Resulta ng FDA evaluation sa Sinovac asahan sa 2 linggo —Domingo

Resulta ng FDA evaluation sa Sinovac asahan sa 2 linggo —Domingo

October 30, 2020 @ 6:32 PM 1 month ago

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Manila, Philippines – Inanunsyo ng Food and Drug Administration (FDA) na lalabas ang ebalwasyon sa clinical trial bid ng COVID-19 vaccine Sinovac sa loob ng dalawang linggo, batay kay director-general Eric Domingo.

“Ongoing, sabay na nating ginagawa ‘yung mga ethics committee plus ‘yung technical and administrative regulatory evaluation ng FDA,” paliwanag ng opisyal.

“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.”

“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,” lahad pa nito.

Maaari ring maunang magsimula ang Sinovac clinical trial sa Solidarity Trial ng  World Health Organization.

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

“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.”

“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,” lahad pa ni Domingo. RNT/FGDC


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