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May 15, 1987

Hepatitis B Vaccines—to Switch or Not to Switch

Author Affiliations

Baylor College of Medicine Houston

Baylor College of Medicine Houston

JAMA. 1987;257(19):2634-2636. doi:10.1001/jama.1987.03390190112033

With the recent licensure of a hepatitis B vaccine prepared in yeast by recombinant DNA technology (Recombivax-HB), a new era in vaccine development has emerged. The vaccine it is designed to compete with—Heptavax-B—is also a uniquely formulated product in that it is prepared from the plasma of humans chronically infected with hepatitis B. Several placebo-controlled, randomized, double-blind trials have clearly documented that the plasma-derived vaccine is highly effective in preventing hepatitis B in high-risk groups.1-3

Shortly after the licensure of Heptavax-B in 1981 and its general availability in July 1982, the discovery of the acquired immunodeficiency syndrome (AIDS) among male homosexuals threatened the success of this product, since some of the hepatitis B surface antigen (HBsAg)-positive plasma donors were members of this high-risk group. Intensive epidemiologic, virological, and serological evaluations were launched, which eventually found no evidence for the transmission of AIDS to recipients of the plasma-derived HBsAg vaccine.