Valneva’s Chikungunya Vaccine IXCHIQ® Now Approved for Use in Individuals 60 and Older

Valneva SE announced that the U.S. Food and Drug Administration (FDA) has lifted its recommended pause on the use of IXCHIQ®, the company’s chikungunya vaccine, in individuals aged 60 and older. This decision follows a thorough review of safety data and updates to the vaccine’s prescribing information.

What Prompted the Pause and Its Reversal?

The pause was initially recommended by the FDA after a mass vaccination campaign in La Réunion, in response to a severe chikungunya outbreak, revealed a pattern of Serious Adverse Events (SAEs). These events were reported primarily in elderly individuals with multiple pre-existing health conditions. The FDA, along with the European Medicines Agency (EMA), initiated a review of these cases.

The recent decision by both the FDA and EMA to lift the temporary restrictions is based on their conclusion that, with updated guidance, the vaccine’s benefits outweigh the risks for this population. The updated Prescribing Information (PI) for IXCHIQ® provides crucial details to help healthcare professionals make informed decisions.

Key Updates to the Prescribing Information (PI)

The revised PI includes several important points for healthcare providers:

Risk-Benefit Assessment: The FDA emphasizes that IXCHIQ® should be administered only after a careful assessment of the potential benefits and risks. For most U.S. travelers, the risk of exposure to the chikungunya virus (CHIKV) is low, and therefore, the vaccine may not be advisable for them.
Expanded Warnings: The “Warnings and Precautions” section has been updated to specifically highlight the SAE profile observed, particularly in individuals aged 65 and older with one or more chronic medical conditions.
Contraindications: The vaccine remains contraindicated for individuals with weakened immune systems due to disease or immunosuppressive treatments.

About Chikungunya

Chikungunya is a mosquito-borne viral disease that has been identified in over 110 countries. It is transmitted by the Aedes species of mosquitoes. The disease is known for causing:

Fever
Severe joint and muscle pain
Headache
Nausea and fatigue

The joint pain is often debilitating and can persist for weeks or even years. The World Health Organization (WHO) has classified chikungunya as a major public health problem, and its medical and economic burden is expected to increase with climate change as the mosquito vectors spread to new geographical areas.

With the lifting of the pause and the updated guidance, healthcare professionals now have clearer instructions to evaluate the appropriateness of the IXCHIQ® vaccine on a case-by-case basis. This allows for targeted protection for those at highest risk while ensuring patient safety.