FDA OKs Janssen application to hold vaccine trial in Philippines
MANILA, Philippines — The country’s Food and Drug Administration has approved the application of Belgium-based Janssen Pharmaceutica to conduct clinical trial of its vaccine candidate in the Philippines.
“Out of the three applications for independent trials, we have approved one yesterday. And that’s the one by Janssen,” FDA Director General Eric Domingo said in a briefing Tuesday.
So what’s next? Domingo said the vaccine expert panel led by the Department of Science and Technology will assign the site of clinical trials and the recruitment of trial volunteers can start.
“I would suppose in the next few weeks, they will be ready to begin the clinical trials,” he said.
The vaccine candidate of Janssen, a subsidiary of Johnson & Johnson, leverages the company’s AdVac platform, which was also used to develop and manufacture the European Commission-approved Ebola vaccine regimen and construct its Zika, RSV and HIV investigational vaccine candidates, it said on its website.
Janssen anticipates interim data from the global Phase 3 clinical trial of its single-dose vaccine candidate will be available by the end of January 2021. The firm said it will submit Emergency Use Authorization application to the US FDA in February and other regulatory agencies around the world if data show that its vaccine is safe and effective.
The country’s FDA is still evaluating the applications of Chinese drugmakers Clover Biopharmaceuticals and Sinovac Biotech Ltd. to hold massive clinical trials in the country.
Domingo said the agency is still waiting for additional documents from Clover, while Sinovac requested to change its trial protocol and research design.
Meanwhile, only Pfizer has so far applied for EUA for its vaccine in the country. Domingo said he is expecting that more vaccine developers will submit EUA to the local regulatory body by January next year.
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