Moderna seeks regulatory approval for its COVID-19 vaccine

Moderna has sought regulatory approval for its Covid-19 vaccine in India. Mumbai-based pharmaceutical firm Cipla, on behalf of the US pharma major, has requested for import and marketing authorisation of these jabs.

DCGI is likely to approve Moderna's Covid-19 vaccine for emergency use in those aged 18 and above, sources told on Tuesday.

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.

If approved, the Modern vaccine will be administered to those above 18 years under the vaccination drive.

Meanwhile, several foreign vaccine makers such as Pfizer and Moderna have demanded an indemnity bond that will exempt them from legal claims in case there are any adverse effects from the vaccines when administered in India.