FDA decision on Pfizer COVID-19 vaccine out on January 14

The Food and Drug Administration (FDA) will decide on the emergency use authorization application of American firm Pfizer for its COVID-19 vaccine by January 14.
 
FDA Director General Eric Domingo made the announcement as the Duterte administration continues to draw sharp criticisms in connection with the members of the Presidential Security Group (PSG) getting inoculated with COVID-19 vaccines which are not registered with FDA.

In a presentation during the Laging Handa briefing on Wednesday, Domingo said Pfizer submitted its EUA application to FDA last December 23, 2020, and that the FDA has already sent clarificatory questions to Pfizer last January 4.
 
Pfizer and BioNTech—which partnered with Pfizer in developing the COVID-19 vaccine—is expected to submit its response by Thursday, January 7.

FDA and the Vaccine Experts Panel under the Department of Science and Technology will then submit their recommendation by January 10 before ultimately deciding on Pfizer’s EUA application on January 14.

“Ang puwede lang po mag-apply ng EUA ay iyong mga bakuna na nabigyan na rin ng EUA sa bansa kung saan sila galing. Hindi puwedeng dito unang gagamitin ang bakuna [na ginawa sa ibang bansa],” Domingo said.

He added that only Pfizer has submitted an EUA application to the FDA so far. 

"Sa limang bansa pa lang po nag-apply ng EUA, kasama po ang Pilipinas," he added.
 
Pfizer-BioNTech’s COVID-19 vaccine has been proven at least 95% effective after human trials. Since then, it has secured EUA from the United States, Canada, United Kingdom, Singapore, among others.
 
Vaccine czar Carlito Galvez, Jr. however said the Pfizer-BioNTech vaccine will only be available by July this year due to lack of global supply.
 
“Pfizer po kasi ang most in-demand COVID-19 vaccine,” Galvez said.
 
Around 50 million to 70 million Filipinos are expected to be vaccinated against COVID-19 in 2021, according to National Task Force Deputy Chief Implementor Vince Dizon. —KG, GMA News