MANILA, Philippines — The coronavirus vaccine candidate of Chinese firm Sinovac Biotech Ltd. has passed the first stage of the country’s review process, the Food and Drug Administration said Thursday.
FDA Director General Eric Domingo said Sinovac has passed the review of the vaccine experts panel chaired by the Department of Science and Technology to conduct Phase 3 clinical trial in the Philippines.
The vaccine of the Chinese drugmaker is still undergoing the review of the ethics board.
Domingo said Sinovac is expected to submit its application to conduct Phase 3 clinical evaluation to the FDA within two weeks.
He added that it is “possible” that Sinovac may start the late-stage trial of its candidate vaccine in the Philippines by November.
“It’s really a matter of when the application is given to FDA. Maybe they will submit next week or two weeks from now,” he said.
Other clinical trials, including the World Health Organization-led solidarity trials, may also start before the end of the year, the FDA head said.
The Philippines is also assessing the application of Russian firm Gamaleya Research Institute and American company Johnson & Johnson’s Janssen to conduct Phase 3 clinical trials in the country.
Johnson & Johnson paused the late-stage clinical trial of its coronavirus vaccine because of an “unexplained illness” in one of the participants.
The country’s COVID-19 caseload reached 348,698 Thursday, with 6,497 deaths. — Gaea Katreena Cabico