PH all set for COVID-19 phase 3 clinical trial by Nov.

Published October 11, 2020, 12:24 PM

by Analou de Vera

The Philippines may start the conduct of COVID-19 vaccine clinical trials by next month, the Department of Health (DOH) said.

The DOH said that the government agencies are now “gearing up for the conduct of COVID-19 vaccine phase 3 clinical trials in the country which are set to begin this coming November.” This initiative is being led by Inter-Agency Task Force’s Sub-technical Working Group (TWG) on COVID-19 Vaccine Development, with the Department of Science and Technology as its chair.

“All applications for clinical trials to be conducted here in the country are submitted to the sub-TWG for Vaccine Development and pertinent documents are reviewed by the Vaccine Expert Panel and the Ethics Review Committees,” the DOH said in a statement.

“These bodies are composed of vaccine experts, technical experts, and scientists who will identify, evaluate, and recommend possible vaccine candidates for the Philippines,” it added.

After thorough review of the clinical trial applications, these will be submitted to the Food and Drug Administration (FDA) for final pass, the DOH said. 

“The vaccine trials may begin upon the FDA’s regulatory review and approval of the conduct of the clinical trials,” the DOH said. 

During the clinical trial Phase 3, a vaccine is tested in a “large group of people” to confirm its efficacy and safety. 

Last Friday, October 9, DOH Undersecretary Maria Rosario Vergeire said that three vaccine developers already sent an application for the possible conduct of Phase 3 clinical trials of their respective  vaccines in the country.

These are Russia’s Gamaleya Research Institute,  Johnson & Johnson’s Janssen Pharmaceuticals, and China’s Sinovac Biotech.  

Six pharmaceutical firms, meanwhile, also signed a confidentiality disclosure agreement that would let the Philippines’ vaccine experts panel to review the results of their respective Phase 1 and Phase 2 trials. 

These are the Gamaleye Research Institute from Russia, University of Queensland from Australia; Adimmune from Taiwan, and the Sinovac, Sinopharm and Anhui Zhifei Longcom Biopharmaceutical from China, said Vergeire. 

“I am confident that all agencies involved in vaccine development will work tirelessly in carrying out each individual responsibility. We also recognize the exigency of these vaccine trials given our ongoing situation,” said Health Secretary Francisco Duque III. 

“This is why in the conduct of these trials, we will work together tirelessly and move expeditiously, of course while always placing primacy on the safety of our clinical trial participants,” he added.