ICMR Issues Clarification To Defend Its August 15 Target To Fast Track Human Trials For Covaxin

Scientific fraternity has reacted sharply and termed it absurd and risky after the Indian Council of Medical Research (ICMR) made claim that it envisaged the “launch” of a Covid vaccine for “public health use latest by August 15”.

After scientific fraternity’s strong criticism against its claims that it envisaged the “launch” of a Covid vaccine for “public health use latest by August 15”, ICMR has today issued clarification, saying that it will develop vaccine to fight Covid-19 as per globally accepted norms of fast tracking.

Though, a large number of vaccines are under various stages of development all across the world, it is important to promote indigenous vaccine development while at the same time ensuring safety, quality, ethics and adherence to all regulatory requirements” says the statement, issued by the ICMR.

Scientific fraternity has reacted sharply and termed it absurd and risky after the Indian Council of Medical Research (ICMR) made claim that it envisaged the “launch” of a Covid vaccine for “public health use latest by August 15”.

Importantly, the August 15 deadline flies in the face of publicly announced timelines for the possible readiness of this vaccine, including the vaccine developer’s own estimate and the timeline provided to the regulatory body, Drug Controller General of India.

Even AIIMS Director Randeep Guleria, the head of the clinical research group of the national task force on COVID-19, seemed surprised.

“It will be a very challenging and difficult task, considering that we have to look at both efficacy and safety of any vaccine that is introduced. Also, if we get the desired results, the other challenge is the process of mass production of the vaccine,” Guleria said.

Shaheed Jameel, a well-known virologist and chief executive of the Wellcome Trust-DBT Alliance that funds health research in India said August 15 timeline was “ridiculous”.

“I fear the global scientific community would be laughing at us for this. It should not have happened. India is a serious player in science. Who is going to trust us if we behave like this? Who is going to believe us even if we indeed come up with a good vaccine tomorrow?… And I am appalled at the kind of language used in the letter. It is not a letter, it reads like a threat,” Jameel said.

The August 15 timeline is mentioned in a letter that ICMR director general Balram Bhargava wrote to the 12 hospitals selected for carrying out clinical trials of Covaxin, a candidate vaccine developed by Bharat Biotech, a Hyderabad-based pharmaceutical company, in partnership with Pune-based National Institute of Virology, an ICMR laboratory.

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