FDA Philippines OKAYS ASTRAZENECA COVID VACCINE for EMERGENCY USE Authorization

Even as the long hoped-for vaccines for COVID-19 begin to be distributed around the pandemic-battered world, and even as some countries have already begun surely vaccinating their respective populations against the still-rampaging virus, the Philippines have taken the slow and steady approach. Vaccines for COVID need to be tested and approved by the country’s Food and Drug Administration (FDA) before they can be utilized, although getting an Emergency Use Authorization (EUA) from them could significantly cut down on the waiting time. For the national government, LGUs and private enterprises that have chosen to deal with AstraZeneca, the wait is over.

CNN Philippines would have it that the Philippine Food and Drug Administration had given its second Emergency Use Authorization for vaccines against COVID-19 to the vaccine manufactured by British-Swedish pharmaceutical firm AstraZeneca. The FDA director-general Eric Domingo announced the news on Thursday, January 28, following a thorough review of AZD1222, the COVID vaccine that AstraZeneca developed in collaboration with Oxford University. It now joins BNT162b2/Comirnaty, the vaccine created by Pfizer and BioNTech, which got its own EUA two weeks ago.

Domingo noted that the AstraZeneca vaccine fulfilled all conditions for allowing a EUA. Local studies found no serious safety concerns with it, therefore minimal risks are outweighed by the benefits, meaning the gained COVID immunity. Adverse effects of its usage, expected of many other vaccines, were also judged as mild, namely pain in the injected area, headaches and fever, much like getting vaccinated against flu. Also helpful are the more manageable requirements for transporting and storing AZD1222, as they do not need to be frozen, only kept at about 2-8°C.

By the terms of the FDA’s Emergency Use Authorization, the AstraZeneca vaccine for COVID-19 is administered in two doses, spaced anywhere from four to 12 weeks apart. Except for pregnant women, anyone at the age of 18 and above is viable for injection. The efficacy rate against COVID has been determined by the FDA to be a 70% from the first dose then gets even better after the second one.

Between efforts by the national government, 39 LGUs and more than 300 businesses from the private sector, AstraZeneca has earmarked about 17 million doses of the vaccine. Overall, the earliest COVID vaccine shipments to the Philippines will arrive by February, with immunization programs beginning either that month or in March.

Image courtesy of Business World

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