THE Philippines’ Food and Drug Administration (FDA) has granted an emergency use authorization (EAU) for AstraZeneca’s COVID-19 vaccine.
“After a thorough review of the current available data by our medical and regulatory experts, the FDA is granting an emergency use authorization for the COVID-19 vaccine of AstraZeneca,” FDA Director General Eric Domingo said Thursday, January 28.
“It is decided that all conditions for an EUA are present and that the benefit of using the vaccine outweighs the known potential risks,” he added.
The COVID-19 vaccine developed by AstraZeneca and the University of Oxford has an efficacy rate of 70% after the first dose, and trials are ongoing to determine the efficacy rate after the second dose.
AstraZeneca’s vaccine regimen consists of two equal standard doses of 0.5 ml each, administered four to 12 weeks apart on individuals aged 18 years and above.
Domingo reassured that the adverse effects of AstraZeneca’s COVID-19 vaccine range from mild to moderate.
“Ang nakitang adverse effects are all very mild, similar to getting any flu injection.
Karamihan ay pananakit sa lugar ng injection, konting sinat, konting sakit ng ulo that are all transient and easily managed (The adverse effects observed are all very mild, similar to getting any flu injection. Mostly the effects are soreness on the injection site, slight fever, and slight headache),” he said.
The Philippines, through the private sector and local government units, signed a tripartite agreement to procure 17 million doses of AstraZeneca’s vaccine. The first batch is expected to arrive in May.
The EUA granted to the vaccine is not a substitute for Certificate for Product Registration, meaning the vaccine cannot be commercially distributed in pharmacies, clinics, or hospitals.
AstraZeneca’s vaccine is the second vaccine to be authorized for emergency use in the country, following Pfizer-BioNTech’s Covid-19 vaccine.
Meanwhile, the applications of Russian drugmaker Gamaleya Research Institute, Indian firm Bharat Biotech and China’s Sinovac are still pending.
The Philippines is aiming to vaccinate 50 to 70 million Filipinos in 2021, with up to 200,000 individuals receiving jabs every day.
