Bavarian Nordic chikungunya vaccine gets FDA okay

There are now two vaccines to protect against chikungunya approved for use in the US, with Bavarian Nordic Vimkunya becoming the first cleared for use in adolescents.

The Danish biopharma company is preparing to launch Vimkunya in the first half of this year for use in people aged 12 and over as an alternative to Valneva's Ixchiq, which got the go-ahead from the FDA in 2023 for use in adults only. Vimkunya is also just weeks away from a likely EU approval after being backed by the EMA's human medicines committee at its January meeting.

Chikungunya is a viral disease spread by mosquitoes that causes fever and debilitating joint pain, as well as muscle aches, joint swelling, headache, nausea, fatigue, and rash. In severe cases, it can cause systemic complications and death.

It is not endemic in the US, so the vaccines are aimed primarily at travellers to chikungunya hotspots in Africa, Asia, the Indian subcontinent and tropical regions of the Americas. That said, the threat posed by chikungunya and other mosquito-borne diseases is also thought likely to intensify in the coming years due to the impact of climate change on the range of the species that carry them.

In trials, Vimkunya induced neutralising antibodies in up to 97.8% of vaccinated individuals at 21 days and demonstrated a rapid immune response starting to develop within one week, 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 travellers and vulnerable populations," said the Copenhagen company's chief executive Paul Chaplin.

"We are proud to provide the first vaccine specifically approved for the prevention of chikungunya virus in individuals aged 12 and over, offering a critical tool to combat this emerging and growing health challenge," he added.

As a bonus, Bavarian Nordic also gets a priority review voucher from the FDA, awarded as an incentive to carry out drug development for a neglected tropical disease, that can be used to reduce the review time for any drug to six months. PRVs can be transferred to other companies and can command sales prices of $100 million or more.

France's Valneva reported that preliminary sales of Ixchiq came in at €1.8 million ($1.9 million) in the first nine months of 2024, from the US only, with a rollout in Europe and Canada due to start in the last three months of last year. Analysts have said that the total chikungunya market is likely to be worth upwards of $500 million.

It also claimed UK approval for the chikungunya shot earlier this month and is waiting to hear from regulators in Brazil – its first in a country where the disease is endemic – within the next few weeks.

Meanwhile, it also has clinical data in adolescents aged 12 to 17 and has already filed to extend Ixchiq's label in the US, EU, and Canada to include the younger age group.