FDA approves clinical trial of Janssen COVID-19 vaccines

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Metro Manila (CNN Philippines, December 29) — Janssen Pharmaceuticals Company of Johnson and Johnson will be the first COVID-19 vaccine maker to hold a clinical trial in the country, the Food and Drug Administration announced on Tuesday.

FDA Director General Eric Domingo said the United States-based company passed the final regulatory review on Monday.

"It has been cleared by the ethics board and of course by the FDA," Domingo told a media briefing. "The regulatory aspect is completed... Siguro mag-i-start na rin sila ng clinical trial mga after ng New Year [It will probably start after the New Year]."

The Phase 3 clinical trials may start in the next few weeks after the vaccine experts panel identify trial sites, conduct preliminary preparations, and recruit participants. During this stage of the medical study, the vaccine is administered to thousands of people and tested for efficacy and safety.

The large-scale clinical trial for Janssen's single-dose vaccine started in the U.S. in September. Johnson & Johnson also intends to run a separate Phase 3 trial in the US, in collaboration with the UK government, to examine the efficacy of using two doses.

Two Chinese vaccine manufacturers, Sinovac Biotech and Clover Biopharmaceutical, have also applied to conduct clinical trials in the country.

Domingo said the FDA is waiting for Clover to submit more documents, while Sinovac requested a change in its research design so it was sent back to reviewers for final clearance. He said the FDA may decide on their application in January.

Meanwhile, Domingo said only Pfizer has applied for emergency use of its COVID-19 vaccines in the Philippines. The documents have been submitted to reviewers and regulators on Monday.

"We hope to complete the preliminary evaluation within two weeks," he added. "Pagkatapos titignan ko ang kanilang [Then I will look at the] evaluation — both on the regulatory side for the quality of the vaccine and the clinical side for the efficacy and safety."

An approved clinical trial application or Emergency Use Authorization application is necessary for the legal distribution, sale, use, and administering of vaccines.