Results of FDA evaluation on Sinovac expected in 2 weeks —Domingo

The Food and Drug Administration (FDA) expects to come up with its evaluation on the clinical trial bid for China's COVID-19 vaccine Sinovac within two weeks, its director-general Eric Domingo said on Friday.

"Ongoing, sabay na nating ginagawa 'yung mga ethics committee plus 'yung technical and administrative regulatory evaluation ng FDA," Domingo said during the Department of Health's online forum.

"So far we are still on schedule, we give it two weeks. We hope to be able to come up with a decision on that maybe by next week or the week after," he added.

The application for the clinical trials of Sinovac in the Philippines has been cleared by the country's Vaccine Expert Panel earlier this month. It is now being vetted by the Ethics Board and the FDA.

"Makaka-start lang siya [clinical trials] kapag tapos 'yung regulatory review and the ethics committees have also given their approval. So both the technical side and the ethics side, all issues have to be settled and protocol has to be approved before they can start," Domingo said.

The Sinovac clinical trial may start ahead of the Solidarity Trial of the World Health Organization.

"Once Sinovac completes all its regulatory requirements, it can start even if the Solidarity Trial has not started," Department of Health Director for Promotion and Communication Service Beverly Ho said.

"The trial zones for independent vaccine developers like Sinovac will be assigned outside of those originally naka-allocate for the Solidarity Trial so hindi po sila mag-o-overlap," she added.

Meanwhile, Japan's Shionogi & Co. has not manifested any intention yet to conduct clinical trials in the Philippines.

"Dito kasi sa atin, tatlo 'yung possible points of contact—either the Department of Foreign Affairs, or the DOST-Vaccine Expert Panel, or the DOH and the FDA. So far, none of the three agencies have received any communication from this company regarding clinical trials," Domingo said. -MDM, GMA News