A day after the Indian drug regulator’s announcement that it has approved the Covid-19 vaccines manufactured by Serum Institute of India
and Bharat Biotech, serious questions have been raised regarding the transparency and credibility of the approval process. It is critical for the government to address these doubts in a transparent and upfront manner instead of leaving the public to rely on random statements from different players in the system. The doubts began with the press conference when the Drugs Controller General of India (DCGI) read a brief statement, declined to take questions, but declared both vaccines “110 per cent safe” without explaining the basis for this endorsement. Doubts principally centre on Bharat Biotech’s Covaxin, for which there is little publicly released data on the Phase I and II trials, including the clinical efficiency data (for Serum Institute, which is manufacturing the Oxford University-AstraZeneca
vaccine, this data is more robust). There is only a statement from Bharat Biotech
that it expects the vaccine to have 60 per cent efficacy, but no explanation for the basis of this claim. This is said to be the first time anywhere in the world that a vaccine candidate has been approved without any efficacy data from phase III studies. The DCGI must be ready to answer inconvenient questions and make a clean breast of the submitted data and continue rolling reviews of the Phase III trials.
Experts have also pointed to confusion arising from the language in the DCGI statement. The regulator said the subject expert committee of the Central Drugs Standard Control Organisation had reviewed the data for the two candidates “for grant of permission … as an abundant precaution, in clinical trial mode”. This statement implies that the initial recipients of the vaccine in India are to be subject to clinical trial, a process that demands a rigorous set of legal protocols, including explicitly informing the recipients and getting their consent, and research standards. It is not known if this will be the case. There are other puzzles embedded in the DCGI’s statements on both vaccines. For instance, the DCGI spoke of approving Serum Institute’s Covishield for restricted use in emergency situations “subject to certain regulatory conditions”. These conditions have not been spelt out. For Bharat Biotech’s Covaxin, the regulator spoke of approval “in the public interest as an abundant precaution”, the words not used for Serum Institute’s candidate. Again, there is no official reasoning behind this, except for AIIMS Director Randeep Guleria’s statement that this suggests that Covaxin is part of a back-up plan. There is confusion also in the use of phrases such as “emergency use authorisation” and “restricted emergency use”, terms that experts say do not exist in Indian regulations and are likely to cause consternation over what form these restrictions will take.
India’s approval process stands in sharp contrast to the US Food and Drugs Administration, which live-streamed the review and issued a detailed memo on the vaccine (with the data and restrictions). In the UK, the press conference announcing the approval involved answering detailed questions. India does not even make public the names of the members of the subject expert committee or the National Expert Group on Covid-19 Administration. Such opacity in an approval mechanism, which has had a troubling history with drug approvals in the past, is likely to lead to widespread mistrust in the vaccine, defeating the very purpose of this fast-tracked approval of a rapid return to normalcy.