As the Pfizer-BioNTech coronavirus vaccine has become the first Covid-19 vaccine to gain approval from the World Health Organization (WHO) for emergency use, an expert organization from the Central Indian Medicines Standard Control Organization (CDSCO) will hold a key assembly on Friday. to the Serum Institute of India’s (SII) emergency use authorization programs for the Oxford-AstraZeneca ‘Covishield’ vaccine and Bharat Biotech for its COVID-19 vaccine ‘Covaxin’.
Citing Reuters, Zee Business editor-in-chief Anil Singhvi said Pfizer is the first company of its kind to get the green light from the World Health Organization. “This is a great achievement for any company that gets the World Health Organization label,” he said. added the market guru.
Meanwhile, on Thursday, the Committee of Subject Matter Experts (SEC) on COVID-19 deliberated and analyzed additional knowledge submitted through the SII and Bharat Biotech Pvt. Limited. Limited.
“The CDSCO SEC met this afternoon to consider the application for Emergency Use Authorization (EUA) of Pfizer, SII and Bharat Biotech,” the Ministry of Health said in a statement on Wednesday.
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“Additional time has been requested on behalf of Pfizer. Additional insights and data submitted through SII and Bharat Biotech Pvt. Limitado. Ltd searched and analyzed through the SEC. Analysis of more insights and data is ongoing. The SEC will meet again on January 1, 2021,” he says.
The UK’s Medicines and Healthcare Regulatory Agency (MHRA) on Wednesday approved the COVID-19 vaccine developed by scientists at the University of Oxford and produced by AstraZeneca for human use.
As for Hyderabad-based Bharat Biotech, after extensive deliberations, the committee asked the company to submit protection and efficacy data from the ongoing phase 3 clinical trial in the country for further review.
SII had applied to India’s Chief Medicines Officer (DCGI) for emergency use authorization for Covishield on Dec. 6, while Hyderabad-based Bharat Biotech had applied for the same green light for its evolved Covaxin on Dec. 7.
Pfizer had applied for approval of its vaccine on Dec. 4.
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