Janssen, AstraZeneca may soon get initial clearance for phase 3 trials in PH
MANILA, Philippines — Two developers of vaccines against COVID-19 may soon get their initial clearance from the vaccine expert panel (VEP) of the Department of Science and Technology (DOST), which they need to conduct phase 3 clinical trials here in the Philippines.
Dr. Nina Gloriani, head of the DOST’s VEP, said Friday that the panel has deferred action on the application of Belgium-based Janssen Pharmaceutical, which had only submitted on Wednesday their updated responses to comments of the body.
“We still have to meet again to discuss our final action. If we are satisfied with their responses, we may actually grant technical clearance so that SJREB (Single Joint Research Ethics Board) can move forward,” she said in a media forum.
She said the VEP likewise deferred action on the application of British drugmaker AstraZeneca pending the submission of its reply to comments of the panel.
“We have deferred action pending submission of replies to comments, so until they reply and we are satisfied with the replies then we have to defer action,” Gloriani explained.
The two companies are among the five developers that have submitted applications to conduct phase 3 clinical trials in the Philippines.
The other applications are from Chinese companies Sinovac, which already secured VEP technical clearance on October 9 and is now pending for SJREB approval, and Clover Biopharmaceuticals which secured technical clearance on November 24 and was already forwarded to the Food and Drug Administration (FDA).
Meanwhile, the application of Gamaleya Institute from Russia at the VEP is also currently deferred pending submission of additional documents. Gloriani said there was missing information from the phase 3 study protocol in the application.
She said the applications would have to undergo initial technical evaluation from the VEP, then to the SJREB, before securing final approval from the FDA.
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