India’s health ministry rejected reports on Wednesday that the country’s drugs regulator had declined emergency authorisation for the AstraZeneca COVID-19 vaccine candidate and one developed locally by Bharat Biotech and the government.
Broadcasters NDTV and CNBC-TV18 reported that India’s Central Drugs Standard Control Organization (CDSCO) had sought more data from the drugmakers after deliberating on applications made this week.
A source with direct knowledge of the matter told Reuters 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.
Another said: “The CDSCO just wants more data on efficacy and safety before making a decision. It is part of the process”.
Both sources declined to be named as they were not authorised to talk to the media.
India’s health ministry denied the media reports in a statement on Twitter. The government had said on Tuesday that some vaccines may be approved in the coming weeks.
The Serum Institute of India, which is the local manufacturer of the AstraZeneca vaccine, only applied for emergency approval on Monday.
The SII did not immediately respond to a request for comment. Bharat Biotech, whose application reached the government on Tuesday, declined to comment. The CDSCO did not immediately respond to a request for comment.
India, the world’s biggest vaccine maker, has reported nearly 10 million COVID-19 infections, putting it behind the United States globally in overall cases.
NDTV said the CDSCO did not consider a similar application from Pfizer Inc because their U.S. experts could not attend the Wednesday meeting. A Pfizer spokeswoman did not immediately respond to a message seeking comment.
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