New Delhi: Both Pune-based Serum Institute and Hyderabad-based Bharat Biotech have not got the go-ahead yet for emergency use of their vaccine candidates.
An expert committee of health experts has asked them to submit more data at the next meeting, the date of which has not yet been decided.
Not unduly perturbed, Serum India sources said it is a normal procedure and the process is expected to continue for two weeks. One view in the committee was to wait for UK to first grant approval to Oxford University's Covid-19 vaccine candidate -- Covishield -- which the Serum Institute is manufacturing in India, and then move forward.
There were certain media reports which said the DGCI had “rejected” the emergency use authorization. The Union Ministry of Health and Family Welfare immediately clarified that the two requests for emergency use have not been turned down and the media report was fake.
A Reuters report quoted sources 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.
The Subject Expert Committee of the Central Drugs Standard Control Organisation met on Wednesday to discuss the emergency authorisation applications. Serum is currently undergoing Phase 3 clinical trials in India while Bharat Biotech is yet to complete these, Associated Press quoted health officials as saying. Apart from these, Pfizer has also applied for emergency use permission and its application is under consideration.
According to Indian rules for accelerated approval of vaccines, a company can be granted a license if regulators are “satisfied with the risk-benefit ratio,” said Balram Bharagava, head of the Indian Council of Medical Research.
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