It’s important to expedite clinical trials of an indigenous virus vaccine: ICMR

The Indian Council of Medical Research on Saturday justified speeding up clinical trials of a promising indigenous Covid-19 vaccine developed by Bharat Biotech International Ltd.

“In the interest of public health, it is important that ICMR streamlines clinical trials with a promising indigenous vaccine,” ICMR said of an ambitious schedule for India’s first potential coronavirus vaccine, from human trials to general use in six weeks.

Bharat Biotech International Ltd., a non-listed vaccine maker, received regulatory approval to begin human clinical trials for experimental injection only earlier this week, but it already has the highest body of medical research from India that speeds up the process.

The developing vaccine is “scheduled” to be implemented “for public health use by August 15 after completing all clinical trials,” ICMR said in a July 2 letter to clinical trial sites, which was seen by Bloomberg News. “It is one of the highest priority projects being monitored at the highest level of government.”

There is still no evidence that the Bharat Biotech vaccine is safe for use in humans, not to mention that it is effective. The predicted timeline is noticeably shorter than other cutting-edge vaccination efforts by American and Chinese drug makers, most of which started human clinical trials months ago and are now entering the last of three testing stages. .

“Given the unprecedented nature of the Covid-19 pandemic, all other vaccine candidates around the world have been similarly accelerated,” ICMR said at launch.

“The ICMR process is exactly in accordance with globally accepted standards to accelerate the development of vaccines for diseases of pandemic potential in which human and animal trials can continue in parallel,” the medical research body said Saturday. apex.

Bharat Biotech plans to enroll 375 people in the first phase and 750 people in the second phase of clinical trials, said an ICMR spokesperson. Whether the vaccine will be approved for general use depends on the results of those trials, he said.

The trial will “probably” start on Monday, said C. Prabhakar Reddy, a professor at the Nizam Institute of Medical Sciences in Hyderabad, one of the trial sites that received the letter from ICMR. “We all work day and night to meet the deadline.” But it will still be a neck-to-neck race, “he told Bloomberg, adding that he does not anticipate any shortage of volunteers” in the current scenario. ”

On Friday, the apex research body wrote to selected medical institutions and hospitals to speed up clinical trial approvals for the candidate for the Covaxin coronavirus vaccine being developed in collaboration with Bharat Biotech, which it plans to launch on August 15.

The vaccine is derived from a SARS-CoV-2 strain isolated by ICMR-National Institute of Virology, Pune.

ICMR and Bharat Biotech are working together for the preclinical and clinical development of this vaccine, a letter from ICMR mentioned, ANI reported.

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