Bavarian Nordic’s Chikungunya Vaccine receives positive CHMP Opinion

DENMARK—Bavarian Nordic has announced that the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has issued a positive opinion recommending the marketing authorization for VIMKUNYA® (CHIKV VLP vaccine).

This announcement, coming just one day after World Neglected Tropical Diseases Day on January 30, highlights renewed global attention on tropical diseases.

The World Health Organization (WHO) emphasizes that 21 such illnesses—including chikungunya—continue to pose serious health challenges.

Chikungunya is a mosquito-borne disease that causes fever and severe joint pain.

While many patients recover within a week, some endure prolonged discomfort and, in rare cases, face severe complications such as multiorgan failure.

The proposed vaccine, if approved, would be the first in the European Union to protect individuals aged 12 and older against this debilitating virus.

The CHMP’s positive opinion is grounded in robust clinical data derived from two Phase III placebo-controlled trials that collectively enrolled over 3,500 participants.

 In one of these studies (NCT05072080), an impressive 96.6% of vaccinated individuals exhibited an immune response by day 22, and immunity was still evident in 84% of the participants six months later.

Furthermore, the trials demonstrated that a rapid immune response begins to develop within just one week after vaccination, with up to 97.8% of participants showing neutralizing antibodies by day 21.

Notably, the vaccine was well tolerated among study participants, with most vaccine-related adverse events being mild or moderate in nature.

To ensure continuous monitoring, the CHMP has requested a post-authorisation study to further evaluate the vaccine’s effectiveness, particularly in adolescents and adults.

Following this accelerated assessment, the European Commission, responsible for granting central marketing authorizations in the EU, will review the CHMP recommendation.

 A final decision is expected in the coming months. If the vaccine is approved, its marketing authorization will extend across all EU member states and Iceland, Liechtenstein, and Norway.

In addition to pursuing European approval, Bavarian Nordic plans to submit a Marketing Authorization Application (MAA) to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) under the International Recognition Procedure.

Approval in the UK could potentially be secured in the first half of 2025. Meanwhile, the vaccine is also under priority review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) action date set for February 14, 2025.

Commenting on the development, Paul Chaplin, President and CEO of Bavarian Nordic, stated that the anticipated approval in Europe represents a huge milestone in their efforts to combat chikungunya.

He emphasized that once approved, the vaccine will significantly broaden the availability of protection for adolescents and adults alike, an especially crucial development given the growing public health risks posed by climate change.

Chaplin also noted that the company looks forward to making the vaccine available to at-risk travelers later this year, while continuing to expand access for populations in endemic regions globally.

Market forecasts further suggest that Vimkunya could generate approximately US$146 million in sales by 2030 if approved.

In contrast, according to Pharmaceutical Technology, a competing vaccine candidate, Ixchiq, is expected to reach sales of about US$238 million in the same period.

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