MANILA, Philippines — The Food and Drug Administration (FDA) has granted China-based drugmaker Sinovac’s Covid-19 vaccine an emergency use authorization (EUA), in time for the expected delivery of half a million doses donated by the Chinese government.
FDA Director-General Eric Domingo made the announcement on Monday, a day before the expected delivery of about 600,000 doses of Sinovac on Feb. 23.
“After a thorough and rigorous review of the currently available published and unpublished data by our regulatory and medical experts, the FDA is granting an EUA to Covid-19 vaccine of Sinovac,” he said in a Laging Handa public briefing.
“It is decided that all conditions for EUA are present and that the benefit of using the vaccine outweighs the known and potential risk,” Domingo added.
This is the third Covid-19 vaccine to have secured an EUA from FDA, following Pfizer-BioNTech and AstraZeneca.
Domingo said Sinovac’s efficacy rate ranged from 65.3% to 91.2%; however, its efficacy rate only stood at 50.4% among healthcare workers, making it not the best vaccine for them.
The vaccine should also only be administered to clinically healthy individuals aged 18 to 59 years old.
Despite this, Domingo assured that the Sinovac vaccine is safe, as its side effects only ranged from mild to moderate.
“‘Yung safety profile niya is good, ‘yung mga adverse event nito is mild to moderate. The usual ‘no, ‘yung pananakit sa braso, kaunting sinat. Ang rate din niya ay maganda doon sa allergy and anaphylaxis. Mababa ang possibilidad na magkaroon ng severe allergic reaction o anaphylaxis sa bakunang ito,” he said.
(Its safety profile is good. The adverse events are only mild to moderate. The usual is soreness of arms and slight fever. It also has a low possibility of having severe allergic reactions or anaphylaxis.)
Some 600,000 doses of the Sinovac vaccine, which are donated by the Chinese government, are expected to arrive in the Philippines this month.
It was originally set to be delivered on Feb. 23, however, it was delayed since the FDA has only granted Sinovac a EUA.
The Chinese government would need three days before delivering the promised initial doses of Sinovac vaccines to the Philippines, Malacañang said.