Metro Manila (CNN Philippines, December 8) — Two coronavirus vaccines from China are now being reviewed by the Food and Drug Administration to hold the third phase of their clinical trial in the country.
The FDA said on Monday it has begun assessing the applications of Chinese companies Sinovac and Clover Biopharmaceutical after both secured the nod of the vaccine experts panel and the ethics review board. It added, however, that it has yet to obtain the reports of the ethics board.
The agency has the final say on whether or not a vaccine firm will be allowed to hold trials in the Philippines.
Dr. Jaime Montoya, executive director of the Department of Science and Technology-Philippine Council for Health Research and Development, previously said UK company AstraZeneca has passed both the vaccine experts panel and ethics review board.
Meanwhile, Health spokesperson Maria Rosario Vergeire said US firm Janssen has also passed the ethics review board, but has yet to secure an approval from the vaccine experts panel.
A go-signal from both reviewers are required for the application to hold trials in the country before they can be forwarded to the FDA. She said the regulatory agency is now looking at the documents of Janssen, Clover, Sinovac, and AstraZeneca.
“Parallel ang pag-aaral. Kung hindi pa papasa sa kahit na isa, kung sa vaccine experts panel or ethics review board, hindi pa siya makakapasok sa FDA process,” she said in a media briefing.
[Translation: It’s a parallel review. If it does not pass both the vaccine experts panel and ethics review board, it cannot be processed by the FDA.]
