PH FDA waiting for Pfizer-BioNTech to apply for 'full approval' for their COVID-19 vaccine

Published August 24, 2021, 10:31 AM

by Analou de Vera

This file photo taken on November 17, 2020 shows vials with COVID-19 vaccine stickers attached, with the logo of US pharmaceutical company Pfizer. (AFP FILE/ MANILA BULLETIN)

The Philippine Food and Drug Administration (FDA) is waiting for Pfizer and its vaccine partner BioNTech to apply for a full FDA approval for their coronavirus disease (COVID-19) vaccine in the country.

“We will wait for their application for a full approval here at the Philippine FDA,” said FDA Director-General Rolando Enrique Domingo on Tuesday, Aug. 24.

The US FDA announced on Monday, Aug. 23, that it has granted full approval to Pfizer and BioNTech for their COVID-19 vaccine.

“The (US) FDA, which gave the two-dose vaccine emergency-use authorization in December, provided its full approval for use in people age 16 and older based on updated data from the companies’ clinical trial and manufacturing review,” Reuters reported.

Domingo welcomed this latest development for the said COVID-19 vaccine brand.

“That is very encouraging. It means that the vaccine has undergone scrutiny and passed all safety and efficacy standards and will be commercially available soon,” he said.

The Philippine FDA has authorized the Pfizer-BioNTech COVID-19 vaccine for emergency use in the country on Jan. 14, 2021.

Department of Health (DOH) Undersecretary Maria Rosario Vergeire said that the “full approval” is also similar to the Certificate of Product Registration (CPR) of the FDA.

Manufacturers applying for a CPR undergo stringent evaluation, said Vergeire. This measure will also be applied if Pfizer-BioNTech decide to seek for a full approval or CPR to the Philippine FDA for their COVID-19 vaccine, said Vergeire.

“Here in the Philippines, we will be waiting for that. If they will apply, that will take us to evaluate again kung talagang compliant na ang manufacturer para makapagbigay na ng marketing authorization ang ating bansa (if the manufacturer is really compliant so that our country can give marketing authorization),” said Vergeire.

“Kapag may CPR na ang isang product, magkakaroon na ng open access ang private individuals (sa) bakunang ito (Once a product has CPR, private individuals will have open access (to) this vaccine). But again, it has to go through a regulatory process and evaluation of our experts,” she added.

Related story: Pfizer vaccine approved for emergency use in PH