COVID-19

Sinovac applies for FDA emergency use approval of its COVID-19 vaccine

Sofia Tomacruz
Sinovac applies for FDA emergency use approval of its COVID-19 vaccine

EMERGENCY USE. An employee inspects vials containing CoronaVac, Sinovac Biotech's vaccine against the coronavirus disease (COVID-19), at Butantan biomedical center in Sao Paulo, Brazil, January 12, 2021.

File photo by Amanda Perobelli/Reuters

FDA Director General Eric Domingo says the agency is waiting for data from Phase 3 trials before it can begin reviewing the vaccine

Chinese pharmaceutical firm Sinovac has filed an application for emergency use authorization of its coronavirus vaccine with the Food and Drug Administration (FDA) in the Philippines. 

FDA Director General Eric Domingo announced this in a virtual press briefing on Thursday, January 14, saying the company submitted documents for its CoronaVac-Sars-Cov2 vaccine on January 13. 

“They’re on pre-assessment now. So from quick glance, their clinical trial data submitted is still somewhat lacking. From what I’ve seen, they’ve given clinical trail data from Phase 1 and 2 (trials),” Domingo said in a mix of English and Filipino. 

Domingo said the FDA was waiting to receive Phase 3 clinical trial results of Sinovac’s vaccine on which an analysis of its risk and benefits was mostly anchored on. 

Domingo said the 21-day timeline for reviewing Sinovac’s vaccine will only start once the FDA receives interim data from late-stage trials. Company officials are expected to submit this after consolidating Phase 3 trial data from Turkey, Indonesia, and Brazil. 

Aside from Sinovac, drug makers AstraZeneca and Gamaleya have applied for an EUA in the Philippines while Pfizer was the first to secure such emergency approval. 

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Philippine government officials have identified Sinovac as one of 3 vaccines that may arrive in the country during the first quarter of 2021, along with Pfizer and AstraZeneca. 

Vaccine czar Carlio Galvez Jr earlier announced the government had signed a term sheet securing 25 million doses of the Sinovac vaccine for Filipinos, with the aim to distribute this to worst-hit areas by the end of February. 

Despite a secured deal and delivery schedule, however, its deployment in the Philippines will be contingent on whether the company secures the FDA’s approval for emergency use. 

Data from Phase 3 trials  conducted in Indonesia, Turkey, Brazil, and China have shown 4 different efficacy results, ranging from a low of about 50.4% to a high of some 90%, leaving experts with more questions on the performance of the vaccine. 

In Indonesia and Turkey – where efficacy of some 65% and 91.25% were reported, respectively – only a small number of participants took part in trials to produce sufficient results. 

In terms of storage requirements, the Sinovac vaccine would be compatible with existing public health facilities in the Philippines since its storage requirement is normal refrigerated temperatures of 2 to 8 degree Celsius. 

Despite some skepticism over the vaccine’s performance, President Rodrigo Duterte had earlier vouched for the Chinese vaccine, claiming it was “as good as any other vaccine” developed by Western pharmaceutical firms. – Rappler.com

Sofia Tomacruz

Sofia Tomacruz covers foreign affairs and is the lead reporter on the coronavirus pandemic. She also writes stories on the treatment of women and children. Follow her on Twitter via @sofiatomacruz. Email her at sofia.tomacruz@rappler.com.