Valneva Concludes FDA Regulatory Submission For One-Shot Chikungunya Vaccine

  • Valneva SE VALN completed a rolling regulatory submission step with the FDA for its single-shot chikungunya vaccine candidate, VLA1553, in persons aged 18 years and above.
  • The application follows the final Phase 3 data reported in March 2022 and the final lot-to-lot consistency results reported in May 2022
  • A clinical study of VLA1553 in adolescents is ongoing in Brazil, which may support future regulatory submissions in this group if VLA1553 is initially approved in adults. 
  • Chikungunya is a mosquito-borne viral disease. Valneva plans to make regulatory submissions for its VLA1553 vaccine in Europe in the second half of 2023.
  • Earlier this month, Valneva announced data from a persistance trial.
  • The antibody persistence trial enrolled 363 healthy adult participants and followed them from month six after vaccination to month 12. 99% of participants retained neutralizing antibody titers above the seroresponse threshold of 1502 12 months after the single-dose vaccination.
  • Price Action: VALN shares are up 6.63% at $14.38 on the last check Friday.
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