Chinese firm Sinovac has applied for emergency use authorization (EUA) before the Philippine Food and Drug Administration (FDA), FDA Director General Eric Domingo said Thursday.
Domingo issued the remark on the same day he announced that FDA granted EUA on Pfizer-BioNTech’s COVID-19 vaccine.
“Yesterday, nag-submit ng application ang Sinovac,” Domingo said during a virtual briefing.
Domingo, however, said that Sinovac has yet to complete submission of requirements needed to secure an EUA.
“Ang naipadala pa lang nila ay ‘yung results ng Phase 1 and Phase 2 clinical trials. Until we see the results of Phase 3 clinical trials, hindi pa natin ma-a-asses iyong benefit at risk,” Domingo said.
Phase 3 is the human trials.
“Iyong balancing kasi [ng benefits at risk], naka-angkla sa results ng Phase 3 clinical trial results,” Domingo said.
Sinovac’s efficacy after human trials has been varied depending on the location where the trials were held thus far.
It registered a 50% efficacy in Brazil, 65% in Indonesia and 91% in Turkey.
The Philippines is hoping to secure 25 million doses of COVID-19 vaccine from Sinovac during the first quarter according to vaccine czar Carlito Galvez Jr.
To date, Sinovac has secured an EUA in China and in Indonesia. — RSJ, GMA News