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Jump to Key Points At its September 2026 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for VaxRabeo (rabies vaccine [inactivated] for human use; Sanofi Winthrop Industrie).
The recommended indication covers pre-exposure and postexposure prophylaxis against rabies in individuals of all age groups, to be used in accordance with official recommendations.
A Potentially Fatal Disease
Rabies is one of the most lethal infectious diseases known, with a case fatality rate approaching 100% once clinical symptoms appear, yet it is preventable through timely vaccination.
Dog bites account roughly 99% of rabies cases in humans.
- CHMP positive opinion for VaxRabeo; EU marketing authorization pending.
- Indication: pre- + postexposure rabies prophylaxis; all age groups.
- Rabies case fatality ≈100% after symptoms; timely vaccination prevents disease.
- Vaccine induces neutralizing antibodies vs rabies glycoprotein; protective in adults + children.
- Common AEs: injection-site pain, myalgia, headache, malaise; pediatric irritability/crying reported.
Protective Antibody Response
VaxRabeo is a purified, inactivated rabies vaccine derived from the WISTAR PM/WI38 1503-3M virus strain, supplied as a powder and solvent for suspension for injection. Vaccination induces neutralizing antibodies against the surface glycoprotein of the rabies virus. The CHMP concluded that the vaccine reliably produces a protective antibody response in both adults and children, whether given before exposure, after exposure, or as a booster dose.
Safety Profile
In adults, the most frequently reported adverse reactions to VaxRabeo were injection-site pain, myalgia, headache, and malaise. In children, the most common reactions were injection-site pain or swelling and myalgia in those aged 2 years or older, along with abnormal crying and irritability in infants aged 12-23 months.
Next Steps
The CHMP opinion now goes to the European Commission, which typically issues a final marketing authorization decision within about 67 days.
Detailed guidance on administration and dosing schedules will be outlined in the Summary of Product Characteristics, which will be published in all official European Union languages following final authorization by the European Commission.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
