Every year, new vaccines are approved by the U.S. Food and Drug Administration (FDA) to help deter public health risks. However, recent enhanced skepticism surrounding vaccine use has made the discussions that need to happen between clinicians and patients challenging. Because clinicians play a critical role in guiding patients toward making informed decisions about their health, by discussing vaccines openly they can help their patients better understand the importance of vaccines.
Informed vaccination decisions protect not only the individual patient but also those they may encounter by reducing the likelihood of transmitting vaccine-preventable diseases. The broad public health benefit underscores the significant population-level impact of vaccinations, which is why the FDA continually evaluates and approves vaccines designed to mitigate specific public health risks.
The FDA has approved nearly 100 vaccines for use against public health risks. Some vaccines include well known vaccines like Varivax (chicken pox vaccine) or YF-VAX (yellow fever vaccine), while others are lesser known vaccines like Biothrax (for anthrax).
In recognition of Immunization Awareness Month, we’re taking a look at seven vaccines that were approved in 2025, as of August 8, 2025. These vaccines come from a variety of manufacturers and help protect patients against health risks like COVID-19, RSV, and more.
| Vaccine | Indication | Date Approved | Manufacturer |
|---|---|---|---|
| mNEXSPIKE | For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). | 5/30/25 | Moderna |
| mRESVIA | For active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older, and individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. | 6/12/25 | Moderna |
| Nuvaxovid | For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older. Also for individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. | 5/19/25 | Novavax |
| Penmenvy | For active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals 10 through 25 years of age. | 2/14/25 | GlaxoSmithKline |
| Shingrix | For prevention of herpes zoster (HZ) (shingles): in adults aged 50 years and older, and in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy. | 7/17/25 | GlaxoSmithKline |
| Spikevax | For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). | 7/9/25 | Moderna |
| Vimkunya | For the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years of age and older. | 2/14/25 | Bavarian Nordic A/S |
Chronological Timeline:
- February 14, 2025 - Vimkunya approved
- February 14, 2025 - Penmenvy approved
- May 19, 2025 - Nuvaxovid approved
- May 30, 2025 - mNEXSPIKE approved
- June 12, 2025 - mRESVIA approved (expanded approval)
- July 9, 2025 - Spikevax approved (expanded approval)
- July 17, 2025 - Shingrix approved (new formulation)
Expanded Approvals
Both Spikevax and mRESVIA received expanded approvals in 2025.
In June, the FDA expanded mRESVIA's approval to include individuals between 18 and 59 years of age who are at increased risk of lower respiratory tract disease caused by RSV. The vaccine was previously approved for adults 60 and older.
In July, the FDA expanded Spikevax's approval to include children 6 months through 11 years of age who are at increased risk for COVID-19 disease. This expansion was in addition to the previous indication for adults 65 years and older. The new indication opens the window for pediatric patients with underlying conditions as well as those 64 and younger with underlying conditions.
As new and more effective formulations targeting public health threats become available, the FDA will continue to evaluate and approve vaccines that demonstrate clear benefits to the overall population.
Look for continuing coverage on new vaccines approved by the FDA and the guidelines they may impact.
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