Key expert panel meet today to review data on Serum Institute, Bharat Biotech Covid-19 vaccines

The SEC had met a second time on Wednesday to review their EUA application, after UK’s MHRA granted emergency-use approval to the SII Oxford-AstraZeneca vaccine

Updated on: Jan 1, 2021, 09:22:42 IST

Hindustan Times, New Delhi | By Rhythma Kaul

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The subject expert committee (SEC) of the national drugs regulator will meet again on Friday to take a decision on the emergency-use authorisation (EUA) application of Serum Institute of India’s (SII) Oxford-AstraZeneca and Bharat Biotech’s vaccine candidates against Coronavirus disease (Covid-19).

The SEC had met a second time on Wednesday to review their EUA application, after UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted emergency-use approval to the SII Oxford-AstraZeneca vaccine on Wednesday.

SII has partnered with the company to conduct clinical trials and manufacture the vaccine in India.

Also Read: From cargo planes to vans: Here’s how Centre plans to distribute Covid-19 vaccine

On December 24, SII had submitted the additional clinical trial data that the Central Drugs Standard Control Organisation (CDSCO)’s SEC had asked for in its meeting held on December 9 to review its application.

The UK regulator (UK-MHRA) was also reviewing the necessary data, and according to experts, it would have been advantageous if there was already an approval in place from the local regulator, even though it was not mandatory.

Three companies have applied for EUA for their Covid-19 vaccine candidates. The companies are Pfizer, SII and Bharat Biotech. While Pfizer did not show up for the presentation on the earlier dates and sought more time, the expert panel reviewed the data of the other two companies and asked for more details.

SEC had recommended that both the companies submit additional data.

In Wednesday’s meeting also some documents were found lacking and needed to be updated by SII and some additional data was sought from Bharat Biotech.

ABOUT THE AUTHOR
Rhythma Kaul
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.Read More

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