US vaccine manufacturing giant Moderna has secured restricted emergency use authorisation for its Covid-19 vaccine in India. The approval was granted by the Drug Controller General of India (DCGI), the government said on Tuesday.
Besides this, Indian drug manufacturer Cipla has been given permission to import Moderna’s Covid-19 vaccine and market it in the country.
Following today’s developments, Moderna has become the fourth Covid-19 vaccine that will be used in India’s vaccination drive. The vaccines that India is currently using are:
- Covishield: It was developed by the Oxford University and AstraZeneca and is manufactured in India by the Pune-based Serum Institute of India.
- Covaxin: It was developed and manufactured by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
- Sputnik V: It was developed and manufactured by Gamaleya Research Institute of Epidemiology and Microbiology in Russia.
“Moderna has been granted restricted emergency use authorisation for its Covid-19 vaccine in India. The issue of indemnity is being examined,” Dr VK Paul, Member (Health), Niti Aayog said.
Besides seeking regulatory approval in India, 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 India use and has sought approval from the Central Drugs Standard Control Organisation (CDSCO) for these vaccines.
Cipla filed its application to import and market Moderna’s Covid-19 vaccine on Monday. In its application, Cipla referred to DCGI notices dated April 15 and June 1 which state that if a vaccine is approved by the USFDA for EUA, it can be granted marketing authorisation in India without bridging trial.
The notices add that for such vaccines, assessment of safety data of first 100 beneficiaries of the vaccines shall be submitted before rolling them out in the immunisation programme.
What is Moderna vaccine’s efficacy?
According to the World Health Organisation, the Moderna vaccine has shown to have an efficacy of approximately 94.1 per cent in protecting against Covid-19, starting 14 days after the first dose.
The WHO adds that based on evidence collected so far, the new variants of SARS-CoV-2, including the B.1.1.7 and the 501Y.V2, do not alter the effectiveness of the Moderna mRNA vaccine.