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COVID-19: Paxlovid EUA Revised, V-safe Reopens

Andrea Lugo
January 30, 2024

The Food and Drug Administration (FDA) announced Jan. 29 that it will end emergency use authorization of Paxlovid, the oral antiviral pill to treat COVID-19 in adults and youth ages 12 and older.

FDA in May 2023 approved Pfizer’s new drug application for Paxlovid to treat mild-to-moderate COVID-19 in pediatric patients at high risk of progressing to severe illness. Paxlovid manufactured under the EUA will remain authorized through March 8 or the labeled or extended expiration date, whichever is earlier.

The drug was first granted EUA for adults in 2021.

HHS Urges Providers to Provide No-Cost Antivirals

In a Jan. 22 meeting with health care provider groups, the Department of Health and Human Services (HHS) emphasized to providers that patients should not pay the full out-of-pocket cost to access Paxlovid, regardless of their insurance status.

All individuals on Medicare, Medicaid, and uninsured patients will still be able to access Paxlovid at no cost through the end of 2024.

HHS encouraged providers to direct patients facing difficulties at the pharmacy counter to the PAXCESS patient assistance program.

V-safe Registration Reopens

V-safe, the Centers for Disease Control and Prevention’s (CDC’s) vaccine safety monitoring system, is once again open to Americans who wish to report how they feel after getting a participating vaccine.

The system originally launched in December 2020 to monitor the safety of COVID-19 vaccines and later expanded to include mpox vaccines.

CDC urges Americans to receive their the updated 2023–2024 COVID-19 vaccine as vaccination rates remain low for not only COVID-19 but also other respiratory diseases.

Currently, JN.1, an omicron subvariant of SARS-CoV-2, the virus that causes COVID-19, accounts for 85.7 percent of the nation’s COVID-19 cases.

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

Contact Director of Policy Rob Nelb, MPH, at rnelb@essentialhospitals.org or 202.585.0127 with questions.

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