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India is working on Moderna offer for Covid-19 vaccine: Top health official

India is racing against time to vaccinate its 135 crore population with at least one dose by the end of this year, and in another shot in the arm in that regard, a top health official in the government on Tuesday said that modalities for the approval of the Moderna vaccine is currently underway.

“There is an offer and we are working on it. Covaxin is conducting their studies and Zydus Cadila has given their study data for their vaccine. We are also encouraging Biological E, Novavax to conduct paediatrics study, once found safe in adults,” Dr VK Paul, Member-Health at NITI Aayog, said.

Moderna Inc is currently in talks with the drug regulators in the United States to expand the size of the ongoing trials in children aged between 5 and 11, the company said today.

“The objective of the discussion with the US Food and Drug Administration (FDA) is to enroll a larger safety database, which increases the likelihood of detecting rarer events,” the vaccine manufacturer said.

According to news agency Reuters, Moderna aims to have a package that supports authorisation by 2021 winter or early 2022.

Union Health Secretary Rajesh Bhushan on Tuesday said that vaccination certificates will be issued only to such vaccines that are approved for emergency use in India and for volunteers who have participated in the trials.

At present, only three vaccines have been approved by the Drug Controller General of India (DCGI) for emergency use in the country – Oxford/AstraZeneca’s Covishield vaccine manufactured by Serum Institute of India, Bharat Biotech’s Covaxin, and the Russian ‘Sputnik V’.

He further said that the Health Ministry “will provide data template to ICMR for compilation of relevant vaccination data for participants of unblinded trials, so that necessary details required for issuing certificates can be captured on Co-WIN”.

 

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