Belgium's Janssen gets FDA nod to conduct COVID vaccine clinical trials | Inquirer News

Belgium’s Janssen gets FDA nod to conduct COVID vaccine clinical trials

By: - Reporter / @DYGalvezINQ
/ 11:39 AM December 29, 2020

Mexico, Chile lead Latin America's first vaccine rollouts

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.

Article continues after this advertisement

“’’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.

FEATURED STORIES

“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.

Article continues after this advertisement

Clover Biopharmaceuticals is still completing its documentary requirements while Sinovac requested for a change in the clinical trial’s protocol.

Article continues after this advertisement

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.

Article continues after this advertisement

“I would suppose that in the next few weeks, they’d be ready to begin the clinical trials,” Domingo said.

RELATED STORY:

Article continues after this advertisement

Several countries confirm fresh cases of new COVID-19 strain

JPV
Your subscription could not be saved. Please try again.
Your subscription has been successful.

Subscribe to our daily newsletter

By providing an email address. I agree to the Terms of Use and acknowledge that I have read the Privacy Policy.

For more news about the novel coronavirus click here.
What you need to know about Coronavirus.
For more information on COVID-19, call the DOH Hotline: (02) 86517800 local 1149/1150.

The Inquirer Foundation supports our healthcare frontliners and is still accepting cash donations to be deposited at Banco de Oro (BDO) current account #007960018860 or donate through PayMaya using this link.

TAGS: approval, COVID-19, FDA, Janssen, vaccine

Your subscription could not be saved. Please try again.
Your subscription has been successful.

Subscribe to our newsletter!

By providing an email address. I agree to the Terms of Use and acknowledge that I have read the Privacy Policy.

© Copyright 1997-2024 INQUIRER.net | All Rights Reserved

This is an information message

We use cookies to enhance your experience. By continuing, you agree to our use of cookies. Learn more here.