Is the COVID Vaccine FDA Approved? EUA, Eligibility, and Labels

Yes. Three COVID-19 vaccines are FDA-approved in the United States: Comirnaty from Pfizer-BioNTech, Spikevax and mNexspike from Moderna, and Nuvaxovid from Novavax. All four hold full approval through the Biologics License Application process, the FDA’s standard pathway for licensing biological products. As of August 27, 2025, the FDA revoked every remaining Emergency Use Authorization for COVID-19 vaccines, so approved products are now the only ones on the market.¹ What changed at the same time is who the vaccines are approved for: eligibility is now limited to adults 65 and older and to people ages 6 months through 64 who have at least one underlying condition that raises their risk of severe illness.²

Which Vaccines Are Approved and for Whom

Four fully approved COVID-19 vaccines are currently available, each with its own labeled age range:

Comirnaty (Pfizer-BioNTech) is approved for ages 5 through 64 with at least one high-risk condition and for all adults 65 and older.³
Spikevax (Moderna) is approved for ages 6 months through 64 with a high-risk condition and for all adults 65 and older.⁴
mNexspike (Moderna), a next-generation vaccine that uses a smaller dose and targets key segments of the spike protein, is approved for ages 12 and older under the same risk-based criteria.⁵
Nuvaxovid (Novavax), a protein-based vaccine, is approved for ages 12 through 64 with an underlying condition and for all adults 65 and older.⁶

For children ages 6 months through 4 years, Moderna’s Spikevax is the only approved option. The Pfizer-BioNTech vaccine is no longer authorized for that age group.⁷ The Johnson & Johnson vaccine is no longer available at all; the company voluntarily withdrew its EUA request in May 2023, and the FDA revoked it on June 1, 2023.⁸

How the Vaccines Moved from Emergency Use to Full Approval

COVID-19 vaccines first reached the public in December 2020 under Emergency Use Authorization, a faster pathway the FDA can use during a declared public health emergency.⁹ The first full approval came on August 23, 2021, when the Pfizer-BioNTech vaccine was licensed as Comirnaty for individuals 16 and older, making it the first mRNA vaccine ever to receive full FDA licensure.¹⁰ Moderna’s Spikevax followed on January 31, 2022, initially for adults 18 and older.¹¹

Over the next few years the FDA extended approvals to younger age groups, cleared updated formulas targeting newer variants, and added additional products. Moderna’s Spikevax received approval for children as young as 6 months in 2025,¹² and Novavax’s Nuvaxovid, previously available only under EUA, received its first full approval in August 2025.⁶

What the 2025 Eligibility Rules Mean If You Want a Vaccine

The biggest change of 2025 was not a change in approval status but a change in who the approvals cover. On May 20, FDA Commissioner Marty Makary and Vinay Prasad, director of the Center for Biologics Evaluation and Research, published a commentary in the New England Journal of Medicine announcing that universal recommendations for everyone 6 months and older were, in their words, “out of step with the rest of the world.” Going forward, the FDA said it would continue to approve vaccines for high-risk groups based on antibody-response data but would require randomized, placebo-controlled trials showing clinical benefit before approving vaccines for healthy people under 65.¹³

The agency acted on that framework on August 27, 2025, approving updated 2025-2026 formula vaccines from Pfizer, Moderna, and Novavax only for adults 65 and older and for people ages 6 months through 64 with at least one high-risk underlying condition. On the same day, it revoked all remaining COVID-19 vaccine EUAs. The FDA said the revocations were not based on safety concerns but on the availability of fully approved products and widespread population immunity.¹⁴

Because these vaccines are fully approved products, doctors can legally prescribe them off-label to people outside the labeled groups. In practice, though, access varies a lot by state. In roughly 16 states, pharmacists are required to follow recommendations from the CDC’s Advisory Committee on Immunization Practices, and major pharmacy chains initially paused vaccinations there while waiting for updated ACIP guidance. CVS pharmacies in nine states and Washington, D.C. require a prescription even for people who meet the FDA’s current criteria.¹⁵

Several states moved to widen access. Massachusetts issued a standing order permitting all pharmacies to administer the vaccine to eligible individuals and required state-regulated insurers to cover it. Pennsylvania’s State Board of Pharmacy voted to let pharmacists follow recommendations from medical organizations beyond the CDC, including the American Academy of Pediatrics. Colorado’s governor directed the state health department to issue a standing order allowing vaccination without an individual prescription.¹⁶ New York Governor Kathy Hochul signed an executive order in September 2025 permitting pharmacists to prescribe COVID-19 vaccines themselves for the first time, enabling off-label administration.¹⁷

Insurance coverage outside the labeled groups is uncertain. The largest insurer trade group has indicated that plans will continue to cover ACIP-recommended vaccines at no cost, but coverage for people who fall outside the FDA’s labeled eligibility depends on the insurer and the state.¹⁵ Out-of-pocket costs for people paying cash can exceed $200.¹⁸

The high-risk conditions that qualify younger people are broadly defined by the CDC and include pregnancy, diabetes, obesity, cancer, asthma, depression, high blood pressure, and a sedentary lifestyle, among others. By some estimates, those conditions cover roughly 75% of U.S. adults.¹⁹

EUA vs. Full Approval in Plain Terms

The distinction between Emergency Use Authorization and full FDA approval is the source of most of the confusion about whether COVID-19 vaccines are “approved.” They are two different regulatory categories.

An EUA lets the FDA make an unapproved product available during a public health emergency when there are no adequate approved alternatives. The legal standard is lower: the FDA must find it “reasonable to believe” that the product “may be effective” and that its known and potential benefits outweigh its known and potential risks. Clinical data requirements are reduced, typically requiring a median of at least two months of safety follow-up.²⁰²¹

Full approval through a Biologics License Application requires the manufacturer to show that the product is “safe, pure, and potent” through extensive clinical trials, typically with at least six months of safety follow-up, detailed manufacturing data, and facility inspections. Once approved, a product can be marketed indefinitely and prescribed off-label by physicians.²²

That off-label piece is what makes the current situation workable for people outside the labeled age and risk groups: a fully approved product can be prescribed to them even when the label doesn’t cover them, subject to state pharmacy rules and insurance coverage.

Updated Safety Labeling

On June 25, 2025, the FDA approved updated warning labels for the mRNA vaccines, Comirnaty and Spikevax, regarding myocarditis and pericarditis, conditions involving inflammation of the heart muscle and surrounding tissue. Warnings about these conditions had been in the labels since 2021; the update added specific incidence figures. The FDA cited roughly 8 cases per million doses in people under 65 and roughly 27 cases per million doses in males ages 12 to 24, the highest-risk group.²³

The updated labels also included findings from a post-approval study showing that abnormal cardiac MRI findings persisted in a significant portion of people who developed vaccine-associated myocarditis, even at a median follow-up of about five months. The FDA said the long-term clinical significance of those findings is not yet known and that manufacturers are required to conduct ongoing studies of potential long-term heart effects.²⁴

1
FDA. Emergency Use Authorization Archived Information
2
RAPS. FDA Approves Updated COVID Vaccines With Restrictions
3
Pfizer. Pfizer and BioNTech’s Comirnaty Receives US FDA Approval
4
FDA. Spikevax
5
FDA. mNexspike
6
Novavax. Novavax’s Nuvaxovid 2025-2026 Formula COVID-19 Vaccine Approved in the US
7
CDC. COVID Vaccine Clinical Considerations
8
FDA. Revocation of Janssen COVID-19 Vaccine EUA
9
Mayo Clinic. COVID-19 Vaccine Timeline
10
FDA. FDA Approves First COVID-19 Vaccine
11
American Hospital Association. FDA Grants Full Approval to Moderna COVID-19 Vaccine
12
CIDRAP. FDA Approves Moderna COVID Vaccine for Kids Under 12 at Higher Risk
13
New England Journal of Medicine. An Evidence-Based Approach to Covid-19 Vaccination
14
Federal Register. Revocation of Emergency Use of Three Biological Products
15
ABC News. COVID Vaccine Complicated After New FDA Restrictions
16
CIDRAP. Three States Take Steps to Ensure COVID Vaccine Access
17
Office of the Governor of New York. Governor Hochul Signs Executive Order Expanding Access to Vaccines
18
NPR. FDA COVID Vaccines Restricted
19
PBS NewsHour. Epidemiologist Breaks Down New Restrictions on COVID Shots
20
FDA. Emergency Use Authorization for Vaccines Explained
21
National Library of Medicine. Emergency Use Authorization Standards
22
Petrie-Flom Center, Harvard Law School. What’s the Difference Between Vaccine Approval (BLA) and Authorization (EUA)
23
FDA. FDA Approves Required Updated Warning Labeling for mRNA COVID-19 Vaccines Regarding Myocarditis and Pericarditis
24
JAMA. Updated Warning Labeling for mRNA COVID-19 Vaccines