Pfizer may soon apply for full use of COVID-19 vaccine in PH- FDA
FILE PHOTO: A vial labeled with the Pfizer-BioNTech coronavirus disease (COVID-19) vaccine is seen in this illustration picture taken March 19, 2021. REUTERS/Dado Ruvic/Illustration
MANILA, Philippines—The country’s Food and Drug Administration (FDA) is now anticipating that Pfizer-BioNTech would soon submit a full application seeking approval of the vaccine against COVID-19 for market release.
On Wednesday, FDA Director General Eric Domingo told the Senate blue ribbon committee that the requirements for Pfizer’s vaccine were sent out already.
When the FDA approves Pfizer’s application, the company will be able to market its products locally, Domingo explained.
Pfizer has already received US FDA approval to use its COVID-19 vaccine fully.
READ: US FDA grants full approval to Pfizer-BioNTech COVID-19 vaccine
“Ang Pfizer, kailangan din pong kumuha sa atin ng certificate of product registration so usually po yung company kukuha muna sa US FDA and then mag-apply na rin po sila sa iba- ibang bansa ng marketing authorization and we anticipate po na sa atin siguro kukuha na rin sila soon,” Domingo said responding to Senator Richard Gordon’s queries.
(Pfizer still needs our certificate of product registration, so they often obtain their product registration first from the US FDA, then apply for marketing authorization in various countries, and we anticipate that they will also get our certification soon.)
“…At pinadalhan na rin po namin sila ng mga requirements para po makapag apply na rin sila,” the FDA chief added.
(And we also sent them the requirement so they could apply to us.)
Gordon, chairman of the blue ribbon committee, lauded FDA for being “proactive.”
“Maganda yun because you’re being proactive. Hindi nyo na hinintay na lumapit sila, talagang sinusugod na natin sila para mas mabilis tayo sa vaccine,” the senator said.
(That’s good because you’re proactive. You did not wait for them to come to us; we are going out of our way to get the vaccine faster.)
At present, Pfizer was issued an emergency use of its Covid-19 vaccine in the Philippines.
READ: FDA grants emergency use authorization for Pfizer COVID-19 vaccine
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