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| Meta Title | Moderna’s 2025-2026 COVID-19 Vaccines Get FDA Approval - Rheumatology Advisor |
| Meta Description | The FDA has approved the 2025-2026 formulations of Moderna’s COVID-19 vaccines Spikevax and mNexspike. |
| Meta Canonical | null |
| Boilerpipe Text | The updated mRNA vaccines target the LP.8.1 variant of SARS-CoV-2.
The Food and Drug Administration (FDA) has approved the 2025-2026 formulations of Moderna’s COVID-19 vaccines Spikevax
®
and
mNexspike
®
.
The updated mRNA vaccines target the LP.8.1 variant of SARS-CoV-2, which was selected as the
preferred strain
at the FDA’s Vaccines and Related Biological Products Advisory Committee meeting in May 2025.Â
Spikevax is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months through 64 years of age with at least 1 underlying condition that puts them at high risk for severe outcomes from COVID-19 and all adults 65 years of age and older. The product is supplied in single-dose prefilled syringes containing 1 dose of either 0.25mL for children 6 months through 11 years and 0.5mL for individuals aged 12 years and older.Â
Moderna’s
new COVID-19 vaccine mNexspike
is approved for individuals 12 through 64 years of age with at least 1 underlying condition that puts them at high risk for severe outcomes from
COVID-19
and all adults 65 years of age and older. The vaccine is supplied in a single-dose prefilled syringe containing 1 dose of 0.2mL.
Moderna’s updated vaccines are expected to be available in the coming days.
This article originally appeared on
MPR
References:
Moderna receives US FDA approval for updated COVID-19 vaccines targeting LP.8.1 variant of SARS-CoV-2. News release. Moderna. August 27, 2025.
https://feeds.issuerdirect.com/news-release.html?newsid=6729249760870595&symbol=MRNA
.
Spikevax. Package insert. Moderna; 2025. Accessed August 27, 2025.
https://static.modernatx.com/pm/6cef78f8-8dad-4fc9-83d5-d2fbb7cff867/5efa7d9d-05e8-46b5-945a-637c2867bd00/5efa7d9d-05e8-46b5-945a-637c2867bd00_viewable_rendition__v.pdf
.
mNexspike. Package insert. Moderna; 2025. Accessed August 27, 2025.
https://static.modernatx.com/pm/6cef78f8-8dad-4fc9-83d5-d2fbb7cff867/9f00fca4-1dca-4c9e-9bdd-d21a1c0bf5c6/9f00fca4-1dca-4c9e-9bdd-d21a1c0bf5c6_viewable_rendition__v.pdf
. |
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# Moderna’s 2025-2026 COVID-19 Vaccines Get FDA Approval
[Diana Ernst, RPh](https://www.rheumatologyadvisor.com/author/dianaernst)
\|
Publish Date
September 5, 2025
 The updated mRNA vaccines target the LP.8.1 variant of SARS-CoV-2.
The Food and Drug Administration (FDA) has approved the 2025-2026 formulations of Moderna’s COVID-19 vaccines Spikevax® and [mNexspike](https://www.rheumatologyadvisor.com/news/fda-approves-modernas-next-generation-covid-19-vaccine-mnexspike/)®.
The updated mRNA vaccines target the LP.8.1 variant of SARS-CoV-2, which was selected as the [preferred strain](https://www.fda.gov/vaccines-blood-biologics/industry-biologics/covid-19-vaccines-2025-2026-formula-use-united-states-beginning-fall-2025) at the FDA’s Vaccines and Related Biological Products Advisory Committee meeting in May 2025.
Spikevax is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months through 64 years of age with at least 1 underlying condition that puts them at high risk for severe outcomes from COVID-19 and all adults 65 years of age and older. The product is supplied in single-dose prefilled syringes containing 1 dose of either 0.25mL for children 6 months through 11 years and 0.5mL for individuals aged 12 years and older.
Moderna’s [new COVID-19 vaccine mNexspike](https://www.empr.com/news/fda-approves-modernas-next-generation-covid-19-vaccine-mnexspike/) is approved for individuals 12 through 64 years of age with at least 1 underlying condition that puts them at high risk for severe outcomes from [COVID-19](https://www.rheumatologyadvisor.com/features/loneliness-and-social-isolation-in-rheumatology/) and all adults 65 years of age and older. The vaccine is supplied in a single-dose prefilled syringe containing 1 dose of 0.2mL.
Moderna’s updated vaccines are expected to be available in the coming days.
**This article originally appeared on [MPR](https://www.empr.com/news/modernas-2025-2026-covid-19-vaccines-get-fda-approval/)**
References:
1. Moderna receives US FDA approval for updated COVID-19 vaccines targeting LP.8.1 variant of SARS-CoV-2. News release. Moderna. August 27, 2025. <https://feeds.issuerdirect.com/news-release.html?newsid=6729249760870595&symbol=MRNA>.
2. Spikevax. Package insert. Moderna; 2025. Accessed August 27, 2025. <https://static.modernatx.com/pm/6cef78f8-8dad-4fc9-83d5-d2fbb7cff867/5efa7d9d-05e8-46b5-945a-637c2867bd00/5efa7d9d-05e8-46b5-945a-637c2867bd00_viewable_rendition__v.pdf>.
3. mNexspike. Package insert. Moderna; 2025. Accessed August 27, 2025. <https://static.modernatx.com/pm/6cef78f8-8dad-4fc9-83d5-d2fbb7cff867/9f00fca4-1dca-4c9e-9bdd-d21a1c0bf5c6/9f00fca4-1dca-4c9e-9bdd-d21a1c0bf5c6_viewable_rendition__v.pdf>.
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| Readable Markdown |  The updated mRNA vaccines target the LP.8.1 variant of SARS-CoV-2.
The Food and Drug Administration (FDA) has approved the 2025-2026 formulations of Moderna’s COVID-19 vaccines Spikevax® and [mNexspike](https://www.rheumatologyadvisor.com/news/fda-approves-modernas-next-generation-covid-19-vaccine-mnexspike/)®.
The updated mRNA vaccines target the LP.8.1 variant of SARS-CoV-2, which was selected as the [preferred strain](https://www.fda.gov/vaccines-blood-biologics/industry-biologics/covid-19-vaccines-2025-2026-formula-use-united-states-beginning-fall-2025) at the FDA’s Vaccines and Related Biological Products Advisory Committee meeting in May 2025.
Spikevax is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months through 64 years of age with at least 1 underlying condition that puts them at high risk for severe outcomes from COVID-19 and all adults 65 years of age and older. The product is supplied in single-dose prefilled syringes containing 1 dose of either 0.25mL for children 6 months through 11 years and 0.5mL for individuals aged 12 years and older.
Moderna’s [new COVID-19 vaccine mNexspike](https://www.empr.com/news/fda-approves-modernas-next-generation-covid-19-vaccine-mnexspike/) is approved for individuals 12 through 64 years of age with at least 1 underlying condition that puts them at high risk for severe outcomes from [COVID-19](https://www.rheumatologyadvisor.com/features/loneliness-and-social-isolation-in-rheumatology/) and all adults 65 years of age and older. The vaccine is supplied in a single-dose prefilled syringe containing 1 dose of 0.2mL.
Moderna’s updated vaccines are expected to be available in the coming days.
**This article originally appeared on [MPR](https://www.empr.com/news/modernas-2025-2026-covid-19-vaccines-get-fda-approval/)**
References:
1. Moderna receives US FDA approval for updated COVID-19 vaccines targeting LP.8.1 variant of SARS-CoV-2. News release. Moderna. August 27, 2025. <https://feeds.issuerdirect.com/news-release.html?newsid=6729249760870595&symbol=MRNA>.
2. Spikevax. Package insert. Moderna; 2025. Accessed August 27, 2025. <https://static.modernatx.com/pm/6cef78f8-8dad-4fc9-83d5-d2fbb7cff867/5efa7d9d-05e8-46b5-945a-637c2867bd00/5efa7d9d-05e8-46b5-945a-637c2867bd00_viewable_rendition__v.pdf>.
3. mNexspike. Package insert. Moderna; 2025. Accessed August 27, 2025. <https://static.modernatx.com/pm/6cef78f8-8dad-4fc9-83d5-d2fbb7cff867/9f00fca4-1dca-4c9e-9bdd-d21a1c0bf5c6/9f00fca4-1dca-4c9e-9bdd-d21a1c0bf5c6_viewable_rendition__v.pdf>. |
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