FOMAT Medical Research is a clinical research institute in Oxnard, working with the World Health Organization (WHO) to host research on a COVID-19 vaccine.
The lab is one of over 100 sites across the globe to host a Phase 3 clinical trial for Regeneron Pharmaceuticals’ COVID-19 vaccine. The trial will enroll about 3,000 participants.
“Being able to be a part of history, it’s kind of what you work for your entire life,” said Nicholas Focil, FOMAT’s CEO.
Focil says the WHO selected 30 vaccine candidates, and each testing site will receive any combination of those 30. Because it’s a double-blind trial, neither FOMAT nor the participants know which vaccine they’ll get.
Starting July 30, any patient can come and get a free COVID test for the Regeneron trial. Those who are positive qualify for one study; those who live with someone that is positive qualify for another; and those who are just negative qualify for the last study. Each study will start one week after the last.
“What they’re looking for is hot spots of COVID, and what’s more of a hot spot than a household that has somebody that has COVID,” Focil said.
For the COVID-negative patients, researchers are looking at whether the vaccine causes participants to contract the virus at a reduced rate from the placebo group.
After the study is finished, the data has to be cleaned up, analyzed and sent to a regulative entity like the Federal Drug Administration.
Usually this process would take multiple years, but through government, pharmaceutical and non-profit collaborations, Focil says FOMAT been cut down to a quarter of that time. He expects to see some sort of judgement made by the FDA on his company’s study by the end of October at the earliest.
“We are at the end of the stage, so these are the studies that will be used to prove these vaccines to work,” Focil said.
The Regeneron study is currently in Phase 3 clinical trial, while the WHO trial is currently in Phase 2/3. That study will begin taking participants in mid-August.
Participants will receive a free, 45-minute COVID-19 test and financial compensation. More information can be found here.