Conduct of the vaccine trials for the first batch of candidate vaccines from the World Health Organization (WHO) is expected to commence in the fourth week of October, the top official of the Department of Science and Technology (DOST) disclosed.
DOST Secretary Fortunato dela Peña mentioned the update on the WHO Solidarity Trial for Vaccines during his weekly report on Friday. He
said that this also includes the recruitment of volunteer vaccine recipients.
He also said that the conduct of the trial needs to pass all levels of the approval process, such as from the Vaccine Expert Panel, Ethics Review Board, and the country’s Food and Drug Administration (FDA), and to comply with the WHO protocol, standard operating procedures (SOPs) and submission of the necessary documentary requirements.
“Since the aforementioned protocol and SOPs are yet to be released by the WHO, the vaccine teams are currently preparing the hospital sites and are planning the community trial sites for the smooth implementation of the said trials,” Dela Pena added.
DOST is funding the local implementation of the WHO Solidarity Trial amounting to P89.1 Million.
The project’s main implementer is the Philippine General Hospital (PGH) with Dr. Jodor Lim as the overall principal investigator. There are 11 participating hospitals that will serve as trial sites of the project.
On September 3, the Inter-Agency Task Force on Emerging Infectious Diseases (IATF-EID) approved through Resolution No. 68 the zoning guideline for the COVID-19 vaccine clinical trials as recommended by the Sub-TWG on Vaccine Development through the assistance of the DOST Vaccine Expert Panel.
The guideline is being issued to avoid competition for clinical trial sites among vaccine developers. The DOST, as sub-TWG chair, will also form a separate Data and Safety Monitoring Committee whose role will be important in monitoring the safety of the vaccines under the WHO Solidarity Trials while the study is ongoing.
A comprehensive communication plan has also been developed by the DOH Health Promotion and Communication Office with the help of DOST, Philippine Health Research Ethics Board (PHREB), PGH and other concerned agencies to inform the general public about the trials; promote transparency, cautious optimism, global cooperation, volunteerism and ownership, and ethics in relation to the upcoming clinical trials for COVID-19 vaccine in the Philippines.