ICMR issues clarification on 40-day target to roll out Covid-19 vaccine

After it was pilloried for setting up a target of just 40 days to roll out India’s first Covid-19 vaccine, Indian Council of Medical Research issued a clarification on Saturday underscoring that “safety and interest of people are the topmost priority” of the agency and the controversial letter from its director general was only meant to cut the red tape.

“The letter by DG-ICMR to investigators of the clinical trial sites was meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants,” the medical research agency said in a press statement.

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In a letter to 12 hospitals chosen for Phase-I and II human clinical trials of the vaccine candidate, ICMR Director General Balram Bhargava wrote that the hospitals have to complete the volunteer recruitment process by July 7 and would have to accord the “highest priority” to the project that was being monitored at the “topmost level in government”.

“It is envisaged to launch the vaccine for public health use latest by August 15, 2020 after completion of all clinical trials,” he said in the letter dated July 2.

A former professor at the All India Institute of Medical Sciences, Delhi, Bhargava has been heading the ICMR since 2018.

Going by the global experience, a minimum of 15-18 months are required for bringing out a vaccine to the market from the preclinical stage and that too if everything goes according to the plan like a clockwork. For a comparison, the indigenous rotavirus vaccine took 30 years to hit the market.

Hyderabad-based Bharat Biotech manufactured the indigenous Covid-19 vaccine using a strain isolated by the National Institute of Virology, Pune.

Based on successful preclinical trials, the Drugs Controller General of India approved the vaccine for phase-I and phase-II trials that would be carried out on 1125 individuals.

In the clarification, the ICMR did not fix any specific date on the indigenous vaccine development process but maintained that the purpose of the letter was to insulate the process from slow file movement.

“The aim is to complete these phases (Phase-I & II) at the earliest, so that population-based trials for efficacy could be initiated without delay.”

“The ICMR process is in accordance with the globally accepted norms to fast-track the vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel. all other vaccine candidates across the globe have been similarly fast-tracked,” it added.

The criticisms, however, refused to die notwithstanding the clarification. "If everything goes absolutely really like a textbook plan, then we are talking about six to eight months to think of something that now we have a vaccine,” said Rakesh Mishra, director of the Centre for Cellular and Molecular Biology, Hyderabad – a CSIR laboratory.

“Fast tracking a vaccine trial in four weeks for safety, immunogenicity and efficacy is just not possible if things are to be done correctly,” said 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.

A group of doctors and scientists representing a body named Progressive Medicos and Scientists Forum demanded resignation of Bhargava for the “sham of a trial” and “vaccine fixing.”