The clinical trials for the Sinovac COVID-19 vaccine in the Philippines will push through amidst FDA’s EUA grant, according to a DOST official.
An official of the Department of Science and Technology – Philippine Council for Health Research and Development (DOST-PCHRD) on Monday said that the independent clinical trials of China’s Sinovac Biotech in the Philipi for its COVID-19 vaccines will push through amidst the decision to the Food and Drug Administration (FDA) to grant an emergency use authorization (EUA) for Sinovac COVID-19 vaccine.
Dr. Jaime C. Montoya, the Executive Director of DOST-PCHRD, said during the “Laging Handa” press briefing that Sinovac — which was “on the final stage of site preparations” — would conduct its clinical trials in the Philippines.
According to Montoya, Sinovac needed to complete its Phase 3 clinical trial for the issuance of a “certificate of product registration” or “full marketing authorization”.
“Sa pagkakaalam ko po ay itutuloy po dahil dapat po nating isipin na kahit may emergency use authorization ng kahit anong bakuna, patuloy pa rin po dapat ang kanilang mga clinical trial. Kailangan nila tapusin ang Phase 3 trial para ma-issuehan ng certificate of product registration or full marketing authorization,” he said.
Montoya explained that Sinovac also had to conduct additional clinical trials if they’re targeting a population, which wasn’t included in its first Phase 3 trials.
Meanwhile, FDA Director-General Eric Domingo said in the same press briefing that the Food and Drug Administration had granted an emergency use authorization (EUA) to Sinovac COVID-19 vaccine — known as “SARS-CoV-2 vaccine Vero Cell Inactivated” or the “CoronaVac” — after a thorough and rigorous review of the currently-available published and unpublished data by the country’s regulatory and medical experts.