The 15 August deadline set by the Indian Council of Medical Research for Bharat Biotech India Limited to launch a coronavirus vaccine is “unfeasible and has raised unrealistic hopes” in the minds of the people, the Indian Academy of Sciences (IASc) said in a statement.
“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,” the statement said.
The statement referred to a letter by ICMR director-general Balram Bhargava which stated the hospitals selected for phase 1 and phase 2 trials, and said that “it is envisaged to launch the vaccine for public health use latest by 15 August, 2020 after completion of all clinical trials”.
The IASc said that the timeline is “unreasonable and without precedent”, the statement said adding that vaccine development requires scientifically executed trials in a phased manner. Despite the “unquestioned urgent need”, the vaccine has to go through the three phases to evaluate safety, efficacy and side effects, and confirmation of safety before release for public use.
“Clinical trials for a candidate vaccine require the 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. Data collected in one phase must be adequately analysed before next phase can be initiated. If the data of any phases are unacceptable, then the clinical trial is required to be immediately aborted,” the statement read.
The Indian Academy of Sciences @IAScBng has put out a press release today expressing concerns on the letter issued by ICMR pic.twitter.com/BpbZakqqZ9
— Anant Bhan (@AnantBhan) July 5, 2020
The candidate vaccine in question was developed by BBIL in collaboration with ICMR’s National Institute of Virology and was granted approval for phase 1 and 2 trials a week ago. After criticism of the ICMR’s announcement of a 15 August deadline to release the vaccine for public use, the body said in a statement that the 2 July letter designating hospitals for trials and seeking the expedition of the process was meant to “cut unnecessary red tape”.
“Just as red tape was not allowed to become a hindrance in the fast-track approval of the new indigenous testing kits for introducing in the Indian market, the indigenous vaccine development process has also been sought to be insulated from slow file movement,” ICMR said in a statement on Saturday.
from Firstpost India Latest News https://ift.tt/3gpwpeY
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