FDA Approves Moderna’s New COVID-19 Vaccine mNEXSPIKE for Seniors 65+
What Is mNEXSPIKE?
- mNEXSPIKE® is Moderna’s next-generation COVID vaccine.
- It uses a smaller dose—one fifth of the original Moderna shot, Spikevax® apnews.com+6modernatx.com+6reuters.com+6en.wikipedia.org+2apnews.com+2cbsnews.com+2.
- It targets a key part of the virus called the spike protein.
- Moderna says it's just as strong, and sometimes stronger, than Spikevax in stopping COVID‑19 .
Who Can Get It?
- All adults 65 or older.
- People ages 12–64 with at least one health risk (like heart disease, lung disease, or diabetes) cbsnews.com+4reuters.com+4investopedia.com+4cbsnews.com.
- Moderna plans to release mNEXSPIKE for the 2025–2026 flu season along with other vaccines cbsnews.com+8reuters.com+8barrons.com+8.
Why This Matters
- Better Protection for Older Adults
- In 2024, more than 47,000 U.S. lives were lost to COVID‑19, mostly in older adults barrons.com+8apnews.com+8cdc.gov+8drugtopics.com+2modernatx.com+2barrons.com+2.
- Easier Storage
- mNEXSPIKE can be kept in a refrigerator, making it easier to give out in communities and rural areas .
- FDA Safety Rules
- The FDA now wants vaccines tested properly. mNEXSPIKE passed big studies with 11,400 people, showing it works as well or better than the old shot modernatx.com+3washingtonpost.com+3cbsnews.com+3webmd.com+6apnews.com+6modernatx.com+6.
- Part of a Big Plan
- Moderna will offer mNEXSPIKE, Spikevax, and mRESVIA (a shot for RSV) next season barrons.com+2investopedia.com+2drugtopics.com+2.
How Do You Get It?
- Go to your doctor, pharmacy, or clinic.
- It’s available during the 2025–2026 respiratory virus season reuters.comdrugtopics.com+3reuters.com+3barrons.com+3.
- If you're 12‑64 with a health risk or 65+, it's recommended by the FDA.
Other updated shots like Pfizer’s Comirnaty® and Novavax’s Nuvaxovid® are also available apnews.com+6reuters.com+6drugtopics.com+6cbsnews.com+3yalemedicine.org+3reuters.com+3.
What Is mNEXSPIKE?
- mNEXSPIKE® is Moderna’s next-generation COVID vaccine.
- It uses a smaller dose—one fifth of the original Moderna shot, Spikevax® apnews.com+6modernatx.com+6reuters.com+6en.wikipedia.org+2apnews.com+2cbsnews.com+2.
- It targets a key part of the virus called the spike protein.
- Moderna says it's just as strong, and sometimes stronger, than Spikevax in stopping COVID‑19 .
Who Can Get It?
- All adults 65 or older.
- People ages 12–64 with at least one health risk (like heart disease, lung disease, or diabetes) cbsnews.com+4reuters.com+4investopedia.com+4cbsnews.com.
- Moderna plans to release mNEXSPIKE for the 2025–2026 flu season along with other vaccines cbsnews.com+8reuters.com+8barrons.com+8.
Why This Matters
- Better Protection for Older Adults
- In 2024, more than 47,000 U.S. lives were lost to COVID‑19, mostly in older adults barrons.com+8apnews.com+8cdc.gov+8drugtopics.com+2modernatx.com+2barrons.com+2.
- Easier Storage
- mNEXSPIKE can be kept in a refrigerator, making it easier to give out in communities and rural areas .
- FDA Safety Rules
- The FDA now wants vaccines tested properly. mNEXSPIKE passed big studies with 11,400 people, showing it works as well or better than the old shot modernatx.com+3washingtonpost.com+3cbsnews.com+3webmd.com+6apnews.com+6modernatx.com+6.
- Part of a Big Plan
- Moderna will offer mNEXSPIKE, Spikevax, and mRESVIA (a shot for RSV) next season barrons.com+2investopedia.com+2drugtopics.com+2.
How Do You Get It?
- Go to your doctor, pharmacy, or clinic.
- It’s available during the 2025–2026 respiratory virus season reuters.comdrugtopics.com+3reuters.com+3barrons.com+3.
- If you're 12‑64 with a health risk or 65+, it's recommended by the FDA.
- Other updated shots like Pfizer’s Comirnaty® and Novavax’s Nuvaxovid® are also available apnews.com+6reuters.com+6drugtopics.com+6cbsnews.com+3yalemedicine.org+3reuters.com+3.
The U.S. Food and Drug Administration (FDA) has officially approved Moderna’s new COVID-19 vaccine, mNEXSPIKE, for use in adults aged 65 and older. This approval marks a significant step in protecting vulnerable populations against evolving respiratory diseases.
Moderna clarified that the vaccine is also authorized for individuals aged 12 to 64 who have underlying health conditions that put them at higher risk of severe illness.
The mNEXSPIKE vaccine is designed to be used proactively during respiratory disease outbreaks expected in the United States between 2025 and 2026, particularly due to seasonal and environmental changes.
This new vaccine aims to strengthen immunity and reduce severe cases, ensuring better preparedness for upcoming respiratory health challenges.
In a significant move to strengthen public health protection, the U.S. Food and Drug Administration (FDA) has officially approved Moderna’s latest COVID-19 vaccine, named mNEXSPIKE, for use in adults aged 65 and older. This approval marks a major milestone in the ongoing fight against COVID-19 and emerging respiratory diseases, particularly as the country anticipates seasonal outbreaks between 2025 and 2026.
How Well Does It Work?
- mNEXSPIKE is not worse—and may be better—compared to Spikevax
- It protects well against current virus types, especially Omicron.
- It lowers the chance of severe illness, hospital stays, and death, especially in older people en.wikipedia.org.
What About Side Effects?
Like other vaccines, you might feel:
- Pain or swelling in the arm
- Tiredness, headache, muscle aches, or fever
These are normal and go away in a few days. Serious problems are rare
Why Older Adults Should Get It
- Older folks are more likely to get very sick from COVID‑19.
- Keeping up-to-date with vaccines keeps communities strong and safe.
- The CDC says older adults should get the 2024‑2025 vaccine washingtonpost.com+7
The FDA’s decision comes after rigorous clinical trials and safety reviews demonstrated that mNEXSPIKE is both safe and effective in boosting immunity among elderly populations, who remain among the most vulnerable to severe illness from respiratory infections.
In addition to senior citizens, Moderna confirmed that mNEXSPIKE is also authorized for individuals aged 12 to 64 who have underlying medical conditions such as asthma, diabetes, heart disease, obesity, or compromised immune systems. These groups are considered high-risk and are more likely to experience serious complications if infected with COVID-19 or other respiratory illnesses.
According to Moderna, the distribution of mNEXSPIKE will begin in Fall 2025, in coordination with federal health agencies, local clinics, and pharmacies nationwide. Eligible individuals are advised to consult their healthcare providers about when and how to receive the vaccine.
Healthcare facilities are being encouraged to prioritize long-term care homes, nursing facilities, and community clinics in underserved areas, where elderly and high-risk individuals may have limited access to transportation and medical services.
The approval of mNEXSPIKE is part of a larger public health strategy by the Centers for Disease Control and Prevention (CDC) and U.S. Department of Health and Human Services (HHS) to enhance national preparedness against infectious disease outbreaks. Public education campaigns, updated vaccine schedules, and increased investment in healthcare infrastructure are also in the works.
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