Permission for Moderna's Covid-19 vaccine has been approved by the Drugs Controller General of India (DCGI) for restricted emergency use in the country. "This permission is for restricted use in emergency situations in the public interest. The firm has to submit 7 days' safety assessment of the vaccine in the first 100 beneficiaries before rolling out of the vaccine for further immunisation programme, according to the approval order," reports PTI quoting an official as saying.
During a health briefing, Niti Aayog Member Dr VK Paul announced that pharmaceutical company Cipla has got approval from DGCI to import Moderna's Covid19 vaccine. Moderna's vaccine will be the fourth jab to be available in India after Covishield, Covaxin and Sputnik. It is said to be 90 per cent effective against Covid.
On behalf of Moderna, Cipla requested DGCI for import and marketing of the vaccine. Cipla is a multinational pharmaceutical company headquartered in Mumbai. Cipla, in its application to the drug regulator, pointed out the government's decision to waive bridging trials for foreign vaccines if it is cleared for emergency use in countries like the US and if the safety assessment data of the first 100 beneficiaries is submitted before mass rollout.
Moderna's vaccine will be the fourth jab to be available in India after Covishield, Covaxin and Sputnik. It is said to be 90 per cent effective against Covid-19.According to DCGI's revised rules issued on June 1, 2021, there is no requirement of testing of every batch by Central Drugs Laboratory (CDL), Kasauli if the batch/lot is released by the CDL of country of origin. However, summary lot protocol review and scrutiny of documents shall be undertaken by the laboratory for batch release according to standard procedures.
Moderna's vaccine is an mRNA vaccine that has fragments of the genetic material known as messenger RNA. The vaccine works by giving cells temporary instructions to make the corona virus spike protein. The protein is found on the surface of the Covid-19 virus.