Janssen gets nod of experts’ panel, moves closer to COVID vaccine clinical trials

MANILA, Philippines — Belgium’s Janssen Pharmaceutical has already secured the approval of the Vaccine Experts Panel (VEP) to conduct clinical trials in the country for its vaccine being developed against the coronavirus disease 2019 (COVID-19), the Department of Health (DOH) announced on Friday.

 “Sinovac, Janssen, and Clover have been approved or given positive recommendations already by our Vaccine Experts Panel,” Health Undersecretary Maria Rosario Vergeire said in a virtual media forum. 

 Previously, only China’s Sinovac and Clover were earlier announced to have secured approval from the VEP of the Department of Science and Technology.

 Janssen and Clover, aside from VEP approval, have also received clearance from the Ethics Review Board (ERB).

The United Kingdom’s AstraZeneca has so far received clearance only from the ERB.

 Vaccine manufacturers need both the approval of the VEP and ERB before their applications to conduct clinical trials can secure the nod of the Food and Drug Administration (FDA).

 The four firms are among the five vaccine manufacturers that have applied to conduct clinical trials in the country.

 The other application is from Gamaleya Institute from Russia.

Previously, Dr. Nina Gloriani, head of the VEP, said the panel has deferred the processing of application for the Gamaleya Institute pending submission of additional documents.  

 This latest update from the DOH shows that of the five developers, only Janssen and Clover have already secured both the approval of the VEP and ERB.

 “For those na naka-approve na sila pareho (that already secured both approvals), like Jansenn and Clover, they will go through the FDA process already and we will await for the information to be given to us by FDA,” Vergeire said. 

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