Drug Regulator Denies EUA To Pfizer's Vaccine
The Times of India Hyderabad|February 06, 2021
Co Withdraws Papers, Says Will Resubmit Request
Sushmi Dey & Rupali Mukherjee
Drug Regulator Denies EUA To Pfizer's Vaccine

New Delhi/Mumbai: The Indian drug regulator's subject expert committee (SEC) has denied emergency use authorization (EUA) to Pfizer's Covid-19 vaccine on the ground that the causality of its reported adverse events was being probed and the company had not presented any plan to generate safety and immunogenicity data.

The regulator's decision came even as US-based Pfizer announced on Friday that it was withdrawing its application for emergency use approval. The expert panel also held the absence of data from local clinical trials as a reason for not proceeding with Pfizer's application.

This story is from the February 06, 2021 edition of The Times of India Hyderabad.

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This story is from the February 06, 2021 edition of The Times of India Hyderabad.

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