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Elasomeran - Moderna Therapeutics/National Institute of Allergy and Infectious Diseases

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Drug Profile

Elasomeran - Moderna Therapeutics/National Institute of Allergy and Infectious Diseases

Alternative Names: COVID-19 Vaccine Moderna; Moderna COVID-19 Vaccine; mRNA-1273; mRNA-1273 SARS-CoV-2 vaccine; SARS-CoV-2 RNA vaccine - Moderna Therapeutics; SARS-CoV-2 vaccine - Moderna Therapeutics/National Institute of Allergy and Infectious Diseases; SARS-CoV-2 variant JN.1 vaccine - Moderna Therapeutics; SARS-CoV-2 variant KP.2 vaccine - Moderna Therapeutics; SPIKEVAX; SPIKEVAX-X; SPIKEVAX-XBB.1.5; SPIKEVAX® KP.2; TAK-919

Latest Information Update: 05 Sep 2025

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At a glance

  • Originator Moderna Therapeutics; National Institute of Allergy and Infectious Diseases
  • Developer Moderna Therapeutics; National Institute of Allergy and Infectious Diseases; Takeda
  • Class COVID-19 vaccines; RNA vaccines; Viral vaccines
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Marketed COVID 2019 infections
  • Phase III Human papillomavirus infections

Most Recent Events

  • 27 Aug 2025 Registered for COVID-2019 infections (In adolescents, In children, In the elderly, In infants, Prevention, In adults) in USA (IM)
  • 24 Jul 2025 Committee for Medicinal Products for Human Use issued positive opinion for update of composition of Elasomeran for COVID-2019 infections in European Union
  • 17 Sep 2024 Health Canada approves elasomeran for the KP.2 variant of COVID-19 infections (In infants, In children, In adolescents, In adults, In the elderly, Prevention) in Canada (IM)

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