Valneva provides update on recommended use of Ixchiq by elderly individuals in the United States

Valneva SE announced that the  FDA  and the U.S. Centers for Disease Control and Prevention (CDC), in a joint communication to the medical community, have recommended a pause in the use of Valneva’s single-dose live attenuated chikungunya vaccine Ixchiq in elderly individuals while ongoing investigations into reported serious adverse events (SAEs) are completed. This update follows an earlier recommendation from the U.S. Advisory Committee on Immunization Practices (ACIP) to include a precaution related to the use of Ixchiq in persons aged 65 and over and a similar decision by the EMA  to temporarily suspend the use of the vaccine for individuals over 65 years old pending investigation.

As highlighted by FDA/CDC, adverse events may not be causally related to vaccination, yet thorough evaluation of these cases is critical to ensure the safe use of Ixchiq , of which over 40,000 doses are estimated to have been utilized to date, worldwide.  Valneva has engaged proactively with health authorities in all territories where Ixchiq is licensed to provide timely information about all known SAEs, most of which have been reported to the Vaccine Adverse Event Reporting System (VAERS) and have been in elderly individuals with significant underlying medical conditions and/or co-medications.

The Company still continues to see a positive risk-benefit in the vast majority of people with potential exposure to the disease. The FDA and CDC maintain their recommendations for use of  Ixchiq  in individuals aged 18 to 60 years. The EMA continues to recommend Ixchiq for individuals aged 12 to 64 years. Additionally, France’s national public health agency, the Haute Autorité de Santé (HAS), continues to vaccinate people aged 18 to 64 years of age in its campaign to combat the current chikungunya outbreak in La Réunion.

Dr. Juan Carlos Jaramillo, Chief Medical Officer of Valneva, said: “We reiterate our support for the precautionary measures that have been taken as well as our commitment to continue monitoring all reported serious adverse events, particularly from the active chikungunya vaccination campaign in La Réunion, as there have not been any further SAEs reported outside of this public vaccination effort to combat this ongoing outbreak. We will continue engaging proactively with the global regulatory authorities while these important investigations continue over the coming months”.

Valneva anticipates formal reviews of the post-marketing safety reports in all territories where Ixchiq  is approved. The Company will provide further updates as these evaluations are concluded.

Safety concerns have spurred the FDA and Centers for Disease Control and Prevention to recommend suspending use of Valneva’s chikungunya vaccine in people at least 60 years of age. The recommendation comes days after the European Medicines Agency temporarily suspended use of the vaccine, known as Ixchiq, in those over 65 pending an investigation. A committee advising the CDC previously suggested a precaution for use in a similar age group. The FDA and CDC have upheld recommendations for use in adults between 18 and 60 years of age, while the EMA still endorses the shot for individuals between 12 and 64.