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China’s anti-Covid-19 Sinovac vaccine has been approved by the Vaccine Expert Panel (VEP) for clinical trials in the Philippines, an official with the Food and Drug Administration said on Thursday.
In an online Kapihan Forum with reporters covering the Department of Health (DOH), FDA Director General Eric Domingo said that after being approved by the Department of Science and Technology (DOST) VEP, Sinovac should also approve the Ethics Board to be able to request FDA clearance before conducting clinical trials.
“They [Sinovac] said they will meet with the Ethics Board this week, ”said Domingo.
Previously, the DOH announced that phase 3 clinical trials of the Covid-19 vaccine in the country are scheduled to begin next 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 DOST along with other government agencies are already preparing for said clinic. essays.
“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 added that they also recognize the “requirement of these vaccine trials given our current situation.”
“That is why in conducting these trials, we will work tirelessly together and move rapidly, of course, while always prioritizing the safety of our clinical trial participants,” Duque added.
As the trials are a scientific research and development initiative, the IATF in its Resolution No. 39 of May 22, 2020 put DOST as a leader.
The DOST chairs the sub-TWG on the development of the Covid-19 vaccine, which includes other government agencies such as DOH, the Department of Foreign Affairs (DFA) and the Department of Commerce and Industry (DTI).
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.
On the other hand, the responsibilities of other agencies involved in conducting these trials are as follows:
- DFA coordinates bilateral partnerships related to vaccine trials and partners with DTI and NDC on 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 the 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 here in the country are sent to the Vaccine Development sub-TWG and the pertinent documents are reviewed by the 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.
