Bavarian Nordic’s Chikungunya vaccine gets FDA approval

USA – The U.S. Food and Drug Administration (FDA) has approved Bavarian Nordic’s chikungunya vaccine, Vimkunya, making it the first vaccine authorized for use in adolescents aged 12 and older.

This approval gives travelers and at-risk populations an additional option to protect against the mosquito-borne disease.

Vimkunya joins Valneva’s Ixchiq, which was approved in 2023 but is only available for adults. Bavarian Nordic plans to launch Vimkunya in the first half of this year, offering a broader age range of protection.

Additionally, the vaccine is expected to receive approval in Europe soon, following a positive recommendation from the European Medicines Agency (EMA) in January.

Chikungunya is a viral disease spread by mosquitoes, causing fever, severe joint pain, muscle aches, swelling, headaches, nausea, fatigue, and rashes.

While not endemic in the U.S., the vaccine is mainly intended for travelers visiting high-risk areas in Africa, Asia, the Indian subcontinent, and tropical regions of the Americas.

However, experts warn that climate change may expand the geographic range of mosquito-borne diseases, increasing the need for preventive measures.

Clinical trials showed that Vimkunya triggered neutralizing antibodies in up to 97.8% of vaccinated individuals within 21 days. The immune response starts developing as early as one week after vaccination, according to Bavarian Nordic.

“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,” said Bavarian Nordic CEO Paul Chaplin.

“We are proud to provide the first vaccine specifically approved for individuals aged 12 and over, offering a critical tool to combat this emerging and growing health challenge.”

In addition to the approval, Bavarian Nordic has earned a priority review voucher (PRV) from the FDA, a valuable incentive granted to companies developing treatments for neglected tropical diseases.

PRVs allow companies to speed up the review process for other drugs, reducing wait times to six months. These vouchers can also be sold, sometimes fetching over US $100 million.

Meanwhile, Valneva’s Ixchiq generated €1.8 million (US $1.9 million) in sales from the U.S. market in the first nine months of 2024.

The company has expanded its reach, securing approval in the UK and awaiting a regulatory decision in Brazil, where chikungunya is endemic.

Additionally, Valneva has submitted applications to extend Ixchiq’s approval to include adolescents in the U.S., EU, and Canada.

With the chikungunya vaccine market expected to surpass US $500 million, the approval of Vimkunya marks a significant step in preventing the spread of this debilitating disease.