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Johnson & Johnson ok’d for PH trials

Republika

The Food and Drug Administration recently approved the application of Johnson & Johnson subsidiary, Belgium-based Janssen Pharmaceutica, to run clinical trials of its vaccine in the country.


An expert panel from the Department of Science and Technology is tasked to assign the area in which Janssen will be conducting their trials.
FDA director general Eric Domingo said that if the Janssen candidate proves to be effective, the only “bonus” would be that several thousand Filipinos would have already received it.


He added that the regulatory aspect would be easier to decide on since their trials can be observed.


Domingo reported that of the two other applications their office received, China’s Clover Biopharmaceuticals and Sinovac were still undergoing review.


Pfizer previously applied for Emergency Use Authorization in the country, and the FDA expects more manufacturers to do the same by the month of January.


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