Three more points about Paxlovid for covid-19

D Phizackerley - bmj, 2022 - bmj.com
D Phizackerley
bmj, 2022bmj.com
Firstly, in the UK, Paxlovid is not currently authorised for use in children. The marketing
authorisation states:“Paxlovid is indicated for the treatment of covid-19 in adults who do not
require supplemental oxygen and who are at increased risk for progression to severe covid-
19,” and,“The safety and efficacy of Paxlovid in paediatric patients younger than 18 years of
age have not yet been established.” 2 The US Food and Drug Administration granted
emergency use authorisation for Paxlovid “for the treatment of mild-to-moderate covid-19 in …
Firstly, in the UK, Paxlovid is not currently authorised for use in children. The marketing authorisation states:“Paxlovid is indicated for the treatment of covid-19 in adults who do not require supplemental oxygen and who are at increased risk for progression to severe covid-19,” and,“The safety and efficacy of Paxlovid in paediatric patients younger than 18 years of age have not yet been established.” 2 The US Food and Drug Administration granted emergency use authorisation for Paxlovid “for the treatment of mild-to-moderate covid-19 in adults and paediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe covid-19, including hospitalisation or death.” 3
Secondly, the evidence for Paxlovid is based on its effects in people who were not vaccinated against SARS-CoV-2. The EPIC-HR study recruited unvaccinated, symptomatic adults with a confirmed diagnosis of SARS-CoV-2 infection within 5 days who were not admitted to hospital and who were at increased risk of progressing to severe illness. 4 Anyone who had received or was expected to receive any dose of a SARS-CoV-2 vaccine was excluded from the study. 5 We do not know how effective the drug will be in a highly vaccinated population.
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