FDA: Sinovac submits application to conduct phase 3 trials

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(FILE PHOTO)

Metro Manila (CNN Philippines, October 22) — Chinese company Sinovac Biotech Ltd. formally submitted its application for phase 3 clinical trials, the Food and Drug Administration said Thursday.

"Sa ngayon po ang lumapit na doon sa ating vaccine expert panel sa DOST ay tatlo iyon pong sa Sinovac na galing China, mayroon po iyong Janssen at iyon din pong Sputnik V na galing po sa Russia. Pero ang nakalusot po sa pre-screening ng vaccine expert panel ay iyon pong Sinovac galing sa China na today ay nag-apply na rin po sa FDA ng clinical trial na permission to conduct a clinical trial here," FDA Director General Eric Domingo said during a televised briefing.

[Translation: There were three who approached our DOST vaccine expert panel Sinovac from China, Janssen and Sputnik V from Russia. The one that got through the pre-screening of the vaccine expert panel is Sinovac from China, and today they applied to the FDA for permission to conduct a clinical trial here.]

Domingo reminded the public that Sinovac cannot be administered just yet as it has no FDA license.

"Dadaan po ito ngayon sa regulatory review at saka technical review dito po sa FDA at saka sa mga grupo din po ng ating eksperto. Titingnan iyong design po noong study at iyon pong bakuna, kung produkto is kung wala po tayong problema at nandiyan din po iyong research ethics board na review to make sure na of course protektado po 'no ang safety ng mga magiging clinical trial participants at lahat po ng sasali dito. Kapag na-complete na po lahat ng requirements na iyon at nabigyan na sila ng approval, then maaari na pong mag-umpisa," he said

[Translation: This wil go through a regulatory review as well as a technical review at the DFA, as well as groups of our experts. They will look at the design of the study and the vaccine, if it has no problems and the research of the ethics board that reviewed it to ensure the safety of those who will take part of the clinical trials. Once all the requirements are complete and they are given approval, then it can start.]

Once all documents are in, Domingo said it could take two to three weeks for the review to be completed.

He added other vaccines are also being studied.

"Mayroon pang dalawang inaaral po ang vaccine expert panel, iyong Janssen saka iyong Sputnik V ng Gamaleya at siyempre po iyong WHO Solidarity Trial for vaccines," he said.

[Translation: There are two vaccines being studied by the vaccine expert panel, the one from Janssen and Sputnik V from Gamaleya as well as the WHO Solidarity Trial for vaccines.]