Metro Manila (CNN Philippines, March 19) — The World Health Organization may submit to the Food and Drug Administration an application to hold a COVID-19 vaccine clinical trial in the Philippines next week, FDA Director General Eric Domingo said on Friday.
“I think they might be applying next week,” Domingo told a media briefing, referring to WHO.
The country’s vaccine expert panel is currently reviewing the safety and efficacy data of the coronavirus shots that will be tested in the WHO Solidarity trial, the FDA chief noted. Approval from both the vaccine expert panel and the ethics review board is needed before the FDA can start its own review.
“So once the vaccine expert panel decides that it is ready,” Domingo said, “then they will apply to FDA.”
Vaccine czar Carlito Galvez, Jr. earlier said the Solidarity trial will enroll up to 15,000 volunteers in the country.
The government is spending over P89 million on this clinical trial, while independent clinical research will be shouldered by vaccine makers.
There is no pending COVID-19 vaccine clinical trial application with the FDA, Domingo noted.
Three pharmaceutical firms are authorized to conduct clinical trials for their vaccines in the country. They are Johnson & Johnson-owned Janssen Pharmaceuticals, China-based biotechnology company Clover Biopharmaceuticals and Sinovac.
