(Eagle News) — The Food and Drug Administration has granted the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine.
FDA director-general Eric Domingo made the announcement on Thursday, January 14.
With the decision, the Pfizer-BioNTech COVID-19 vaccine is the first vaccine that can be administered legally in the Philippines.
“The interim data from the ongoing Phase 3 trial shows the vaccine has an efficacy rate of 95% in the study population and at least 92% among all racial groups,” he said.
He said the EUA means “the benefits outweigh the known and potential risks.”
Domingo said no specific safety concerns were identified during a limited two-month-long follow-up, but noted that some adverse effects may crop up.
He said the vaccine “shall be administered only by vaccination providers, and used only to prevent COVID-19 in individuals ages 16 and older,” adding that it would require storage with temperature of -80 to -60 degree Celsius .
“Close surveillance and monitoring is needed after immunization,” he said.
He said the vaccine, however, cannot be sold commercially as the EUA was not a certificate of product registration. With a report from Madz Moratillo