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Sinovac's clinical vaccine trials to push through amid FDA's EUA grant - DOST exec
Sinovac's clinical vaccine trials to push through amid FDA's EUA grant - DOST exec
The independent clinical trials of China's Sinovac Biotech will push through, amid the decision to the Food and Drug Administration to grant an emergency use authorization (EUA) for its vaccine, an official of the Department of Science and Technology - Philippine Council for Health Research and Development (DOST-PCHRD) said on Monday, Feb. 22.
DOST-PCHRD Executive Director Dr. Jaime C. Montoya said the Chinese vaccine developer, which is "on the final stage of site preparations," will conduct its clinical trials in the country.
“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 (To my knowledge, it will push through because we have to bear in mind that even though there is emergency use authorisation granted to any vaccine, their clinical trials should push through. They need to complete the Phase 3 trial for the issuance of certificate of product registration or full marketing authorization),” he said during the “Laging Handa” press briefing.
The PCHRD top official explained that Sinovac also has to conduct additional trials if they are targeting a population, which is not included in its first Phase 3 trials.
"Halimbawa po, sa matatanda, sa mga may iba pang maysakit ito ay kailangan gawin. Patuloy po ang mga trials kahit may EUA sila (For example, for the elderly, for those who have underlying medical conditions, they have to do this. The clinical trails even though they have EUA will continue),” Montoya pointed out.
In the same press briefing, FDA Director General Eric Domingo said after a thorough and rigorous review of the currently available published and unpublished data by the country’s regulatory and medical experts, the FDA has granted EUA to Sinovac’s vaccine,. known as SARS-CoV-2 vaccine Vero Cell Inactivated, or the CoronaVac.