The Janssen Pharmaceuticals has already started its Phase 3 clinical trials for its coronavirus disease (COVID-19) vaccine in the Philippines, an official of the Department of Science and Technology (DOST) said on Friday, Feb. 19.
"Janssen has already started with the clinical trial proper; patients screening, recruitment, and vaccination," said DOST Undersecretary Rowena Guevarra in a press briefing hosted by the Department of Health.
The Food and Drug Administration (FDA) has approved the application of Janssen to hold clinical trials in the country on Dec. 29, 2020. It is a Belgium-based pharmaceutical company, which is owned by American firm Johnson & Johnson.
Guevarra said that they cannot reveal the total number of participants and the specific sites where the trials are being held. In a clarificatory statement, the DOST said that the trial sites were located in the National Capital Region, Calabarzon, and Western Visayas.
The FDA also approved the clinical trial applications of two Chinese firms: Sinovac Biotech and Clover Pharmaceuticals. Both have yet to start their trials.
"For Clover and Sinovac, site preparations are ongoing. For the WHO (World Health Organization) Solidarity Trial , we are still waiting for the standard operating procedure and the name of the vaccine (which will be used)," said the DOST official.
Guevarra said that there are still some pharmaceutical companies who are expressing their interests to hold clinical trials here for their respective COVID-19 vaccines.
“Ang daming mga bilateral partners that are still keen in holding clinical trials. However, one of the things we are looking at is that we are waiting for their Phase 3 applications. Kasi madami dito sa mga vaccine na dinedevelop, nasa Phase 1 and Phase 2 pa lang. And our preference is that we only participate in the Phase 3 clinical trial (Many bilateral partners are still keen in holding clinical trials. However, one of the things we are looking at is that we are waiting for their Phase 3 applications. Because many of the vaccines that are currently being developed are still in Phase 1 and Phase 2. And our preference is that we only participate in the Phase 3 clinical trials),” she said.
Guevarra said that the Philippines should continue to consider participating in clinical trials.
“So far, the vaccines approved are still in emergency use authorization (EUA) and having an EUA does not guarantee that they will be granted full marketing approval by the FDA in the future. Second, there is a need to generate vaccine efficacy and safety data specific to the Filipino population,” she said.