FDA: Pfizer, AstraZeneca, Sinovac, Sputnik applied for modification of EUAs to include booster shots

Food and Drug Administration (FDA) Director General Eric Domingo disclosed that the agency has received applications to amend the emergency use authorizations of some COVID-19 vaccines to include a third dose in their regimen.

During the pre-recorded public address of President Rodrigo Duterte that aired Wednesday morning, Domingo said the FDA has received applications from Pfizer, AstraZeneca, Sinovac, and Sputnik V.

"Sa ngayon po ang FDA nakatanggap na po kami nitong bago mag-Undas ng applications for product variations o modification po, amendment ng EUA, galing po sa Pfizer, sa AstraZeneca, sa Sinovac at saka sa Sputnik," Domingo said.

(The FDA has received applications for modifications of the EUAs of Pfizer, AstraZeneca, Sinovac, Sputnik V.)

"Nagrequest po sila na ma-include ang third dose sa kanilang regimen o ang booster dose at pinadala po nila 'yung kanilang scientific data available at ito po 'yung inaaral ngayon ng ating mga experts," he added.

(They requested that a third dose or booster dose would be included in their regimen. They sent their scientific data and our experts are now studying these.)

The FDA chief said studies are ongoing about the effectiveness of booster shots. He added that the Department of Health is also assessing the possible mix and match of vaccines.

Earlier, DOH Undersecretary Maria Rosario Vergeire said the EUA of the vaccines must be amended as it specifically states the number of doses that must be administered to complete the vaccination.

According to Domingo, it is possible that not all individuals need to be administered with COVID-19 booster shots.

"Ang nakikita rin naman natin na magiging trend ay hindi lahat kakailanganin ng third dose kung hindi talagang 'yun pong selected na mangangailangan, the elderly, the immunocompromised and healthcare workers," Domingo said.

(The trend that we are seeing is that not all need a third dose, but only the elderly, the immunocompromised and the healthcare workers.)

Domingo said the Philippines is also waiting for the recommendation of the World Health Organization regarding booster shots. — RSJ, GMA News