As of mid-2026, the U.S. Food and Drug Administration has granted full approval to four mRNA vaccines. Three protect against COVID-19 — Comirnaty, Spikevax, and mNexspike — and one, mResvia, protects against respiratory syncytial virus (RSV). Full approval here means a Biologics License Application (BLA), the FDA’s standard permanent authorization, not the temporary Emergency Use Authorization pathway that first brought two of these products to market. No other mRNA vaccines have cleared that bar in the United States.
Comirnaty (Pfizer-BioNTech)
Comirnaty was the first mRNA vaccine to receive full FDA approval, on August 23, 2021, for individuals 16 and older. It had launched under Emergency Use Authorization on December 11, 2020, the first COVID-19 vaccine authorized for use in the United States.1Pfizer. Pfizer-BioNTech COVID-19 Vaccine Receives Full U.S. FDA Approval
Since the original approval, the FDA has issued supplemental approvals to update the vaccine’s strain composition. The most recent approval letter on the FDA’s Comirnaty page is dated February 20, 2026.2FDA. Comirnaty For the 2025–2026 respiratory virus season, the vaccine was updated to a monovalent formulation targeting the LP.8.1 sublineage of SARS-CoV-2, approved on August 27, 2025.3Pfizer. Pfizer and BioNTech’s Comirnaty Receives U.S. FDA Approval
The approved indication has narrowed. As of 2026, Comirnaty is approved for individuals 65 and older, and for individuals ages 5 through 64 who have at least one underlying condition that puts them at high risk for severe COVID-19 outcomes.2FDA. Comirnaty
Spikevax (Moderna)
Spikevax, made by ModernaTX, Inc., received Emergency Use Authorization on December 18, 2020, initially for adults 18 and older.4Drugs.com. Spikevax Approval History Full FDA approval followed on January 31, 2022.5FDA. Spikevax The formulation has been updated repeatedly since — from the original strain to bivalent Omicron boosters to newer monovalent variants. The 2025–2026 formulation targeting LP.8.1 was approved on August 27, 2025.
Spikevax is currently approved for individuals 65 and older, and for individuals ages 6 months through 64 who have at least one condition placing them at high risk for severe COVID-19. Full approval for children ages 6 months through 11 years at increased risk was granted on July 10, 2025.4Drugs.com. Spikevax Approval History
mNexspike (Moderna)
mNexspike is a second, separate COVID-19 mRNA vaccine from Moderna, first approved by the FDA on May 30, 2025. It is approved for individuals 65 and older and for those ages 12 through 64 with at least one high-risk underlying condition.6FDA. mNexspike
The construct differs from Spikevax. Where Spikevax encodes the full spike glycoprotein, mNexspike encodes only the linked N-terminal domain and receptor-binding domain. It also uses a lower dose, 10 micrograms of mRNA against Spikevax’s 50 micrograms.7FDA. Package Insert, mNexspike On August 27, 2025, mNexspike was approved alongside Spikevax with an updated LP.8.1 formulation for the 2025–2026 season.8Contagion Live. FDA Approves Moderna’s Updated COVID-19 Vaccines Targeting LP.8.1 Variant for Fall 2025
mResvia (Moderna)
mResvia is the first FDA-approved mRNA vaccine for a disease other than COVID-19. ModernaTX, Inc. received initial approval on June 14, 2024, for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in adults 60 and older.9FDA. mResvia10Nature. FDA Approves Moderna’s mRNA RSV Vaccine On June 12, 2025, the FDA expanded the indication to include adults ages 18 through 59 who are at increased risk of RSV-related lower respiratory tract disease. It is given as a single intramuscular dose.11FDA. Package Insert, mResvia
Full Approval vs. Emergency Use Authorization
Two of these vaccines — Comirnaty and Spikevax — reached patients under Emergency Use Authorization before receiving full approval, and the distinction is worth keeping straight when reading older coverage. A Biologics License Application is the FDA’s standard, permanent pathway. It requires the manufacturer to demonstrate that a vaccine is safe, pure, and potent based on robust clinical trial data, including at least six months of safety follow-up, along with detailed manufacturing information and facility inspections.12Petrie-Flom Center, Harvard Law School. What’s the Difference Between Vaccine Approval and Authorization
An Emergency Use Authorization is temporary. During a declared public health emergency, the FDA can authorize an unapproved product if it finds it “reasonable to believe” the product may be effective and that its known and potential benefits outweigh known and potential risks.13FDA. Emergency Use Authorization for Vaccines Explained An EUA lasts only as long as the underlying emergency declaration and can be revised or revoked. All four of the vaccines listed above now hold full BLA approval.
Label Updates After Approval
Full approval is not the end of FDA oversight. On June 25, 2025, the agency required manufacturers to update the labeling for mRNA COVID-19 vaccines with additional data on myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue around the heart), both recognized as rare but serious side effects. The FDA cited post-vaccination incidence rates and cardiac MRI findings, and put the occurrence at fewer than 1 in 200,000 vaccinated individuals.14FDA. mRNA COVID-19 Vaccines – FDA Safety Communication
What Is Not Yet Approved
Several mRNA vaccines are further along than the general public may realize, but none beyond the four above hold FDA approval. Moderna’s standalone influenza vaccine, mFlusiva, is the closest. On June 18, 2026, the FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously, 9–0, to recommend it for adults 50 and older. Moderna said that if the FDA grants final approval and the CDC recommends it, the vaccine could be available for the following flu season. The FDA initially declined to review the application in February 2026 before reversing that decision two weeks later.15NPR. FDA Advisory Committee Backs Moderna’s mRNA Flu Vaccine
Moderna’s combination flu-and-COVID vaccine, mCombriax, sits further back. The company submitted a BLA to the FDA in 2024 but withdrew it in May 2025 after the agency requested additional data on the influenza component.16CIDRAP. European Regulators Recommend Approval of Combined mRNA Vaccine for Flu and COVID European regulators recommended marketing authorization for mCombriax in February 2026, the first combination flu-COVID vaccine to receive a positive opinion from the European Medicines Agency.17EMA. First Combined COVID-19-Influenza Vaccine for People 50 Years and Older A resubmission to the FDA has not been announced.18Medscape. After FDA Recently Declines Review, EMA Backs First-Ever Combo Flu-COVID Vaccine
Pfizer and BioNTech have no mRNA vaccines beyond COVID-19 near FDA approval; their combination COVID-flu candidate, standalone flu candidate, and varicella and pandemic flu candidates are all still in Phase 1 or Phase 2 trials.19Pfizer. Pipeline Update20Merck. Moderna and Merck Present 5-Year Data for Intismeran Autogene21NPR. Cancer Vaccine mRNA Melanoma It is not approved.