FDA clarifies: Donated Covid-19 vaccines still require EUA

MANILA, Philippines — The Food and Drug Administration (FDA) on Wednesday clarified that donated Covid-19 vaccines still require its approval – in the form of emergency use authorization (EUA) – before it can be used in the country.

The government regulator said in a statement that entities intending to donate vaccines to the government are required to coordinate with the Department of Health (DOH), which will facilitate the acceptance and processing of the donation.

“Thereafter, the proposed donation shall be evaluated,” it said.

According to the FDA, the DOH will conduct the evaluation by considering the relevance of the donated product to the needs of beneficiaries, reliability of the source, shelf life, and other applicable factors.

“If the Covid-19 vaccine for donation does not have a EUA from FDA, then the DOH has to apply for a EUA for the donated lot to ensure the safety, quality, and efficacy of the product being donated,” the FDA explained.

Only after authorization of the FDA can the DOH distribute the product to intended beneficiaries.

“Let it be stressed that the approval of the donated product does not mean free use thereof. FDA’s authorization is limited to the donated lot and carries conditions for use depending on the nature of the donated product,” the FDA added.

The DOH, as the donee, is likewise mandated by the FDA to assume full responsibility for the use of the donated product. “Thus, if the DOH would accept donated Covid-19 vaccines and is granted a EUA, it shall assume full responsibility for the said health product.”

The FDA issued the clarification after its director-general Eric Domingo earlier said that the Philippines may accept and use Covid-19 vaccines donated by China even without the approval of the agency.

Domingo cited the Bayanihan to Recover as One Act, which he said allows the DOH to accept donated medications as long as it is registered from its country of origin.

The health department, however, later said it will wait for the FDA’s authorization before accepting and using Covid-19 vaccines that will be donated by China.

Some senators, meanwhile, have raised concerns over the “very dangerous preposition” of the FDA that the government may accept and use donated Covid-19 vaccines even without its approval.

Chinese State Councilor and Foreign Minister Wang Yi earlier announced that Beijing will donate 500,000 doses of Covid-19 vaccines to the Philippines.

So far, only US-based pharmaceutical giant Pfizer has secured a EUA from the Philippines’ FDA.

KGA