FDA OKs emergency use authorization for Sinovac COVID-19 vaccines

The Philippine Food and Drug Administration (FDA) has granted emergency use authorization for Sinovac’s COVID-19 vaccine, its director general, Dr. Eric Domingo, announced on Monday.

This development makes Sinovac, a Chinese pharmaceutical firm, the third company to secure an EUA in the Philippines after AstraZeneca of UK and Pfizer-BioNTech of US/Germany which 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.

He said that Sinovac’s efficacy ranged from 65.3% to 91.2%, but only reached 50.4% among health workers 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. 

Domingo cited that human trials of the Sinovac vaccine in Brazil, which had health workers as participants, showed that it is not the best vaccine choice for health workers. 

“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.

He, however, said Sinovac rated well in terms of side effects which just ranged from mild to moderate categories. 

“Iyong safety profile niya, iyong adverse effects, 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.

Presidential spokesperson Harry Roque, for his part, stressed that Sinovac is not a sub par vaccine even if the two other COVID-19 vaccine brands issued EUA, namely Pfizer-BioNTech and AstraZeneca, registered a higher efficacy rate ranging from 70% to 95% and thus, can be used for health workers, unlike Sinovac. 

“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.

Roque said the 600,000 doses of Sinovac donated by the Chinese government to the Philippines are due to arrive this week.

The Department of Health (DOH) meanwhile will use its savings to buy Sinovac COVID-19 vaccines, Health Secretary Francisco Duque III said on Monday.

“Ang paggagamitan po nu'ng [savings], sa Sinovac na aangkatin natin. Kaunti lang [muna] ito, 50,000 doses muna ang babayaran,” Duque said during the Laging Handa briefing.

“Iyan ang sabi ng National Task Force [Against COVID-19]. Meron pong savings na puwedeng magamit para sa [pambili ng] bakuna, at tinitignan po natin iyong Sinovac para sa karagdagan o sa labas ng donated ng 600,000 [doses]. Diyan po gagamitin ‘yan,” he added. — RSJ/KG, GMA News