FDA grants EUA to AstraZeneca’s COVID-19 vaccine

The Food and Drug Administration () in the Philippines granted authorization (EUA) for AstraZeneca’s COVID-19 vaccine, according to FDA chief Dr. Eric Domingo on Thursday.

This makes the British pharmaceutical firm the second company to get a EUA in the country after Pfizer BioNTech.

According to Domingo, the vaccine from AstraZeneca developed with Oxford University has an efficacy rate of 70% after the first dose.

“All conditions for EUA are present, and the benefit of using the vaccine outweighs potential risk,” Domingo said during the day’s Laging Handa briefing.

“The interim data, taken in its entirety, showed an efficacy rate of 70% after the first dose. Tumataas ito pagkatapos bigyan ng second dose, depende rin sa length of time kung kelan ibinigay iyong second dose,” he added.

The FDA chief added that AstraZeneca initially showed it is very effective in preventing severe COVID-19 infection.

“Iyong data ng AstraZeneca showed it is very good in preventing severe COVID-19, halos 100% rin. Kaya lang maliit pa ang datos nila, at maa-update pa ‘yan. So iyong 70% [na efficacy after first dose], kahit may nagkasakit [ng COVID-19], hindi grabe,” he added.

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FDA grants EUA to AstraZeneca’s COVID-19 vaccine

Domingo said that the two doses of AstraZeneca could be given four to 12 weeks apart on individuals aged 18 years and above. It could only be given by vaccinators and providers identifies by the Department of Health.

However, Domingo clarified that vaccine recipients needed to be closely monitored after the .

The FDA chief also clarified AstraZeneca’s vaccine’s potential efficacy rate was not dependent on the number of doses given to an individual.

“Tuloy tuloy pa po ang clinical trials [for AstraZeneca’s vaccine], but currently it does not depend on half dose then standard dose, or standard dose then [another standard dose]. It is more [dependent] on the time difference between first and second doses,” he said.

“Ang pananakit doon sa lugar ng injection, konting sinat, konting sakit na ulo…that can all be easily managed. Walang special na precaution up to date kasi walang specific concerns na naidentify,” Domingo said.