FDA approves Janssen's Phase 3 COVID-19 vaccine trial
The Food and Drug Administration (FDA) approved Janssen Pharmaceutica's application to conduct Phase 3 clinical trials for its COVID-19 vaccine in the Philippines.
FDA Director General Enrique Domingo announced that the trials could begin in the next few weeks after the Department of Science and Technology assigns areas and recruits volunteers.
Janssen's trials will be the first late-stage trials for a COVID-19 vaccine in the country, with Sinovac and Clover Biopharmaceuticals still undergoing regulatory review.
While FDA approval does not guarantee a supply deal, Domingo assured that successful trials could expedite regulatory authorization if the vaccine proves effective.
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