Hepatitis B vaccine development and implementation.

Vaccination against hepatitis B is the most effective strategy to control HBV infection. The first licensed hepatitis B vaccine was developed by the purification of hepatitis B surface antigen (HBsAg) from plasma of asymptomatic HBsAg carriers. Then, the recombinant DNA technology enabled the development of recombinant hepatitis B vaccine. A series of three doses vaccine can elicit long-term protection more than 30 y. Concurrent use of hepatitis B immunoglobulin and hepatitis B vaccine has substantially reduced the mother-to-child transmission of HBV, nearly zero infection in children of carrier mother with negative hepatitis B e antigen (HBeAg) and 5-10% infection in children of HBeAg-positive mothers. By the end of 2018, 189 countries adopted universal hepatitis B vaccination program, which has dramatically reduced the global prevalence of HBsAg in children <5 y of age, from 4.7% in the prevaccine era to 1.3% in 2015. However, the implementation of universal hepatitis B vaccination in some regions is suboptimal and timely birth dose vaccine is not routinely administered in more than half of newborn infants. Optimal worldwide universal hepatitis B vaccination requires more efforts to overcome the social and economic challenges.