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COVID-19: FDA Paxlovid Approval, Long COVID-19 Study

The Food and Drug Administration approved on May 25 the oral antiviral Paxlovid to treat mild-to-moderate COVID-19 in adults at high risk of progressing to more severe illness.

Paxlovid is the first oral antiviral pill approved by the agency to treat COVID-19 in adults. It was first granted emergency use authorization (EUA) in 2021.

The FDA clarified that Paxlovid manufactured, packaged, and distributed by the Department of Health and Human Services under the previous EUA will remain available for adults and eligible children ages 12–17.

On May 30, the Administration for Strategic Preparedness and Response (ASPR) updated its threshold determination amounts of COVID-19 therapeutics available for states, territories, federal entities, and pharmacy partners. The ASPR COVID-19 Therapeutics Summary includes not only Paxlovid but Lagevrio and Renal as well.

New Long COVID-19 Findings

A study published in the Journal of the American Medical Association and coordinated through the National Institutes of Health’s Researching COVID to Enhance Recovery (RECOVER) initiative offers deeper insight into long COVID-19, a prolonged illness that develops after COVID-19.

Researchers examined nearly 10,000 participants and identified 12 symptoms that distinguish those with and without long COVID: post-exertional malaise, fatigue, brain fog, dizziness, gastrointestinal symptoms, heart palpitations, issues with sexual desire or capacity, loss of smell or taste, thirst, chronic cough, chest pain, and abnormal movements.

Findings indicated that certain symptoms occurred together, and researchers defined four subgroups or “clusters” with a range of effects on health.

Researchers also found that long COVID-19 was more common and severe in those infected before the omicron variant of SARS-CoV-2, the virus that causes COVID-19, circulated in 2021.

An estimated 6 percent of the more than 100 million Americans who have been infected with SARS-COV-2 continue to experience and suffer from long COVID-19, according to data from the federal government’s Household Pulse survey.

Researchers say studying the underlying biological mechanisms of long COVID-19 is key to advancing informed interventions and identifying effective treatment strategies.

Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.

Contact Senior Director of Policy Erin O’Malley at eomalley@essentialhospitals.org or 202.585.0127 with questions.

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About the Author

Andrea Lugo is a senior communications associate at America's Essential Hospitals.

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