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URLhttps://www.rheumatologyadvisor.com/news/modernas-2025-2026-covid-19-vaccines-get-fda-approval/
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Meta TitleModerna’s 2025-2026 COVID-19 Vaccines Get FDA Approval - Rheumatology Advisor
Meta DescriptionThe FDA has approved the 2025-2026 formulations of Moderna’s COVID-19 vaccines Spikevax and mNexspike.
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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.  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 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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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>. - ![Related Icon](https://www.rheumatologyadvisor.com/wp-content/plugins/hm-related-recommendations-manager/assets/images/related-icon.svg) #### Related News - [March 2026: Notable Drug Approvals](https://www.rheumatologyadvisor.com/news/march-2026-notable-drug-approvals/) - [High Dose Spinraza Receives FDA Approval for Spinal Muscular Atrophy](https://www.rheumatologyadvisor.com/news/high-dose-spinraza-receives-fda-approval-for-spinal-muscular-atrophy/) - [FDA Approves Teva's Prolia Biosimilar Ponlimsi, Accepts Xolair Biosimilar for Review](https://www.rheumatologyadvisor.com/news/fda-approves-tevas-prolia-biosimilar-ponlimsi-accepts-xolair-biosimilar-for-review/) - ![Top Picks Icon](https://www.rheumatologyadvisor.com/wp-content/plugins/hm-related-recommendations-manager/assets/images/top-pick-icon.svg) #### Top Picks from our Haymarket Medical Network 1. 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![](https://www.rheumatologyadvisor.com/wp-content/themes/hm-advisor-child/assets/svg/key-point_icon.svg) 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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