Pfizer begins stage 2 and 3 trials of COVID-19 antiviral treatment on children
Pfizer on Wednesday announced it has begun the Phase 2 and 3 stages of its study into the use of its antiviral COVID-19 treatment in young children.
The oral COVID-19 treatment called Paxlovid is currently one of two authorized SARS-CoV-2 antiviral treatments in the U.S. It is permitted for use in people as young as 12 who weigh at least 40 kg (88 lbs).
“Since the beginning of the pandemic, more than 11 million children under the age of 18 in the United States alone have tested positive for COVID-19, representing nearly 18% of reported cases and leading to more than 100,000 hospital admissions,” Mikael Dolsten, Pfizer’s chief scientific officer, said.
“There is a significant unmet need for outpatient treatments that can be taken by children and adolescents to help prevent progression to severe illness, including hospitalization or death.”
Pfizer’s trial will include about 140 participants under the age of 18. The participants will be split into two groups of participants between the ages of six and 17. One group will be of participants weighing at least 88 lbs and the other will be of participants weighing between 44 and 88 lbs.
The pharmaceutical company said it was also working on an antiviral treatment for participants under the age of 6.
Paxlovid was given emergency use authorization by the Food and Drug Administration in December for high-risk adults and high-risk pediatric patients as young as 12 who are experiencing mild-to-moderate cases of COVID-19.
During his first State of the Union address last week, President Biden announced a new “Test to Treat” initiative, which will allow individuals to get tested for COVID-19 at a pharmacy and receive an antiviral treatment on the same day for free if they test positive.
Along with Pfizer’s Paxlovid, Merck and Ridgeback’s Molnupiravir also received emergency use authorization in December for adults with mild-to-moderate cases of COVID-19.