FDA grants EUA for Sinovac COVID-19 vaccines

The Philippine Food and Drug Administration (FDA) approved the emergency use authorization (EUA) for Sinovac’s COVID-19 vaccine, according to FDA chief Dr. Eric Domingo on Monday.

Sinovac is the third drug maker granted with EUA after AstraZeneca of UK and -BioNTech of US/Germany. The COVID-19 vaccines from western pharmaceutical companies have been found to have a 70% to 95% efficacy rate.

“After thorough and rigorous review by our regulatory and medical experts, the FDA issues EUA to Sinovac,” Domingo said during the Laging Handa briefing.

The FDA chief said that Sinovac’s efficacy is from 65.3% to 91.2%. However, it only reached 50.4% among with COVID-19 exposure.

“This should be administered by vaccination providers and to prevent COVID-19 in clinically healthy individuals aged 18 to 59 years old,” Domingo said.

“The use of Sinovac COVID-19 vaccine on health care workers is not recommended as it has an efficacy rate of 50.4% in this group,” he added.

Doming said the Sinovac vaccine is not the best option for health care workers, citing the trials conducted in Brazil.

“Mas mabuti na po ito [na may Sinovac na bakuna] kesa wala, pero ang rekomendasyon po ng ating mga experts ay hindi ito ang pinakamagandang bakuna para sa kanila,” Domingo pointed out.

FDA grants EUA for Sinovac COVID-19 vaccines

However, the FDA chief said the Sinovac COVID-19 vaccine’s side effects are only under mild to moderate categories.

“Iyong safety profile niya, iyong , usual lang na pananakit sa vaccination area, kaunting sinat. Pero sa allergy/anaphylaxis (difficulty in breathing) analysis, mababa ang posibilidad ng mga ito sa bakunang ito,” Domingo said.

Meanwhile, Presidential spokesperson Harry Roque maintained that Sinovac is not a sub-par vaccine and could be used for health care workers.

“It is not a low quality vaccine. It is better than no protection. Ang iniiwasan po talaga natin iyong pagkakasakit ng seryoso o nakamamatay,” Roque said during Palace briefing.

“It is accepted by WHO (World Health Organization) standards. Ibig sabihin, 50% chance na hindi mo makukuha ang sakit, 100% chance na hindi ka mamamatay sa COVID-19. Bakit naman hindi tatanggapin ng tao ang bakunang magbibigay ng kasiguruhan na hindi ka mamamatay sa COVID-19?” Roque added.