Showmanship is for politics, not science, warn researchers on the ICMR’s rush to launch Covaxin by August 15
Science cannot be rushed”, is a common refrain across our scientific community as the nation’s topmost medical research body, the Indian Council of Medical Research (ICMR), said it was attempting to launch the nation’s first COVID-19 vaccine, Covaxin, on August 15. The Ministry of Science had to curb such ambition with a statement saying it would not be ready before 2021. In effect, the ICMR is saying that while all the other countries, who are way ahead of us in terms of their research and trials on the vaccine and still would not be able to release it by the year-end, India by some miracle, would be able to do so in less than two months of it being approved for trial. This is a timeline unheard of anywhere in the world and even the Oxford COVID-19 vaccine, which is miles ahead of us, is expected to hit the Indian market at the end of this year at the earliest. ICMR may defend itself, saying it is cutting through red tape but vaccine development does take time. Under normal circumstances, clinical trials on volunteers who are innoculated take over 10 years. However, given the pandemic and its effects on the world economy and health, this timeline has been compressed by most scientists around the world. The trials will now combine Phase 1 and Phase 2 to speed up the process. Phase 1, usually small, is used to determine a vaccine’s safety profile while Phase 2 employs a bigger sample size and looks at the immune responses. However, a vaccine is deemed safe to be commercially available only after Phase 3, which is a much larger efficacy trial involving thousands of participants. But even with a telescoped timeline, experts don’t expect to see a vaccine before 12-18 months. This makes the ICMR’s plans scientifically implausible.
Worryingly, for Indians, who will be the final recipient of the shots, the trial document for Covaxin does not mention Phase 3. Even for Phase 1 and Phase 2, there appears to be some confusion over the sequence to be followed. Seven of the 12 participating institutes are yet to receive a green signal from independent ethics committees, a prerequisite for conducting clinical trials. And in one month, it is only possible to determine immediate safety, tolerability and immunogenicity of a candidate vaccine. It is not enough to find out if it is effective in preventing infections. Earlier, Bharat Biotech (BBIL), the Hyderabad-based firm which is developing the vaccine jointly with the ICMR, had itself indicated its availability for mass use by early 2021. Now, it seems to be toeing the Government line. As the country’s top research body, ICMR should have the gumption to resist political pressure and explain to its political bosses that human health and lives cannot be put at risk for the sake of showmanship or electoral gains.
Source: The Pioneer