Experience with the yeast recombinant hepatitis B vaccine Engerix-B now exceeds 10 years. We reviewed published studies on this vaccine. These show the vaccine to be safe, causing mostly only minor local symptoms and to be highly immunogenic both in monitored clinical trials and under field conditions. Engerix-B consistently elicits high geometric mean antibody titres and a high protective efficacy has been established in three groups at high-risk of hepatitis B infection, homosexual men, institutionalised mentally handicapped subjects and neonates of chronic carrier mothers. The profile of the recombinant hepatitis B vaccine in certain high-risk groups and immuno compromised people is discussed. Finally we present updated post marketing surveillance data based on 496 million distributed doses of vaccine.