US FDA gives full approval to Pfizer COVID-19 vaccine Comirnaty

By Christine Fabro

Pfizer-BioNTech’s COVID-19 vaccine becomes the first jab to be granted full approval by the US Food and Drug Administration (FDA) on Monday, Aug. 23.

The US FDA said in a release that the vaccine will be marketed as “Comirnaty,” for the prevention of COVID-19 disease in individuals 16 years old and above.

“The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals,” FDA stated.

Pfizer COVID-19 vaccine was also the first vaccine listed under EUA on Dec. 11, 2020.

This also means that the private sector here will soon be able to procure their own Pfizer COVID-19 vaccines.

“Pwede na siyang CPR [Certificate of Product Registration], meaning, pwede nang bilhin ng private sector iyong Pfizer,” National Task Force Against COVID-19 Chief Implementer Secretary Carlito Galvez said in a public briefing on Monday.

CPR refers to a certificate issued by the Philippine FDA “for products that have been approved and registered in the Philippines.”

Galvez also said that the vaccine manufacturers’ application for full authorization here may fall in between December this year and the first quarter of next year.

To date, there are 9 COVID-19 vaccines listed under the EUA by the FDA including Pfizer-BioNTech, Oxford AstraZeneca, Sinovac, Gamaleya Sputnik V, Janssen, Bharat Biotech, Moderna, Sinopharm, and Sputnik Light. – bny

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