India on Tuesday approved the import of US pharmaceutical major Moderna’s mRNA technology-based coronavirus disease (Covid-19) vaccine, paving the way for the entry of the first international vaccine against the infectious disease into the country. On behalf of Moderna, Indian pharmaceutical company Cipla Ltd applied to the country’s drugs regulator, the Drugs Controller General of India, for grant of approval to import the vaccine to India.
The mRNA vaccine was cleared by India on Tuesday. VK Paul, member, healthy, Niti Aayog, said the emergency use authorisation is now in operation and the country’s vaccine basket is now richer by this addition, and the vaccination programme will gain further momentum for larger coverage of the population. Cipla had filed the application on June 28 seeking permission to import the Moderna’s vaccine. Moderna is coming to India in a ready-to-inject form and will not undergo any bridging study. The Moderna vaccine has approval from the USFDA for EUA so it has got a marketing authorisation without bridging trials. They would only have to share data of first 100 beneficiaries of vaccines before rolling it out as part of the immunisation programme. After Covishied, Covaxin and Sputnik, this will be the fourth Covid vaccine to be available in India. This is the first international vaccine to be given emergency use authorisation and the government will be continuing talks with Pfizer and Johnson vaccines.