“Covaxin by Aug 15”: Why is India Defying Science to Win Brownie Points on Independence Day?

Coronavirus

“Covaxin by Aug 15”: Why is India Defying Science to Win Brownie Points on Independence Day?

Illustration: Reynold Mascarenhas

There are deadlines set to college assignments and office projects, but India became the first country in the world to set a deadline for the release of a vaccine during a pandemic. Hyderabad-based Bharat Biotech is developing Covaxin in collaboration with the Indian Council of Medical Research and National Institute of Virology. In a letter to 12 institutes dated July 2, the ICMR asked them to “fast track clinical trials” of Covaxin, the country’s first indigenous Covid-19 vaccine. In a sentence that raised eyebrows, the ICMR stated, “It is envisaged to launch the vaccine for public health use latest by 15 August, 2020 after completion of all clinical trials.”

Yes, you read that right… which is six weeks from now.

The deadline was interpreted as giving Prime Minister Narendra Modi an opportunity to make a big announcement in his Independence’s Day speech.

Experts pointed out that these rushed timelines were unheard of, for any vaccine development anywhere in the world. Assuming efficacy of Covaxin and completing trials within a month was a grave compromise of scientific process and could pose unpleasant outcomes. “It has lowered the credibility of ICMR, and along with that of India’s scientific community, regulatory system government, and the potential vaccine (itself)… its reputation is dented before it is even ready. It’s bad enough to have (Baba) Ramdev declaring a Covid-19 cure by press release, now we have ICMR appearing to ask investigators to bypass scientific protocols,” said Dr T Jacob John, virologist and former professor at Christian Medical College, Vellore, Tamil Nadu.

India’s foremost science academy, the Indian Academy of Sciences issued a stinging statement on the Aug 15 deadline. “Scientific processes of experimentation and data collection have a natural time span that cannot be hastened without compromising standards of scientific rigour. Data collected in one phase must be adequately analysed before the next phase can be initiated. The Academy strongly believes that any hasty solution that may compromise rigorous scientific processes and standards will likely have long-term adverse impacts of unforeseen magnitude on citizens of India.”

Similar concerts were echoed by World Health Organisation’s chief scientist Soumya Swaminathan. “The development of a potential coronavirus vaccine must show efficacy and safety, adding that the completion of its trials could take six to nine months,” she said.

However, there was a twist in the tale to the Covaxin story. In a press release, the Ministry of Science and Technology said that the development of a potential coronavirus vaccine is unlikely to be ready for mass use before 2021. “Along with the 2 Indian vaccines, COVAXIN and ZyCov-D, the world over, 11 out of 140 vaccine candidates have entered the human trials.  None of these vaccines is unlikely to be ready for mass use before 2021,” the statement read. It was seen as a quiet acceptance by the government of its earlier blunder. However when pointed out, the line was later deleted, citing incorrect grammar.

The ICMR has justified its July 2 letter saying it was “meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants.” It said that while feedback in the public domain is welcomed, the best of Indian medical professionals and scientists should not be second-guessed for their professionalism. “In the larger public health interest, it is important for ICMR to expedite clinical trials with a promising indigenous vaccine. Faced with the unprecedented nature of the COVID-19 pandemic, all other vaccine candidates across the globe have been similarly fast-tracked,” it added.

Yes, India needs the vaccine as it could save millions of lines. But now is not the time for optics. One can only hope that science will be the driver in the development and clinical trials related to Covaxin, and not politics.

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