A day after asking Bharat Biotech to fast-track COVID-19 vaccine, ICMR on Saturday issued a clarification saying the process is in accordance with globally accepted norms.
ICMR had on July 2 asked Bharat Biotech in an internal communication to fast-track clinical trials of the indigenous COVID-19 vaccine.
In an official statement, ICMR Director General Balram Bhargava had stated that ICMR envisages the launch of the indigenous COVID-19 vaccine by August 15. Bharat Biotech recently got a nod for the clinical trial of its vaccine - COVAXIN.
"ICMR’s process is exactly in accordance with globally accepted norms to fast-track the vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel," it said.
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"The letter by DG-ICMR to investigators of the clinical trial sites was meant to cut unnecessary red tapes, without bypassing any necessary process, and speed up recruitment of participants," ICMR added.
Several scientists have expressed concerns saying "it is imperative to strike a balance between giving it a high priority and rushing into a process that takes months, even years."
"Fast-tracking a vaccine trial in four weeks for safety, immunogenicity and efficacy are just not possible if things are to be done correctly,” Shahid Jameel, virologist and CEO of the Wellcome Trust/DBT India Alliance, a public charity that invests in building biomedical sciences and health research framework, told PTI.
“The ICMR 'letter' is, to say the least, a deeply inappropriate letter, in tone and content, both in terms of the integrity of due processes of product development, and in terms of technically realistic estimates,” immunologist Satyajit Rath said.
Meanwhile, Opposition leaders have alleged that the ICMR was trying to fast-track the production of a coronavirus vaccine so that Prime Minister Narendra Modi could make the announcement on Independence Day.
"A vaccine would be the most decisive redemption from the pandemic. The world is waiting for a safe vaccine, which is universally accessible. But...scientific advances can never be 'made to order'. Forcing the development of an indigenous vaccine as a cure for COVID-19, bypassing all health & safety norms, to be announced by PM Modi on Independence Day is fraught with horrendous human costs," CPI(M) general secretary Sitaram Yechury tweeted on Saturday.
Congress leader Prithviraj Chavan, too, on Saturday alleged that the ICMR's plans to launch a coronavirus vaccine by August 15 was aimed only at enabling the Prime Minister to make a big announcement from the Red Fort.
(With agency inputs)
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