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Sinovac COVID vaccine cleared for Phase 3 clinical trials by PH vaccine experts panel
Sinovac COVID vaccine cleared for Phase 3 clinical trials by PH vaccine experts panel
A COVID-19 vaccine candidate developed by China's Sinovac Biotech has passed the review of the Philippines' vaccine experts panel for clinical trials in the country, the Food and Drug Administration (FDA) bared Thursday.
FDA Director General Rolando Enrique Domingo said that the vaccine experts panel, chaired by the Department of Science and Technology, has cleared Sinovac for Phase 3 clinical trials. However, the Chinese firm still needs to get an approval from the Philippines’ Ethics Board Committee before it can apply for the FDA for an application for clinical trials.
Domingo said that Sinovac passed the vaccine panel’s review last Monday.
“Meron na kaming hinihintay na mag-submit kasi inindorse na sa amin ng vaccine experts panel, hinihintay lang namin ‘yung submission nila ng documents. ‘Yung sa Sinovac (We are already waiting for a specific firm to submit (an application) because the vaccine experts panel has already endorsed it to us, we are just waiting for their submission of documents. Those in Sinovac),” said the FDA chief in an online forum.
If Sinovac is able to secure an approval from the Ethics Board, the FDA’s evaluation for its application for clinical trials would be 14 to 21 days, Domingo said.
“’Yung Ethics Board I think in progress pa. Hindi puwedeng maka start ang any study until hindi complete ang ethics approval (The Ethics Board (review) I think is still in progress. No clinical study can start until the ethics approval is complete),” he said.
The vaccine experts panel reviews the results of clinical trial Phase 1 and Phase 2 of a candidate vaccine while the Ethics Board checks the process of choosing the participants for the trials and other safeguards.
Domingo said that there is a possibility that the clinical study for Sinovac may begin in November given this development from the vaccine experts panel.
“It's possible. Depende nga kung kailan mag submit ng application. Like I said, officially wala pang application sa FDA. Nasabihan lang kami ng vaccine experts panel na may pumasa na sa kanila (It’s possible. It depends on when they will submit their application. Like I said, there is still no application to the FDA. The vaccine experts panel just told us that a firm have already passed their review),” he said.
“We haven't seen the application yet so we don't know the details and it's really a matter of when the submission is given to the FDA. Maaring next week pa sila mag-submit (They may submit it next week) or two weeks from now,” he added.
In a press briefing last Oct. 11, DoH Undersecretary Maria Rosario Vergeire said that three vaccine developers are seeking approval to conduct Phase 3 clinical trials in the Philippines. Aside from Sinovac, the other two are Russia's Gamaleya Research Institute and Jannsen Pharmaceutical Companies of Johnson & Johnson from the United States.