Pfizer Inc. said it launched a study of its oral Covid-19 treatment among children age 6 and up who have been infected by the virus and are at risk of progressing to severe disease.
The New York-based drugmaker said in a statement on Wednesday that it will enroll 140 children age 6 to 17 in the late-stage trial of its COVID-19 pill, Paxlovid. Pfizer seeks to eventually include even younger children in the safety and efficacy study.
“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,” Chief Scientific Officer Mikael Dolsten said in a statement.
Paxlovid, which reduced hospitalizations and deaths by 89% in an earlier study, is authorized for emergency use in the U.S. and other countries among COVID-19 patients over age 12 who are at high risk of developing severe disease. To-date, 1.5 million treatment courses have been delivered globally. Patients are prescribed 30 pills — a combination of the compounds nirmatrelvir and ritonavir — to be taken over the course of five days.
In the new study, Pfizer will divide the participants into two groups: Children who weigh 88 pounds or more will receive the dosage currently authorized for those age 12 and up. Those who weigh between 44 and 88 pounds will receive half the standard dose of nirmatrelvir.
In the U.S., children under age of 5 remain unable to access COVID-19 vaccines, making the need for treatments all the more urgent.
Pfizer said it is working to develop an “age-appropriate formulation” for three additional trial groups that include children younger than 6. It will enroll younger children as data from the first two groups are available, and as it creates its new formulation.
