A new study finds that the antiviral drug Paxlovid can safely be used by children aged 6 and older.
The study, published recently in Pediatrics, found Paxlovid, which combines the drugs nirmatrelvir and ritonavir, is safe for children who weigh at least 44 pounds who have mild to moderate COVID-19 but are at risk of developing severe disease.
Paxlovid is approved by the US Food and Drug Administration in children at least 12 years old who weigh at least 88 pounds.
No serious adverse events
The study included 75 children 6 to 17 years old who received at least one dose of Paxlovid. One group received a lower dose and the other a higher dose.
Researchers found that both doses were safe and well-tolerated, with no serious adverse events. In 90% of participants in both groups, blood concentrations of the drug reached levels that have been shown to have antiviral effects in adults.
The most frequently reported medical problems among the study participants were diarrhea and headaches, although these were uncommon, occurring in only 4% of each group. None of the participants stopped taking Paxlovid because of side effects.
None of the children were hospitalized or died from COVID-19 during the study, which was funded by Pfizer, which makes Paxlovid.
The study authors say the results provide important data for clinicians treating pediatric patients with mild-to-moderate COVID-19.
“Given the continued burden of disease in pediatric patients, even in a postpandemic era, a convenient outpatient oral treatment option for preventing severe disease in individuals with mild-to-moderate COVID-19 continues to be an unmet medical need,” they wrote.