DOH: Regulatory approval needed before Cavite can start COVID-19 vaccine trials
MANILA, Philippines — The Department of Health (DOH) on Wednesday reminded local officials of the province of Cavite that regulatory approval is needed before they can conduct a COVID-19 vaccine clinical trial.
In an online media forum, Health Undersecretary Maria Rosario Vergeire said the DOH has reached out to the head of Cavite’s research team informing them that they need to secure the approval of the Food and Drug Administration (FDA) and ethics review board before starting the Phase 3 of the trial to ensure the safety of the participants in the study.
Vergeire said the head of the Cavite study agreed and vowed to update them “regularly”.
“Walang pwedeng mag-umpisa ng any clinical trial kung walang approval ng FDA at wala kayong approval ng ethics review. If you do that, you are violating specific laws. So, you will be sanctioned and you will be asked to stop,” the Health official said.
“We have to remember itong clinical trials na ginagawa natin…this involves individuals, mga tao, so kailangan nareregulate ng gobyerno para masiguro natin na magiging ligtas ito para sa ating mga kababayan,” she added.
Cavite Governor Jonvic Remulla announced last week that his province would undertake a COVID-19 vaccine trial with the De La Salle Medical and Health Sciences Institute. He said the trials will start in two weeks.
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