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Moderna’s Covid vaccine gets nod for restricted use

Our Bureau New Delhi | Updated on June 29, 2021

Cipla says it is part of US donation, only helping with regulatory norms

Moderna’s mRNA vccine has become the first Covid-19 vaccine to get Emergency Use Authorisation (EUA) without  bridge trials in India. Mumbai-based pharmaceutical company Cipla has got the  regulatory approval to import Moderna for  use in India, VK Paul, NITI  Aayog, Member-Health, told the media here on Tuesday. With this, the country will have four Covid vaccines — Covaxin, Covishield, Sputnik and Moderna.

But a Cipla source told BusinessLine that no definitive commercial agreement had been formalised between the companies and this was part of the US donation. Cipla was supporting all regulatory activity for Moderna in India, the source said.

Paul said; “There must be other formalities which we will have to follow. Our efforts to invite and to have other internationally developed vaccines specifically like Pfizer and J&J will also continue. We are also looking to further increase the availability of our own vaccines.

“The regulatory step has been cleared. The technical modalities...  let’s wait and watch, how this opportunity is to be used for importing vaccines,” he said  responding to a query if  the clearance for Moderna’s vaccine is a commercial deal or relates to the donation promised by the US administration. He also said though exempt from bridging trials, the first 100 doses administered will be watched.

Vaccine industry-insiders are watching the Moderna development  closely, as there are issues to do with pricing and indemnity when it comes to foreign vaccines. The pricing issue may not come-up just yet, since this is a donation. But the Centre has not yet articulated how it will address the indemnity that vaccine-makers, especially the foreign ones, have sought against litigation.

More rural cover

On vaccination coverage in the country, Lav Agarwal, Joint Secretary, Health Ministry, said 56 per cent of the jabs between May 1 and June 24 was in rural areas and the rest  in urban areas.

On vaccination of pregnant women, he  said, “The National Technical Advisory Group on Immunisation recommendation has come and is being examined with other stakeholders. Based on that  orders will be issued soon.”

Paul cautioned that guard should not be lowered as  still there are 111 districts reporting more than 100 Covid cases daily, and these are mostly in Kerala, Tamil Nadu, Karnataka, Andhra Pradesh, Odisha and West Bengal.

Published on June 29, 2021

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