Belgium’s Janssen gets FDA nod to conduct COVID vaccine clinical trials
Stock photo / INQUIRER.net
MANILA, Philippines — Belgium’s Janssen Pharmaceutical has already secured the approval of the Food and Drug Administration (FDA) to conduct Phase 3 clinical trials in the country for its COVID-19 vaccine.
FDA Director-General Eric Domingo made the announcement on Tuesday, saying that Janssen will be the first to hold clinical trials in the Philippines.
“’’Yung clinical trials natin [Our clinical trials], we have received three applications. Yesterday, we have already approved one: Ito po ‘yung clinical trial ng [This is the clinical trial of] Janssen,” Domingo said in an online media forum.
“This has been given the go-signal by the FDA and siguro mag-start na rin sila ng kanilang clinical trial baka after ng New Year [and the company will start its clinical trial maybe after New Year],” he added.
The applications of two other drugmakers — Clover Biopharmaceuticals and Sinovac — are still undergoing review, he added.
Clover Biopharmaceuticals is still completing its documentary requirements while Sinovac requested for a change in the clinical trial’s protocol.
After the FDA approval, the country’s vaccine experts panel will identify the area where the trial will be conducted. Janssen will then prepare and start recruiting subjects for the study.
“I would suppose that in the next few weeks, they’d be ready to begin the clinical trials,” Domingo said.
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