Protein-based subunit vaccines
More about Hepatitis B vaccines
The first available hepatitis B vaccines were plasma-derived, produced by harvesting hepatitis B surface antigen (HBsAg) from the plasma of persons with chronic HBV infection. The particles are highly purified, and any residual infectious particles are inactivated by various combinations of urea, pepsin, formaldehyde and heat. Although concerns about transmission of bloodborne pathogens, including HIV, from plasma-derived vaccines have proven to be unfounded., public concerns over the safety of the plasma-derived vaccine hampered its acceptance in many populations. Therefore increased research efforts were made to develop a recombinant vaccine.
In 1986, a hepatitis B vaccine produced by recombinant technology was licensed, and a second followed in 1989. The recombinant technology expressed HBsAg in other microorganisms and offered the potential to produce unlimited supplies of vaccine.
Although both the plasma-derived and recombinant hepatitis B vaccines are safe and highly effective in protecting against acute hepatitis disease as well as chronic disease, including cirrhosis and liver cancer, competition among the various hepatitis B vaccine producers drove down the price. When the price of both the plasma-derived and recombinant hepatitis B vaccines was relatively similar, the recombinant gradually replaced the plasma-derived hepatitis B vaccine.