Chinese firm seeks FDA nod to test coronavirus vaccine on human subjects in PH

MANILA, Philippines—Chinese pharmaceutical firm Sinovac Biotech Ltd sought permission from the Food and Drug Administration (FDA) to conduct mass human testing for its candidate coronavirus vaccine in the Philippines.

FDA Director General Enrique Domingo on Thursday (Oct. 22) said the Chinese company had filed on the same day an application to conduct phase 3 clinical trials of the vaccine it was developing against SARS Cov2, the virus that causes COVID-19 and which originated from China.

“The target is, in about two to three weeks, we can already finish our review and we can already give them permit and approval for their clinical trials,” Domingo said in a televised briefing.

Sinovac filed its application at the FDA though the planned mass testing was still being reviewed by an ethics board of the Department of Health (DOH) to ensure that the rights of volunteer test subjects will not be violated at any stage in the trial.

Last week, Sinovac hurdled preliminary vetting by a panel of vaccine experts from the Department of Science and Technology (DOST).

The vaccine expert panel and the ethics review board are also evaluating the proposals of Janssen Pharmaceuticals, which is the vaccine arm of the American company Johnson & Johnson, and Russia’s Gamaleya Research Institute to conduct clinical trials in the Philippines.

In the United States, Johnson & Johnson halted trials after one volunteer got sick.

TSB