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MANILA, Philippines – The Food and Drug Administration may present its evaluation on the clinical trial proposal for the COVID-19 vaccine from China Sinovac within two weeks, FDA Director General Eric Domingo said Friday.
“At the same time, we are doing the ethics committees plus the FDA technical and administrative regulatory review,” he said in an online media forum.
(The ethics committee review and the FDA administrative regulatory review are ongoing simultaneously.)
“So far we are on Naman’s schedule, we give him two weeks, so we hope we can make a decision on that maybe next week or the following week,” Domingo added.
Sinovac previously passed the preselection of the country’s Vaccine Expert Panel. Earlier this month, it submitted its request to the FDA to conduct Phase 3 of the clinical trials of its COVID-19 vaccine in the country.
Domingo said Sinovac could only begin its clinical trials once FDA regulatory review and the ethics committee board have approved it.
“Both technically and ethically, all issues must be resolved and the protocol must be approved before they can begin,” he said. [ac]
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