COVID-19 Emergency Use Authorizations did not expire on any single date. The end of the federal Public Health Emergency on May 11, 2023 is often confused with the end of EUA authority, but they are separate legal mechanisms. What has actually happened is a rolling transition: the major COVID-19 vaccines and treatments have moved to full FDA approval for their primary populations, some uses remain under EUA, many diagnostic test EUAs have been revoked, and updated seasonal vaccine formulations may cycle in and out of emergency authorization as new variants emerge.
Why the Public Health Emergency Ending Didn’t End the EUAs
The Public Health Emergency declaration issued under Section 319 of the Public Health Service Act expired at the end of the day on May 11, 2023.1Office of Inspector General. OIG’s COVID-19 Public Health Emergency Flexibilities End on May 11, 2023 That is the declaration people usually mean when they talk about the pandemic “officially ending” in federal terms.
Emergency Use Authorizations operate under a different statute. They come from Section 564 of the Federal Food, Drug, and Cosmetic Act, which lets the Secretary of Health and Human Services declare that circumstances justify emergency use of specific categories of medical products.2U.S. Food and Drug Administration. Emergency Use Authorization For COVID-19, HHS issued four separate EUA declarations in early 2020 covering diagnostic tests, personal respiratory protective devices, other medical devices, and drugs and biological products. Each of those has its own lifecycle. Individual EUAs stay active as long as their underlying declaration is in effect, or until the FDA revokes them one by one.
So the practical answer is that the PHE is over, but EUA authority for COVID-19 products did not automatically turn off with it. Products transition off EUA either by earning full FDA approval, by being revoked, or by manufacturers exiting the market.
Where the Vaccines Stand Now
The three major COVID-19 vaccines have moved substantially to full licensure, but approval is limited by age and risk category. Outside those categories, the same product may still be given under EUA, or use may be considered off-label.
Pfizer’s Comirnaty is approved for adults 65 and older and for people ages 5 through 64 who have at least one underlying condition putting them at high risk for severe COVID-19.3U.S. Food and Drug Administration. COMIRNATY Moderna’s Spikevax carries the same structure: people 65 and older, and those ages 6 months through 64 with at least one high-risk condition.4Food and Drug Administration. SPIKEVAX Novavax’s Nuvaxovid is approved for adults 65 and older and for people ages 12 through 64 with high-risk conditions.5U.S. Food and Drug Administration. NUVAXOVID
For a healthy adult under 65 with no qualifying risk factors, receiving one of these vaccines is considered off-label once the EUA for that age group is no longer active. Off-label use is legal and routine in medicine, but it can affect insurance coverage and the informed consent paperwork a provider must give you.
The FDA has also moved COVID-19 vaccines to an annual update cycle similar to seasonal flu vaccines. For the 2025-2026 season, the agency advised manufacturers to use the LP.8.1 strain.6U.S. Food and Drug Administration. COVID-19 Vaccines (2025-2026 Formula) for Use in the United States Beginning in Fall 2025 A newly updated formulation may initially be authorized under EUA while its manufacturer compiles data to support a supplemental approval, so the underlying platform can hold full approval while the current seasonal composition operates temporarily under emergency authorization.
Where the Treatments Stand Now
The main COVID-19 treatments have completed their transition to full approval.
Paxlovid, Pfizer’s oral antiviral, received FDA approval on May 25, 2023, for treatment of mild-to-moderate COVID-19 in adults at high risk of severe disease. Paxlovid manufactured under the original EUA labeling remains available so that adults and eligible adolescents ages 12 through 18, who are not covered by the adult approval, still have access.7U.S. Food and Drug Administration. FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults
Remdesivir, sold as Veklury, also holds full FDA approval, including a supplemental approval for a shorter three-day dosing regimen for non-hospitalized patients at high risk of severe outcomes.8U.S. Food and Drug Administration. FDA Approval Letter – NDA 214787/S-10 Other COVID-19 drug EUAs that were no longer supported by current evidence have been revoked.
Where Tests and Devices Stand Now
Diagnostic tests and other medical devices went through a phased wind-down that began on May 11, 2023 and continued through the following months.9Food and Drug Administration. Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Manufacturers who wanted to keep selling their COVID-19 tests permanently had to pursue traditional marketing authorization, typically through 510(k) clearance or a De Novo classification request. The FDA tracks tests that have completed that step on a dedicated page.10U.S. Food and Drug Administration. COVID-19 Tests Granted Traditional Marketing Authorization by the FDA Many test EUAs have been revoked, and the FDA maintains a public record of those actions.
What It Costs You Now
The end of federal purchasing and free distribution has changed what you pay out of pocket, and the change is not uniform across products.
If you have insurance, COVID-19 vaccines are still generally free. The CARES Act requires non-grandfathered group and individual health plans to cover any immunization recommended by the Advisory Committee on Immunization Practices without cost-sharing, and that requirement survived the end of the PHE.11U.S. Department of Labor. FAQs About Affordable Care Act and Coronavirus Aid, Relief, and Economic Security Act – Part 59 Medicare Part B covers the updated 2025-2026 formula vaccines from Moderna, Pfizer, and Novavax at no cost when the provider accepts assignment.12Medicare.gov. Coronavirus Disease 2019 (COVID-19) Vaccine
If you are uninsured, the situation is harder. The CDC’s Bridge Access Program, which had provided free COVID-19 vaccines to uninsured adults, ended in 2024 after federal funding was cut. Retail prices for a dose can run well over $100. Some community health centers and local health departments still offer reduced-cost or free vaccines, but availability varies. For children, the Vaccines for Children program covers eligible kids at no charge for the vaccine itself, though providers can charge an administration fee.
Rapid at-home tests are now a retail purchase. Insurance plans are no longer required to reimburse for over-the-counter tests the way they were during the emergency. Prescription treatments like Paxlovid have moved to commercial distribution, so what you pay depends on your plan’s formulary and cost-sharing rules.
Liability and Informed Consent
Two other things change as a product moves from EUA to full approval.
Liability protections for COVID-19 countermeasures come from the Public Readiness and Emergency Preparedness Act, which covers manufacturers, distributors, and healthcare providers administering the products. The end of the PHE did not automatically terminate PREP Act coverage.13HHS Administration for Strategic Preparedness and Response. PREP Act Injuries from covered countermeasures are handled through the Countermeasures Injury Compensation Program rather than the Vaccine Injury Compensation Program that covers most routine childhood vaccines. The CICP has stricter filing deadlines and more limited compensation than the VICP, so which program applies to your specific situation matters.
Informed consent paperwork also differs. Products still under EUA require the provider to give you a product-specific EUA Fact Sheet covering the emergency authorization, known side effects, and alternatives. For fully licensed vaccines given to age groups covered by the approval, providers use a standard Vaccine Information Statement instead. Providers are legally required to give you the correct document based on the product’s current status, so the paperwork you receive is a useful signal of how the product you are getting is authorized.
How to Check the Status of a Specific Product
Because the transition is rolling and product-specific, the reliable way to check the current authorization status of a particular vaccine, treatment, or test is the FDA’s EUA database, which the agency updates as authorizations are granted, converted to full approval, or revoked.2U.S. Food and Drug Administration. Emergency Use Authorization If you are checking on a vaccine, confirm both the approval status and the age or risk group it applies to, since a single product can carry a full approval for one population and an EUA (or off-label status) for another.