Recombivax HB / HBVaxPro (hepatitis B vaccine, recombinant)

Recombivax HB is Merck's recombinant hepatitis B vaccine. The FDA Purple Book lists it under BLA 101066 (Merck Sharp & Dohme), first licensed on 23 July 1986, in strengths of 5 micrograms per 0.5 millilitre, 10 micrograms per millilitre and 40 micrograms per millilitre, with pre-filled syringes added in 1996. In the European Union the same company's vaccine is HBVaxPro (EMEA/H/C/000373, Merck Sharp & Dohme B.V.), authorised on 27 April 2001; the EMA indication for the 5-microgram presentation covers individuals from birth through 15 years of age considered at risk of exposure to hepatitis B virus.

Why it is a cancer vaccine: WHO estimates that hepatitis B caused 1.1 million deaths in 2024, mostly from cirrhosis and hepatocellular carcinoma (primary liver cancer), and that infection in infancy and early childhood becomes chronic in about 95% of cases. WHO recommends that all babies receive the vaccine as soon as possible after birth (within 24 hours), followed by two or three further doses (WHO fact sheet, 28 July 2026).