A letter by the Indian Council of Medical Research (ICMR) urged fast-tracking of clinical trials and launch of Bharat Biotech’s coronavirus vaccine- COVAXIN. The deadline for the launch has been set as August 15. Looking at the complexity and time required by trials, scientists find the deadline difficult to adhere to.
Bharat Biotech partnered with ICMR and NIV to develop the vaccine and got approval for human clinical trials earlier this week. The ICMR Director General Balram Bhargava advised: ‘to fast-track all approvals related to the initiation of the clinical trials and ensure that the subject enrollment is initiated no later than July 7’. He stated that it’s an ‘urgency to launch the vaccine’.
The publicly announced timelines by ICMR are both absurd and risky. It is the first indigenous vaccine being developed in India and must be dealt with as ” Top priority projects” is what ICMR believes. AIIMS Director Randeep Guleria, the head of the clinical research group of the national task force on COVID-19, seemed surprised. “It will be a very challenging and difficult task, considering that we have to look at both the efficacy and safety of any vaccine that is introduced. Also, if we get the desired results, the other challenge is the process of mass production of the vaccine,” Guleria told The Indian Express.
The vaccine got approval for phase I and II human trials on June 29 and it was said that the results will be out only by October. Now, the changed timeline seems unrealistic to the scientific community. ICMR said that the motive of the letter was to convey the urgency of the project and that we need the vaccine at the earliest. But the tone of the letter conveyed it differently, suggesting that noncompliance will be treated seriously. It seemed more of a threat than a message.
As a result, the process is being rushed and we can hope for the vaccine to meet the unrealistic timelines.
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