Vaccine Info

RabAvert Rabies Vaccine

RabAvert Rabies Vaccine

RabAvert is a vaccine that contains an inactivated rabies antigen. The RabAvert vaccine is indicated for preexposure vaccination, in both primary series and booster dose, and for postexposure prophylaxis against rabies in all age groups.

RabAvert Rabies Vaccine is a sterile, freeze-dried vaccine obtained by growing the fixed-virus strain Flury Low Egg Passage (LEP) in primary cultures of chicken fibroblasts. The strain Flury LEP was obtained from American Type Culture Collection as the 59th egg passage, stated GSk

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 further processed by zonal centrifugation in a sucrose density gradient. The vaccine is lyophilized after the addition of 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 CDC’s Advisory Committee on Immunization Practices, or World Health Organization, guidelines and as soon as possible after rabid animal contact.

Bavarian Nordic announced on August 5, 2020, the commercial operations in the USA after completing the acquisition of the manufacturing and global rights to Rabipur®/RabAvert® from GSK. Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacture, and commercialization of life-saving vaccines.

RabAvert Rabies Vaccine Indication

RabAvert is indicated for preexposure vaccination, in both primary series and booster dose, and for postexposure prophylaxis against rabies in all age groups.

Pre-exposure vaccination does not negate the need for post-exposure treatment should a potential rabies exposure occur, it simply reduces the doses of treatment needed post-exposure.

Patients considered to be 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, in view of the almost invariably fatal outcome of rabies, there is no contraindication to post-exposure prophylaxis, including pregnancy.

Administration of Human Rabies Immune Globulin (HRIG), which along with prompt local cleaning of wounds should take place before postexposure prophylaxis, must not exceed the recommended dose, since active immunization to the vaccine may be impaired. HRIG should not be administered to previously vaccinated persons as it may blunt their rapid memory response to rabies antigen.

RabAvert Rabies Vaccine Dosage

RabAvert is indicated for preexposure vaccination, in both primary series and booster dose, and for postexposure prophylaxis against rabies in all age groups.

RabAvert is intended for intramuscular (IM) injection. In adults, administer vaccines by IM injection into the deltoid muscle. In small children and infants, administer vaccines into the anterolateral zone of the thigh.

An unintentional intravascular injection may result in systemic reactions, including shock. Syncope (fainting) can occur in association with administration of injectable vaccines, including RabAvert. Procedures should be in place to avoid falling injury 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 is to be used immediately. The vaccine may not be used after the expiration date given on package and container.

RabAvert Rabies Vaccine News

August 5, 2020 - Bavarian Nordic announced the initiation of full commercial operations in the U.S. only eight months after completing the acquisition of the manufacturing and global rights to Rabipur®/RabAvert® (Rabies Vaccine) and Encepur® (Tick-Borne Encephalitis Vaccine) from GSK.

October 21, 2019 - Bavarian Nordic announced that it has entered an agreement with GlaxoSmithKline to acquire the manufacturing and global rights to Rabipur®/RabAvert® and Encepur®, two commercial vaccines with combined annual sales of approximately EUR 175 million[3] holding strong positions in growing markets. Rabipur/RabAvert provides pre- and post-exposure protection against rabies, while Encepur protects against European (Western) tick-borne encephalitis (TBE) virus. 

RabAvert Rabies Vaccine Clinical Trials

Clinical Trial NCT02956746A Comparison of the Safety, PD, and PK of a Single Dose of SYN023 Administered With Licensed Rabies Vaccines (RabiesMab): Last Update Posted: February 27, 2019.

  • This is a single site, randomized, blinded comparison of the immunogenicity, of Imovax (RVi) and Rabavert (RVa) rabies vaccines when subjects are administered rabies immune globulin (RIG) or SYN023.
  • Subjects will be randomized into one of four dose groups: RVi + SYN023, RVi+RIG, RVa+SYN023 and RVa+RIG.
  • The initial dose of RVi and RVa will be co-administered with either RIG or SYN023.
  • Rabies virus neutralizing activity (RVNA) and blood levels of SYN023 will be measured for the remainder of the trial while the rest of the five RVi and RVa doses are given. The study will last 112 days. SYN023 concentrations and anti-SYN023 antibodies will also be measured.
Updated
08/05/2020 - 09:23