Malacañang: Pfizer files for emergency use application in PH

Dennis Gasgonia, ABS-CBN News

Posted at Dec 27 2020 12:18 AM

American pharmaceutical company Pfizer has filed for emergency use authorization (EUA) to make available its COVID-19 vaccine in the Philippines, Presidential Spokesperson Harry Roque said in a statement Saturday.

Food and Drug Administration (FDA) Director-General Rolando Domingo confirmed to Malacañang that Pfizer submitted an EUA application for its Pfizer-BioNTech COVID-19 vaccine on December 23, Wednesday.

The FDA said it would take at least 21 days to evaluate and approve the application.

The Palace said inoculation would start as soon as doses are available.

A vaccine or any type of a newly produced medicine requires an emergency use authorization for it to be made available in a country that wants to purchase doses.

"Kapag galing na sa stringent regulatory agency like USFDA (US Food and Drug Administration) or UK, minimal na lang ang additional requirements natin," Domingo said Saturday during a meeting led by President Rodrigo Roa Duterte and attended by the Inter-Agency Task Force (IATF) on pandemic mitigation.

The meeting, broadcast live from the Palace and which ran for about 3 hours, was put together to discuss the new COVID-19 variant and the government's planned response.

According to Domingo, the FDA would also ask for additional information, such as the vaccine's stability under a tropical climate and its efficacy when used for an Asian population.

The FDA will also have to check if it is the same vaccine actually being distributed in the US.

"Kailangan lang siguraduhin na yung niregister nila sa Amerika 'yun din ang dadalhin nila dito sa atin," Domingo said.

"Mabilis lamang po (na maaprubahan), basta galing sa stringent regulatory agency."

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