The Department of Science and Technology (DOST) said Thursday, Aug. 12, that the clinical trial protocol and other related documents for the three coronavirus disease (COVID-19) vaccines that will be used in the World Health Organization’s (WHO) Solidarity Vaccine Trial (SVT) are now being reviewed by the Food and Drug Administration (FDA).
DOST Undersecretary for Research and Development Rowena Cristina L. Guevara, who leads the Task Group on Vaccine Evaluation and Selection (TG-VES), said the trial protocol for the three vaccine brands got technical clearance from the agency’s Vaccine Expert Panel (VEP), chaired by Dr. Nina Gloriani, and was approved by the Single Joint Research Ethics Board (SJREB).
“The Clinical Trial Protocol and other-related documents for the three vaccines to be studied under the WHO Solidarity Vaccine Trials have been technically cleared by the Vaccine Expert Panel, ethically approved by Single Joint Research Ethics Board (SJREB) already and ongoing Food and Drug Administration (FDA) regulatory review,” she told the Manila Bulletin in a VIber message.
She cited the possibility of having more vaccine brands in the WHO’s SVT.
“Initially three brands, but the number can still increase,” Guevara said.
She said they are still waiting for the final date of the SVT.
“Preparations for launching the Solidarity Vaccine Trial, in coordination with WHO Headquarter, are ongoing, with the start of vaccination targeted one day after WHO global launch this August,” the DOST official said.
Guevara had disclosed that the WHO’s SVT in the country is targeted to be conducted by August 15.
Before it starts, the SVT should first get the nod of the VEP, SJREB and the FDA.
Department of Health (DOH) Secretary Francisco Duque III and WHO Chief Scientist Dr. Soumya Swaminathan had signed a letter of agreement for the conduct of SVT in the country.
The WHO SVT team met on July 9 with the Metro Manila Development Authority (MMDA) and mayors in the National Capital Region (NCR) to apprise them of the status of the SVT and to map out strategies for the smooth implementation of the vaccine trials.
In an interview with the Manila Bulletin, Guevara disclosed on July 10 that the actual rollout of the WHO SVT could be expected by the end of July or early August.
During the virtual town hall meeting organized by the Civil Service Commission (CSC) on the “COVID-19 Vaccine Deployment” on March 17, DOST-Philippine Council for Health Research and Development (PCHRD) Executive Director Dr. Jaime C. Montoya Montoya said 21 areas, mostly in Manila and Quezon City have been identified as sites for the SVT.
Based on the documents presented by Montoya, seven areas in Manila City and six areas in Quezon City have been identified as WHO SVT sites. Some areas in Pasay City, San Juan City, Paranaque City and Taguig City have also been selected as vaccine trial sites.