Moderna gets emergency use nod in India from DCGI; Cipla to import US-made COVID vaccine

COVID vaccine Moderna has been granted new drug permission for restricted emergency use in India, Dr VK Paul, Member-Health, Niti Aayog informed on Tuesday. The Drugs Controller General of India (DCGI) granted approval to pharma major Cipla to import Moderna COVID vaccines for restricted emergency use. Studies in foreign drug regulating and controlling agencies have shown Moderna to be 90 percent effective.

"New drug permission has been granted to Moderna, the first internationally developed vaccine. This new drug permission is for restricted use. We are looking forward for more production of our vaccines," Dr VK Paul said during a press briefing.

Now, there are four COVID-19 vaccines in the country, namely, Bharat Biotech's COVAXIN, AstraZeneca & Serum Institute of India's COVISHIELD, Sputnik V developed by Russia's Gamaleya Institute, and US vaccine Moderna, made by the Massachusettes-based company of the same name. Hours after approving Moderna's COVID vaccine for restricted usage in India, the Centre added that it was determined to close the deal with Pfizer Inc soon as well. Pfizer and Moderna were the first two vaccines to be approved and administered en masse in the US. 

During the Health Ministry's briefing, Dr VK Paul added, "There are four vaccines now - COVAXIN, COVISHIELD, Sputnik V and Moderna. We will soon close the deal on Pfizer as well".

Moderna's COVID vaccine in 2 doses

According to Dr VK Paul, there are no 'serious' side-effects of any of these COVID vaccines available in India. After Moderna published its peer-reviewed Phase 3 data, the US Food and Drug Administration issued an emergency use authorization in December 2020.

The evidence from the Phase 3 clinical trial involving nearly 30,000 participants aged 18-95 showed that the Moderna vaccine was 94.1% effective at preventing COVID-19 infection in people who received two doses and had no evidence of being previously infected. The possible side effects include pain, redness and swelling in the arm where a person gets the shot and tiredness, headache, muscle pain, fever and nausea throughout the rest of the body. It is recommended that two doses of the vaccine are taken 28 days apart.

"Moderna, the first international vaccine in India, will be administered in two doses," Dr Paul of Niti Aayog said.

Dr VK Paul went ahead to explain that while some state governments have shut vaccination centres already, in the coming months they will be informed to resume as per COVID-19 vaccines quotas made available to them. 

"This is a part of the normal process for upgrading the health infrastructure of a country," Dr Paul added.