The Indian Council of Medical Research’s (ICMR’s) target of August 15 to “launch for public health use” the Covid-19 vaccine candidate Covaxin is “unfeasible” and has raised “unrealistic” hopes, some of India’s most eminent scientists said on Sunday.
The Council and the Fellowship of the Indian Academy of Sciences (IASc), a forum comprising 1,100 of the country’s foremost scientists, welcomed the development of the vaccine candidate by ICMR and Bharat Biotech, but cautioned against rushing into “any hasty solution that may compromise rigorous scientific processes and standards”.
In a statement, the scientists said: “IASc welcomes the exciting development of a candidate vaccine and wishes that the vaccine is quickly made available for public use. However, as a body of scientists — including many who are engaged in vaccine development — IASc strongly believes that the announced timeline is unfeasible. This timeline has raised unrealistic hope and expectations in the minds of our citizens.”
In a communication issued to clinical trial sites on July 2, ICMR Director-General Dr Balram Bhargava had said, “It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials.” Following strong criticism from scientists and experts, ICMR said on Saturday that its letter “was meant to cut unnecessary red tape”, but remained silent on the August 15 timeline.
“While there is an unquestioned urgent need, vaccine development for use in humans requires scientifically executed clinical trials in a phased manner,” the IASc said. “These trials involve evaluation of safety (Phase 1 trial), efficacy and side effects at different dose levels (Phase 2 trial) and confirmation of safety and efficacy in thousands of healthy people (Phase 3 trial) before its release for public use.”
The development of a vaccine is a long, uncertain process that can run for decades and still yield no results. Even after three decades of research, a vaccine for HIV is still in phase III of clinical trials. The vaccine for mumps was one of the fastest to be developed, but it still received approval four years after trials began in 1963.
“While the administrative approvals can be put on a fast track, the scientific process in developing a vaccine needs to take its natural course,” Prof Partha P Majumder, president of the IASc Council, said. “First of all timelines for vaccines differ from vaccine to vaccine and cannot be predicted. Essentially, you cannot have a timeline for the launch of a vaccine because, for instance, if your first phase fails, then you have to discard the entire process and start afresh,” he said.
“An injectable vaccine, which Covaxin will be, takes longer than an oral vaccine,” Prof Majumder said. “And the ICMR has announced a clinical trial period of a month – this is unprecedented. This is unheard of and gives a bad name to the industry of biomedical research and pharmaceuticals. It is foolish and a shame on any organisation.’’
The Council had met on Saturday and decided to issue the statement “in the public interest”, Prof Majumder said.
In its statement, the IASc said that it “believes that the announced timeline is unreasonable and without precedent” and that it “strongly believes that any hasty solution that may compromise rigorous scientific processes and standards will likely have long-term adverse impacts of unforeseen magnitude on citizens of India”.
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