DOH should apply for permit for donated COVID-19 vaccine

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Metro Manila (CNN Philippines, January 20) — The Department of Health needs to apply for emergency use authorization of donated COVID-19 vaccines, the Food and Drug Administration said on Wednesday.

“If the COVID-19 vaccine for donation does not have an EUA from FDA, then the DOH has to apply for an EUA for the donated lot to ensure the safety, quality and efficacy of the product,” the regulator said in a statement.

The FDA said entities that intend to donate vaccines to the government should coordinate with the DOH since it will facilitate the acceptance and processing to evaluate these based on reliability of source and shelf life. The DOH is also designated to distribute these donations after the FDA issues authorization, it added.

“DOH, as the donee, is mandated by the FDA to assume full responsibility on the use of the donated product,” the FDA said.

In a forum, Health Undersecretary Ma. Rosario Vergeire also noted the need for an EUA for donated vaccines.

Ang gagamitin lang at ipapagamit natin o ibibigay sa ating kababayan ay ang mga bakunang may EUA na,” she said.

[Translation: What will be used or given to our citizens are vaccines that already have EUA.]

During his recent visit, Chinese State Councilor and Foreign Minister Wang Yi said China will donate half a million vaccine doses. Meanwhile, vaccine czar Carlito Galvez, Jr. said they have ongoing negotiations with two countries on possible vaccine donations as well.

The FDA granted EUA to the Pfizer-BioNTech COVID-19 vaccine so far, while application of China’s Sinovac, British company AstraZeneca, and Russian firm’s Gamaleya Institute are pending.