Pfizer on March 9 said it has started phase 2 and 3 trials evaluating its COVID-19 antiviral Paxlovid in children.
Paxlovid is currently authorized for use in patients 12 and older who weigh at least 88 pounds and are at high risk of progressing to severe illness.
Four notes:
1. Pfizer's trial will enroll about 140 participants under age 18 split into two cohorts: one including patients aged 6-17 weighing at least 88 pounds, and a second cohort with participants of the same age group who weigh between 44 and 88 pounds.
2. The trial will test safety and efficacy of the Paxlovid pill regimen among pediatric patients.
3. The drugmaker is also working on an "age appropriate formulation" of its antiviral to test among children younger than 6.
4. The antivirals are part of the White House's recently launched "test-to-treat" initiative, which allows high-risk patients who test positive for COVID-19 at select pharmacies to receive free antivirals on the spot.
"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."