THE Department of Health (DOH) announced on Sunday that the conduct of Covid-19 vaccine phase 3 clinical trials in the country will begin this November.
Health Secretary Francisco T. Duque III said the Inter-Agency Task Force’s (IATF) Sub-Technical Working Group (sub-TWG) on Covid-19 Vaccine Development, led by the Department of Science and Technology (DOST), and the other government agencies on the team are gearing up for the said clinical trials.
“The responsibilities of each agency under the Sub-TWG on Vaccine Development are clear. I am confident that all agencies involved in vaccine development will work tirelessly in carrying out each individual responsibility,” Duque said.
He said they also recognize the “exigency of these vaccine trials given our ongoing situation.”
Duque added, “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.”
As the trials are a scientific research and development initiative, the IATF in its Resolution No. 39 dated May 22, 2020 put the DOST as lead.
Joining the DOST are the DOH, the Department of Foreign Affairs (DFA) and the Department of Trade and Industry (DTI).
Other members of the sub-TWG include the Food and Drug Administration (FDA) and the Research for Tropical Medicine, both of which are under the DOH; and, the National Development Company (NDC) under the DTI.
The responsibilities of other agencies involved in the conduct of these trials are:
- The DFA coordinates bilateral partnerships related to the vaccine trials and partners with the DTI and the NDC for the possibility of manufacturing the vaccines locally in partnership with the pharmaceutical companies.
- The DOH, the vice chair of the sub-TWG, will oversee the hospitals joining the clinical trials and will manage the operations and logistics of the clinical trials. The DOH will also lead in the communication campaign for the vaccine clinical trials to be conducted.
- The FDA will monitor the entities approved to conduct clinical trials. It will also approve vaccines that will be released and sold to the public.
All applications for clinical trials to be conducted in the country are submitted to the sub-TWG for Vaccine Development and pertinent documents are reviewed by the Vaccine Expert Panel (VEP) and the Ethics Review Committees.
These bodies are composed of vaccine experts, technical experts, and scientists who will identify, evaluate, and recommend possible vaccine candidates for the Philippines.
After a thorough review of the clinical trial applications, these will be submitted to the FDA for final pass.
The vaccine trials may begin upon the FDA’s regulatory review and approval of the conduct of the clinical trials.
Image credits: AP Photo/Aaron Favila