Pfizer needs to apply first before full approval of COVID-19 vaccine —Domingo

Pfizer needs to apply first before its COVID-19 vaccine could be given full use approval in the Philippines, according to the head of the Food and Drug Administration (FDA) on Tuesday.

"Kailangan muna sila mag-apply at ma-approve dito ng Application for certificate of product registration," said FDA director general Eric Domingo in a text message to GMA News.

(They first need to file application for certificate of product registration and get an approval.)

This was after the US FDA on Monday gave full approval to the COVID-19 vaccine made by Pfizer and German partner BioNTech SE for use in people over the age of 16. It was the first such approval of a COVID-19 shot.

In an interview on Super Radyo dzBB, Domingo said Pfizer will likely begin to seek full approval of its COVID-19 vaccine in other countries such as the Philippines, which will make the jab more accessible.

“Maaari na po siyang ibenta hindi lamang sa gobyerno katulad ngayon, kundi [pati] sa mga ospital, sa mga clinic, sa mga pharmacy, maaari na rin pong i-distribute ‘yan,” he explained.

(The vaccine can then be sold not just to the government but also to hospitals, clinics, pharmacies.)

Domingo said it would take the FDA around one month to process an application for full approval. The issuance of a CPR to a COVID-19 vaccine would also mean that the FDA will no longer grant emergency use authorization (EUA).

“So ‘yun pong mga EUA natin, after one year ‘yan, mag-e-expire na po lahat ‘yan at ang maaari na lamang gamitin ay mga fully approved product,” he said.

(So our EUAs will expire after one year. After that, only fully approved products can be used.)

Pfizer's vaccine has been authorized for emergency use in the Philippines and is one of the brands being used in the government's vaccination program. 

The Philippines is expecting the delivery of around 5 million doses of Pfizer COVID-19 vaccine in September.

Vaccine czar Carlito Galvez Jr. last week said the government will focus on purchasing COVID-19 vaccine doses from Pfizer and Moderna once the delivery of their supply stabilizes.  — with Julia Mari Ornedo/KBK/RSJ, GMA News