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Pfizer’s vaccine is first to be approved in PH, AstraZeneca review ongoing

By PhilSTAR L!fe Published Jan 14, 2021 1:36 am

The Philippine Food and Drug Administration (FDA) issued an emergency use authorization (EAU) for Pfizer and BioNTech’s COVID-19 vaccine today, Jan. 14.

“The FDA today is granting an emergency use authorization to Pfizer and BioNTech’s COVID-19 vaccine. It is decided that all conditions for an EUA are present and that the benefit of using the vaccine outweighs the known and potential risks,” FDA Director General Eric Domingo said in a virtual press briefing. 

The EUA is the first of its kind in the country; it is an authorization issued for unregistered drugs and vaccines in a public health emergency. This means it can now be used in the government’s inoculation program.

US pharmaceutical company Pfizer officially applied for FDA approval on Dec. 23. The DOH said it takes 21 days to evaluate and approve the EUA, “but vaccination would start as soon as stocks become available.”

The government’s first phase of inoculation aims to vaccinate 100,000 to 200,000 Filipinos daily.

Pfizer has secured regulatory approvals in several countries including the US, UK, Canada, Bahrain and Saudi Arabia. Its vaccine has a 95% efficacy.

AstraZeneca's vaccine is now udner review by the FDA.

Vaccine czar Carlito Galvez said yesterday that Pfizer will be distributed through Covax Facility, an international platform for equitable access to COVID-19 vaccines.

At the Senate hearing this week, WHO Representative to the Philippines Dr. Rabindra Abeyasinghe said the first shipment of vaccines could arrive by Feb. 20 through the Covax Facility.

Galvez had earlier described negotiations with vaccine makers as “tedious” and the global supply chain as “very volatile.”

On Monday, Jan. 11, Presidential Spokesperson Harry Roque said the country has secured 25 million doses of China’s Sinovac with the first 50,000 expected to arrive in February.

Sinovac (whose vaccine has 50% efficacy) is expected to officially file for FDA approval this week, according to Philippine Ambassador to China Chito Sta. Romana.

In a press statement last week, the FDA said review is ongoing for AztraZeneca’s ChAdOx1-S vaccine (70% efficacy).

Sinovac is expected to officially apply for approval this week. 

The official application for Sputnik V, developed by Russia’s Gamaleya National Center of Epidemiology and Microbiology, was received by the FDA on Jan. 7. “The submission was pre-assessed and the applicant was instructed to comply with the lacking documents,” Domingo said. Gamaleya’s Sputnik V has 91.4% efficacy.

On Dec. 28, 2020 the FDA granted approval for clinical trials of the COVID-19 vaccine developed by Janssen Vaccines & Prevention B.V. The FDA also approved the clinical trials of Clover Biopharmaceuticals on Jan. 8.

There are 232 vaccines being developed around the world, and 60 are in clinical trials, according to WHO Coordinator for Essential Medicines Health Technologies Dr. Socorro Escalante.

"These vaccines differ from each other based on their platforms, cold chain requirements, and the number of doses required," Escalante said.

Only 10 have reached Phase 3 clinical trials and were granted emergency use authorization around the world. Only Pfizer was granted WHO’s emergency use listing (EUL).