Moderna

Spikevax

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Moderna's original COVID-19 mRNA vaccine (mRNA-1273), the product that validated mRNA vaccines at global scale. Now sold as a seasonal respiratory vaccine and the company's largest historical revenue driver.

Latest update Sep 7, 2026

Spikevax

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Current status

Fully FDA-approved (2022) and marketed globally as a seasonal COVID-19 vaccine. The FDA approved the 2026-2027 XFG (JN.1-lineage) formula on August 27, 2026 for high-risk people aged 6 months through 64 and all adults 65 and older; next-generation mNEXSPIKE received the same-season XFG update for high-risk people aged 12 through 64 and all adults 65 and older. The UK MHRA separately authorized the XFG Spikevax update for ages 6 months and older, with doses to be made at Harwell, Oxfordshire, for the NHS 2026/27 programme.

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Specifications2

First Authorized
Dec 2020 (EUA); full approval Jan 2022
Platform
mRNA

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In the news2

  1. UK MHRA authorizes Moderna XFG Spikevax update

    The UK Medicines and Healthcare products Regulatory Agency authorized Moderna's updated Spikevax COVID-19 vaccine targeting the SARS-CoV-2 XFG variant for adults and children aged six months and older. Doses will be made at the Moderna Innovation and Technology Centre in Harwell, Oxfordshire, for the NHS 2026/27 vaccination programme. The European Medicines Agency's Emergency Task Force separately recommended that 2026/2027 COVID-19 vaccines target the XFG variant.

    PMLiVE ChemDiv

  2. FDA approves Moderna's updated 2026-2027 COVID vaccines

    Moderna said on August 27 that the FDA approved the 2026-2027 formulas of Spikevax and mNEXSPIKE, both targeting the JN.1-lineage XFG subvariant of SARS-CoV-2. Spikevax is cleared for high-risk people aged 6 months through 64 and all adults 65 and older, while mNEXSPIKE is cleared for high-risk people aged 12 through 64 and all adults 65 and older; the company said the shots should be available in the coming days.

    Moderna (ACCESS Newswire)

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