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Serum Institute, Bharat Biotech Vaccines Emergency Use Not Cleared Yet

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The requests for emergency use of vaccines being manufactured by the Serum institute and Bharat Biotech were not cleared today by a committee of health experts. Both companies have been asked to submit more data at the next meeting, the date of which has not yet been decided.

The final call on the suitability of the vaccine will be taken by the Drug Controller of India or DCGI.

The Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) met today to review the applications of Pfizer, Serum Institute of India and Bharat Biotech. Pfizer was on the agenda but was not considered today as their experts from the US were not available.

Serum Institute has been asked to submit updated safety data of clinical trials in the country, immunogenicity data from the clinical trial in UK and India and the outcome of the assessment of the UK regulator. Bharat Biotech has been asked for safety and efficacy data from the ongoing Phase III clinical trials in the country.

Approvals are a long process and today’s review is only the start, sources said.

Reuters quoted a “source with direct knowledge of the matter” as saying that a decision on the vaccines would be taken “in toto” and it was too early to say whether they would be rejected or accepted.

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