MANILA — To organize a COVID-19 vaccine clinical trial in the Philippines, Russia’s Gamaleya Research Institute must now find a local research group, the Department of Health said Friday.
Health Undersecretary Maria Rosario Vergeire said finding a local contract research institute to jointly conduct the clinical trial is part of the regulatory requirement of the Philippines.
“So ngayon tinutulungan natin ang Gamaleya Institute so they can find an appropriate contract research organization dito sa atin, which is reputable,” she said.
She said the Philippine Clinical Research Professionals Inc. (PCRP) is now coordinating with the Russian Direct Investment Fund for this.
Vergeire said this is being done while the vaccine expert panel is waiting for Russia’s response to their initial questions.
Besides Russia, there are two other companies that have already officially applied for clinical trials in the Philippines: Johnson & Johnson’s Janssen Pharmaceuticals and Chinese company Sinovac.
While Sinovac has already submitted its requirements, Janssen is still completing the required documents.
Janssen is interested in holding clinical trials in Cavite, according to Vergeire.
Currently, there are 6 pharmaceutical companies that already have signed confidential disclosure agreements. The CDAs would allow the Philippines’ expert panel to review the results of their Phase 1 and Phase 2 trials.
According to Vergeire, the 6 are Sinovac, Sinopharm and Anhui Zhifei Longcom Biopharmaceutical from China; Gamaleye Institute from Russia; University of Queensland from Australia; and Adimmune from Taiwan.