16/04/2021

Sinovac applies for emergency use authorization in Philippines

Chinese business Sinovac has applied for crisis use authorization (EUA) ahead of the Philippine Meals and Drug Administration (Food and drug administration), Food and drug administration Director Basic 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-post ng software ang Sinovac,” Domingo stated throughout a digital briefing.

Domingo, having said that, explained that Sinovac has yet to complete submission of prerequisites essential to safe an EUA.

“Ang naipadala pa lang nila ay ‘yung success ng Stage 1 and Phase 2 scientific trials. Right up until we see the benefits of Phase 3 scientific trials, hindi pa natin ma-a-asses iyong gain at threat,” Domingo reported.

Period 3 is the human trials.

“Iyong balancing kasi [ng benefits at risk], naka-angkla sa effects ng Period 3 scientific demo final results,” Domingo stated.

Sinovac’s efficacy immediately after human trials has been diversified relying on the location where the trials had been held so much.

It registered a 50% efficacy in Brazil, 65% in Indonesia and 91% in Turkey.

The Philippines is hoping to protected 25 million doses of COVID-19 vaccine from Sinovac through 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