Philippines approves AstraZeneca COVID-19 jab for emergency use
MANILA, Philippines (Updated 12:41 p.m.) — The country’s Food and Drug Administration has issued an emergency use authorization for the coronavirus vaccine developed by AstraZeneca, making it the second COVID-19 jab to get the approval needed for it to be rolled out in the government's inoculation program.
“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. It is decided all conditions for EUA are present and that the benefits of using the vaccine outweigh the known and potential risks,” FDA Director General Eric Domingo said in a Thursday.
The EUA provides that AstraZeneca will supply the shots to “emergency response stakeholders” such as the Department of Health, the National Task Force Against COVID-19 or their designees which include hospitals, health facilities of other government agencies, local government units and private firms.
The authorization also clears the vaccine for use in individuals aged 18 and above. It can only be administered by vaccine providers designated by the DOH.
The FDA earlier granted EUA to the COVID-19 vaccine developed by Pfizer and its German partner BioNTech.
The emergency authorization will be valid only within the duration of the declared public health emergency or upon the issuance of certificate of product registration.
17 million doses
The AstraZeneca shot, developed in partnership with the University of Oxford, was found to be 70% effective on average. This is lower than the 95% reported for the COVID-19 jabs from Pfizer/BioNTech and Moderna.
But unlike Pfizer jabs which require sub-arctic temperatures for storage, AstraZeneca vaccines only need to be stored at around 2°C, which is the standard temperature that is within the existing cold chain system in the country.
An emergency authorization does not necessarily mean the AstraZeneca vaccine will be immediately available for use as the country has yet to receive vaccine supplies from the British-Swedish pharmaceutical company.
The national government, several local government units and private firms signed a deal with drugmaker for a total of 17 million doses of its coronavirus vaccines.
Authorities are scrambling to lock in supply to inoculate at least 50 million Filipinos this year and help contain Southeast Asia’s second worst COVID-19 crisis.
Russian drugmaker Gamaleya Research Institute, Indian firm Bharat Biotech and China’s Sinovac have pending EUA applications before the FDA.
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