The confusion over setting the August 15 deadline for the launch of indigenous Covid-19 vaccine, Covaxin, was wholly avoidable. While there is no doubt that the ongoing pandemic infuses a sense of urgency in efforts to find a solution, it is science, and not politics, that should guide the parameters and pace of research. There should be no room for short cuts when it comes to public health and safety. Even the most optimistic estimates say that the new vaccine candidates could be ready for public use towards the end of the year or early 2021. Releasing a vaccine into the general population without rigorously ensuring safety and efficacy will be dangerous and counterproductive. The Indian Council of Medical Research (ICMR) sent out a clumsily-worded directive to the 12 hospitals across the country, selected for clinical trials, that they should complete the process and be ready for the launch by Independence Day. This makes it clear that there was political pressure in setting such an unreasonable time frame. The clarification, issued by the apex medical research body that the circular was meant to cut red tape, has not served to clear the air. Cutting red tape should not mean creating a situation where hospital ethics committees are put under duress, researchers made to go easy on informed consent for participants, outcomes are fudged and dissent faces disciplinary actions. This is particularly crucial in view of the questions being raised over the criteria for selecting the hospitals for conducting clinical trials.
The Indian Academy of Sciences has rightly pointed out that science and data cannot be subordinated to political deadlines and exigencies. In this regard, the ICMR must shore up its credibility for the long road ahead because such an accelerated development pathway has never been attempted for any kind of vaccine, anywhere in the world. There is no evidence as yet that the vaccine, being developed by Bharat Biotech, in coordination with the ICMR’s National Institute of Virology, is safe for use on humans. The envisioned timeline for the indigenous vaccine is markedly shorter than other front-runner vaccine efforts from American and Chinese drug makers, most of which started human clinical trials months ago and are now entering the last of the three-stage human trials. There is no alternative to following the international best practices and rigour involved in vaccine development. Though ‘Covaxin’ was approved for human clinical trials by the Drugs Controller General of India, the ICMR director general’s directive to have the vaccine ready for public health use by August 15 has understandably raised eyebrows. This impractical deadline was interpreted as giving Prime Minister Narendra Modi an opportunity to win political points during his Independence Day speech.
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