Rabies Vaccines
Rabies Vaccines 2025
Rabies is a vaccine-preventable viral disease found in more than 150 countries and territories, according to the World Health Organization (WHO). Two types of vaccines protect people against Rabies: nerve tissue and cell culture vaccines. Cell culture vaccines, which are more affordable and require less vaccine, have been developed recently. Unlike conventional, inactivated rabies vaccines, live-attenuated viruses are genetically modified viruses that can replicate in a vaccinated person without causing adverse effects while eliciting robust and effective immune responses against viral infection.
As of 2025, according to the WHO, intradermal immunization using cell-culture-based rabies vaccines is an acceptable alternative to standard intramuscular administration. In the United Kingdom, rabies vaccines must be inactivated or recombinant and approved for use in the country.
Rabies Vaccines Approved
As of 2025, the WHO has pre-qualified rabies vaccines, including Bavarian Nordic's RabAvert vaccIVAX-S by Serum Institute of India Pvt. Ltd., VaxiRab N by Zydus Lifesciences Limited, and VERORAB by Sanofi Pasteur.
RabAvert is a vaccine that contains an inactivated rabies antigen, indicated for preexposure vaccination, primary and booster doses, and post-exposure prophylaxis against Rabies in all age groups.
Chirorab®, previously known as Rabipur, is an inactivated rabies virus of Flury LEP. Chiron Behring Vaccines is relaunching Rabipur, a purified chick-embryo-celline. It will continue manufacturing at its WHO-prequalified facility in Ankleshwar, Gujarat, India.
Rabipur is an inactivated rabies vaccine produced by Valneva SE, which has over 35 years of worldwide clinical experience.
Rabivax-S is a lyophilized vaccine manufactured by Serum Institute of India Pvt. Ltd. It contains inactivated, purified rabies antigen and was developed using Vero cells (ATCC CCL81), derived from the Pitman-Moore strain. The inactivated vaccine is freeze-dried until ready for immunization.
Rabies Vaccine Candidates
Rabies vaccine candidates are seeking participants for various clinical trials in 2025.
YS Biopharma Co., Ltd. PIKA Rabies Vaccine utilizes the company's proprietary PIKA adjuvant technology, designed to produce a more robust immune response in a shorter timeframe than traditional rabies vaccines. On April 9, 2024, YS Bio announced positive interim results from the ongoing Phase 3 clinical trial, indicating that the PIKA Rabies Vaccine has successfully met the primary endpoints and has the potential to achieve best-in-class accelerated protection and meet the WHO's goal of a one-week rabies vaccine regimen to replace the conventional three- or four-week regimens. On June 1, 2023, the Food and Drug Administration of the Philippines approved a Phase 3 clinical trial, and on May 16, 2023, Pakistan issued study approval.
Replicate Bioscience announced on September 12, 2023, the dosing of the first participant in a Phase 1 trial of its RBI-4000 vaccine candidate for rabies prevention. The Trial marks the first time a human has been dosed with Replicate's next-generation srRNA technology, which will be a benchmark for its utility in this indication.
VitriVax, Inc. received a grant of up to $5 million from the Coalition for Epidemic Preparedness Innovations to develop further Atomic Layering Thermostable Antigen and Adjuvant (ALTA) technology, using Rabies as a vaccine target. ALTA® could replace multi-dose vaccines for protection against infectious diseases with a single-administration alternative.
Rabies Vaccine Preexposure Prophylaxis (PrEP)
The WHO recommends preexposure prophylaxis (PrEP) for individuals at high risk of exposure. The WHO position paper on rabies vaccines recommends a one-week, two-site intradermal post-exposure prophylaxis (PEP) schedule with 0.1 mL of vaccine injected on days 0, 3, and 7. The U.S. Centers for Disease Control and Prevention (CDC) updated its recommendations for rRabies post-exposure prophylaxis (PrEP) for humans, replacing the three-dose vaccination schedule with a two-dose program intended to protect people for at least three years. On May 6, 2022, the U.S. CDC published Use of a Modified Preexposure Prophylaxis Vaccination Schedule to Prevent Human Rabies: Recommendations of the Advisory Committee on Immunization Practices — United States, 2022.
Rabies Vaccine Breakthrough Infections
A case report by Holzbauer et al. in the March 2023 issue of Clinical Infectious Diseases is not a situation of inappropriate prophylaxis; rather, it represents a textbook response to accurate exposure to Rabies. An 84-year-old awoke to a bat biting his finger. The man washed his finger with soap and water, as recommended. Post-exposure prophylaxis was initiated three days after exposure. He received a complete four-vaccine regimen and more than the recommended 20 IU/kg of human rabies immunoglobulin (the actual dose was reportedly 30.9 IU/kg, as determined by potency testing of the immunoglobulin used), partially injected into the bite site, with the remaining amount given intramuscularly. Yet, five months later, he developed clinical Rabies and succumbed to it.
Importation of Dogs Without Rabies
In the U.S., stray dog control programs were initiated in the 1940s, and routine rabies vaccination of owned dogs eliminated the canine rabies virus variant from circulation by 2008. The American Animal Hospital Association Canine Vaccination Guidelines were updated in 2022. As of August 2023, a valid CDC Rabies Vaccination and Microchip Record is needed to obtain a permit or make a reservation. The CDC does not accept foreign-issued pet passports or other certificates for rabies vaccinations administered outside the United States. Rabies-vaccinated dogs vaccinated in the U.S. by a U.S.-licensed veterinarian may re-enter the country from a high-risk country without a CDC Dog Import Permit if the dog has a current, valid U.S.-issued rabies vaccination certificate and an ISO-compatible microchip. The CDC has temporarily suspended the importation of dogs from high-risk countries with Rabies until July 31, 2024.
Rabies Vaccines Raccoons
The U.S. Department of Agriculture's Animal and Plant Health Inspection Service announced on August 4, 2023, that it will begin its annual distribution of RABORAL V-RG®, an oral rabies vaccine bait, in select areas in the eastern United States to prevent the spread of raccoon rabies. Raccoons, foxes (including red and gray varieties), skunks, and bats are considered primary carriers of the rabies virus in the United States.
