MANILA – The Food and Drug Administration (FDA) has approved clinical trials of the coronavirus disease 2019 (COVID-19) vaccine of Johnson & Johnson’s Janssen Pharmaceuticals Company in the country.
FDA Director General Eric Domingo announced that the United States-based company passed the final regulatory review on Monday and will start their clinical trial next month.
“It has been cleared by the ethics board and of course by the FDA,” Domingo said. “The regulatory aspect is completed. Siguro mag-i-start na rin sila ng clinical trial mga after ng New Year.”
“Janssen’s clinical trials in the Philippines will be beneficial to Filipinos in terms of speeding up regulatory approval, and if this turns out to be a good vaccine, it will be easier for us to make authorization,” he added.
The Phase 3 clinical trials may start in the next few weeks after vaccine experts identify trial sites, conduct preliminary preparations and recruit participants. During this stage, the vaccine is administered to thousands of people and tested for efficacy and safety.
The large-scale clinical trial for Janssen’s single-dose vaccine started in the US in September. Johnson & Johnson also intends to run a separate Phase 3 trial in the US, in collaboration with the UK government, to examine the efficacy of using two doses./PN
