FDA OKs use of AstraZeneca vaccine

BY ANALOU DE VERA

The Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) for the COVID-19 vaccine developed by British drug-maker AstraZeneca.

“After a thorough review of the currently available data by our medical and regulatory experts, the FDA is granting an emergency use authorization to the COVID-19 vaccine AstraZeneca,” said FDA Director-General Rolando Enrique Domingo in a public press briefing.

“It is decided that all conditions for an EUA are present and that the benefit of using the vaccine outweighs the known and potential risk. The interim data from the ongoing Phase 3 trials when taken to its entirety show that the vaccine has an efficacy of 70 percent after the first dose,” he added.

AstraZeneca’s vaccine was the second to be approved for emergency use in the Philippines. The first one was the COVID-19 vaccine developed by Pfizer-BioNTech. The FDA’s approval comes three weeks after AstraZeneca submitted its application for an EUA.

Domingo said that the adverse events reported when given an AstraZeneca vaccine are “mostly mild to moderate (which is) similar to common vaccine reactions.”

“Ang nakitang adverse events nya are all very mild, very similar to getting flu injections. Ang karamihan yung pananakit doon sa lugar ng injection, konting sinat, konting sakit ng ulo that are all transient and easily manage,” he said.

“The company AstraZeneca will be working with the Department of Health, FDA, and of course the surveillance system that is being setup by the vaccination program to assure all adverse events are reported so we can monitor them very closely,” he added.

This vaccine is authorized for use in people 18 years and older.