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Metro Manila (CNN Philippines, December 11) – Johnson & Johnson’s Janssen vaccines division will now undergo final scrutiny by the Food and Drug Administration to conduct its clinical trial of the COVID-19 vaccine in the country, Health spokesperson Maria Rosario Vergeire said Friday.
Janssen’s application recently passed both pre-selection reviews by the country’s vaccine expert panel and the ethics review board. It is the second vaccine manufacturer to come one step closer to conducting its phase 3 trials after Chinese firm Clover Biopharmaceuticals.
“It means they are about to enter the FDA process,” Vergeire said of Janssen and Clover.
[Translation: They will now go through the process of the FDA.]He added that Sinovac has only obtained approval from the vaccine expert panel, while AstraZeneca received approval from the ethics board. The approval signal is required from both the vaccine expert panel and the ethics review board.
The PH-Australia agreement stands for now
Meanwhile, the confidentiality agreement signed by the Philippines and Australia’s University of Queensland, which expressed interest in conducting clinical trials in the country, will remain in effect despite recent news that trial participants gave false positive test results. of HIV.
The DOH said the applicant must formally submit its report so the government can make an informed decision on its next steps.
“Manufacturers must provide specific information with all the details. If we find it valid, we will decide,” Vergeire said.
[Translation: The manufacturer needs to submit all the details. If we find that the report is valid, that’s when we’ll decide.]The candidate coronavirus vaccine produced in Australia has been discarded after the unexpected result. The test, which was being developed jointly by the University of Queensland and Australian biotech company CSL, revealed that antibodies generated by the vaccine interfered with HIV diagnosis and led to false positives in some HIV tests. Australia has ruled out the trial as it could undermine public health by causing a wave of false positive HIV tests in the community.
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