RabAvert® Rabies Vaccine Clinical Trials, Indication, Side Effects
Bavarian Nordic's Rabipur / RabAvert® vaccine contains an inactivated rabies antigen. It is indicated for preexposure vaccination in both primary series and booster doses and 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 the propagation of the virus is a synthetic cell culture medium with the addition of 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 adding a stabilizer solution that consists of 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 was administered according to U.S. CDC's Advisory Committee on Immunization Practices, or World Health Organization (WHO), guidelines and as soon as possible after rabid animal contact.
On August 5, 2020, Bavarian Nordic announced that the USA's commercial operations were launched after acquiring the manufacturing and global rights to Rabipur®/RabAvert® from GSK. As of November 15, 2024, the bulk manufacturing process for Rabipur/RabAvert was approved by the regulators in October, thus completing the entire technology transfer for the product to Bavarian Nordic, as the fill and finish process had already been established and approved.
Bavarian Nordic is a fully integrated biotechnology company that develops, manufactures, and commercializes life-saving vaccines. The expected revenue from the Travel Health business in 2024 was recently upgraded from DKK 2,100 million to DKK 2,200 million.
RabAvert Indication
RabAvert is indicated for preexposure vaccination, in both primary series and booster doses, and for postexposure prophylaxis against rabies in all age groups. Preexposure vaccination does not negate the need for post-exposure treatment should a potential rabies exposure occur; it simply reduces the doses of medicine needed post-exposure. 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 3 doses on Day 0, Day 7, and Day 21 or 28. RabAvert is intended for intramuscular (IM) injection. In adults, vaccines are 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 in association with the administration of injectable vaccines, including RabAvert. Therefore, procedures should be in place to avoid falling injuries 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; ovalbumin 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
September 26, 2024 - Bavarian Nordic now expects revenue between DKK 5,400 million and DKK 5,800 million and EBITDA between DKK 1,450 million and DKK 1,700 million.
August 5, 2020 - Bavarian Nordic announced the initiation of entire commercial operations in the U.S. only 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.
