Bavarian Nordic preps chikungunya vaccine filings

Bavarian Nordic is preparing to file for regulatory approval of a vaccine against chikungunya virus after its CHIKV VLP candidate showed protective efficacy in a second phase 3 trial, in hot pursuit of Valneva.

The Danish biotech said this morning that its shot met all the efficacy objectives in the study, involving adolescents and adults aged 12 to 64, with a strong antibody response stimulated by a single intramuscular injection within a couple of weeks for most patients.

It is now expecting to file for approval of CHIKV next year, but will be playing catch-up with French biotech Valneva, which submitted its VLA1553 candidate for approval in May and is currently on track to bring the first licensed jab for chikungunya to market.

Bavarian Nordic acquired the vaccine from Emergent BioSolutions in May, as part of a $380 million deal to transfer rights to the latter's travel vaccines business. Other companies with chikungunya vaccines in development include Bharat Biotech and, until recently, MSD, which abandoned its V184 candidate earlier this year.

Chikungunya is a mosquito-borne disease that causes fever and debilitating joint pain, as well as muscle aches, joint swelling, headache, nausea, fatigue, and rash, and has no approved vaccines or drug treatments. In severe cases, it can cause systemic complications and death.

The illness – most common in Asia and Africa – is highly debilitating and places a very high burden on health systems, as well as being associated with significant workforce absenteeism and loss in productivity. Countries in South America, particularly Paraguay and Brazil, are currently experiencing large outbreaks.

Bavarian Nordic's trial enrolled 3,254 participants, with 98% of those given the vaccine showing neutralising antibodies against the virus 22 days after vaccination. Most of the patients (97%) showed an antibody response that should provide protective immunity within two weeks, said the company.

"With a fast and durable response, our vaccine has the potential to be the best in class to prevent chikungunya infections in adolescents to elderly adults," said chief executive Paul Chaplin.

"Chikungunya […] can often result in a severe and incapacitating disease [that] affects large parts of the world and, with international travel on the rise again, our CHIKV vaccine offers a significant opportunity to address this large unmet medical need."

In Valneva's trials, VLA1553 generated a 98.9% protective neutralising antibody response at one month, which was maintained at 96.3% after six months.

Market research firms typically estimate that the market for chikungunya vaccines could be worth upwards of $500 million to $600 million from 2030 onwards.

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 mosquito species that spread them.