The world's first vaccine against mosquito-borne viral infection chikungunya is to be manufactured in Scotland.
It comes after French biotech company Valneva announced that the European Commission (EC) has granted marketing authorization in Europe for its single-dose vaccine, IXCHIQ®, for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older.
The approval was unanimously endorsed by Member States following a stringent assessment by the European Medicines Agency (EMA).
The EC decision marks the third approval the specialty vaccine company has received for IXCHIQ® following approval from the U.S. Food and Drug Administration in November 2023 and Health Canada last month. Valneva said it expects to deliver the first doses in Europe in the fourth quarter of 2024.
The company confirmed to The Herald that the vaccine will be manufactured at its site in Livingston.
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Chikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes which causes fever, severe joint pain, muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to year.
In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, CHIKV has now been identified in over 110 countries in Asia, Africa, Europe and the Americas.
Between 2013 and 2023, more than 3.7 million cases were reported in the Americas and the economic impact is considered to be significant. The medical and economic burden is expected to grow with climate change as the mosquito vectors that transmit the disease continue to spread geographically. As such, the World Health Organization (WHO) has highlighted chikungunya as a major public health problem.
Commenting on the EC decision, Dr Juan Carlos Jaramillo, Chief Medical Officer of Valneva, said: “The EC approval marks a crucial milestone toward making this vaccine available to as many European citizens as possible. In recent years, climate change has caused the Aedes mosquito, a known carrier of chikungunya and dengue viruses, to spread to areas in Europe that were previously unaffected.
“It is critical to provide a vaccine solution not only to European travelers going to endemic chikungunya areas, such as South America or Africa, but also to the local European populations experiencing invasive mosquito attacks. We would like to thank our partner, CEPI, for supporting us in this endeavor.”
Dr Richard Hatchett, Chief Executive Officer of the Coalition for Epidemic Preparedness Innovations (CEPI), added: “Supported by CEPI and EU funding, IXCHIQ is the world’s first vaccine offering protection against the debilitating Chikungunya virus.
“The EU’s rapid approval of the vaccine, following recommendation by the European Medicines Agency, is a historic moment to help protect the lives and livelihoods of European populations against Chikungunya outbreaks, which are becoming more frequent and widespread in the region.
“But the fight is not over – as a matter of priority CEPI is working with Valneva and the EU to expand access to the vaccine to those living in endemic countries who are greatest risk from the disease.”
Valneva is Scotland’s largest vaccine producer, with the company’s Manufacturing Centre of Excellence located at Oakbank Industrial Park in Livingston employing nearly 180 staff. Valneva recently picked up two accolades at the annual Life Sciences Scotland Awards 2024, as well as a RoSPA Silver Award 2024 for health and safety excellence.
In February 2022, Valneva Scotland was awarded research and development funding of up to £20 million by Scottish Enterprise. The investment from Scotland’s national economic development agency followed advanced discussions reported in 2021, and comprises of two grants, which build on the agency’s longstanding engagement with Valneva and will benefit the company’s manufacturing site in Livingston.
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The first grant of up to £12,500,000 is in support research and development related to the manufacture of VLA2001, Valneva’s inactivated, whole virus COVID-19 vaccine candidate. The second grant of up to £7,500,000 is in support research and development connected to Valneva’s manufacturing processes for other vaccines.
Speaking at the time, Ivan McKee, then Minister for Business, Trade, Tourism and Enterprise, said: “Valneva is a valued contributor to our life sciences sector and the Livingston facility is an important asset, developing and manufacturing vaccines for the prevention and treatment of several infectious diseases. This funding package will support high quality jobs create, drive further research and underpin the company’s operations in Scotland.”
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