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JAPANESE ENCEPHALITIS VACCINE LICENSED

 WASHINGTON, Dec. 18 /PRNewswire/ -- The Food and Drug Administration today announced the licensing of a vaccine against Japanese encephalitis. The Japanese encephalitis virus, which is mosquito-borne, is common in parts of Japan, other Pacific Islands and the Far East, and it can cause a fatal inflammation of the brain.
 Infection with the virus leads to overt disease in only one of 200 instances. Illness, however, is usually severe, resulting in death in 25 percent of cases and residual brain disorders in an additional 50 percent of cases.
 The new vaccine is recommended for certain travelers to Asia -- persons spending a month or more in areas where the virus is prevalent, or those on a trip involving extensive outdoor activities in rural areas. The labeling will advise travelers also to take personal precautions to reduce exposure to mosquito bites.
 "This new vaccine represents a major improvement," said FDA Commissioner David A. Kessler, M.D. "It is safer and more effective than previously available products."
 To determine efficacy, the U.S. Army conducted a controlled trial, involving 65,224 Thai children, that demonstrated a 91 percent efficacy rate for the vaccine.
 In 1990, the U.S. Army conducted a safety and immunogenicity clinical trial of the vaccine at two different dosing schedules. At two months, all of those vaccinated had developed antibodies. One year later, all of the 252 patients vaccinated who volunteered to be sampled still had the protective antibodies.
 In June 1992, FDA's Vaccines and Related Biological Products Advisory Committee, a panel of outside experts, recommended approval of the new vaccine. The panel had previously received data concerning allergic reactions that had been reported in non-U.S. populations.
 This recommendation was based on additional clinical data from a study conducted by the U.S. Navy regarding allergic adverse reactions following immunization with the vaccine. In this study, the U.S. Navy immunized 35,253 active duty military personnel and their dependents following an outbreak of Japanese encephalitis on Okinawa. The overall adverse reaction rate was 62 per 10,000 persons vaccinated, and reactions were generally mild to moderate, including hives, itching and wheezing. Nine persons were hospitalized (three per 10,000 persons vaccinated), primarily to allow for administration of intravenous steroids for hives. None of these reactions were considered life-threatening.
 Approximately 20 percent of those who received the Japanese encephalitis virus vaccine experienced mild to moderate local side effects including tenderness, redness and swelling. Ten percent reported fever, headache, malaise, rash, chills, dizziness, muscle pain, nausea, vomiting or abdominal pain.
 Persons with certain allergic histories appear to be more likely to experience an adverse reaction following vaccination.
 The Japanese encephalitis virus vaccine is manufactured by the Research Foundation for Microbial Disease of Osaka University, Japan (BIKEN). Connaught Laboratories, Inc., Swiftwater, Pa., is the U.S. distributor.
 FDA is a Public Health Service agency within HHS.
 -0- 12/18/92
 /NOTE: TV Broadcasters please use open caption for the hearing impaired./
 /CONTACT: Monica Revelle of the Food and Drug Administration, 301-443-4177, or after hours, 410-290-6575/


CO: Food and Drug Administration ST: District of Columbia IN: MTC HEA SU:

IH -- DC006 -- 8121 12/18/92 10:25 EST
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Date:Dec 18, 1992
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