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Controversy over vaccine trial deadline: not meant to bypass process, ICMR clarifies.

The Indian Council of Medical Research’s letter for speeding up the vaccine trial so as to made available by August 15 has been severely scrutinized by medical fraternity. The letter sent to the 12 hospitals where the clinical trial of the COVAXIN—a COVID 19 vaccine candidate from India—is going to take place, virtually exhorting the scientists to expedite the process and providing it for ‘public health use by August 15’ triggers strong reaction from health experts and scientist. 

“I would find it very surprising if it is done. Even the most ambitious companies in the world that are in more advanced stages of development for their Covid-19 vaccines have a longer time-frame. Even having all the trial results, with safety and efficacy data, by August 15 is difficult. This raises several questions,” Dr Anant Bhan, Researcher, Global Health, Bioethics and Health Policy told the Indian Express. 

Most of the scientists were critical of the ICMR instruction and said that well established scientific norms should not be compromised in an ‘unquenched thirst to proclaim first’ and ‘process and standard operating procedure’ (SOP’s) must not be disregarded.

Dr. Sanjeev Bagai, Chairman and M. D. Nephron Clinics said, “you can fast track approval, license or even ethical committee review but you cannot fast track human beings, the human beings’ cells, immunology to show response”.

Whenever a body is challenged to produce antibody to know about the efficacy of vaccine, it takes weeks and months to show response. It takes 4 to 8 weeks to get a fair view into large cohort to see what kind of antibody response is appearing, Dr. Sanjeev said. 

“Questions such as what would be the side effect? what would be the immunogenicity? what would be the dose? what would be the indications and contraindications etc.? should be properly considered to ensure proper safety”, he stressed.

Meanwhile ICMR clarifies that letter doesn’t ask to make any compromise on safety standards. It was a bid to reduce red tapism and would not bypass any process. 

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