In a significant development for global public health, the European Medicines Agency (EMA) has recommended granting marketing authorization for Ixchiq, the first vaccine in the EU to protect adults aged 18 and older against Chikungunya. This groundbreaking vaccine, developed by Valneva Austria GmbH, is administered as a single dose and represents a major advancement in the fight against the Chikungunya virus (CHIKV).
Chikungunya, also known as CHIK fever, is a viral disease transmitted to humans by infected mosquitoes, primarily Aedes aegypti and Aedes albopictus. The disease manifests with symptoms such as fever, joint pain, headache, muscle pain, joint swelling, and rash. While most patients recover within a week, some experience prolonged joint pain that can last for months or even years. Severe acute disease, which can lead to multiorgan failure, is rare but more likely to occur in newborns and adults over 65. Currently, there is no licensed treatment for Chikungunya.
Ixchiq aims to provide a cost-effective alternative to existing therapies, addressing a significant unmet medical need. In 2019, approximately 32 million Europeans aged 50 or older were affected by osteoporosis, with women making up 25.5 million of these cases. Although Chikungunya is not endemic in Europe, the spread of mosquitoes due to climate change poses a potential threat. The majority of Chikungunya cases in the EU are reported by travelers infected outside of mainland Europe, with some sporadic incidents of onward transmission occurring in Southern Europe.
EMA Validates Ixchiq’s MAA Following Robust Phase III Trial and International Collaboration
The validation of Ixchiq’s Marketing Authorization Applications (MAAs) by the EMA followed a comprehensive Phase III clinical trial. This international, randomized, double-blind, parallel-controlled multicenter study assessed the vaccine’s efficacy, safety, tolerability, and immunogenicity against the EU-sourced reference denosumab (Prolia). Ixchiq’s immune response was evaluated in 362 participants, demonstrating robust and lasting antibody titers against CHIKV.
The EMA assessed Ixchiq under its OPEN framework, which promotes international collaboration and the sharing of scientific expertise to enhance global public health. This initiative included participation from the World Health Organization (WHO) and ANVISA, Brazil’s medicines regulatory authority. Brazil has been experiencing significant Chikungunya outbreaks, reporting over 160,000 cases in the first quarter of 2024.
Ixchiq also received support from the Emergency Task Force (ETF) as part of its public health preparedness activities and from the EMA’s PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support for medicines addressing unmet medical needs.
EMA Moves Closer to EU-Wide Approval for Chikungunya Vaccine
The CHMP’s opinion on Ixchiq is based on data from a placebo-controlled study involving 3,610 participants with a 6-month follow-up. The most common side effects included headache, tiredness, muscle pain, joint pain, fever, nausea, tenderness, and injection site pain. Chikungunya-like adverse reactions were identified as an important risk, warranting further characterization through post-authorisation safety studies.
The CHMP’s positive opinion marks an intermediary step towards Ixchiq’s market availability. The decision will now be sent to the European Commission for the adoption of an EU-wide marketing authorisation. Post-approval, individual EU Member States will determine the price and reimbursement conditions, considering the vaccine’s potential role in their national health systems.
The approval of Ixchiq underscores the critical importance of addressing vector-borne diseases exacerbated by climate change. The EMA, along with other EU agencies, has recently published a joint One Health framework to enhance Europe’s capacity to prevent, predict, prepare, and respond to emerging public health threats. This development highlights the growing need for innovative vaccines and treatments in the face of global health challenges, reinforcing the value of strategic partnerships and advanced scientific collaboration in improving public health outcomes.
Resource: European Medicines Agency, May 31, 2024
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