COVID-19 PANDEMIC: PHILIPPINES COVID-19 vaccine phase 3 trials to begin in November — DOH
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The update-10.11.2020
Sick Earth-Plague Day 317
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In a statement, the Department of Health said that the phase, during which patients will actually be treated with a vaccine to test its safety, would first begin with an application review by a vaccine expert panel and ethics review committees in the Philippines before the clinical trials led by the Department of Science and Technology.
“After 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,” the statement read.
Three developers have already submitted applications to conduct phase 3 trials as of this publishing, including Russia’s Gamaleya Research Institute, China’s Sinovac and Jannsen Pharmaceuticals Companies of Johnson & Johnson from the United States of America.
For the trials, the foreign affairs department is set to coordinate bilateral partnerships related to the vaccine trials “for the possibility of manufacturing the vaccines locally in partnership with the pharmaceutical companies,” while 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 Food and Drug Administration “will monitor the entities approved to conduct clinical trials. It will also approve vaccines that will be released and sold to the public,” the statement added.
“The DOST chairs the sub-TWG on COVID-19 vaccine development which includes other government agencies such as the Department of Health (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,” it also said.
RELATED: Tolentino shuns DOST role in clinical trials for COVID-19 vaccine, says matter is ‘purely’ for DOH
On Friday, October 9, Sen. Francis Tolentino questioned the role of the DOST on the sub-TWG, pointing out that such a venture would need the expertise of medical doctors and practitioners.
As of the department’s latest case bulletin, the national caseload stands at 336,926, with 54,594 of which still classified as active cases.
Worldwide, over 37.4 million coronavirus cases have been recorded, leading to over 1.07 million deaths, according to latest data from the World Health Organization.
President Rodrigo Duterte has routinely emphasized in his public addresses that securing a vaccine is the only solution to the Philippines’ coronavirus situation moving forward.
“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…We also recognize the exigency of these vaccine trials given our ongoing situation,” Health Secretary Francisco Duque said.
— Franco Luna
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