FDA: Applications for full COVID-19 vaccine registration possible in late 2021

Applications for full registration of a COVID-19 vaccine in the Philippines could possibly be filed this year, the chief of the Food and Drug Administration (FDA) said Thursday.

FDA director general Eric Domingo said a certificate of product registration (CPR) requires a completed Phase 3 clinical trial.

“You have to complete your Phase 3 trial, meaning talagang natapos na lahat ng endpoints na hinahanap... and then they will see of course dapat ‘yung safety data is very good and ‘yung efficacy data is very high,” he said in an interview on ANC.

(You have to complete your Phase 3 trial, meaning all endpoints have been covered… and then they will see of course that the safety data is very good and the efficacy data is very high.)

“So ako personally, I expect the earliest na may mag-a-apply for CPR would be late this year or early next year,” he added.

All COVID-19 vaccines that have been rolled out in the country so far are still under an emergency use authorization, which is issued for drugs and vaccines during a public health emergency.

A CPR, on the other hand, is a marketing authorization that would allow the sale of a COVID-19 vaccine.

Authorities have warned the public against purchasing fake COVID-19 vaccines from unauthorized suppliers.

The Philippines has vaccinated over 1.7 million individuals with the Sinovac, AstraZeneca, and Sputnik V shots as of May 4.—AOL, GMA News