(Eagle News) — The Food and Drug Administration (FDA) said that three clinical trials for COVID-19 vaccines which it had earlier approved are about to begin in the country.
These are the Phase 3 clinical trials for the vaccines developed by Janssen Pharmaceuticals of Johnson and Johnson, Clover Biopharmaceuticals, and Sinovac.
“So wala na po tayong pending ngayon na mga applications for clinical trials with FDA, and all these three clinical trials have been given the go signal by FDA. Karamihan sa kanila ay nasa preparatory stage na po ngayon at mag-uumpisa na,” FDA director general Eric Domingo said in a Laging Handa press briefing on Jan. 28.
Domingo said that the first to be given approval for clinical trials in the country was Janssen Pharmaceuticals, followed by Clover, and finally Sinovac.
The FDA approved the application for clinical trial of Janssen vaccines on Dec. 28 last year. Janssen applied for clinical trial in the Philippines for its vaccine on Dec. 13.
On Jan. 8 this year, the FDA approved the clinical trial application of Clover Biopharmaceuticals which had earlier partnered with the Coalition for Epidemic Preparedness Innovations (CEPI), GSK, and Dynavax for the advancement of its COVID-19 vaccine program. Domingo said that Clover Biopharmaceuticals had applied for a clinical trial on Nov. 25, 2020. The Clover vaccine clinical trial is a joint Chinese-Australian initiative, he said.
The third vaccine developer to be given approval is the Chinese biopharmaceutical firm, Sinovac. The FDA approved its application on Jan. 15, 2021. The firm applied on Oct. 10 last year.
Domingo said that these three clinical trials “can start anytime” after getting the FDA approval.
“Kaya lang it usually takes a few weeks for preparation ng site and of course before they start recruiting volunteers for the clinical trials,” he said.
“But I believe they will be starting very soon kasi alam ko nagre-ready na rin talaga sila sa mga hospitals,” he added.
The FDA chief said that applications for clinical trial for vaccines pass through a rigorous process before they are given the green light by the FDA. These would first have to pass through the Philippine Vaccine Expert Panel, and the Ethics Board, before finally going to the FDA.
Presently, Domingo said that the FDA is just waiting for the application of the Department of Science and Technology (DOST) and the Department of Health (DOH) for the World Health Organization (WHO) Solidarity Vaccine Trial.
The FDA said that there are 64 vaccines against COVID-19 which are currently undergoing clinical trials worldwide.
(Eagle News Service)