Bavarian Nordic has won US Food and Drug Administration (FDA) approval for its chikungunya vaccine Vimkunya, becoming the second company in the US to market a vaccine for the tropical disease.
The approval is indicated for individuals aged 12 years and older, meaning the Danish biotech has succeeded in undercutting French biotech Valneva, which has a chikungunya vaccine already marketed in the US but only for those 18 years of age and older.
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Shares in Bavarian Nordic jumped 4.6% at market open compared to a pre-approval market close. The Copenhagen-listed company has a market cap of $13.5bn.
Infectious disease specialist Bavarian Nordic aims to roll out the vaccine in the US in the first half of 2025. Valneva’s vaccine, marketed as Ixchiq, has been available in the country since November 2023 and before Bavarian Nordic joined the scene, it was the world’s only licensed vaccine for the disease. Vimkunya could soon be available in Europe – where Ixchiq is also already approved – after receiving a positive recommendation from the European Medicines Agency (EMA).
Aiming to keep up with Bavarian Nordic’s wider eligibility, Valneva has revealed plans to seek a teenager label expansion for Ixchiq in Europe, Canada and, eventually, the US. The vaccine generated global sales of €1.8m ($1.89m) in the first nine months of 2024.
Chikungunya, caused by its namesake virus, is a mosquito-borne disease mainly found in tropical regions. Whilst cases are not prevalent in North America, there is a risk of disease transmission to travellers visiting outbreak-affected countries in Africa and South America, along with islands in the Indian and Pacific Oceans. There have even been isolated cases of local transmission in Southern Europe, with health agencies saying the global risk of chikungunya transmission is increasing with global warming as mosquitos spread into new areas.
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By GlobalDataBavarian Nordic’s CEO Paul Chaplin said: “As climate change continues to expand the reach of mosquito-borne illnesses like chikungunya, this milestone underscores the importance of cutting-edge solutions to safeguard travellers and vulnerable populations.”
Vimkunya is intended to prevent the disease caused by the chikungunya virus. FDA approval was based on two Phase III studies (NCT05072080 and NCT05349617) that demonstrated a strong immune response. The vaccine induced neutralising antibodies in up to 97.8% of 3,500 healthy participants aged 12 years and older 21 days after vaccination. Bavarian Nordic reported a rapid immune response developed within one week. For comparison, Ixchiq sustained a sero-response rate of 98.3% one-year post-vaccination.
Additional clinical studies are required to confirm the clinical profile of Bavarian Nordic’s jab, with post-marketing commitments such as confirmatory efficacy studies required.
Vimkunya is a virus-like particle (VLP) vaccine, meaning it works by mimicking the chikungunya virus to trigger an immune response. Ixchiq, on the other hand, is a live-attenuated vaccine that contains a weakened strain of the chikungunya virus. Both Bavarian Nordic and Valenva’s products are administered as a single shot.
Since the chikungunya virus is designated as a neglected tropical disease, Bavarian Nordic received a priority review voucher upon Vimkunya’s approval. The FDA’s voucher programme intends to incentivise pharmaceutical development of medicines for low-commercial value diseases. The voucher can either be used to fast-track a future candidate or be sold to generate funds. Bavarian Nordic said it intends to monetise the voucher “when appropriate”. Valneva went down the same route when it received one for Ixchniq’s approval, selling the voucher for $103m in February 2024.
Bavarian Nordic’s underwhelming 2024
Vimkunya follows a mpox-focused 2024 for Bavarian Nordic as it became the only company with a fully approved vaccine for the disease amid outbreaks in Africa. Mpox orders and its strong travel health business performance weren’t enough to maintain growth, however, with the biotech’s total sales down 18.5% in 2024 compared to 2023. Preliminary sales for 2024 reached $800m (DKr5.7bn) and the company is issuing 2025 guidance in a similar ballpark, between DKr5.7bn and DKr6.7bn.
Similar to Valneva and other vaccine specialists, Bavarian Nordic might also have to contend with a frostier regulatory landscape in the US in 2025 with vaccine-sceptic Robert F Kennedy Jr heading up the Department of Health and Human Service (HHS).
