FDA awaits WHO clinical trial application

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(FILE PHOTO)

Metro Manila (CNN Philippines, January 26) — The Food and Drug Administration is still waiting for the World Health Organization to submit an application to conduct a COVID-19 vaccine clinical trial in the Philippines, its chief Rolando Domingo said on Tuesday.

“Wala pa [Not yet],” Domingo told CNN Philippines in a text message when asked if WHO has already sent its formal request to hold a clinical trial in the country.

According to FDA rules, the agency’s regulatory reviewers should make a recommendation within 14 days upon receipt of the application for a COVID-19 vaccine clinical trial. The FDA will then issue a decision within eight days upon receiving the recommendation.

WHO was supposed to start testing the safety and efficacy of select COVID-19 vaccines on thousands of Filipinos this mid-January through its Solidarity Trial, but it cannot do so without FDA's approval. The original start date of the study was set in October 2020, then it was moved to December, as WHO took caution in selecting vaccines.

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 the Solidarity Trial. Meanwhile, independent clinical research will be shouldered by vaccine makers.