The Development of the Hepatitis B Vaccine

In the October 9, 1980 issue of The New England Journal of Medicine Szmuness et al. published the results of a clinical trial. This trial assessed the efficacy of an inactivated hepatitis B vaccine (produced by Merck) in a placebo controlled, randomized, double blind trial in 1083 homosexual men at high risk for hepatitis B virus infection. Within the limits of the studies that have been reported, the vaccine was found to be safe; the incidence of side effects was low. After a third dose was administered, 96% of those who received the vaccine developed antibodies against HBsAg and none of the individuals who developed antibodies had a hepatitis episode. The results of this trial were discussed at the 1981 International Symposium on Viral Hepatitis in New York City March 30 through April 2, 1981, and celebrations appeared to be in order for the first hepatitis B vaccine to be placed on the market.