Mosina bi 01/07/2021

 

Government gives Moderna emergency use nod, may first come in only as donations

donations

While the government said details on the quantity of doses to be imported to India by Cipla are still under consideration, The Indian Express has learnt that the vaccine is initially expected to be provided to India in limited quantities — as donations by the US drug maker.

Written by Kaunain Sheriff M , Prabha Raghavan | New Delhi |Updated: June 30, 2021 7:18:58 am

This is also the first internationally developed vaccine to be granted a waiver from conducting bridging trials in India.

The national drug regulator on Tuesday granted emergency use authorisation to US biotechnology firm Moderna for its vaccine against the novel coronavirus, paving the way for its Indian partner Cipla to import the first mRNA Covid-19 vaccine into the country for commercial use. This is also the first internationally developed vaccine to be granted a waiver from conducting bridging trials in India.

While the government said details on the quantity of doses to be imported to India by Cipla are still under consideration, The Indian Express has learnt that the vaccine is initially expected to be provided to India in limited quantities — as donations by the US drug maker

Confirming the emergency use approval to Moderna’s mRNA Covid-19 vaccine, Dr V K Paul, head of the national Covid task force, on Tuesday said, “I am pleased to inform that an application received from Moderna, through an Indian subsidiary and partner of theirs, Cipla, has been granted new drug permission for restricted use, commonly known as Emergency Use Authorisation. This is the first internationally developed vaccine for which such permission exists as of today,” Paul said.

Explained |How Moderna vaccine works and why DCGI nod for its emergency use is significant

He, however, said discussions on whether Moderna and Cipla would receive indemnity — protection from legal liability in the case of adverse effects — are still