Chinese vaccines undergo FDA evaluation for local clinical trials in PH

The Food and Drug Administration (FDA) is assessing the usage of China's COVID-19 vaccines Clover and Sinovac for clinical trials in the Philippines.

Director general of FDA Eric Domingo said they are checking Clover's documents that were submitted last week; Sinovac applied in November, but its documents are still lacking.

As of Dec. 3, Russia’s Gamaleya Center has also applied to hold Phase 3 clinical trials in the Philippines for its Sputnik V vaccines.

Gamaleya’s application has been delayed and pending submissions of some required documents on Phase 3 Study Protocol and Informed Consent.

Vaccine manufacturers are required to apply with the Vaccine Expert Panel (VEP) congregated by the Department of Science and Technology (DOST) according to protocols.

According to Domingo, "Once the companies have submitted all the required documents, it would likely take the FDA 30 days to decide."

Sinovac has secured the approval of the ethics board to conduct trials of its COVID-19 vaccine here in the Philippines while Clover Biopharmaceuticals received clearances from the panels.

Words by Kyrs Mejares

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