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Philippines approves emergency use of Pfizer-BioNTech COVID-19 vaccine


The Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to the COVID-19 vaccine manufactured by Pfizer-BioNTech, FDA Director General Eric Domingo announced on Thursday.

"After thorough review, the FDA is granting EUA to Pfizer-BioNTech COVID-19. 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. The EUA means the benefits outweigh the known and potential risks,” Domingo said.

"This is effective immediately," he added.

Domingo said Pfizer-BioNTech’s COVID-19 vaccine can be administered to people 16 years old and above.

This decision makes Pfizer-BioNTech’s product as the first ever COVID-19 vaccine which can be legally administered in the Philippines.

Likewise, Domingo said that Pfizer-BioNTech’s COVID-19 vaccine side effects were found to be transient, mild to moderate, and similar to common vaccine reactions.

“No specific safety concerns were identified," he said.

Domingo then clarified that these observations were made during a limited period of two-month long follow up, and that more adverse effects may emerge.

As such, Domingo said the Pfizer-BioNTech’s COVID-19 must only be administered by health professionals who have the resources and are trained to recognize and manage such side effects.

“Close surveillance and monitoring is needed after immunization,” he said.

Domingo said that the issuance of the  EUA, however, is not a certificate of product registration and as such, cannot be sold commercially.

According to Domingo, the Pfizer-BioNTech COVID-19 vaccine has been administered on five billion people in the world so far.

Pfizer-BioNTech requires an ultra cold storage of -70 to-80 degrees Celsius, a facility that can only be provided in  Metro Manila as well as in Cebu and Davao cities.

Sinovac

At the same briefing, Domingo said Chinese firm Sinovac has applied for emergency use authorization before the FDA.

“Yesterday, nag-submit ng application ang Sinovac,” Domingo said during a virtual briefing.

Domingo, however, said that Sinovac has yet to complete submission of requirements needed to secure an EUA. — KBK/RSJ, GMA News