"Two years on, Bavarian Nordic’s $380 million vaccine M&A move appears to be paying off.
The Danish company’s chikungunya vaccine, Vimkunya, has now crossed the FDA finish line, heating up the competition with Valneva by countering with a label that covers a broader population.
The FDA approved Vimkunya’s use in people who are at least 12 years old, marking the first chikungunya vaccine that can be given to those younger than 18. With the nod, Bavarian Nordic also picked up a priority review voucher (PRV) under the FDA’s tropical disease PRV program; the company plans to monetize the PRV ""when appropriate,"" it said The approval of our chikungunya vaccine is a testament to our unwavering commitment to addressing unmet medical needs and protecting communities worldwide,” Bavarian Nordic’s CEO Paul Chaplin said in a statement. “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 travelers and vulnerable populations.”
The company plans to make the vaccine commercially available in the first half of 2025 and is gearing up for launch in key European markets upon a pending final authorization from the European Commission. The chikungunya virus has been identified in more than 110 countries since its discovery, with 620,000 cases reported and 200 deaths tied to the virus worldwide in 2024, according to Bavarian Nordic.
In 2023, Bavarian Nordic picked up the single-dose viruslike particle vaccine candidate from Emergent BioSolutions in a $380 million deal that also included two established travel vaccines: typhoid fever shot Vivotif and cholera vaccine Vaxchora.
In studies, Vimkunya induced neutralizing antibodies in up to 97.8% of vaccinated participants within 21 days and elicited a rapid immune response starting at Week 1, according to Bavarian Nordic. French biotech Valneva first broke into the previously untouched chikungunya virus market with its world-first approval for Ixchiq in 2023. That vaccine, which Valneva has predicted can achieve 100 million euros ($107 million) in annual sales within three years of launch, is a live-attenuated shot recommended for adults at an increased risk of exposure.
Despite having the chikungunya vaccine market to itself last year, Valneva on Tuesday reported “lower than anticipated” launch-year Ixchiq sales in the U.S. The company is chasing a label expansion and plans to initiate a phase 3 pediatric trial this year.