3 firms seek approval to hold COVID-19 vaccine trials in PH

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Metro Manila (CNN Philippines, October 8) — Three vaccine developers have submitted applications to conduct a Phase 3 clinical trial on potential COVID-19 vaccines in the Philippines, an official disclosed on Thursday.

Jaime Montoya, executive director of the Department of Science and Technology-Philippine Council for Health Research and Development, identified the developers during a briefing as the Gamaleya Research Institute from Russia, Jannsen Pharmaceuticals Companies of Johnson & Johnson from the United States, and Sinovac from China,

Gamaleya, the manufacturer of the Sputnik V, which is the first registered coronavirus vaccine in Russia, as well as Jannsen Pharmaceuticals, have yet to submit all of the documentary requirements, Montoya noted.

Meanwhile, the application of Sinovac is being studied by the vaccine expert panel, Montoya said, adding the review may take about 14 days.

READ: 1,000 Filipinos to join Russia vaccine clinical trial

If the application passes the panel’s standards, it will be forwarded to the Food and Drug Administration “for the final regulatory process.” The FDA may approve or deny the application, depending on its findings.

Montoya expressed hope these developers will seek approval to distribute their products once the conduct of their independent medical research is approved.

“Of course, ina-assume natin na they will also apply for eventual marketing dito sa ating bansa dahil sila ay gagawa ng clinical trial dito,” he said.

[Translation: Of course, we are assuming they will also apply for eventual marketing here in our country since they will hold clinical trials here.]

The Philippines will also be part of the World Health Organization-led solidarity trials on potential coronavirus vaccines, which could begin at the end of the month.

In an ideal scenario, the vaccine could be ready by the first or second quarter of next year, Philippine officials have said. That may happen if phase 3 trials will be completed in the shortest time possible and if the manufacturers will pass all the requirements and submit proper documents to Philippine agencies.

READ: COVID-19 vaccine in PH by April 2021? 'Best case scenario,' FDA says

Phase 3 of the clinical trial is the critical stage where thousands of patients have to be inoculated with the potential vaccine to test its safety and efficacy. It is also usually the final step before approval for mass rollout.