This is an archive article published on December 23, 2020
Serum Institute submits fresh data for Covishield emergency approval
“Serum Institute India has submitted additional data. The regulator’s office, internally, will review these documents. Only then they will request the Subject Expert Committee (SEC) to meet,” sources told The Indian Express.
New Delhi | Updated: December 23, 2020 07:34 AM IST
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At the Pune-based Serum Institute of India, which has collaborated with Oxford University and pharmaceutical major Astra Zeneca for the production of one of the five vaccine candidates in India. (Reuters)
Just two weeks after the expert committee scrutinising applications for emergency use authorisation (EUA) of Pune-based Serum Institute of India’s Covid-19 vaccine sought additional late-stage safety and efficacy data, the firm has submitted fresh data to the regulator, government sources said.
“Serum Institute India has submitted additional data. The regulator’s office, internally, will review these documents. Only then they will request the Subject Expert Committee (SEC) to meet,” sources told The Indian Express.
Significantly, the media has reported that the UK regulator is set to “clear” the Oxford-AstraZeneca vaccine, “possibly on December 28 and December 29”. In India, SII which sought EUA from the Drugs Controller General of India (DGCI) on December 10 was asked to submit safety data on Phase 2/3 clinical trials in India of its vaccine candidate named Covishield, developed by Oxford-AstraZeneca.
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During the weekly briefing, Dr V K Paul, who co-chairs the high-level committee on vaccine administration, without naming the Pune-based firm, Tuesday said the process of examining additional data has begun. “As everyone knows, there are three applications before the DGCI; they include Pfizer, Serum Institute and Bharat Biotech. Pfizer has not yet submitted data. The other two companies had presented the data and the regulator sought additional data. This is a normal process,” Paul said.
Paul further reiterated that the decision for granting approval for EUA will be based on established scientific norms.
The SEC, which consists of a panel of experts, had earlier said that SII has presented their proposal along “with the interim safety data from Phase II/III clinical trial carried out in the country and the interim safety and efficacy results of Phase II/III and Phase III clinical trials carried out in the UK, other countries & India before the committee”.
Kaunain Sheriff M is an award-winning investigative journalist and the National Health Editor at The Indian Express. He is the author of Johnson & Johnson Files: The Indian Secrets of a Global Giant, an investigation into one of the world’s most powerful pharmaceutical companies.
With over a decade of experience, Kaunain brings deep expertise in three areas of investigative journalism: law, health, and data. He currently leads The Indian Express newsroom’s in-depth coverage of health.
His work has earned some of the most prestigious honours in journalism, including the Ramnath Goenka Award for Excellence in Journalism, the Society of Publishers in Asia (SOPA) Award, and the Mumbai Press Club’s Red Ink Award.
Kaunain has also collaborated on major global investigations. He was part of the Implant Files project with the International Consortium of Investigative Journalists (ICIJ), which exposed malpractices in the medical device industry across the world. He also contributed to an international investigation that uncovered how a Chinese big-data firm was monitoring thousands of prominent Indian individuals and institutions in real time.
Over the years, he has reported on several high-profile criminal trials, including the Hashimpura massacre, the 2G spectrum scam, and the coal block allocation case. Within The Indian Express, he has been honoured three times with the Indian Express Excellence Award for his investigations—on the anti-Sikh riots, the Vyapam exam scam, and the abuse of the National Security Act in Uttar Pradesh. ... Read More
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