Chinese vaccine cleared for Philippines clinical trials

MANILA, Philippines, October 16 ------ China’s candidate vaccine for COVID-19 has been cleared by a panel of experts for phase 3 clinical trial in the Philippines possibly by November, according to the Food and Drug Administration. FDA director general Eric Domingo said the vaccine expert panel or VEP of the Department of Science and Technology (DOST) on Monday gave the required clearance for pharmaceutical company Sinovac Biotech Ltd.

“We have been advised by the VEP that the (Sinovac vaccine) has passed their evaluation,” Domingo said during a virtual forum yesterday. With the clearance from VEP, Domingo said Sinovac needs only to secure approval from the Single Joint Research Ethics Board (SJREB) of the Department of Health (DOH) before applying for clearance from the FDA. He said the VEP reviews Phase 1 and 2 clinical trials of the candidate vaccine, while the ethics board evaluates the selection for trial participants.

“The clearance from the ethics board is still in progress. Though they (Sinovac) said they would be meeting the ethics board this week. We will be waiting for the result, because the FDA cannot start any study without Ethics Board approval,” Domingo noted. “We have not seen the application yet so we don’t know the details and it’s really a matter of when the submission is given to the FDA. It is possible that they will submit their application next week or two weeks from now,” he said.

The start of the clinical trial depends on when all the requirements are complied with, although Domingo said it is possible that the Sinovac clinical trial may begin by November. Domingo said that FDA evaluation on Sinovac for clinical trials upon approval of the ethics board should take 14 to 21 days.

Source: philstar.com