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Friday, July 19, 2024

FDA: Pfizer to undergo process for full approval

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Pfizer will need to apply first for a certificate of product registration before its COVID-19 vaccine could be given full use approval in the Philippines, the chief of the Food and Drug Administration (FDA) said on Tuesday.

FDA director-general Eric Domingo made the statement after the US FDA on Monday gave full approval to the COVID-19 vaccine made by Pfizer and German partner BioNTech SE for use in people over the age of 16. It was the first such approval of a COVID-19 shot.

Pfizer’s vaccine has been given an emergency use authorization (EUA) in the Philippines and is one of the brands being used in the government’s vaccination program.

“Our EUAs will expire after one year. After that, only fully approved products can be used,” Domingo said.

Domingo said it would take the FDA around one month to process an application for full approval.

The Philippines is expecting the delivery of around 5 million doses of Pfizer COVID-19 vaccine in September.

Vaccine czar Carlito Galvez Jr. last week said the government would focus on purchasing COVID-19 vaccine doses from Pfizer and Moderna once the delivery of their supply stabilizes.

In related developments, medical cold chain firm Pharmaserv Express delivered Tuesday shipments of COVID-19 vaccine doses to various areas in Mindanao, including South Cotabato and Sarangani.

More than 16,000 doses of Sinovac vaccines shipped to South Cotabato Integrated Provincial Health Office will be used to inoculate senior citizens, persons with comorbidity, and frontline healthcare workers.

Pharmaserv also transported shipments of COVID-19 vaccine doses to the Sarangani Healthcare Facility as well as to Dumaguete City.

Dumaguete City Health Officer Dr. Maria Sarah Talla and Executive Assistant for Security Concerns Rey Lyndon Lawas received the COVID-19 vaccines at the airport.

The Health department has tapped Pharmaserv as its third party cold chain facility and logistics partner in the country’s vaccination program.

Galvez earlier announced that over five million doses COVID-19 vaccines will be arriving within the last week of August.

He said they expected the arrival of three million doses of Sinovac, 1.8 million doses of Moderna, and over 300,000 doses of Pfizer.

The government has already administered more than 30 million COVID-19 jabs since the vaccination program was rolled out in March.

As of August 22, a total 30,389,160 jabs have been administered nationwide, of which 17,258,675 have been administered as the first dose, while 13,130,485 Filipinos are now fully vaccinated.

Meanwhile, Metropolitan Manila Development Authority chairman Benjamin Abalos Jr. said local chief executives in the National Capital Region have agreed to open their vaccination sites to neighboring areas outside the NCR to help scale up the country’s vaccination rate.

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