Bharat Biotech International Ltd., an unlisted vaccine maker, received regulatory approval to start human clinical trials for its experimental shot earlier this week and it already has India’s top medical research body expediting the process.India has set an ambitious timeline for its first potential coronavirus vaccine — from human trials to general use in six weeks.
The under-development vaccine is “envisaged” to be rolled out “for public health use by Aug. 15 after completion of all clinical trials,” Indian Council of Medical Research, or ICMR, said in a July 2 letter to clinical trial sites, which was seen by Bloomberg News. It “is one of the top priority projects which is being monitored at the topmost level of the government.”
The bid underscores India’s urgent need for a way to halt the coronavirus, which has sickened more than 6,97,000 people and killed over 19,600 in the Asian nation — the world’s third-largest outbreak. In its letter, ICMR urged the trial sites to enroll volunteers by July 7.
The speediness has alarmed some in the medical fraternity. “Such an accelerated development pathway has not been done EVER for any kind of vaccine, even the ones being tried out in other countries,” Anant Bhan, a medical researcher at India’s Manipal University, said in a Twitter post. “Even with accelerated timelines, this seems rushed and hence, with potential risks.”
There’s been no evidence yet that Bharat Biotech’s vaccine is safe for use on humans, not to mention effective. The envisioned timeline is markedly shorter than other front-runner vaccine efforts from American and Chinese drugmakers, most of which started human clinical trials months ago and are now entering the last of three stages of testing.
