New Delhi | Jagran News Desk: A week after Pfizer's COVID-19 vaccine received emergency use authorisation, US Food and Drug Administration (FDA) on Saturday (local time) approved Moderna Inc's vaccine candidate for the same. 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).

The Moderna approval comes exactly a week after the US Food and Drug Administration okayed a shot from Pfizer and its German partner BioNTech. Moderna expects to have 85-100 million shots available in the US in the first three months of 2021, and the vaccinations are set to begin Monday.

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.

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.

The US government has ordered at least 200 million Moderna doses at a time when the country is getting hammered by the pandemic winter surge. Deaths in the US are at record highs, crossing 3,000 per day at a steady clip. The virus, which originated in China a year ago, has killed more than 3,12,000 Americans in 11 months. New cases in the US are running at over 2,16,000 per day on average.

The Pfizer-BioNTech vaccine is now being administered to millions of healthcare workers and in nursing homes, which have borne the maximum burden of the US outbreak. For Moderna, the US FDA approval is a world first. For Pfizer, the US approval came after Britain and Canada authorised nationwide use.

Ongoing studies of the Moderna two-shot vaccine show more than 94 per cent effectiveness and strong protection among older adults. America counts more than 53 million people in the category of senior citizens and 40 per cent of deaths have been in nursing homes.

According to the Centers for Disease Control and Prevention, more than 100 million Americans have underlying medical conditions that put them at higher risk for severe Covid-related illness.

 

(With Agencies Inputs)

Posted By: Talib Khan