Panel clears withdrawal of ‘clinical trial’ tag for Covaxin
Covaxin was being administered as an extension to its clinical trial, with those receiving the dose required to provide informed consent and the company needed to make follow-up calls to check for adverse effects for at least some period.
The subject expert committee of central drugs standards organisation (CDSCO) cleared Bharat Biotech’s coronavirus vaccine Covaxin for emergency use authorization (EUA), recommending the “clinical trial mode” condition be relaxed, which will bring it at par with the other dose, Covishield.
Last week, the company determined it was 81% effective in preventing Covid-19 in an interim analysis. (AP)
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Covaxin was being administered as an extension to its clinical trial, with those receiving the dose required to provide informed consent and the company needed to make follow-up calls to check for adverse effects for at least some period. This was because the company was yet to determine efficacy at the time of the approval on January 3.
Last week, the company determined it was 81% effective in preventing Covid-19 in an interim analysis.
“The company submitted the interim phase 3 trials data three-four days back,” confirmed a senior official in the know of things in CDSCO. The SEC looked into the phase 3 interim data before making its recommendation, which will now need to be cleared by the Drugs Controller General of India (DCGI). The change could give a further boost to the dose, helping address hesitancy concerns.
Rhythma Kaul is the national health editor of the Hindustan Times. She has been reporting on public health, medicine, and medical research, with a particular focus on how government decisions and health system reforms shape people’s lives. Rhythma has over 25 years of journalistic experience. She joined Hindustan Times in 2008, and has since covered everything from pandemics and infectious diseases to cutting‑edge medical research and climate‑related health challenges. Her stories routinely track the work of the Ministry of Health and Family Welfare, department of pharmaceuticals, and key national health programmes, making complex medical science and policy accessible to a wide audience. One of her prominent news breaks has been the 2012 Baby Falak case: A two-year-old brutally battered baby girl was admitted to AIIMS-Delhi with severe head injuries, multiple fractures, human bite marks, and burns. The police investigation revealed this to be a case of multi-state human-trafficking racket. She was profiled by The Wall Street Journal for breaking this story. Rhythma holds a Master’s degree from Jawaharlal Nehru University, Delhi. Prior to Hindustan Times, she worked with the India Today Group. Rhythma can be contacted at rhythma.kaul@hindustantimes.com. Her X handle is @RamblingBrook.
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