COVID/Corona Vaccine development in India: Progress and challenges

News: At present development of 34 COVID/Corona Vaccine candidates, is at Clinical Trials Level. 8 COVID/Corona Vaccines are on the 3rd stage of Clinical Trials.

News developments

• In India at least 8 COVID/Corona Vaccine candidates are being developed, of there almost 3 vaccine candidates at advanced stages of development.
• The Oxford-AstraZeneca vaccine or ChAdOx1 is in Phase 3 human trial which is supported by the Serum Institute of India.
• Serum Institute of India (SII) and Indian Council of Medical Research (ICMR) are jointly conducting a Phase II/III trial of Covishield.
• Indigenous vaccines like COVAXIN (developed by Bharat Biotech and ICMR) and ZyCoV-D (developed by Zydus Cadila) are in Phase 2/3 trials.
• Bharat Biotech, a Hyderabad-based pharmaceutical company, has a deal to manufacture 1bn doses of Washington University’s intranasal vaccine.
• The entire process might take six months and the final assessment on safety and the level of production of antibodies would be made by a safety board.
• The phase-III or the last stage of clinical trial of the Covid-19 vaccine ‘Covishield’, being developed by Oxford University, and manufactured by the Serum Institute of India (SII), began recently in Pune at the state-run Sassoon General Hospital.

About Covaxin

• Covaxin is India’s first indigenous vaccine. Developers have sought the start of 3rd Phase Clinical Trial.
• Vaccine developed by: Bharat Biotech (Hyderabad) in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).
• In response, Drugs Controller General of India (DGCI) has asked Bharat Biotech to submit “complete safety and immunogenicity data of the phase II trial” and some clarifications before proceeding for the next stage.
• The vaccine candidate has been tested in 12 hospitals across India, where volunteers between the ages of 18 and 55 participated in the trial.

Covaxin is being derived from a strain of the novel ‘deactivated’ coronavirus isolated by the National Institute of Virology in Pune. A ‘deactivated’ virus doesn’t have any potential to infect or replicate, upon injection into the body.

However, some unharmful parts of the virus are left intact, so that it can make an identification of the Virus in Immune system of the body.

Understand the phases/process of Vaccines development

Researchers and scientists would have taken years in Vaccine development in normal circumstances; however, it is only due to the emergency situation arising due to Corona Virus Pandemic. It is expected that a Vaccine would be developed within 4-5 months.

Phase 1 – It involves a basic understanding of the virus to identify the structure of proteins and genetics that make up the virus. It provides a basis for developing diagnostics kits and potential treatment options.

Phase-2 – It involves the identification of vaccine candidates by isolating the live virus before inactivating or weakening that can be used for immunity development.

Phase -3 – Pre-clinical testing: This is the stage before the vaccine can be tested on human, Vaccine is tested on the animals in this stage to see the response.

Phase -4 – Clinical trials: It involves testing on humans. There are 3 phases of clinical trials

1. Phase I of a clinical trial is conducted on 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. 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 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 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.

Phase- 5: After Vaccine is successfully tested, it would require regulatory approval before it can be produced in bulk quantity.

Importance of Vaccine development for India

• India is the largest vaccine producing country in the world and if India is able to produce an indigenous vaccine, it will help in matching the demand in time, which otherwise would not have been possible for one more year.
• India is the one of the most affected country due to COVID, it would have to wait for long time, if it was not being developed indigenously. Once the trials are done, Bharat Biotech will be targeting a manufacturing capacity of 300 million doses.
• Approximately 70 per cent of vaccines for low- and middle-income countries are manufactured in India and delivered through partnerships with UNICEF and Gavi. Vaccine development in India ensures availability of affordable vaccines.

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What are the challenges across distribution of COVID-19 vaccine?

• Priority– Within the country, it is certainly not clear who should be treated first or it should be determined by need, affordability, vulnerability or some other criterion or a combination of all.
• Guideline– The need of a policy regarding how much of the vaccine produced should go to other countries and at what cost. It must ensure whether agencies funding the research or the researchers or government authorities or citizens decide on a global policy of distribution.
• Adult Vaccination program: mass-scale immunization programs aimed at the adult population does not have much awareness right now. Vaccination is currently limited to children and pregnant women
• Distributive hierarchy–The cost of the vaccine and its possible loss will have to be borne by the last receiver which likely to be more needy people of the society.
• Cost– If open market forces determine the cost of the vaccine and affordability then, the section of society most vulnerable to the disease would get left out. Affordable prices ensure that more people around the globe have access to these life-saving tools.
• Post-Vaccination antibody tests: Even if the immunization is done on mass level, there will be requirement of reliable anti-body tests that can provide right info. on impacts of Vaccination. Presently available anti-body tests are unreliable.

Way forward

• Government need to ensure there is enough awareness and availability to fulfil the needs of the vulnerable sector.
• Immunizing a billion people will be a staggering operational challenge for the country.  It is important, that the government opens the conversation to a variety of specialists like epidemiologists, ethicists, economists, patient groups, social scientists.
• Authorities have ascertained the need to create a priority order which would cover healthcare workers, essential staff and high-risk people.
• Government need to plan effectively against the possibility of black marketing of Covid vaccine, due to its extremely high demand among general public.

Conclusion

The government also keeping an eye on immunity data with regard to COVID-19 disease while finalizing plans on vaccine distribution. Vaccine procurement was being done centrally and each consignment would be tracked real time until delivery to ensure it reached those who needed it most.

As per the source of government, Vaccines will be distributed as per pre-decided priority and in a programmed manner. To ensure transparency and accountability. Government should start the discussion among experts and public so that there is no panic situation to get the vaccine at any cost.