FDA approves emergency use authorization for Pfizer-BioNTech COVID-19 vaccine

This picture taken in Mulhouse, eastern France, on January 13, 2021 at the Emile Muller hospital’s pharmacy shows vials of the Pfizer-BioNTech Covid-19 vaccine. (Sebastien Bozon/ AFP)

(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

 

 

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