Warning from the Indian Academy of Sciences
On 2nd July 2020, the Director General of Indian Council of Medical Research (ICMR) issued a letter to eight heads of hospitals and medical institutions directing them to expedite the human clinical trials of a vaccine for the Covid-19 developed by Bharat Biotech International Limited (BBIL) with support from CSIR. The vaccine was given approval by the Drug Controller General of India for phase I/II human trials on 29th June. The ICMR letter indicates that it wants all clinical trials to be completed in less than six weeks, before 15th August, so that the vaccine launch can be announced on the Independence Day.
Typical vaccine development takes many years and average time for development of safe vaccines is about a decade. This is because the proposed vaccine has to be tested to ensure that it is not dangerous to humans. Vaccines contain parts of the viral genetic material and can potentially harm the person who receives the vaccine. It is difficult to predict what long term affect such injections into human body can bring about. Long term studies have shown that use of some vaccines can result in onset of cancer and other deadly diseases. Therefore, new vaccines are generally tested on animals before trials on humans are permitted to begin to see if it may be harmful to humankind. After animal trials, there are three to four stages of human trials with progressively larger numbers of subjects before the vaccine can be approved for use.
Several scientists across the country are aghast at the unprecedented plans to run human trials of the vaccine without prior animal studies. The statement of Indian Academy of Sciences (IASc), which is being reproduced below, points out that “(IASc) strongly believes that the announced timeline is unfeasible” and 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.”
Subsequent to this protest from the scientific and medical community, ICMR came up with the feeble excuse that the letter issued to the hospitals shortlisted for clinical trials was meant “to cut down unnecessary red tape.”
The Indian Academy of Sciences (IASc) has noted that a letter reportedly issued by the Indian Council of Medical Research (ICMR) is circulating in the news and other media. It is mentioned in this letter that ICMR and Bharat Biotech India Limited, a private pharmaceutical company, are jointly developing a vaccine against the novel coronavirus, SARS-CoV-2. The letter also states that “It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials.”
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.
While there is an unquestioned urgent need, vaccine development for use in humans requires scientifically executed clinical trials in a phased manner. 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. Clinical trials for a candidate vaccine require participation of healthy human volunteers. Therefore, many ethical and regulatory approvals need to be obtained prior to the initiation of the trials. While administrative approvals can be expedited, the scientific processes of experimentation and data collection have a natural time span that cannot be hastened without compromising standards of scientific rigour. For example, immune responses usually take several weeks to develop and relevant data should not be collected earlier. Moreover, data collected in one phase must be adequately analysed before the next phase can be initiated. If the data of any phase are unacceptable then the clinical trial is required to be immediately aborted. For example, if the data collected from Phase 1 of the clinical trial show that the vaccine is not adequately safe, then Phase 2 cannot be initiated and the candidate vaccine must be discarded.
For these reasons, the Indian Academy of Sciences believes that the announced timeline is unreasonable and without precedent, and is therefore issuing this statement in the public interest. The Academy 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.
On behalf of the Council and the Fellowship of the Indian Academy of Sciences,
Partha P. Majumder