ICMR vaccine timeline - An unrealistic approach?
Bio Spectrum|August 2020
A letter written by the ICMR Director General Prof Balram Bhargava to the heads of 12 selected institutions for fast-track clinical trials of the indigenous COVID-19 vaccine, COVAXIN and launching it by August 15 has stirred waves of uncertainty across the country.
Dr.Manbeena Chawla

On July 2, an announcement from the Indian Council of Medical Research (ICMR) to launch the world’s first COVID-19 vaccine by August 15 stirred waves of uncertainty across the country.

This plan was disclosed in a letter written by the ICMR Director General Prof Balram Bhargava to the heads of 12 selected institutions informing them that it has partnered with Hyderabad based Bharat Biotech International Limited (BBIL) to fast-track clinical trials of the indigenous COVID-19 vaccine, COVAXIN. The letter also directed the 12 institutions to initiate subject enrollment for clinical trials by July 7.

Soon after this deadline announcement, huge concerns started to get raised within the scientific community. On July 5, the Indian Academy of Sciences (IASc) voiced out that while it welcomes the exciting development of a candidate vaccine and wishes it is quickly made available for public use, it strongly believes that the deadline is unfeasible and it has raised unrealistic hopes and expectations in the mind of citizens.

“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 rigor. 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 analyzed 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 I of the clinical trial show that the vaccine is not adequately safe, then Phase II 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”, points out Professor Partha Pratim Majumder, President, IASc, Kalyani.

Around the same time, an official statement was issued by the government on the Press Information Bureau (PIB) website highlighting the development of two vaccine candidates by India- COVAXIN by Bharat Biotech and ZyCov-D vaccine by Zydus Cadila. A point worth noting here is that, a sentence- ‘None of these vaccines is unlikely to be ready for mass use before 2021’, was hurriedly removed from the press note within a few hours of uploading it on the website.

Also, a statement issued by Dr. Soumya Swaminathan, Chief Scientist, World Health Organization in a media interview has gone viral in this context, which says “A realistic but very optimistic timeline from the start of Phase I to the completion of Phase III could be about six to nine months if all goes exactly according to plan.”

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