The Philippine Food and Drug Administration granted an emergency use authorization for Sinovac’s COVID-19 vaccine, after a review of late-stage trial data reaffirmed the shot was safe and effective.

FDA Director General Eric Domingo made the announcement in a virtual press briefing on on Monday, February 22, just a day before Duterte government officials said Sinovac’s vaccines were supposed to arrive in the Philippines. 

“After a thorough and rigorous review of the currently available published and unpublished data by our regulatory and medical experts, the FDA is granting an emergency use authorization to the COVID-19 vaccine of Sinovac Life Science Company,” Domingo said. 

Sinovac is now the third company to be granted emergency approval in the Philippines. Its approval follows that of Pfizer and AstraZeneca’s, and may speed up the start of the country’s inoculation campaign set back by delays in paperwork and limited global supply. 

Health Secretary Francisco Duque III said on Monday that the Chinese embassy in Manila advised Philippine officials it would need 3 to 5 days to prepare for the delivery of vaccines once emergency use for it was issued in the Philippines. 

Aside from the Philippines, China, Indonesia, Turkey and Brazil have granted emergency authorization for the Chinese vaccine. 

Not for use among health workers

While the FDA granted Sinovac’s vaccine emergency approval, Domingo said the FDA’s regulatory and medical experts cited conditions and recommendations for its use in the country. 

Foremost among these was that experts did not recommend its use among health workers, as the group has high exposure to COVID-19. 

A review of published and unpublished data on the vaccine from ongoing Phase 3 trials showed the vaccine had an efficacy of 65.3% to 91.2% among healthy individuals aged 18 to 59 years old. The findings, coming from community trials in Indonesia and Turkey, means the vaccine is a viable option for this group. 

But its lower efficacy of 50.4% from trials in Brazil led experts not to recommend its use in the priority sector. The Brazil trials involved health workers exposed to COVID-19.

“The safety profile is good, adverse events were mild to moderate, and possibility of allergy or anaphylaxis is minimal,” Domingo said in Filipino. “When the vaccines arrive in the country, this can be used  in groups where safety and efficacy is proven – 18 to 59 year old clinically healthy individuals.”

Under scrutiny

The emergency approval of Sinovac’s vaccines comes after Philippine lawmakers in the Senate scrutinized the Duterte government’s seeming preference for the Chinese vaccine despite reportedly higher prices and lower efficacy findings compared to other vaccine options.

Before the EUA was issued, health experts held off on judging the vaccine due to limited publicly available data on late-stage trials. Despite this, some of the government’s expert advisers sought to quell concerns over the country’s decision to consider the vaccine, saying its findings on preventing severe COVID-19 infections and death can contribute toward the government’s goal of taming the pandemic.

The use of Sinovac in the Philippines is among the few that will be done from the government’s direct purchase of vaccines. Duque said some 600,000 doses may be delivered before the end of the month.

Domingo stressed that while the FDA granted Sinovac an EUA, it is not full approval. Securing full marketing authority – which is necessary to commercialize and sell the vaccine – would be contingent on Sinovac’s commitment to finish development of the product. – Rappler.com