(PNA file photo)
MANILA - - The Food and Drug Administration (FDA) continues to accept applications for the conduct of coronavirus disease 2019 (Covid-19) vaccine clinical trial (CT) in the country.
To date, FDA has received three applications which underwent review and assessment of the Department of Science and Technology-Vaccine Expert Panel (DOST-YEP) and the Single Joint Ethics Review Board (SJREB), it said in a press release on Jan. 8.
On December 28, the FDA has granted approval for the conduct of CT on Covid-19 vaccine developed by Janssen Vaccines & Prevention B.V.
The FDA also approved on Friday the clinical trial for the vaccine developed by Clover Biopharmaceuticals AUS Pty Ltd.
"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.
Acceptance and review of applications for Emergency Use Authorization (EUA) of Covid-19 vaccines is also underway.
Evaluation of Pfizer-BioNTech Covid-19 Vaccine and the AztraZeneca Pharmaceuticals-ChAdOx 1-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.
The EUA application for Sputnik V developed by Gamaleya National Center of Epidemiology and Microbiology-Ministry of Health Russia was received on Thursday (Jan. 7).
"The submission was pre-assessed and the applicant was instructed to comply with the lacking documents," Domingo said. (PR)
