COVID-19 vaccine: Pfizer, Moderna have not submitted applications for EUA, says DCGI

The Drugs Controller General of India (DCGI) is yet to receive the applications of US-based pharma giants Pfizer and Johnson and Johnson for emergency use authorisation for their respective COVID-19 vaccine. Moderna is also yet to provide 7 million doses to India from the US under the COVAX facility. Since DCGI approved Moderna, Cipla will import the vaccines but no call has been taken on legal indemnity so far.

Both Moderna and Pfizer have sought legal indemnity in case of any adverse effects of their vaccine. "Talks initiatives, no reply has come from them. We are waiting for the process. Negotiations are on with a positive mind. We are in the process of trying to clinch it but there's back and forth as it's a negotiated process," Niti Aayog member Dr VK Paul told news agency ANI.  

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This is the third time the Indian drug regulator has appealed Pfizer to file application papers to bring its vaccine to India. In its letter to the DCGI, Pfizer had sought protection against legal proceedings in case of any side effects or adverse events due to its vaccine.

Pfizer CEO Albert Bourla had stated last month that Pfizer's vaccine is in the final stages of getting approved in India. "I hope very soon we will finalise an agreement with the government," Bourla stated at the 15th Annual BioPharma and Healthcare Virtual Summit of USA in June.

Edited by Mehak Agarwal; with ANI inputs

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