Udayavni Special

Moderna seeks regulatory approval for its COVID-19 vaccine


Team Udayavani, Jun 29, 2021, 1:27 PM IST

 

New Delhi: India’s drug regulator may soon grant restricted emergency use authorisation for Moderna’s COVID-19 vaccine, official sources said on Tuesday.

Moderna has also informed that the US Government has agreed to donate a certain number of doses of the Moderna COVID-19 vaccine through COVAX to the Government of India for use and has sought approval from the Central Drugs Standard Control Organisation (CDSCO) for these vaccines.

Mumbai-based pharmaceutical firm Cipla, on behalf of the US pharma major, has requested for import and marketing authorisation of these jabs.

According to the sources, an approval is likely to come anytime as the CDSCO is in favour of doing so.

Cipla filed an application on Monday seeking permission for import of Moderna COVID-19 vaccine referring to DCGI notices dated April 15 and June 1 stating that if the vaccine is approved by the USFDA for EUA, the vaccine can be granted marketing authorization without bridging trial and assessment of safety data of first 100 beneficiaries of vaccines shall be submitted before rolling out in immunization programme.

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