Donated COVID-19 vaccines require EUA – FDA

Published January 20, 2021, 5:20 PM

by Analou de Vera

All donated COVID-19 vaccines still require an emergency use authorization (EUA) before it can be used in the country, the Food and Drug Administration (FDA) said Wednesday.

“The Food and Drug Administration clarifies that donated COVID-19 vaccines require FDA authorization in the form of Emergency Use Authorization (EUA) prior to use,” the FDA said in a statement. 

The agency said that entities that intend to donate vaccines are required to coordinate with the DoH “which will facilitate the acceptance and processing of the donation.“

“Thereafter, the proposed donation shall be evaluated. The DoH evaluates by considering the relevance of the donated product to the need of the beneficiaries, reliability of the source, shelf life and other relevant criteria,” the FDA said. 

“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 being donated,” the FDA said. 

The DoH could distribute the products to the intended beneficiaries “only after authorization of the FDA.”

“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 agency noted. 

“DoH, as the donee, is mandated by the FDA to assume full responsibility on the use of the donated product. Thus, if DoH would accept donated COVID-19 vaccines and is granted an EUA, it shall assume full responsibility for said health product,” it added. 

Chinese Foreign Minister Wang Yi said that his country will donate 500,000 doses of COVID-19 vaccines to the Philippines. However, it is not yet known what vaccine brand will be donated by the Chinese government. 

The Philippine FDA has so far granted an EUA for the COVID-19 vaccine developed by American drugmaker Pfizer.