Pfizer may apply for market release of COVID-19 vaccine in 2022 — FDA
MANILA, Philippines — US drugmaker Pfizer may apply for market release of its COVID-19 vaccine in the Philippines in 2022, the chief of the Food and Drug Administration (FDA) said Wednesday.
FDA Director General Eric Domingo said the drug regulator asked Pfizer when it will apply for a certificate of product registration (CPR) in the country which would allow the market release of its product.
“Baka next year pa po ‘yan. Tinanong namin ang Pfizer kung mag-aapply na sila dito sa atin ng marketing authorization. Mag-aapply po muna ata sila sa European Union after US FDA. At kapag pumasa doon, tsaka pa sila mag-apply sa ibang bansa katulad natin,” Domingo told ABS-CBN’s Teleradyo.
(It may happen next year. We asked Pfizer when they will apply for marketing authorization. It looks like they will apply first to the European Union after getting full approval from the US FDA. Once they get approval from the EU, they will apply to other countries like the Philippines.)
“So sa ngayon po tingin ko baka 2022 pa sila mag-aapply sa atin ng certification of product registration (So right now, I think they will apply for a CPR from us in 2022),” he added.
In August, the US FDA granted full approval to the Pfizer vaccine for use in people over the age of 16. The vaccine has only been approved for emergency use in the US since December last year.
Pfizer got an emergency use authorization in the Philippines in January this year.
So far, only the COVID-19 vaccines from Pfizer and Moderna were approved for adolescents aged 12 and above in the Philippines.
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