Duque says he’s hesitant to endorse waiver by PH of Phase 4 clinical trials in COVID-19 vaccine development
Health Secretary Francisco Duque III on Tuesday admitted he is hesitant to endorse plans for the Philippines to participate in a COVID-19 vaccination plan that did not undergo Phase 4 clinical trial.Duque said the fourth phase in vaccine development is critical as this is the completion of the post marketing surveillance and is meant to ensure that a novel vaccine is safe and efficient for use of thousands and millions of people.
“If the phraseology in the Bayanihan Law would be such that, if WHO and other countries with recognized and mature FDAs would approve the waiving of a Stage 4. Would that seem acceptable to you?” Cayetano asked. She said she fears that the Philippines could be left behind if other countries decided to waive Phase 4 of the clinical trials for COVID-19 vaccine while the government decides to wait for the final stage before approving it.
On the other hand, Cayetano said she does not “believe in legislating science.” Congress, however, is in a rush to approve the Bayanihan 2, which aims to boost the country’s COVID-19 efforts and revive the Philippine economy battered after the series of lockdowns imposed to contain the spread of the disease.
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