Recombinant Hepatitis B

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The recombinant hepatitis B vaccine is produced from genetically engineered Saccharomyces cerevisiae, a yeast. The vaccine is noninfectious, and it contains hepatitis B surface antigen (HBsAg) (Keating & Noble, 2003). The first recombinant hepatitis B vaccine, Recombivax HB, was approved by the Food and Drug Administration in 1983, followed by Engerix-B in 1989 (Hepatitis B Vaccine Safety, n.d.). safety. The Vaccine Adverse Event Reporting System (VAERS) is one way that the Centers for Disease Control (CDC) monitors the safety of vaccinations. In a study of VAERS reports from May 2001 to September 2003 the CDC found that no unexpected health problems were reported from a combination Hepatitis A inactivated and a recombinant Hepatitis B vaccine …show more content…
When tested against each other, recombinant hepatitis B vaccines and plasma derived vaccines all produced high rates of seroprotection. (Levels were tested one month after the final dose.) The recombinant vaccine also demonstrated high protective efficacy in a variety of high risk populations, including neonates born to mothers that were carriers of hepatitis B. Recombinant hepatitis B has a tolerability profile similar to other hepatitis B vaccines, and it has a high level of protective efficacy. The recombinant vaccine is also promising because it offers flexibility in dosing schedules, and appeared to confer immunity for at least ten years (Keating & Noble, …show more content…
In a 1997 study published in the New England Journal of Medicine, a randomized double-blind trial with 180 participants suffering from rheumatoid arthritis did not reveal anything unsafe about recombinant TNF (Moreland, 1997). Three studies conducted in 2001 showed a remarkable safety profile for a different variation of recombinant human necrosis factor (binding protein-1). Intravenous, intramuscular, or subcutaneous injections were given to healthy volunteers. The safety profile was based on vital signs, hematology and blood chemistry, and antibodies to study drug and local tolerability (Trnchard-Lugan, Ho-Nguyen, Bilham, et. al.,

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