THE Food and Drug Administration yesterday disclosed that several COVID vaccine manufacturers have already applied for application to amend their emergency use authorization to include a third dose in their regimen.
FDA Director General Eric Domingo said they have 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,” he said.
Domingo said experts in the FDA are now studying the scientific data submitted by the said manufacturers to support their request to include a third dose or booster shot in their regimen.
He added studies are ongoing about the effectiveness of booster shots, noting further 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.
The FDA chief pointed out that 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,” he said.
Domingo said the Philippines is also waiting for the recommendation of the World Health Organization regarding booster shots.