FDA: Sinovac evaluation results to be out in 2 weeks

MANILA, Philippines — The Food and Drug Administration may come up with its evaluation on the clinical trial proposal for China’s COVID-19 vaccine Sinovac within two weeks, FDA Director General Eric Domingo said Friday.

“Sabay na natin ginagawa ‘yung mga ethics committee plus ‘yung technical and administrative regulatory evaluation ng FDA,” he said in an online media forum.

(The ethics committee review and the administrative regulatory evaluation of the FDA is being simultaneously done.)

“So far we’re still on schedule naman, we give it two weeks, so we hope to be able to come up with a decision on that maybe by next week or the week after that,” Domingo added.

Sinovac earlier passed the pre-screening of the country’s Vaccine Experts Panel. Earlier this month, it submitted to FDA its application to conduct Phase 3 of clinical trials of its COVID-19 vaccine in the country.

Domingo said Sinovac could only start its clinical trials once the FDA regulatory review and the ethics committee board have approved it.

“Both the technical side and the ethics side, all issues have to be settled and protocol has to be approved before they can start,” he said. [ac]