The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has confirmed the marketing authorization application (MAA) for Bavarian Nordic's chikungunya vaccine, CHIKV VLP, which is a single-dose vaccine. The vaccine is to be used for active immunization against chikungunya virus infections in people aged 12 years and above.
The application was submitted under the procedure of international recognition, following a favorable opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). The vaccine, previously approved in the United States and European Union as Vimkunya, is now waiting for possible UK approval in the first half of 2025.

Important Points of the CHIKV VLP Vaccine Approval Process
1. UK Review Based on Worldwide Approvals

• February 2025: Bavarian Nordic presented its MAA to the MHRA.

• January 2025: CHMP of the EMA rendered a positive vote regarding the vaccine.

• February 2025: The US FDA and European Commission cleared the vaccine in the trade name Vimkunya.

• Likely UK Approval: First half-year of 2025, owing to the worldwide regulatory architecture.

2. Expansion of Bavarian Nordic to the UK Market

• The firm has extended its UK operations to manage the launch of the chikungunya vaccine.

• Bavarian Nordic currently provides rabies, typhoid, and cholera vaccines in the UK and is a major supplier of mpox vaccines to the UK Health Security Agency (UKHSA).

Paul Chaplin, President & CEO of Bavarian Nordic, said:
"After last month's approvals of our chikungunya vaccine in the US and EU, we are looking forward to making its availability available in European countries later this year."

Understanding Chikungunya and the Need for a Vaccine
1. Chikungunya Virus (CHIKV) Overview

• A viral disease transmitted by mosquitoes due to the chikungunya virus (CHIKV).

• Present in Asia, Africa, and the Americas, including tourist hotspots.

• Symptoms include fever, rash, fatigue, headache, and intense joint pain.

• Though the majority of patients recover, 30-40% have chronic symptoms for months or years.

2. Increase in Global Chikungunya Cases
2024 Figures:

• 620,000 reported cases globally.

• 200+ deaths through severe complications.

• The illness is frequently underreported and misdiagnosed as dengue fever because of similar symptoms.

How CHIKV VLP Vaccine Works
1. Composition of the Vaccine and Mode of Action

• CHIKV VLP vaccine is a recombinant protein vaccine.

• Uses virus-like particles (VLPs)—have no genetic content, so are unable to cause infection or multiply.

• Expected to stimulate the immune system by stimulating neutralizing antibodies against the chikungunya virus.

2. Adjuvant-Improved Protection
Comprises an adjuvant that aids in immunization response quality and duration of protection.3. Phase 3 Clinical Studies & Efficacy
Compared with 3,500+ participants in the age range of 12 years and older.
Results:

• 97.8% of individuals vaccinated produced neutralizing antibodies by day 21.

• Immune response triggered within one week of vaccination.

• Generally well-tolerated with predominantly mild or moderate adverse effects.

Potential UK Approval Impact

• Travel Health Market Expansion: The vaccine will be an important addition to Bavarian Nordic's travel health business, assisting travelers to chikungunya-endemic areas.

• Public Health Preparedness: As outbreaks rise globally, this vaccine will be a necessary preventive intervention, particularly in regions with recurring mosquito-borne infections.

• UK Strategic Expansion: The firm's established position in vaccine supply chains will facilitate speedy deployment on approval.

The MHRA's consideration of Bavarian Nordic's CHIKV VLP vaccine is an important milestone toward increasing access to a chikungunya vaccine in the UK. With approvals already in place globally, the vaccine will be an important weapon in the prevention of chikungunya outbreaks, to the benefit of travelers, public health authorities, and endemic areas.
With chikungunya cases still on the increase, this one-dose vaccine is set to transform prevention and enhance global travel health measures.