Sinovac applies for FDA approval for Phase III COVID-19 vaccine trials in PH

Sinovac Biotech has applied to the FDA for approval to conduct Phase III clinical trials for its COVID-19 vaccine candidate in the Philippines.

The Chinese firm's vaccine candidate successfully passed the initial evaluation by the Department of Science and Technology's vaccine experts panel.

According to FDA Director-General Rolando Enrique Domingo, Sinovac is the only company so far to pass the pre-vaccination screening phase locally, out of three applicants.

The Phase I and Phase II results of the Sinovac vaccine showed only very mild and non-serious side effects.

The evaluation by the Single Joint Research Ethics Board is currently underway to ensure the safety of trial participants.

The FDA anticipates it will take two to three weeks to review Sinovac's clinical trial application, with trials expected to begin soon.

Meanwhile, the Gamaleya Research Institute and Janssen Pharmaceutica are still being studied by the panel.

Philippine Ambassador to China Jose Santiago Santa Romana stated that November is an optimistic projection for China to mass produce COVID-19 vaccines.