FDA approves emergency use of Sinovac vaccine

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The Philippine Food and Drug Administration has issued an emergency use authorization for COVID-19 vaccines produced by Chinese firm Sinovac Biotech. A top official however cautioned that the vaccine cannot be given to medical frontliners due to its low efficacy rate.

The drug underwent a long review as their submission of Phase 3 clinical data was incomplete.

FDA Director General Eric Domingo advised against administering the vaccine to frontliners, elderlies, and those with co-morbidities. This is because the Sinovac has a lower efficacy rate, which means it is only advisable to be received by healthy people aged 18-59 with an interval of four weeks between doses.

“Ang nakita kasi sa trial sa Brazil na binigay ito sa healthcare workers sa hospitals treating COVID-19 ay 50.4% ang efficacy niya. Mas mabuti na kaysa wala. Pero ang rekomendasyon natin, ng mga experts ay hindi ito ang pinaka magandang bakuna para sa kanila,” Domingo explained.

“It has a lower efficacy rate of 50.4% when used on healthcare workers exposed to COVID-19. Therefore, it is not recommended for use in this group.”

In late -stage trials in Brazil, Sinovac coronavirus vaccine was found to be 50.38% effective which is significantly lower than earlier published results. While the number exceeds the threshold required for regulatory approval, it falls far below the 78% initial data.

Domingo said it showed 65.3% to 91.2% efficacy rate when used on healthy people within the recommended age range.