PH FDA approves Covavax COVID-19 vaccine for emergency use

Published November 17, 2021, 12:38 PM

by Analou de Vera

Food and Drug Administration

The Food and Drug Administration (FDA) has approved the Covavax coronavirus disease (COVID-19) vaccine for emergency use in the Philippines.

The two-dose vaccine was developed by US-based biotechnology company Novavax and the Serum Institute of India.

“Ngayong araw na ito, meron tayong nadagdagan na isang bakuna na under emergency use authorization. Ito ay nag apply sa atin a few months ago—ito yung SARS-CoV-2 protein nanoparticle vaccine [Covavax] (Today, we have an additional vaccine that is under emergency use authorization. It applied to us a few months ago — this is the SARS-CoV-2 protein nanoparticle vaccine [Covavax]),” said FDA-Director General Rolando Enrique Domingo on Wednesday, Nov. 17.

“It is approved for the active immunization of individuals 18-years-old and above for the prevention of COVID-19,” he added.

The first and second dose should be given at least “three to four weeks apart,” said Domingo.

“Nakita po sa kanyang mga clinical trials na very mild ang mga adverse events na reported at maganda naman po ang safety profile niya…About 89.7 percent ang kanyang efficacy rate (It was observed during the clinical trials for this vaccine that the adverse events reported are very mild and it has a good safety profile… It’s efficacy rate is about 89.7 percent),” said Domingo.

“So, ito ay isang possible natin na maaring magamit na bakuna lalo na sa towards the end of the year or sa darating na 2022 (So, this is a possible vaccine that we can use especially towards the end of the year or in 2022),” he added.

Previously, the FDA has granted emergency use authorization to the following vaccines: Pfizer-BioNTech, AstraZeneca, Sinovac, Sputnik V, Janssen, Covaxin, Moderna, and Sinopharm.