In 1982, the first hepatitis B viral vaccines, developed by Merck and also by the Pasteur Institute, were licensed by the U.S. Food and Drug Administration (FDA). Both had independently developed plasma-based hepatitis B viral vaccines.

These vaccine has been recommended as preexposure prophylaxis for persons at high or moderate risk of HBV infection. In addition, the combination of HB vaccine and hepatitis B immunoglobulin (HBIG) was recommended for postexposure prophylaxis in susceptible persons who have perinatal or needle-stick exposure to known HBV-positive persons or their blood.