Can Paxlovid Be Given to a 15-Year-Old with COVID-19?

No, Paxlovid is not FDA-approved for use in patients under 18 years of age, as the current indication is limited to adults only. 1

FDA Approval Status

Paxlovid (nirmatrelvir/ritonavir) is indicated only for adults with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death 1
The FDA label does not include pediatric patients under 18 years in its approved indications 1
The standard dosing regimen is 300 mg nirmatrelvir with 100 mg ritonavir taken together twice daily for 5 days, initiated within 5 days of symptom onset 1

While not FDA-approved for pediatric use, there is emerging real-world evidence in adolescents:

Small case series suggest feasibility in children aged 12-17 years with underlying conditions at risk for severe COVID-19 2, 3, 4
A Chinese study of 3 adolescents (ages 12,14, and 17 years) with underlying diseases showed symptom resolution within 1-2 days and viral clearance within 2-4 days, with minimal adverse effects (one case of transient rash) 3
A cohort study of 5 children aged 6-14 years with underlying diseases (including congenital heart defects, cerebral palsy, Down syndrome, and leukemia) showed recovery in all cases, though viral shedding times were not significantly different from controls 2
A PICU study showed effectiveness in critically ill pediatric patients with acceptable safety profile, though two patients had transient liver enzyme elevations 4

Significant drug-drug interactions are the primary concern, as ritonavir is a strong CYP3A inhibitor that can lead to potentially severe, life-threatening, or fatal events with certain concomitant medications 1
Transient adverse effects reported in pediatric case series include diarrhea, elevated liver enzymes (ALT 125 U/L, AST 83 U/L), and skin rashes 2, 3
Hepatotoxicity with hepatic transaminase elevations has been documented with ritonavir-containing regimens 1

For a 15-year-old with COVID-19, consider the following:

Assess disease severity and risk factors:
- Is the patient at high risk for progression to severe disease (underlying conditions such as immunosuppression, congenital heart disease, obesity, diabetes)? 2, 3
- Is the patient within 5 days of symptom onset? 1
- Does the patient have mild-to-moderate disease (not requiring hospitalization)? 1
Review all concomitant medications:
- Screen for contraindicated drugs highly dependent on CYP3A clearance 1
- Identify medications requiring dose adjustment or temporary discontinuation 1
- Assess renal function (eGFR) for potential dose adjustments 1
If high-risk features are present and no contraindications exist:
- Off-label use may be considered in consultation with pediatric infectious disease specialists, recognizing this is outside FDA-approved indications 2, 3, 4
- Document informed consent discussion with family regarding off-label use
- Monitor liver enzymes during treatment 2, 3
If not high-risk or contraindications exist:
- Provide supportive care with close monitoring 5
- Reserve treatment for documented clinical deterioration

The lack of FDA approval means there are no established pediatric dosing guidelines, safety data, or efficacy data from large randomized controlled trials in this age group 1
All published pediatric data comes from small case series and retrospective cohort studies with significant limitations 2, 3, 4
The decision to use Paxlovid off-label in a 15-year-old should involve shared decision-making with the family and consultation with specialists experienced in pediatric COVID-19 management 2, 3
Most children and adolescents with COVID-19 have mild disease and recover with supportive care alone, making the risk-benefit calculation different than in adults 5