MANILA – The Food and Drug Administration (FDA) in the Philippines on Thursday granted the emergency use authorization (EUA) of Pfizer’s coronavirus disease 2019 (COVID-19) vaccine.
FDA Director General Eric Domingo announced the EUA grant three weeks after the US-based company applied for one making them the first COVID-19 vaccine that can legally be administered in the country.
“After thorough review, the FDA is granting EUA to Pfizer-BioNTech COVID-19. The EUA means the benefits outweigh the down and potential risk,” Domingo said. “This is effective immediately.”
An EUA allows Pfizer’s vaccine to be imported, distributed and administered in the Philippines through a national immunization program. It can only be administered to people 16 years old and above.
Domingo, however, said the Pfizer-BioNTech’s COVID-19 vaccine could have adverse effects and as such, must only be administered by health professionals trained to control and manage such side effects.
Domingo said the issuance of the EUA is not a certificate of product registration thus the vaccines cannot be sold commercially. Pfizer-BioNTech also requires an ultra-cold storage of -70 to-80 degrees Celsius.
Pfizer’s vaccine is the only one that has been included in the World Health Organization’s emergency list. Among other vaccine frontrunners, it also has EUAs in the most number of countries.
Domingo also noted that China’s Sinovac already applied for EUA in the Philippines, but the documents submitted by the company were incomplete.
“Ang EUA is from China and they are undergoing pre-assessment now. Medyo kulang pa ang clinical trial data na pinadala nila (Phase 1 and 2 pa lang). Until we see Phase 3 results, hindi natin ma-assess,” Domingo said.
Domingo said the 21-day processing time will only start once Sinovac submits their Phase 3 results./PN
