Hepatitis B Vaccine components (Engerix-B)

Engerix-B is available in vials and prefilled syringes and it is formulated without preservatives. Hepatitis B Vaccine components are:

  • Each 0.5-mL pediatric/adolescent dose contains 10 mcg of HBsAg adsorbed on 0.25 mg aluminum as aluminum hydroxide.
  • Each 1-mL adult dose contains 20 mcg of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide.
  • Sodium chloride
  • Phosphate buffers (disodium phosphate dihydrate; sodium dihydrogen phosphate dihydrate).

*It used to contain thiomersal (organomercury compound), but it does not contain it anymore.

We also know other hepatitis vaccine e.g. Havrix that protects from hepatitis A and Twinrix that protects from hepatitis A and from hepatitis B.

Engerix-B [Hepatitis B Vaccine (Recombinant)] is a sterile suspension of noninfectious HBsAg for intramuscular administration. It contains purified surface antigen of the virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Surface antigen is the same as that in Pediarix.

The HBsAg expressed in the cells is purified by several physicochemical steps and formulated as a suspension of the antigen adsorbed on aluminum hydroxide. The procedures used to manufacture Engerix-B result in a product that contains no more than 5% yeast protein.

Primary immunization for persons aged 20 years and older consists of a series of 3 doses (1 mL each). Primary immunization for infants (born of hepatitis B surface antigen [HBsAg]-negative or HBsAg-positive mothers), children (birth through 10 years), and adolescents (aged 11 through 19 years) consists of a series of 3 doses (0.5 mL each).

Source:
https://www.fda.gov/media/119403/download
https://www.fda.gov/media/79830/download
old components:
https://www.ema.europa.eu/en/documents/referral/engerix-b-article-30-referral-summary-product-characteristics_en.pdf

, ,

Related posts

Pediarix components

Pediarix components are similar to Pentacel components. Single-dose, prefilled syringes containing a 0.5-mL suspension...

Pentacel components

Pentacel components are a bit more complex, if you compare it against monovalent vaccines...

Daptacel components

Daptacel is a sterile isotonic suspension of pertussis antigens and diphtheria and tetanus toxoids...

Rotarix components

Rotarix components are:

Human rotavirus RIX4414 strain (live, attenuated)**Produced on Vero cells

Powder:

SucroseDextranSorbitolAmino acidsDulbecco’s Modified Eagle...

Latest posts

Gardasil 9 components (HPV)

Gardasil 9 is a sterile suspension for intramuscular administration. Gardasil 9 components are:

Human Papillomavirus...

Pediarix components

Pediarix components are similar to Pentacel components. Single-dose, prefilled syringes containing a 0.5-mL suspension...

Pentacel components

Pentacel components are a bit more complex, if you compare it against monovalent vaccines...

Daptacel components

Daptacel is a sterile isotonic suspension of pertussis antigens and diphtheria and tetanus toxoids...