Authorized for Emergency Use

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Authorized for Emergency Use

PAXLOVID™ has not been approved, but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA), for the treatment of mild-to-moderate COVID-19 in pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death.

The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.

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Information to help inform your decision-making

Select a topic below for information that could be helpful when considering prescribing PAXLOVID for emergency use.

Drug interactions

View boxed warning, contraindicated drugs, and other potentially significant drug interactions.

See Drug Interactions

Efficacy

See the efficacy data from the phase 2/3 EPIC-HR trial of adult participants with a laboratory-confirmed diagnosis of SARS‑CoV‑2 infection at high risk for progression to severe disease.

See Efficacy

Safety

Find out about the safety data from clinical studies and post-authorization experience and how to report an adverse event.

See Safety

Dosing

Learn about the standard and reduced doses of PAXLOVID.

Discover Dosing

The PAXCESS™ Patient Support Program offers insurance coverage information and provides financial assistance resources to eligible patients who are 12 years of age and older who have been prescribed PAXLOVID. Available resources include insurance benefits verification and help with identifying financial assistance options for both commercially insured patients and patients who have Medicare, Medicaid, or are uninsured. Visit here or call 877‑C19‑PACK (877-219-7225).

SARS-CoV-2=severe acute respiratory syndrome coronavirus 2.

Reference:

Fact Sheet for Healthcare Providers: Emergency Use Authorization for PAXLOVIDTM. Pfizer Inc.; 2024.

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