fraction of the vaccine output in the event it is readied.
• m-RNA technology: The vaccine candidate is based on an m-RNA technology, which avoids the use of an infectious particle, such as a portion of the virus, and uses a piece of RNA that is then made into an antigen by the body’s own machinery.
• Faster production: It also does not need to be cultured in chicken eggs or other mammalian cells, allowing it be made faster and more inexpensively.
• Optimum temperature required: They also reportedly need to be refrigerated to nearly minus 70°C and India, with its limited cold chain infrastructure, lacks efficient vaccine storage capacity.
• Basic strategy: It shows that scientists’ basic strategy of developing a vaccine to target the spike protein of the virus is correct and given that this is an approach most vaccine developers are following, the chances of several encouraging results are high.
• Moderna, also employs an m-RNA based approach, it is likely that the new vaccine platform may prove to be a breakthrough approach in developing future vaccines.

Way forward

• India must keep a close watch on such platform-technology and develop expertise. It must also not lose an opportunity to improve its cold chain infrastructure which currently is developed only for rudimentary vaccines.

Exclusive arbitration body for financial disputes

What are serological surveys

Context: The Indian Council of Medical Research conducted two serosurveys: May 11 to June 4 and August 17 to September 22.

What is serological survey?

• Serological surveys are used to detect the prevalence of antibodies against COVID-19/any diseases.
• Their purpose is to measure the proportion of a population already infected as evidenced by prevalence of antibody against the disease.

How serological surveys are carried out?

• Statisticians stratify the population and select a random sample from all strata so that the prevalence figure obtained is representative of the whole population.
• Random samples are tested from the entire population then, the data are extrapolated to the whole population.

Why antibody is tested?

• Antibodies are the evidence of the host’s response to virus infection.
• Their presence in the blood-serum confirms past infection.

Why the data derived from serosurveys must be interpreted with caution?

• Issue with Asymptomatic cases: Asymptomatic cases constitute more than 80% of those infected with the virus. In people with asymptomatic infections, these antibody levels decline over time and become undetectable by 60 days after proven infection.
• Swift disappearance of S2 antibodies: In a study on exposure-prone healthcare workers in Tennessee, nearly half the subjects with S2 antibodies became negative in two months.
• Inaccuracy: The latent period between infection and the appearance of a detectable antibody is about four weeks. Those who got infected recently before the survey may not be covered.
• If taken at face value, serosurveys may not reflect the true level of antibodies prevalence.

What is the way forward?

• The predicted herd immunity level needed to end the epidemic was 60%. In India, according to the serological surveys, half of the herd immunity level required to end the epidemic was already reached by mid-September.
• However, during the festival the Governments must enforce strict norms regarding crowding, especially inside buildings.
• This will ensure safety of the individuals, family members particularly senior citizens.

Assisted Reproductive Technology Regulation Bill, 2020

News: Government of India has introduced “The Assisted Reproductive Technology (Regulation) Bill, 2020” in the Lok Sabha.

Facts:

• Aim: To regulate the assisted reproductive technology (ART) clinics and the assisted reproductive technology banks, prevention of misuse, safe and ethical practice of assisted reproductive technology services.
• Key Provisions of the bill:
  • National Board: It shall lay down code of conduct to be observed by persons working at ART clinics, to set the minimum standards of physical infrastructure, laboratory and diagnostic equipment and expert manpower to be employed by clinics and banks.
  • Regulatory Boards at State Level: The States and Union Territories shall constitute the State Boards and State Authorities. It shall have the responsibility to follow the policies and plans laid by the National Board for clinics and Banks in the State.
  • National Registry and Registration Authority: It will maintain a Central database and assist the National Board in its functioning.

• Punishment: The bill also proposes for stringent punishment for those practising sex selections, sale of human embryos or gametes, running agencies/rackets/organisations for such unlawful practices.