Approval to Covaxin, and Covishield Vaccines: Concerns and way forward

This article has been developed based on the Indian Express article “Turning point”.

Synopsis- The Drug Controller General of India (DCGI) approved two vaccines — the indigenously developed Covaxin, and Covishield. There are several concerns associated with the hasty approval of vaccines.

About Vaccines

COVISHIELD:

• This vaccine is incubated in the laboratories of Oxford University and Swedish-British pharma firm, AstraZeneca. It is manufactured by the Serum Institute of India.
• Type of vaccine: It is made from a weakened version of a common cold adenovirus that causes infections in chimpanzees.

COVAXIN:

• It has been indigenously developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
• Approval of this vaccine has raised many concerns as the Vaccine was still undergoing phase-3 clinical trials.

Read More about Vaccines

As per the regulators, Phase I and Phase II clinical trials were conducted on approximately 800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response. 

An efficacy trial of this vaccine was initiated in India on 25,800 volunteers, and the data provided till now has been found to be safe, according to regulators.

However, there is no clarity about the type of data available.

Conditions associated with approval

• The emergency use approval is conditional on the vaccine developers submitting details of any adverse effect to the drug regulator, every 15 days. 
• A factsheet with safety details will also be provided to those receiving the first lot of vaccines.

Accelerated approval process in India

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

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.

Read more – Emergency Use authorisation of vaccines

What are the concerns associated with the hasty approval of vaccines?

India which is regarded as a manufacturer of vaccines, has put its credibility at a stake by this hasty approval of vaccine. It has raised a wave of concerns by scientific and healthcare communities about a “public rollout of an untested product. 

• First, Covaxin has been approved without clinical efficacy data. This vaccine was on the 3^rd stage, which is always a key to prove its efficiency. Government’s approval to this vaccine might hurt India’s credibility in case of any adverse impacts.  

• • Efficacy data is an indication of how effective the vaccine is in preventing the virus attack.

• Second, As regulators have themselves evaded their rules, credibility of regulator at stake- This lack of transparency could lead to a lack of trust in the vaccine. There are several issues with the way the approval has been granted, which can lead to people losing confidence in the regulatory system. 
• Third, approval an untested vaccine makes it nearly impossible to conduct a proper phase-3 trial. 

• • It will be unethical to expect volunteers to participate in a trial where there is only a 50% chance of being administered the actual vaccine, when they have the option of the real dose elsewhere.
• Fourth, While Pharmaceutical giants like Pfizer, Moderna, and AstraZeneca have given a go-ahead only after partial results of vaccine’s abilities in their own populations, In India Covishield has not been tested for vaccine ability among Indian population.
  • As it is a possibility that vaccine response among Indian population may not be the same as among the European Population.  
• Fifth, several data and reports have suggested the Vaccine hesitancy among people due to Emergency Use authorization. Approval without even base-level data will only strengthen this hesitancy among the public.

The rush to approve the COVID-19 vaccine without proper clinical trial may do more harm than good. So, it would be better to wait for the preliminary data from the phase-III trials to come in, and then grant the approval. 

What is the way forward? 

• Government needs to strengthen its vaccine distribution and administration mechanism to meet the need of 1/4^th of the population it is looking to vaccinate in the first phase.
• Immunogenicity of both the vaccines could vary, thus there is a need to understand the adverse effects.
• Prioritising the elderly people needs to be re-examined because the elderly are less mobile and have a lower level of social interaction, they are less likely to spread the virus. So, in the long run, prioritizing the elderly people may not actually minimize the total social and economic cost inflicted by the virus.
• Surveillance and monitoring systems will require to be tweaked as per the efficiency and effectiveness data of the Vaccine.
• Vaccinators required to be educated on the finer details of the two vaccines.