4 firms seek permit for Covid vaccine clinical trials

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A FOURTH company has applied for a permit to conduct clinical trials in the Philippines for its coronavirus disease 2019 (Covid-19) candidate vaccine.

In a virtual press briefing, Food and Drug Administration (FDA) Director General Eric Domingo said Australian firm Clover Biopharmaceuticals AUS PTY Ltd. is undergoing pre-screening by the Vaccine Experts Panel (VEP).

Three others have sought permission to conduct clinical trials, namely, Sinovac Biotech Ltd. from China, Johnson & Johnson - Janssen Pharmaceuticals from the United States and Gamaleya Research Institute from Russia.

Domingo said Sinovac has already passed the VEP evaluation, while undergoing a separate regulatory evaluation from the Single Joint Research Ethics Board (SJREB) and the FDA.

Janssen, on the other hand, is currently undergoing pre-screening by the VEP.

Gamaleya is expected to submit additional documents before formal evaluation by the VEP begins.

The FDA chief said there is still no approved clinical trial for candidate Covid-19 vaccines in the country.

"The most advanced one is still undergoing evaluation and we hope to have a decision within one to two weeks. Either we give an approval or a denial," said Domingo.

A clinical trial is a study on human subjects to discover or verify clinical pharmacological effects of an investigational product. It also aims to ascertain the safety and efficacy of the product. (HDT/SunStar Philippines)


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