Proactive regulator

Credibility of an approved vaccine should be ensured

On Wednesday, the subject expert committee (SEC) that is advising India’s drug regulator, the Drug Controller General of India (DGCI), on the development and approval of vaccines for Covid-19 met with two of the major players in India’s vaccine race. These two were the representatives of Bharat Biotech, which is testing an indigenously developed vaccine candidate, and the Pune-based Serum Institute of India, which is the licensee for the vaccine developed by AstraZeneca and Oxford University. It is good news that the SEC is engaging closely with the vaccine developers even before it is officially required for the DGCI to approve the candidates. This will, in fact, make the process more secure and make it less likely to be derailed by poor communication or red tape. Certainly, speed is essential in approving the vaccine: The sooner a vaccine is approved, the sooner it can be rolled out to a reasonable proportion of India’s vast population— and the sooner some of the social distancing norms can be suspended. AstraZeneca has already suffered delays in its target markets, including the US, because of poor communication with regulators. That the Serum Institute and the Indian regulators are being proactive in an attempt to avoid such problems is welcome.

The SEC reportedly asked the indigenous developer, Bharat Biotech, to return when it had more data from its Phase-3 trial, the one where a vaccine’s efficacy in the broader population is judged. The Serum Institute, meanwhile, was asked for additional information. One piece of additional information was about the alleged negative reaction of a trial volunteer in Chennai, which has led to lawsuits. In large-scale trials, of course, individuals can suffer many illnesses or reactions that may not in fact be due to the vaccine (or placebo) shot they have taken. AstraZeneca trials elsewhere were halted when one participant demonstrated neurological symptoms, which were later found to be caused by previously undiagnosed multiple sclerosis. The SEC also asked the Serum Institute to return when it had detailed data on the immune response provoked by the vaccine, which will not be available for a few days still as that response can only be checked 15 days after the booster shot is given. The SEC has said that ideally a vaccine candidate should have 2,000 Indian participants in a trial — AstraZeneca has 1,600 currently. The committee also sought to know why the UK regulator had not yet approved the AstraZeneca candidate. The answer is, as the chief of the UK regulator told British MPs this week, the final tranche of data is yet to arrive. The UK regulator only began official scrutiny of that vaccine on November 27. The UK has, of course, already cleared the Pfizer/BioNTech vaccine, representatives of which did not attend the SEC’s meeting on Wednesday but reportedly will soon.

The credibility of any approved vaccine must be assured. Thus, the DGCI is right to be as cautious as it can be. It must also, however, learn from other regulators that push back effectively against sensationalist news stories about vaccine reactions. A successful rollout of a vaccine in India will depend as much on proactive briefing of the public by regulators as it will on proactive meetings with the developers.