Cipla seeks DCGI nod to import Moderna's Covid-19 vaccine, decision likely today

Moderna's Covid-19 vaccine mRNA-1273 is sold under the brand name 'Spikevax' in the US. The DCGI is likely to decide soon on whether Cipla will be allowed to import the vaccine for emergency use in India, news agencies reported.

Mumbai-based pharmaceutical company Cipla has sought the approval of India's top drug regulator -- the Drugs Controller General of India (DCGI) -- to import American vaccine manufacturer Moderna's vaccine against the coronavirus disease (Covid-19) to the country, said people familiar with the development on Tuesday. A decision in this regard is likely soon, news agencies reported, adding that it is likely that Moderna's vaccine will be approved for emergency use in India for those aged 18 and above.

Moderna's Covid-19 vaccine mRNA-1273 is sold under the brand name 'Spikevax' in the United States. (File Photo)

Moderna's Covid-19 vaccine mRNA-1273, sold under the brand name 'Spikevax' in the United States, was developed by the pharmaceutical company in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) in the US. It is composed of nucleoside-modified mRNA (modRNA) and encodes a SARS-CoV-2 spike protein encapsulated in lipid nanoparticles, according to the European Medicines Agency (EMA).

Moderna has informed, according to PTI, that the US government will be providing India with a certain number of doses of its Covid-19 vaccine through the central government's Covax initiative. It is also likely that the DCGI will be providing Moderna with the much sought-after nod for emergency use since the Central Drugs Standard Control Organisation (CDSCO) itself is in favour of this decision, the news agency added citing officials in the know.

Cipla filed the application on Monday seeking permission for import of the Moderna Covid-19 vaccine, referring to DCGI notices dated April 15 and June 1. The Mumbai-based pharmaceutical company said that according to earlier directions passed by India's top drug regulator if a certain vaccine has already been approved by the US Food and Drug Administration (FDA) for emergency use approval, the same can be granted marketing authorisation in India without the necessity of bridging trials. However, the assessment of safety data of the first 100 beneficiaries of the Covid-19 vaccines shall still need to be submitted before rolling it out for a full-scale immunisation programme.