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The Department of Health (DOH) announced on Sunday that the conduct of phase 3 clinical trials of the Covid-19 vaccine in the country will begin in November.
The Secretary of Health, Francisco T. Duque III, said that the Sub-Technical Working Group (sub-TWG) of the Inter-institutional Working Group (IATF) on Covid-19 Vaccine Development, led by the Department of Science and Technology ( DOST), and the other government agencies team are preparing for such 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 to fulfill each individual responsibility, ”said Duque.
He said they also recognize the “demand of these vaccine trials given our current situation.”
Duque added: “That is why in conducting these trials, we will work tirelessly together and advance rapidly, of course, while always prioritizing 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 DOST as a leader.
The DOH, the Department of Foreign Relations (DFA) and the Department of Commerce and Industry (DTI) join DOST.
Other members of the sub-TWG include the Food and Drug Administration (FDA) and the Research for Tropical Medicine, both under the Department of Health; and the National Development Company (NDC) under the DTI.
The responsibilities of other agencies involved in conducting these trials are:
- DFA coordinates bilateral partnerships related to vaccine trials and partners with DTI and NDC for the possibility of manufacturing vaccines locally in partnership with pharmaceutical companies.
- DOH, the vice president of the sub-TWG, will oversee the hospitals joining clinical trials and will manage the operations and logistics of the clinical trials. DOH will also lead the communication campaign for the clinical trials of vaccines.
- The FDA will monitor entities approved to conduct clinical trials. It will also approve the vaccines that will be released and sold to the public.
All requests for clinical trials to be carried out in the country are sent to the Vaccine Development sub-TWG and the relevant documents are reviewed by the Vaccine Expert Panel (VEP) and the Ethics Review Committees.
These bodies are comprised of vaccine experts, technical experts, and scientists who will identify, evaluate, and recommend potential vaccine candidates for the Philippines.
After a thorough review of clinical trial applications, these will be submitted to the FDA for final approval.
Vaccine trials can begin with FDA regulatory review and approval of clinical trials.
