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India denies reports it rejected emergency approval for AstraZeneca shot

FILE PHOTO: AstraZeneca’s logo is reflected in a drop on a syringe needle in this illustration taken November 9, 2020. REUTERS/Dado Ruvic/File Photo

NEW DELHI – 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.

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 in the past three days.

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.

India’s health ministry denied the 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 declined to comment. The CDSCO did not immediately respond to a request for comment.

NDTV said the CDSCO did not consider a similar application from Pfizer Inc because their U.S. experts could not attend the Wednesday meeting.

Reuters

December 9, 2020

Reporting by Krishna N. Das, Chandini Monappa and Abhirup Roy; Editing by Andrew Heavens and Alexander Smith

Our Standards: The Thomson Reuters Trust Principles.

https://in.reuters.com/article/health-coronavirus-india-vaccine/india-denies-it-rejected-emergency-astrazeneca-shot-approval-idINKBN28J1KH

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