China’s Clover gets FDA clearance to hold COVID-19 vaccine trials in PH

FILE PHOTO: The word “COVID-19” is reflected in a drop on a syringe needle in this illustration taken November 9, 2020. REUTERS/Dado Ruvic/Illustration/File Photo

MANILA, Philippines — The Food and Drug Administration (FDA) has approved the application of China-based Clover Biopharmaceuticals to conduct COVID-19 vaccine clinical trials here in the Philippines.

In a statement, the FDA said announced that it gave its approval on Clover’s clinical trial application on Friday.

Clover and fellow Chinese firm Sinovac Biotech were among the pharmaceutical firms that applied to conduct clinical trials in the country.  Sinovac’s application, meanwhile, is still pending with the FDA.

“The FDA is currently awaiting response to clarifications for the proposed study on the Sinovac Life Sciences vaccine before issuing a decision on the application,” FDA director-general Eric Domingo said.

Clover is the second vaccine maker to secure FDA approval for clinical trials following US-based Janssen Pharmaceuticals Company of Johnson and Johnson.

The FDA is likewise reviewing the application of US firm Pfizer, UK’s AstraZeneca, and Russia’s Gamaleya Institute for emergency use authorization (EUA) of their respective candidate coronavirus vaccines. A decision on Pfizer’s EUA application is expected on Jan. 14.

The Philippines has so far secured only 2.6 million doses from British drugmaker AstraZeneca which are expected to arrive in the second quarter of 2021.