On Wednesday, July 6th, the United States Food and Drug Administration (FDA) expanded emergency use authorization (EUA) for Paxlovid, an antiviral treatment for mild-to-moderate COVID-19, allowing state-licensed pharmacists to prescribe the drug to eligible patients with certain limitations.
Paxlovid originally received emergency use authorization on December 22, 2021. The drug, a Pfizer product, was approved to treat COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 88 lbs) having tested positive for COVID-19 and who are at high risk for progression to severe COVID-19, including hospitalization or death.
An FDA official explained the rationale behind expanding Paxlovid’s EUA in a press release:
‘The FDA recognizes the important role pharmacists have played and continue to play in combatting this pandemic,’ said Patrizia Cavazzoni, M.D., director for the FDA’s Center for Drug Evaluation and Research. ‘Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19.’
Under the FDA’s revised EUA, at-home rapid test results may be used to confirm Paxlovid eligibility. Additionally, the FDA has compiled a fact sheet detailing Paxlovid’s potential side effects and contraindications, such as impaired kidney or liver function.
To date, the Maryland Department of Health has quickly followed the FDA’s suit, revising the state’s guidance whenever a COVID-related EUA has been granted or expanded- just as it recently did with child booster eligibility.