FDA decision on Pfizer's emergency use application out by Jan. 14

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FILE PHOTO

Metro Manila (CNN Philippines, January 6) — The Food and Drug Administration's decision on whether to allow the emergency use of Pfizer's COVID-19 vaccines in the Philippines will be released next week, its chief said on Wednesday.

FDA Director General Eric Domingo said he is set to issue the findings on Jan. 14. The application has undergone scientific evaluation and the FDA is waiting for the response of Pfizer-BioNTech to some clarificatory questions.

The regulatory chief said the review is fast-tracked because Pfizer has already secured emergency use authorization (EUA) approval from other countries and emergency use listing from the World Health Organization.

"Napakabilis ng proseso pero dinadaanan natin each and every step to make sure na ang kalidad, safety, and efficacy ng bakuna ay sigurado tayo bago natin aprubahan," Domingo said in a media briefing.

[Translation: The process is fast but we are going through each step to ensure the quality, safety, and efficacy of the vaccines before we give approval.]

Pfizer is the only manufacturer to apply for emergency use in the Philippines. An EUA issuance from the regulators are required for the vaccines to be legally rolled out in the country.

Vaccine czar Carlito Galvez Jr. said the country's supply of Pfizer vaccines will likely arrive by third or fourth quarter of 2021 since it's the "most in demand" vaccine brand. However, it is unclear how many vaccine doses will reach the country since government officials have yet to close a deal with the drug maker.

The FDA also said UK's AstraZeneca and China's Sinovac are expected to apply soon.