With the announcement of the 3 vaccines, people began wondering which one would be the best in terms of efficacy and India isn't too far behind in the race. Our drug regulatory board officially approved 2 COVID 19 vaccines for emergency use on Sunday. The first one is Covishield, a locally manufactured by the Serum Institute of India and is a version of the Oxford-AstraZeneca vaccine which has already been approved globally. The other vaccine is the Covaxin which has been developed by Bharat Biotech in partnership with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). While the approval of 2 Indian vaccines should be a cause of celebration, their announcement has been met with the public’s scepticism and doubt.
Although the Drugs Controller General of India (DCGI) has announced that the vaccines are safe for the public to use, expert raise concerns over lack of transparency in the approval process of the vaccine. In fact, studies show that around 69% of the surveyed people were hesitant about taking a COVID 19 vaccine! Data from phase 1 and 2 trials of Covaxin looked promising but according to experts, the efficacy data from the vaccine’s phase 3 trial was not yet released. This data is of utmost importance since it is an indicator of how competent the vaccine is in preventing the virus from attacking the body.
“Even emergency use authorisation requires efficacy data… These Indian vaccines would eventually go into the international market as well. It is very important that there is trust in our regulatory institutions. Otherwise, these same companies would suffer.” says Said Shahid Jameel, a virologist and director of Trivedi School of Biosciences at Ashoka University.
Even Dr Swapneil Parikh, an infectious diseases researcher, agrees that transparency from the government over a vaccine is needed before it is administered to the public. She tells BBC “I understand there is a need to go through the process quickly, remove regulatory hurdles. … However… [governments and regulators] have a duty to be transparent about the data they have reviewed and the process involved in making the decision to authorize a vaccine because if they don’t do this, it can affect the public’s faith in the process.”
On the other hand, Randeep Guleria, director of AIIMS and member of the National Covid-19 task force tells Indian Express the reason why the rollout of Covaxin would be fast-tracked. According to him, the approval of Covaxin was fast-tracked in case there was a sudden surge in cases and the Oxford university vaccine was in short supply, only then the vaccine would be administered under ‘clinical trial mode’.
Did India follow due processes while approving COVID 19 vaccine?
While some people are worried about the safety of the vaccine, others are concerned that the governing bodies are becoming lax about such serious issues. Satyajit Rath, an immunologist says “The problem is not in the form of an enhanced risk to the individual who is taking the vaccine. The problem is at the policy level, at the regulatory level. There are several issues with the way the approval has been granted, which can lead to people losing confidence in the regulatory system.”
In an interview with BOOM, Dr Anant Khan explains the normal process that is followed before a vaccine is approved. Those due processes are -
- The vaccine is given as a ‘preventive modality’ to healthy individuals, hoping that it would help prevent infections.
- The vaccines are also expected to have certain data sets regarding their safety, efficacy and dosing. These data sets are crucial because they help us understand how useful the vaccine would be when given to a larger population.
However, India’s health secretary had stated that there would be 2 different conditions under which a vaccine would be approved and those conditions are-
- Permission from a foreign regulatory body as well as releasing ‘bridging data’ which is what Covishield is applying for, in order to get approval for emergency use.
- Permission-based on local efficacy data which is what Covaxin is doing.
While Covishield’s bridging study is still ongoing, no data has been released into the public domain yet. Similarly, a phase 3 efficacy study is ongoing with Covaxin and has supposedly recruited its target of 26,000 participants. However, it is still in the early stages.
Given this background, various health experts are questioning the basis on which the vaccines were approved. Murali Neelakantan, a former global general consul at CIPLA and Glenmark says that rent precedents involving drug approval have been significantly different from earlier. The regulatory board in 2020 was approving drugs like Remdesivir, HCQ etc without any efficacy data and since then has decided to not follow ‘old rules’ regarding vaccine approval. Mr Neelakantan also states that there has been a general trend of ‘flexibility’ that is seen in clinical trial rules and the ‘general rules’ have not to be followed for the COVID 19 vaccine.
Whether you are sceptical about the vaccine’s safety or it’s approval process, experts suggest that its best to wait out until the official rollout of the vaccine has begun. Once that happens, there would be sufficient data regarding its efficacy as well it’s administered effect. Till then, it’s best to practice social distancing and wearing a mask.