Metro Manila (CNN Philippines, October 10) — There’s a clear process on the conduct of clinical trials for a potential COVID-19 vaccine, the Department of Health said Saturday in response to criticisms on the involvement of another agency.
Health Spokesperson Maria Rosario Vergeire said there’s an “institutional structure” in place in the steering committee composed of the DOH, its attached regulatory agency Food and Drug Administration, and the Department of Science and Technology.
All vaccine developers will have to go be evaluated by the vaccine experts panel of the DOST first, and then obtain a regulatory certificate from the FDA, Vergeire said.
“Kapag nabigyan rin po ng positive recommendation at naaprubahan, ang DOH na po ang magpapatupad (Once it is given positive recommendation and approval, it will be implemented by the DOH),” Vergeire said.
“This is really a process. Lahat po kami nagtatrabaho nang sama-sama (We are all working together). This is whole of government,” Vergeire said, adding that the layers provide “additional safeguard” to ensure the safety and efficacy of the vaccine.
Senator Francis Tolentino earlier questioned the involvement of DOST in the process, saying these sensitive trials should be left to health authorities. He also called for a clear communication plan, citing “conflicting” statements from the DOH, DOST, and FDA on the status of potential vaccines.
The DOST-Philippine Council for Health Research and Development earlier identified three firms from Russia, the United States, and China, that have submitted applications to conduct a Phase 3 clinical trial in the country. This is the critical stage where thousands of patients have to be inoculated with the potential vaccine. It is also usually the final step before approval for mass rollout.
The Philippines will also be part of the World Health Organization-led Solidarity trials on potential coronavirus vaccines, which could begin at the end of the month. The government said this will be prioritized in the assignment of trial sites, but independent trials by private vaccine companies will be accommodated as well.
