FDA grants EUA to Sinovac vaccine

The Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) to the Sinovac vaccine, Coronavac.

The Pfizer and AstraZeneca vaccine has been initially approved by the FDA making the Sinovac the third vaccine to be granted an EUA in the Philippines.

“It is decided that all conditions for EUA are present and that the benefit of using the vaccine outweighs the known and potential risks,” FDA Director General Eric Domingo disclosed.

According to Undersecretary Domingo, the interim analysis of the said vaccine’s clinical trial showed that it is effective with healthy individuals aged 18 to 59. Its efficacy rate in Indonesia is 65.3% while the rate based on its clinical trial in Turkey is 91.2%.

However, the FDA Chief pointed out that its efficacy rate on healthcare workers exposed to the Coronavirus Disease 2019 (COVID-19) is only 50.4%. The Sinovac vaccine is not recommended for the said group.

The dosing regimen of Coronavac is 2 equal standard doses that must be given within 4 weeks. USec. Domingo also revealed that the reported adverse effects of the vaccine are only mild to moderate. Report from Mark Fetalco

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