FDA stresses: Sinovac vaccine cannot enter PH without emergency use approval

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Metro Manila (CNN Philippines, January 27)— China's Sinovac vaccine, CoronaVac, will not be brought to the Philippines until an emergency use authorization is issued for the product, the Food and Drug Administration stressed on Wednesday.

FDA Director General Eric Domingo told CNN Philippines that vaccine czar Carlito Galvez Jr. agreed to hold the Sinovac delivery pending regulatory approval.

"Secretary Charlie Galvez and I spoke. And he agrees that they will not bring it in until we get that emergency use authorization for the product," Domingo said in an interview with The Source. "And we are communicating closely with the applicant, for them to be able to submit immediately all the requirements."

An EUA issuance is required for vaccines to be legally rolled out in the country.

The Philippine government earlier announced it has closed a deal to purchase 25 million doses from Sinovac, but Galvez noted they could still opt out from the agreement, since the vaccine has yet to gain local regulatory approval.

Officials also previously said that the initial 50,000-dose batch is set to arrive by February 20.

Domingo said Sinovac has submitted a manuscript of the required phase 3 clinical trial results, but noted the findings have not yet been published in peer-reviewed journals, making the review time longer than the other applicant vaccines.

"Wala tayong complete reports that we can appreciate and that can help base our decisions on," the FDA chief noted. "So medyo raw nang konti 'yung data."

[Translation: We don't have complete reports that we can appreciate and that can help base our decisions on. So the data is quite raw.]

Domingo said the FDA and expert panels may need around two or three more weeks to come up with a decision on Sinovac's application for EUA.