Moderna gets authorisation for emergency use on its COVID-19 vaccine in US

Washington, Dec 19: Moderna has become the second company to get emergency use authorisation for its anti-coronavirus vaccine from the US Food and Drug Administration (FDA), a week after the one developed by Pfizer received a similar approval.

According to an official statement, the FDA has determined that the Moderna COVID-19 vaccine has met the statutory criteria for issuance of an emergency use authorisation (EUA).

"Congratulations, the Moderna vaccine is now available!" President Donald Trump tweeted soon after. The FDA based its recommendation on the totality of scientific evidence shared by Moderna, including a data analysis from the pivotal phase three clinical study announced on November 30.

The primary efficacy analysis conducted on 196 cases indicated a vaccine efficacy rate of 94.1 per cent. This vaccine is for people aged 18 or older. An immunisation drive using the vaccine developed by Pfizer has begun in the US earlier this week. Vice President Mike Pence took the shot publicly on Friday.

Health Secretary Alex Azar said, "To have two vaccines against a novel coronavirus authorized and distributed within a year is extraordinary, and to have one of these vaccines developed by scientists at the NIH (National Institutes of Health) should be a great source of pride for every member of the HHS family and every American."

National Institutes of Health was a partner in the development of Moderna's vaccine. "Authorization of Moderna's vaccine means we can accelerate the vaccination of frontline healthcare workers and Americans in long-term-care facilities, and, ultimately, bring a faster end to this pandemic," Azar said.

Moderna said that its mRNA-1273 vaccine is now authorized for distribution and use under an emergency use authorization. Delivery to the US government will begin immediately. Moderna will continue to gather additional data and plans to file a Biologics License Application (BLA) with the FDA requesting full licensure in 2021, it said.