 VIMKUNYA (chikungunya vaccine (recombinant, adsorbed)) - Chikungunya

Name: Avis sur  VIMKUNYA (chikungunya vaccine (recombinant, adsorbed)) - Chikungunya
Item:  VIMKUNYA (chikungunya vaccine (recombinant, adsorbed)) - Chikungunya
Author: Haute Autorité de Santé

Opinions on drugs - Posted on Dec 12 2025

Reason for request

Inclusion on list

Summary of opinion

Favourable opinion for inclusion in the list of covered drugs for inpatients and various public services approved for use in the “active immunisation for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations.”

On the date of the present opinion, this use corresponds to the population of travellers specified in the French National Council for Public Health (HCSP) recommendations updated in June 2025.

Maintenance of this opinion is dependent on analysis of the results of ongoing studies, pharmacovigilance data and real-world efficacy data within a maximum period of two years.

Clinical Benefit

Moderate

The clinical benefit of VIMKUNYA (chikungunya vaccine (recombinant, adsorbed)) is moderate in the active immunisation for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years of age and older, in accordance with the current HCSP recommendations for travellers pending new data.

Clinical Added Value

minor

Considering:

the available immunogenicity data:
- a predictive protection threshold set at an anti-CHIKV serum neutralising antibody (SNA) titre ≥ 100, a conservative threshold agreed with the FDA and the EMA;
- the seroresponse obtained in 97.8% (95% CI [97.2; 98.3]) of individuals 12 to 64 years of age, and in 3% (95% CI [81.8; 91.3] of individuals 65 years of age and older, with anti-CHIKV serum neutralising antibody (SNA) titres greater than or equal to the predictive protection threshold 22 days following administration of a single dose of the VIMKUNYA vaccinein two phase 3 studies;
- the geometric mean titre (GMT) at D22 post-vaccination of 1,618.05 [95% CI: 1,522.11; 1,720.04]) in individuals 12 to 64 years of age, and of 723.93 [584.13; 897.20]) in individuals 65 years of age and older;
- a decrease in immune response over the 6-month study follow-up period, with:
  - a seroresponse falling from 97.8% (D22, peak), to 85.5% (D183);
  - GMTs that are two times (65 years of age and older) or three times (12 to 64 years of age) higher than the predictive protection threshold at 6 months post-vaccination (versus 16 times higher at D22);
- a lower immune response in individuals 65 years of age and older, compared to that observed in individuals 12 to 64 years of age;
the available safety data demonstrating an acceptable safety profile;

but:

the absence of data concerning the clinical efficacy of the vaccine on infections, symptomatic forms, hospitalisations and deaths;
uncertainties concerning the duration of vaccine protection following vaccination with VIMKUNYA (chikungunya vaccine (recombinant, adsorbed)) beyond 6 months;

the Committee deems that VIMKUNYA (chikungunya vaccine (recombinant, adsorbed)) provides a minor clinical added value (CAV IV) in the care pathway in accordance with the current HCSP recommendations (2025 Health recommendations for travellers).