FDA licensed vaccines and where to find approval records
Find FDA-licensed vaccines, their manufacturers and approval records. Use FDA product pages to check package inserts, COVID vaccines and recent approvals.
FDA licensed vaccines are listed on FDA's Vaccines Licensed for Use in the United States page. Find the vaccine there, then open its FDA product page for the manufacturer, package insert and dated approval documents.
The page date is October 8, 2026. It includes routine, COVID-19, influenza and other vaccines, including older influenza formulations. It does not show commercial availability, approved ages or dosing. A listing alone does not establish that a presentation is marketed or suitable for the current season. Use the FDA list as a document-finding tool, not a vaccination schedule.
Examples of FDA-licensed vaccines and manufacturers
These examples are not the full US vaccines list. Manufacturer names follow FDA's product pages rather than familiar parent-company brands.
| Vaccine | Category | FDA-named manufacturer |
|---|---|---|
| Gardasil 9 | HPV | Merck Sharp & Dohme LLC |
| Shingrix | Shingles | GlaxoSmithKline Biologicals, S.A. |
| FluMist | Influenza | MedImmune, LLC |
| MFLUSIVA | Influenza, mRNA | ModernaTX, Inc. |
| Comirnaty | COVID-19, mRNA | BioNTech Manufacturing GmbH |
| Spikevax | COVID-19, mRNA | Moderna Tx, Inc |
| MNEXSPIKE | COVID-19, mRNA | ModernaTX, Inc. |
| Nuvaxovid | COVID-19, adjuvanted | Sanofi Vaccines US, Inc |
Approval-date records and later product pages can name different applicants. FDA's 2025 approval table names Novavax Inc. for Nuvaxovid. The newer product page names Sanofi Vaccines US, Inc. That table reflects information as of the approval date and is not updated for later applicant or application-status changes.
Older lists need care, too. On August 22, 2025, FDA recorded "FDA Suspends the Biologics License for IXCHIQ Vaccine". The October 8, 2026 vaccine list includes VIMKUNYA but not IXCHIQ.
Which COVID vaccines have FDA approval?
Comirnaty, Spikevax, MNEXSPIKE and Nuvaxovid are FDA-approved COVID-19 vaccine brands. The first three are mRNA vaccines. MFLUSIVA is a licensed mRNA influenza vaccine, not a COVID-19 vaccine.
Check each product's current prescribing information before recording eligibility or a seasonal formulation. Initial approval dates do not identify current-season formulations. FDA records Nuvaxovid's initial BLA approval on May 16, 2025, and MNEXSPIKE's on May 30, 2025, in its 2025 approval table.
Selected recent vaccine approvals
FDA's 2025 approval table records the PENMENVY and VIMKUNYA approvals below. These are approval dates, not website-update dates.
- PENMENVY, from GlaxoSmithKline Biologicals, received initial approval on February 14, 2025, for invasive meningococcal disease from serogroups A, B, C, W and Y in people aged 10-25.
- VIMKUNYA, from Bavarian Nordic A/S, was approved on February 14, 2025, for chikungunya prevention in people aged 12 and older.
- MFLUSIVA, from ModernaTX, Inc., received initial approval on August 5, 2026, for influenza prevention in people aged 50 and older. FDA's 2026 approval table applies accelerated approval to the indication in people aged 65 and older, not to every approved age group.
How to find package inserts and approval letters
Start with the official list and select the product. On pages such as PENMENVY and MFLUSIVA:
- Open "Product Information," then "Package Insert" for prescribing information.
- Open "Supporting Documents" for dated approval letters.
- Check "Letters, Reviews, Related Documents" for supporting records.
Keep the document's date separate from the product page's update date. For regulatory records, save the specific document you used rather than relying on a changing product-page heading.
Licensure, emergency authorization and recommendations
FDA approval is also called licensing. An emergency use authorization can cover an unapproved product or an unapproved use of an approved product. It is not a BLA approval.
RegAffairs AI's answer on FDA-licensed vaccines is a starting point for this lookup.
CDC describes approval review separately from ACIP recommendations. Those recommendations become official CDC guidance after CDC Director approval.