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New Human Rabies Vaccine Approved In U.S. EMERYVILLE, CA -- November 3, 1997 -- Chiron Corporation announced its RabAvert(TM) rabies vaccine has been cleared for marketing in the United States for use in pre-exposure vaccination and post-exposure prophylaxis against rabies. RabAvert is the first new vaccine against rabies to be introduced in the U.S. in almost 10 years. "In clinical studies, RabAvert has not induced type III hypersensitivity reactions in individuals who need a booster vaccination against rabies to date," said Magnus Lundberg, president of Chiron Vaccines. "The production process by which RabAvert is manufactured removes most of the human albumin. Human albumin is thought to cause hypersensitivity reactions, which sometimes occur with other marketed rabies vaccines. RabAvert contains 0.3 mcg of human albumin per dose. "Furthermore, the vaccine is freeze-dried during the production process and has a shelf life of up to three years, which is longer than any other rabies vaccine available in this country." RabAvert has been administered for post-exposure prophylaxis and as pre-exposure vaccination in more than 16 million doses and in 29 countries worldwide since 1985. Among patients who received RabAvert in post-exposure prophylaxis, none developed rabies when treated in compliance with World Health Organization guidelines. In international clinical trials, RabAvert provided protective titers of neutralizing antibody in 158 of 160 patients within 14 days and 215 of 216 patients by days 29 to 38. Furthermore, no case of rabies was observed among the 203 patients who were followed for at least 10 months. The protective ability of RabAvert also has been demonstrated when the vaccine is administered to healthy individuals who, for a variety of reasons, are at risk for coming in contact with rabies. The immunogenicity of RabAvert, given as a primary series, has been demonstrated in clinical trials conducted worldwide, including in the U.S., United Kingdom, Croatia and Thailand. RabAvert also has proven effective in boosting titers when administered as a booster dose to individuals who previously were immunized with RabAvert or a human diploid cell vaccine. While RabAvert was generally well tolerated in pre- and post-exposure clinical trials, the most frequently observed local reactions included pain, induration, swelling and reddening at the injection site; usually these reactions can be managed successfully with anti-inflammatory and antipyretic agents. Systemic reactions were rare, but included headache, myalgia and malaise. RabAvert has not been associated with hypersensitivity. Rabies has become increasingly more prevalent in the U.S. in recent years, with more than 7,000 animals, most of which are wild, found to have the disease each year, according to statistics released in May 1997 by the Centers for Disease Control (CDC). The viral infection, which is often found in bats, foxes, raccoons and skunks, can be transmitted to any warm-blooded animal, including domestic dogs and cats, as well as humans. Although rabies in humans is very rare in the U.S., more than 22,000 people in this country each year require vaccination against rabies after being exposed to rabid, or potentially rabid, animals, according to the CDC. States with the highest number of reported rabies cases include: New York, New Jersey, Connecticut, New Mexico, Texas, Massachusetts, Pennsylvania, North Carolina, New Hampshire, Maryland and parts of northern California. Certain groups of people have been identified by the CDC as being at greatest risk for coming in contact with rabid animals. These include veterinarians, their technicians and staff, as well as veterinary students, animal control personnel park rangers, and wildlife workers. Adventure travelers to countries where rabies is prevalent, such as Asia, Africa and South America, also have been identified as potentially at risk. E-mail this page to a friend or colleague! To print, use this version