What is HBVAXPRO?
HBVAXPRO is a vaccine available as a suspension for injection in vials and pre-filled syringes. The active substance consists of components of the hepatitis B virus. HBVAXPRO is available in two concentrations (10 and 40 micrograms / ml).
What is HBVAXPRO used for?
HBVAXPRO is used for hepatitis B vaccination of those at risk of exposure to hepatitis B virus, as established on the basis of official recommendations.
The medicine can only be obtained with a prescription.
How is HBVAXPRO used?
A vaccination course must include at least three injections of HBVAXPRO. The recommended dose for patients up to 15 years of age is 0.5 ml of the lowest concentration (10 micrograms / ml) per injection. For adult patients and adolescents aged 16 and over, 1 ml of the lowest concentration should be given by injection. The highest concentration (40 micrograms / ml) is used in patients who are undergoing or about to undergo dialysis (a blood clearance technique).
HBVAXPRO is usually given to newborns and very young children by injection into the thigh muscle and, in children, adolescents and adults, into the shoulder muscle.
The schedule of injections depends on the age of the patient, the condition of the immune system, the response to the vaccine and the probability of exposure to the hepatitis B virus. For complete information, see the Summary of Product Characteristics included in the EPAR.
How does HBVAXPRO work?
HBVAXPRO is a vaccine. Vaccines "teach" the immune system (the body's natural defenses) to defend itself against diseases. HBVAXPRO contains small amounts of "surface antigens" (proteins present on the surface) of the hepatitis B virus. When a person is vaccinated, his immune system recognizes surface antigens as "foreign" and produces antibodies to fight them. Later, if this person naturally comes into contact with viruses, his immune system will be able to produce antibodies more quickly. This helps to protect the vaccinated person from infection with hepatitis B virus. HBVAXPRO surface antigens are produced with the so-called "recombinant DNA technology", that is by inserting a gene (DNA) into a yeast that becomes so able to produce proteins. The surface antigens are also "adsorbed", ie they are fixed on aluminum components to help induce a better response.
HBVAXPRO has been specifically developed starting from a vaccine already in use in the European Union in order to eliminate the thiomersal preservative, which contains mercury. Repeated exposure to mercury from sources such as medicines and food could lead to an accumulation of this substance in the organs. This accumulation can be dangerous and a cause for concern.
What studies have been carried out on HBVAXPRO?
Since the active substance in HBVAXPRO was already authorized for use within the EU, no official studies on HBVAXPRO were conducted. The company provided information on the comparison between other vaccines containing or not thiomersal, including studies on a vaccine containing the same active ingredient present in HBVAXPRO.
What benefits has HBVAXPRO shown during the studies?
The results of the studies presented showed that vaccines that do not contain thiomersal allow a defense against the hepatitis B virus to be obtained, once the vaccination cycle is completed, with levels of antibodies similar to those of the vaccines that contain it, among the such as vaccines that contain the same active ingredient as HBVAXPRO.
What is the risk associated with HBVAXPRO?
The most common side effects of HBVAXPRO (ie seen in between 1 and 10 patients in 100) are reactions at the injection site, including temporary tenderness, erythema (redness) and hardening. For the full list of all side effects reported with HBVAXPRO, see the Package Leaflet.
HBVAXPRO should not be used in patients who may be hypersensitive (allergic) to the active substance or to any of the other ingredients or in patients with a very high fever.
As with all vaccines, if HBVAXPRO is used in very premature newborns, there is a risk that apnea will occur (short breaks during breathing). In this case, breathing should be monitored for up to three days after vaccination.
Why has HBVAXPRO been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that eliminating thiomersal from vaccines did not reduce its efficacy in protecting against infection with hepatitis B virus but reduced its associated risks. Therefore the committee decided that the benefits of HBVAXPRO outweigh its risks in active immunization against hepatitis B virus infection caused by all known subtypes in people considered at risk of exposure to the virus and recommended the release of marketing authorization for HBVAXPRO.
More information on HBVAXPRO:
On 27 April 2001, the European Commission granted an EU-wide marketing authorization for HBVAXPRO to SANOFI PASTEUR MSD SNC. The authorization was renewed on 27 April 2006.
For the full version of the evaluation (EPAR) of HBVAXPRO click here.
Last update of this summary: 02-2008.
