Study Supports Paxlovid Safety in Children Aged 6 Years and Older Suffering from COVID-19

A new study published in the journal of American Academy of Pediatrics showed that when treating mild-to-moderate COVID-19 in children 6 years of age and older who weigh at least 44 pounds (20 kg) and are at risk of developing severe illness, Paxlovid (nirmatrelvir/ritonavir) is safe.

Children with underlying illnesses are at risk for severe illness and hospitalization, even though COVID-19 is typically moderate in children. Adolescents 12 years of age and older who weigh at least 40 kg are permitted to use nirmatrelvir/ritonavir (Paxlovid), an effective oral antiviral licensed for high-risk adults.

The current EPIC-Peds trial is assessing the therapy in high-risk youngsters in order to determine optimum dose for younger groups. The results for individuals who weigh 20 kg or more and are at least 6 years old are the main focus of this paper.

Participants who were at least 6 years old and weighed at least 40 kg (Cohort 1) or 20 to <40 kg (Cohort 2) were given oral NMV/r twice daily (BID) for five days. To mimic exposure, sparse PK data from days 1 and 5 were added to a population PK model that had already been created.

By comparing juvenile exposure to that of COVID-19-infected adults, efficacy was extrapolated from adults. SARS-CoV-2 RNA concentration across time, hospitalization/death, and safety through Day 34 were assessed as supported effectiveness objectives.

At least one dosage was administered to 75 subjects in total. 

More than 90% of individuals attained minimum NMV concentrations above the 90% effective concentration following dose 1 and at steady state, according to simulated exposure of NMV/r 300/100 mg BID for Cohort 1 and 150/100 mg BID for Cohort 2. 

NMV/r was well-tolerated and safe. Diarrhea and headache were the most often reported adverse effects (AEs) (n = 3 [4%] individuals each). 

Treatment-related adverse events did not result in any discontinuations. There were no significant adverse events (AEs) linked to the medication. 

There were no known all-cause fatalities or hospitalizations linked to COVID-19. SARS-CoV-2 RNA was found to have significantly decreased from baseline to the conclusion of therapy.

A simple outpatient oral therapy option for avoiding severe illness in people with mild-to-moderate COVID-19 remains an unmet medical need given the ongoing burden of disease in juvenile children, even in the post-pandemic age.

Source:

Gerhart, J., Leister-Tebbe, H., Chan, P. L. S., McComsey, G. A., Carey, W., Shi, H., Yan, J., Leaney, J., Singh, N., Baniecki, M. L., Guan, S., Wisemandle, W., Singh, R. S. P., & Hammond, J. (2026). Nirmatrelvir/ritonavir for the treatment of COVID-19 in children aged 6 years and older. Pediatrics, 158(1). https://doi.org/10.1542/peds.2025-073999