Rabipur® RabAvert® Rabies Vaccine Clinical Trials, Indication, Side Effects
Bavarian Nordic's Rabipur® / RabAvert® vaccine contains an inactivated rabies antigen. It is indicated for pre-exposure vaccination in both primary series and booster doses, as well as for protection against rabies in all age groups. RabAvert is a sterile, freeze-dried rabies vaccine obtained by growing the fixed-virus strain Flury Low Egg Passage (LEP) in primary cultures of chicken fibroblasts. The growth medium for propagating the virus is a synthetic cell culture medium supplemented with human albumin, polygeline (processed bovine gelatin), and antibiotics. The virus is inactivated with β-propiolactone and processed by zonal centrifugation in a sucrose density gradient. Finally, the vaccine is lyophilized after being added to a stabilizer solution containing buffered polygeline and potassium glutamate.
RabAvert, in combination with passive immunization with Human Rabies Immune Globulin [HRIG] and local wound treatment in postexposure treatment against rabies, has been shown to protect patients of all age groups from rabies when the vaccine is administered as soon as possible after rabid animal contact according to the guidelines of the U.S. CDC's Advisory Committee on Immunization Practices or the World Health Organization (WHO).
On August 5, 2020, Bavarian Nordic announced the launch of its commercial operations in the USA following the acquisition of the manufacturing and global rights to Rabipur/RabAvert from GSK. As of November 15, 2024, the regulators approved the bulk manufacturing process for Rabipur/RabAvert in October, thereby completing the entire technology transfer for the product to Bavarian Nordic, as the fill-and-finish process had already been established and approved. In May 2025, Bavaria Nordic announced that revenue from Rabipur/RabAvert sales in the first quarter increased to DKK 359 million (DKK 235 million).
Bavarian Nordic is a fully integrated biotechnology company that develops, manufactures, and commercializes life-saving vaccines. On November 14, 2025, BN announced Rabipur/RabAvert vaccine revenues had increased 30% in 2025. The vaccine is market-leading in Western markets, and more than 80% of its revenue comes from the U.S. and Germany.
Rabipur/RabAvert Availability 2025
The Rabipur/RabAvert vaccine is marketed globally in 20 countries, including the USA and Canada. As of May 2025, the U.S. market grew 3% (Jan-Feb) compared to the prior year. RabAvert's market share was 77%. The German market grew by 118% in the first quarter compared to the same period in the previous year. Rabipur's market share was 97%, significantly higher than the last year (82%), during which a temporary stock-out impacted sales and was in line with year-end levels for 2024.
Rabipur/RabAvert Indication
Rabies is present in more than 150 countries and territories worldwide, except Antarctica. Tens of thousands of people die each year from rabies, mainly in Asia and Africa, with 40% being children under 15 years of age.
RabAvert is indicated for pre-exposure vaccination, in both primary series and booster doses, as well as for post-exposure prophylaxis against rabies in all age groups. Pre-exposure vaccination does not eliminate the need for post-exposure treatment in the event of a potential rabies exposure; it simply reduces the dose of post-exposure therapy required.
Patients at risk of a severe hypersensitivity reaction (e.g., anaphylaxis) to RabAvert or any of its components should receive an alternative rabies vaccine if a suitable product is available. However, given the almost invariably fatal outcome of rabies, there is no contraindication to post-exposure prophylaxis, including pregnancy.
RabAvert Dosage
According to the U.S. FDA-approved prescribing information, RabAvert is administered intramuscularly in three doses on Days 0, 7, and 21 or 28. RabAvert is intended for intramuscular (IM) injection. In adults, vaccines are typically administered by IM injection into the deltoid muscle. In small children and infants, vaccines are administered into the anterolateral zone of the thigh. An unintentional intravascular injection may result in systemic reactions, including shock. In addition, syncope (fainting) can occur during the administration of injectable vaccines, including RabAvert. Therefore, procedures should be in place to prevent falls and to restore cerebral perfusion following syncope.
One dose of reconstituted vaccine contains ≤12 mg polygeline (processed bovine gelatin), ≤0.3 mg human serum albumin, 1 mg potassium glutamate, and 0.3 mg sodium EDTA. Small quantities of bovine serum are used in the cell culture process. Bovine components originate only from the United States, Australia, and New Zealand. Minimal amounts of chicken protein may be present in the final product; ovalbumen content is ≤3 Ng/dose (1 mL), based on ELISA.
RabAvert should be stored protected from light at 2°C to 8°C (36°F to 46°F). After reconstitution, the vaccine should be used immediately. It may not be used after the expiration date given on the package and container.
RabAvert Vaccine News
November 14, 2025 - Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic, said: "Our travel health portfolio has shown continued strength, contributing to our best quarter for this business to date. Driven by higher demand and strong performance by our rabies and TBE vaccines in key markets."
May 9, 2025 - Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic, said: "A robust first quarter for our Travel Health business, demonstrating a 52% growth year-over-year and puts us ahead of our strategic goal of an average annual growth rate of 10-12% for this part of the business until 2027."
February 3, 2025 - "We delivered strong results in 2024 after an extraordinary performance in our Travel Health business, demonstrating a 22% growth year-over-year, combined with additional mpox vaccine orders, as we made significant strides in strengthening the public health response in Africa and other regions during the current outbreak. Thus, we exceeded our base projections for the Public Preparedness business, which will continue into 2025," said Paul Chaplin, President and CEO of Bavarian Nordic.
January 23, 2025 - Health Canada has received additional units of the rabies vaccine. It expects them to be distributed by the end of the month, as Toronto continues to ration its doses amid a shortage.
August 5, 2020 - Bavarian Nordic announced the initiation of its entire commercial operations in the U.S., just eight months after acquiring the manufacturing and global rights to Rabipur/RabAvert from GSK.
October 21, 2019 - Bavarian Nordic announced that it had entered an agreement with GlaxoSmithKline to acquire the manufacturing and global rights to Rabipur®/RabAvert® and Encepur®.
RabAvert Clinical Trials
The RabAvert vaccine has been tested in several clinical trials.
