The vaccine candidate is a virus-like particle (VLP)-based, adjuvanted vaccine designed for active immunisation against chikungunya virus (CHIKV) infection.
This expedited review process is a significant step towards the vaccine’s potential approval for individuals aged 12 years and older, aiming to prevent disease caused by chikungunya virus infection.
Under the priority review status, the FDA will complete its evaluation within six months, a reduction from the standard ten-month review period.
The US regulator will make a decision on the vaccine approval under the Prescription Drug User Fee Act (PDUFA) by 14 February 2025.
CHIKV VLP is also undergoing an accelerated assessment review by the European Medicines Agency (EMA), which could lead to approval by the European Commission in the first half of next year, the company noted.
Upon approval, the single-dose vaccine is planned to be distributed in a pre-filled syringe format, simplifying the administration process, saving time for healthcare providers, and minimising the risk of errors during vaccination.
The CHIKV VLP vaccine candidate has previously been recognised by the FDA with breakthrough therapy designation in October 2020 and fast track designation in April 2018.
Additionally, it received PRIME designation from the EMA in September 2019.
Bavarian Nordic president and CEO Paul Chaplin said: “We are encouraged by the FDA’s decision to grant Priority Review to our chikungunya vaccine, allowing for a shorter review time, and we look forward to working closely with the regulators to make our vaccine available to individuals 12 years of age and older at risk of chikungunya virus infection.
“The FDA review, along with the ongoing review of our CHIKV VLP vaccine by EMA, represent the first regulatory reviews of a chikungunya vaccine for adolescents, potentially providing a broader usage by populations at risk of this debilitating disease.”