March 10, 2022 – Pfizer has started the phase 2/3 trials to evaluate the effectiveness of the COVID-19 antiviral pill Paxlovid in children. Paxlovid is currently authorized for use in patients 12 and older who weigh at least 88 pounds and are at a higher risk of progressing to severe illness.
Pfizer’s trial will enroll about 140 participants under the age of 18 into two groups. One will include patients aged 6-17 weighing at least 8 pounds, and the other will include participants in the same age group who weigh between 44-88 pounds. This trial is intended to test safety and efficacy of the Paxlovid pill regimen among pediatric patients.
Additionally, Pfizer is also working on an “age-appropriate formulation” of Paxlovid to test among children younger than 6 years old.
“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 percent of reported cases and leading to more than 100,000 hospital admissions,” said Mikael Dolsten, MD, PhD, chief scientific officer at Pfizer. “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.”