EMA has recommended granting a marketing authorisation in the European Union (EU) for Ixchiq, the first vaccine in the EU to protect adults 18 years and older against Chikungunya. It is given as a single dose.

Chikungunya (also called CHIK fever) is a viral disease caused by Chikungunya virus (CHIKV), a virus transmitted to humans by infected mosquitoes (primarily Aedes aegypti and Aedes albopictus).

Most people infected with CHIKV develop symptoms within 3–7 days. The most common symptoms of acute disease are fever and joint pain. Other symptoms can include headache, muscle pain, joint swelling, or rash. Most patients recover within a week, but some develop joint pain for several months or longer, which can be disabling. A small proportion of patients may develop severe acute disease, which can lead to multiorgan failure and is most often observed in newborns exposed to the virus during childbirth and adults over 65 years old. There is no licensed treatment for Chikungunya.

CHIKV infections affect people mostly in the tropics and subtropics, and the majority of countries reporting high disease burden are located in Central and South America. Chikungunya is not endemic in Europe. The majority of cases in the EU concern travellers who were infected outside of mainland Europe. However, there have been sporadic incidents of onward transmission by infected travellers after their return, mainly in Southern Europe where the Aedes. albopictus mosquito is established. Spread of the mosquito due to climate change could lead to cases of Chikungunya in regions so far spared.

Considering the significant global public health implications of this vaccine, Ixchiq was assessed under EMA’s OPEN initiative that fosters international collaboration and sharing of scientific expertise to promote global public health. The OPEN framework allowed the World Health Organization and ANVISA, the Brazilian medicines regulator authority, to participate in the discussions of EMA’s Human Medicines Committee (CHMP) and its advisory bodies. Brazil is currently experiencing outbreaks of Chikungunya in a number of regions, reporting over 160,000 cases in the first quarter of 2024.

Ixchiq has been discussed and supported by the Emergency Task Force (ETF) in the context of its public health preparedness activities. It was also supported through EMA's PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients' unmet medical needs. The CHMP reviewed the application for marketing authorisation under an accelerated timetable because the vaccine is considered to be of major public health interest.

The CHMP’s opinion is largely based on data from a placebo-controlled study that assessed the immunogenicity and safety of the vaccine in adults from 18 years. The immune response was evaluated in 362 participants (266 treated with Ixchiq and 96 with placebo). The clinical efficacy of Ixchiq was inferred from a post-vaccination CHIKV-specific neutralising antibody titre threshold. At 28 days after vaccination, 98.9% of individuals administered Ixchiq had antibody titres against CHIKV above the threshold. At 12 months and 24 months after vaccination, antibody titres above the threshold persisted in 99.5% and 97.1% of individuals administered the vaccine, respectively. Antibody titres will be monitored for up to five years.

The CHMP has requested a post authorisation efficacy study to confirm the effectiveness of Ixchiq in preventing Chikungunya in adults.

The safety profile of Ixchiq is based on pooled data from three completed clinical studies with 3,610 participants with a 6-month follow-up. The most common side effects reported were headache, tiredness, muscle pain, joint pain, fever, nausea, tenderness and injection site pain. Chikungunya-like adverse reactions are an important identified risk and will be further characterised with post-authorisation safety studies.

The opinion adopted by the CHMP is an intermediary step on Ixchiq’s path to patient access. The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country.

Climate change can drive many of the health threats we are facing today. The rise in cases of vector-borne diseases transmitted through mosquitos such as Chikungunya is a clear example of the impact of climate change on health and reinforces the need for a One Health approach. EMA, together with other EU Agencies, has recently published a joint One Health framework for action to support the implementation of One Health in Europe and help build a region better able to prevent, predict, prepare, and respond to emerging public health threats.

Notes

  1. The applicant for Ixchiq is Valneva Austria GmbH.
  2. On 10 June 2024, the time points were updated in line with the information in section 5.1 of the Summary of Product Characteristics.

Share this page