Pfizer starts trial of COVID-19 antiviral pill for children

March 9 (UPI) -- Pfizer has started a Phase 2/3 study for its Paxlovid antiviral COVID-19 pill for kids aged 6 to 17, the company said Wednesday.

Pfizer said in a press statement that Paxlovid (nirmatrelvir and ritonavir tablets) is the first oral therapy specifically designed to combat COVID-19 to be evaluated in a pediatric clinical study.

"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," said Mikael Dolsten, chief scientific officer of Pfizer.

Dolsten said there's 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.

Paxlovid is already authorized for use in many countries around the world for people 12 and over, with more than 1.5 million treatment courses delivered thus far and 30 million expected by July to help combat COVID-19.

Pfizer said the Phase 2/3 trial includes approximately 140 pediatric participants under 18.

The company said it's also working "to develop an age-appropriate formulation for three additional planned cohorts of younger than 6 years old."

According to Pfizer, study data for high-risk adults showed Paxlovid cut risk of hospitalization or death by 89% within three days of symptom onset and by 88% when given within five days of symptom onset.