Bavarian Nordic gets swift EU review of chikungunya shot

Bavarian Nordic will get an accelerated review of its chikungunya vaccine CHIKV VLP at the EMA, as it tries to chase down a lead held by rival Valneva.

The Danish pharma group said it is planning to file for approval of its vaccine in the first half of this year, adding the EU regulator’s human medicine committee, the CHMP, has said it will cut the review time from 210 to 150 days under its accelerated assessment procedure.

French biotech Valneva - which already has approval in the US for its Ixchiq (formerly VLA1553) chikungunya shot in people aged 18 and over - filed in the EU last October and is also getting an accelerated review by the CHMP.

Chikungunya, which means “disease that bends up the joints” in the language of the Makonde tribe in Africa, is an emerging global health threat with at least five million cases reported in the past 15 years, with the highest risk seen in tropical and subtropical regions of Africa, Southeast Asia, and parts of the Americas.

The virus – spread by the bite of an infected mosquito – causes fever and excruciating joint pain, as well as muscle aches, joint swelling, headache, nausea, fatigue, and rash. In severe cases, it can cause systemic complications and death.

The tiger mosquito (Aedes albopictus) that carries the chikungunya virus is now moving into new habitats in Europe and North America thanks to climate change, according to Gavi, the Vaccine Alliance, which has suggested that the disease has the potential to become “a global pandemic threat.”

The global market for chikungunya vaccines could exceed $500 million per year by 2032, according to Valneva estimates.

Bavarian Nordic has completed two phase 3 trials that showed that CHIKV VLP induced high levels of neutralising antibodies against chikungunya in individuals 12 years and above, with antibody titres equal to or above the threshold set by health authorities for seroprotection.

In one study, a single intramuscular injection with the vaccine stimulated neutralising antibodies in 98% of recipients 22 days after administration, with seroprotective levels in 88% of them six months later. A second study showed it was also effective in older subjects aged 65 and over, with a neutralising antibody response in 87% of them at 22 days.

In trials, Ixchiq - also administered as a single intramuscular injection - showed an antibody response rate of 98.9% in adult recipients 28 days, with almost all participants maintaining this response for at least 12 months.

Bavarian Nordic acquired rights to its CHIKV VLP candidate from Emergent BioSolutions in May 2023 as part of a $380 million deal to transfer rights to the latter’s travel vaccines business.