FDA approves clinical trial for Clover COVID-19 vaccine

MANILA, Jan 9 (Mabuhay) — The  Philippines’ Food and Drug Administration approved Friday the clinical trial for the coronavirus disease 2019 (COVID-19) vaccine developed by Chinese firm Clover Biopharmaceuticals AUS Pty Ltd.

Before securing the go signal from FDA, the Department of Science and Technology – Vaccine Expert Panel (DOST-VEP) and the Single Joint Ethics Review Board (SJREB) gave clearance to Clover Biopharma for the conduct of the clinical trial.

In December 2020, the FDA approved the clinical trial on the vaccine developed by Janssen Vaccines & Prevention B.V.

The FDA said it continues to accept applications for the conduct of COVID-19 vaccine clinical trial in the country. To date, FDA has received three applications which underwent review and assessment of the DOST-VEP and the SJREB.

“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,” Director General Eric Domingo said.

He added acceptance and review of applications for emergency use authorization (EUA) of COVID-19 vaccines is also underway.

The evaluation of Pfizer-BioNTech COVID-19 Vaccine and AstraZeneca Pharmaceuticals-ChAdOx1-S (recombinant) COVID-19 vaccine is ongoing.

Domingo said the decision of approval is expected to be released within 21 calendar days upon filing of application. He earlier said the decision on Pfizer, which applied in December 2020 will issued by January 14.

AstraZeneca, on the other hand, applied for EUA on January 6, 2021.

The EUA application for Sputnik V developed by Gamaleya National Center of Epidemiology and Microbiology- Ministry of Health Russia was received on January 7 2021. Prior to this, Gamaleya withdrew its application to conduct clinical trials in the Philippines.

“The submission was pre-assessed and the applicant was instructed to comply with the lacking documents,” Domingo said. (MNS)

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