Yet again, the pandemic has revealed cracks in the conduct of the Indian Council of Medical Research (ICMR). A letter by the agency’s head, Dr. Balram Bhargava, to doctors last week, preparing to test a vaccine for human trials, appeared to be coercing them into getting a vaccine ready by August 15 . After public uproar the agency clarified that its intent was to infuse a sense of urgency given the pandemic and that there were no plans to deviate from the rulebook on vaccine development. However, there was no rationale extended for why the date August 15 cropped up. Given the crisis at hand, regulatory agencies the world over have relaxed rules on drug testing and vaccine trials. While scientific rigour cannot be compromised, there is a move, globally, to allow more leeway to formulations that show some promise, and allow them into the market under medical guidance. This is why drugs such as remdesivir and favipiravir — despite limited evidence of success — have made it to the bedside of patients.
Vaccines are an entirely different game. The basic philosophy of all vaccines involves introducing fragments — in some cases the whole virus, albeit in a weakened form — into healthy volunteers. Therefore, the first checkpoint is that the vaccine candidate should not sicken a healthy person. The second hurdle is that a vaccine must stimulate the immune system just enough to get it to produce protective antibodies. In other words, it must be efficacious and finally, only if all were to go well, it must be tested in several thousand people in real world conditions. And they must be shown, over time, to be better protected than those who were unvaccinated. Each one of these steps cannot in principle be rushed, and each is necessary to ensure that the vaccine can be released for public use. The Hyderabad-based Bharat Biotech , the makers of ‘Covaxin’, has experience and credibility in vaccine manufacture. ‘Covaxin’ is developed from a strain of SARS-CoV-2 isolated at NIV. However, this only makes it one of hundreds of potential vaccines being tested and the consensus of experts is that no vaccine can be readied for use until next year. This is now largely understood by most and hence the behavioural changes on social distancing and an insistence on wearing masks in public. It is therefore perplexing why the ICMR, with its panoply of eminences, would want to cut corners with a basic premise of research: that science does not progress in a hurry. The pandemic has brought into focus the unavoidable role of uncertainty. New aspects of the disease are being brought to light, sometimes every day. The best strategy, in the midst of such flux, is to maintain absolute transparency, and proceed surely, even if slowly.
