FDA grants emergency approval for Moderna's COVID-19 vaccine

Published May 5, 2021, 10:09 AM

by Analou de Vera

The Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to the coronavirus disease (COVID-19) vaccine developed by American drug firm Moderna.

(Manila Bulletin File Photo)

FDA Director-General Rolando Enrique Domingo made the announcement on Wednesday, May 5, during the Kapihan sa Manila Bay forum.

“Today, after a rigorous and thorough review by our regulatory and medical experts using the currently available published and unpublished data, the FDA is granting an emergency use authorization… for the COVID-19 vaccine Moderna,” said Domingo.

“It has been decided that all conditions for an EUA are present and that the benefit of using the vaccine outweighs the known and potential risks. The interim data from the ongoing Phase 3 trials as published showed that the vaccine has an overall efficacy rate of over 94 percent in preventing COVID-19,” he added.

Like other vaccine brands, the Moderna COVID-19 vaccine requires two doses that should be administered four weeks apart, said Domingo.

“The adverse events that were reported during the clinical trials and actual use of the vaccine….were mostly mild and transient, similar to common vaccine reactions that we expect,” he said.

“The vaccine shall be administered only by vaccination providers, and used only to prevent COVID-19 in individuals aged 18 years and above,” he added.

Domingo noted that the EUA is not a marketing authorization or a Certificate of Product Registration (CPR).

“Hence, this EUA cannot be used as an authorization to market the vaccine commercially,” the FDA chief said.

“This EUA shall be valid only within the duration of the declared public health emergency due to COVID-19, or upon the issuance of a marketing authorization (or) Certificate of Product Registration,” he added.

Aside from Moderna, vaccines developed American drugmaker Pfizer, United Kingdom-based AstraZeneca, China’s Sinovac Biotech, Russia’s Gamaleya Research Institute, India’s Bharat Biotech, and US-based firm Johnson & Johnson have been given an EUA in the country.