Chinese Firm Seeks FDA Clearance to Test Coronavirus Vaccine on Human Subjects at HP

MANILA, Philippines – Chinese pharmaceutical company Sinovac Biotech Ltd has applied to the Food and Drug Administration (FDA) for permission to conduct mass human testing for its candidate coronavirus vaccine in the Philippines.

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

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

Sinovac filed its application with the FDA, although a Department of Health (DOH) ethics board was still reviewing the planned massive tests to ensure that the rights of volunteer test subjects will not be violated at any stage of the trial.

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

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

In the United States, Johnson & Johnson stopped trials after a volunteer fell ill.

TSB

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