MedPath
EMA Approval

Vimkunya

Chikungunya vaccine (recombinant, adsorbed)

Chikungunya virus

Chikungunya virus (CHIKV) virus-like particle (VLP) proteins (capsid protein (C) and envelope proteins E1 and E2) derived from CHIKV Senegal strain 37997 produced in human embryonic kidney cells by recombinant DNA technology, adsorbed on aluminium hydroxide, hydrated

Basic Information

EMA regulatory identification and product classification information

EMA Identifiers

EMA European Classification

Overview Summary

Comprehensive product overview and regulatory summary

Vimkunya is a vaccine used to protect adults and adolescents from 12 years of age against chikungunya. Chikungunya is a disease caused by chikungunya virus, which is transmitted to humans by infected mosquitoes.

Vimkunya contains proteins from a chikungunya virus strain called Senegal strain 37997 (capsid protein and envelope proteins E1 and E2). These proteins are assembled into virus-like particles that are not infectious. The vaccine cannot cause chikungunya in people who receive the vaccine.

Authorisations (1)

EMEA/H/C/005470

Bavarian Nordic A/S,Philip Heymans Alle 3,2900 Hellerup,DENMARK

Authorised

February 28, 2025

Active Substances (1)

Chikungunya virus (CHIKV) virus-like particle (VLP) proteins (capsid protein (C) and envelope proteins E1 and E2) derived from CHIKV Senegal strain 37997 produced in human embryonic kidney cells by recombinant DNA technology, adsorbed on aluminium hydroxide, hydrated

Documents (4)

Vimkunya : EPAR - Medicine overview

March 24, 2025

OVERVIEW_DOCUMENT

Vimkunya : EPAR - Product information

March 24, 2025

DRUG_PRODUCT_INFORMATION

CHMP summary of positive opinion for Vimkunya

January 31, 2025

CHANGES_SINCE_INITIAL_AUTHORISATION

Vimkunya : EPAR - All authorised presentations

March 24, 2025

AUTHORISED_PRESENTATIONS

Overview Q&A (7)

Question

How is Vimkunya used?

Answer

Vimkunya is given as a single injection into the muscle of the upper arm.

Vaccinated people should continue to apply personal protection measures against mosquito bites after vaccination.

Vimkunya can only be obtained with a prescription and should be used according to official recommendations.

For more information about using Vimkunya, see the package leaflet or contact your doctor or pharmacist.

Question

How does Vimkunya work?

Answer

Vimkunya is a vaccine. Vaccines work by preparing the immune system (the body’s natural defences) to defend the body against a specific disease.

When a person is given the vaccine, the immune system recognises the virus-like particles as foreign and makes antibodies against them. If the person later comes into contact with the chikungunya virus, these antibodies, together with other components of the immune system, will be able to fight off the virus more effectively and help protect the person against the disease.

The virus-like particles in Vimkunya are fixed (adsorbed) onto an aluminium compound, called an adjuvant, which increases the effect of the vaccine.

Question

What benefits of Vimkunya have been shown in studies?

Answer

Two main studies showed that Vimkunya was effective at triggering the production of antibodies against the chikungunya virus in adults and adolescents.

The first study, involving 3,258 adolescents and adults aged 12 to 64 years, showed that, 22 days after the injection, 98% of people who received the vaccine developed antibodies against the chikungunya virus above the established threshold, compared with 1% of those who received placebo.

The second study, involving 413 adults aged 65 years and older, showed that, 22 days after the injection, 87% of people who received the vaccine developed antibodies against the chikungunya virus above the established threshold, compared with 1% of those who received placebo.

In both studies, most people given Vimkunya maintained their immune response for at least 6 months.

Question

What are the risks associated with Vimkunya?

Answer

For the full list of side effects and restrictions with Vimkunya, see the package leaflet.

The most common side effects with Vimkunya (which may affect more than 1 in 10 people) include pain at the injection site, tiredness, headache and myalgia (muscle pain).

Question

Why is Vimkunya authorised in the EU?

Answer

Vimkunya triggers an immune response against chikungunya virus in adults and adolescents from 12 years of age. This immune response is expected to protect against chikungunya disease.

Chikungunya virus is mostly present in tropical and subtropical regions. However, as a consequence of climate change, the virus is considered an important future public health threat in Europe. At the time of approval, a vaccine containing live attenuated (weakened) chikungunya virus was already authorised in the EU for use in adults to help protect against the disease. Vimkunya provides an alternative for those who cannot receive live attenuated virus vaccines and allows adolescents from 12 years of age to be vaccinated against chikungunya virus.

Vimkunya’s safety profile is acceptable, with most side effects being mild to moderate.

The European Medicines Agency therefore decided that Vimkunya’s benefits are greater than its risks and that it can be authorised for use in the EU.

Question

What measures are being taken to ensure the safe and effective use of Vimkunya?

Answer

The company that markets Vimkunya must submit results from a study looking at the safety and effectiveness of Vimkunya in adults and adolescents in areas where the chikungunya virus is present.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vimkunya have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Vimkunya are continuously monitored. Suspected side effects reported with Vimkunya are carefully evaluated and any necessary action taken to protect patients.

Question

Other information about Vimkunya

Answer

Vimkunya received a marketing authorisation valid throughout the EU on 28 February 2025.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Vimkunya - EMA Approval | MedPath