New Chikungunya Vaccine Nears Approval in Europe: A Breakthrough in Preventive Care

Introduction

Valneva SE, a specialty vaccine company, is on the brink of a significant milestone. The company has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for its single-dose chikungunya vaccine, IXCHIQ®.

What is Chikungunya?

Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV). It's transmitted by Aedes mosquitoes and causes symptoms like fever, joint and muscle pain, headache, nausea, rash, and chronic arthritis. Although the mortality rate is low, the virus can cause severe long-term issues.

Positive Steps Towards Approval

The CHMP's positive opinion is a major step towards making the vaccine available in the European Union, Norway, Liechtenstein, and Iceland. The European Commission will review the recommendation, and a final decision is expected by the third quarter of 2024.

Valneva is also preparing to submit a Marketing Authorization Application (MAA) to the UK's Medicines and Healthcare products Regulatory Agency (MHRA), enhancing its global reach.

FDA Approval and Other Regulatory Bodies

In November 2023, the U.S. Food and Drug Administration (FDA) approved IXCHIQ®, making it the first chikungunya vaccine available in the U.S. Applications are also under review by Health Canada and the Brazilian Health Regulatory Agency (ANVISA), with potential approvals expected in 2024.

Importance of the Vaccine

Dr. Juan Carlos Jaramillo, Valneva's Chief Medical Officer, emphasized the significance of this approval given the spread of Aedes mosquitoes to new areas due to climate change. This vaccine is critical for both European travelers and local populations facing invasive mosquito attacks.

The Role of CEPI

The Coalition for Epidemic Preparedness Innovations (CEPI) has been a key partner in this endeavor. CEPI's CEO, Dr. Richard Hatchett, highlighted that over a billion people live in chikungunya-endemic areas, making the development of this vaccine a global priority.

Phase 3 Clinical Trials

Data from Phase 3 clinical trials published in The Lancet showed a 98.9% seroresponse rate at 28 days post-vaccination. This robust immune response lasted for 24 months in 97% of participants across different age groups.

Further positive data were reported in adolescents, supporting potential label extension for ages 12 to 17 and future approvals in endemic regions like Brazil.

Global Health Impact

Before IXCHIQ®, there were no preventive vaccines or effective treatments for chikungunya, making it a major public health concern. The availability of this vaccine will help mitigate the disease's significant medical and economic burden worldwide.

Partnership with Instituto Butantan

To make IXCHIQ® more accessible to low- and middle-income countries, Valneva partnered with Instituto Butantan in Brazil. This collaboration aims to bring this critical vaccine to those who need it most, supported by funding from CEPI and the EU's Horizon 2020 program.

Conclusion

Valneva's chikungunya vaccine, IXCHIQ®, represents a significant advancement in the fight against this debilitating disease. With regulatory reviews ongoing and potential approvals on the horizon, this vaccine could become a crucial tool in global preventive care.