Pfizer (NYSE:PFE) is looking to expand the use of the antiviral Paxlovid, which FDA has authorized to treat mild-to-moderate COVID-19 in individuals who are at least 12 years of age who weigh at least 40 kg. The authorization covers individuals with a risk of developing severe disease.
A recently launched Phase 2/3 study will test Paxlovid in non-hospitalized symptomatic pediatric patients with COVID-19. Known as EPIC-PEDS (Evaluation of Protease Inhibition for COVID-19 in Pediatric Patients), the study will focus on patients at risk of developing severe COVID-19.
“We are proud to expand studies of our novel COVID-19 treatment to include pediatric participants to further evaluate the safety and efficacy of this treatment in this important population,” said Mikael Dolsten, Pfizer’s chief scientific officer at Pfizer.
The EPIC-PEDS study will be an open-label, multi-center, single-arm study involving roughly 140 pediatric participants under 18 years of age. The first cohort will have participants between the ages of 6 and 17 who weigh at least 40 kg. The second cohort will include individuals in the same age group who weigh between 20 kg and less than 40 kg.
Since FDA authorized Paxlovid late last year, demand for the antiviral has been strong. Pfizer notes that it has delivered 1.5 million treatment courses to date and plans to provide 30 million by July.
President Biden recently signaled that the U.S. government was looking to make more aggressive use of Paxlovid, providing it to eligible individuals soon after they receive a positive COVID-19 diagnosis.