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SP 0253

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Drug Profile

SP 0253

Alternative Names: Adjuvanted recombinant protein-based COVID-19 vaccine - Sanofi; Coronavirus vaccine - Sanofi; GSK-4353001A; Recombinant baculovirus vaccine - Sanofi; Recombinant COVID19 Vaccine C; Recombinant COVID19 Vaccine E; SARS-CoV-2 recombinant protein vaccine - Sanofi; SP-0253; Vaccin SP/GSK CoV2 preS dTM-AS03 adjuvanted vaccine, strain D614; Vaccin SP/GSK, CoV2 preS dTM-AS03 adjuvanted vaccine, strain B.1.351; Vidprevtyn

Latest Information Update: 14 Nov 2024

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At a glance

  • Originator Sanofi
  • Developer GSK; Sanofi; Sanofi Pasteur
  • Class Adjuvants; COVID-19 vaccines; Peptide vaccines; Subunit vaccines; Synthetic 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

Highest Development Phases

  • Phase III COVID 2019 infections

Most Recent Events

  • 11 Mar 2024 Regulatory submission withdrawn for COVID-2019 infections (Prevention) in European Union (IM)
  • 24 Jun 2022 Immunogenicity and adverse events data from a phase III trial in COVID-2019 infections released by Sanofi
  • 23 Feb 2022 Sanofi and GlaxoSmithKline announces intention to submit regulatory applications for SP 0253

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