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FDA Approves Valneva's Single-Shot Vaccine for Chikungunya Virus

  • 20 Nov 2023

Recently, the US Food and Drug Administration (FDA) has granted approval to Valneva's single-shot vaccine, Ixchiq, for individuals aged 18 and above, particularly those at an increased risk of exposure to the chikungunya virus, a mosquito-borne disease.

Key Points

  • First US Approval: Valneva's Ixchiq becomes the inaugural preventive shot sanctioned in the United States for combatting the chikungunya virus, transmitted through mosquito bites.
  • Chikungunya Symptoms: The virus typically causes symptoms such as fever, joint pain, headache, muscle pain, joint swelling, or rash in infected individuals.
  • Late-Stage Trial Success: FDA's approval is founded on late-stage trials, revealing that the vaccine successfully generated antibody levels capable of neutralizing the chikungunya virus in 98.9% of participants within 28 days post-vaccination.
  • Post-Marketing Study: Despite approval, the FDA has requested Valneva to conduct a post-marketing study to evaluate the potential risk of severe chikungunya-like adverse reactions following the administration of Ixchiq.