Heplisav B
Authorised
This medicine is authorised for use in the European Union
hepatitis B surface antigen
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Heplisav B is a vaccine for preventing hepatitis B virus infection in adults. It is also likely to prevent infection with the hepatitis D virus as this virus is only present in people with hepatitis B infection.
Heplisav B is used in accordance with official recommendations. It contains a protein from the hepatitis B virus.
Heplisav B is given as two injections into the muscle of the upper arm 1 month apart.
For more information about using Heplisav B, see the package leaflet or contact your doctor or pharmacist.
Heplisav B is a vaccine. Vaccines work by preparing the immune system (the body’s natural defences) to defend the body against a specific disease.
Heplisav B contains a protein found on the hepatitis B virus. When a person is given the vaccine, the immune system recognises the protein in the vaccine as foreign and makes antibodies against it. If the person then comes into contact with virus, these antibodies, together with other components of the immune system, will be able to fight off the virus more effectively and so help protect the person against the infection. The vaccine also contains an adjuvant to stimulate a better response.
Results from three main studies involving over 13,000 participants showed that Heplisav B was more effective than Engerix B (another hepatitis B vaccine) at stimulating an immune response against the virus. Taken together the studies found that around 96% of people given Heplisav B developed enough antibodies to kill off the virus and protect against the disease compared with 80% of those given Engerix B.
People given Heplisav B also had higher levels of antibodies and sufficient levels developed earlier with Heplisav B than with Engerix B.
The most common side effects with Heplisav B (which may affect more than 1 in 10 people) are pain at the injection site, headache, feeling generally unwell, tiredness, muscle pain and fever.
People who have a severe allergic reaction after the first dose should not have a second dose. The vaccine should also not be given to people allergic to yeast.
For the full list of restrictions and side effects, see the package leaflet.
Studies have shown that Heplisav B provides protection against hepatis B infection in 96% of people given the vaccine. Side effects occurred slightly less frequently with this vaccine than with the comparator vaccine (Engerix B) and they are considered manageable.
The European Medicines Agency therefore concluded that Heplisav B’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Heplisav B have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Heplisav B are continuously monitored. Side effects reported with Heplisav B are carefully evaluated and any necessary action taken to protect patients.
Heplisav B received a marketing authorisation valid throughout the EU on 18 February 2021.
Product information
Latest procedure affecting product information:
II/0037
27/02/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Heplisav B
- Active substance
- hepatitis B surface antigen
- International non-proprietary name (INN) or common name
- hepatitis B surface antigen
- Therapeutic area (MeSH)
- Hepatitis B
- Anatomical therapeutic chemical (ATC) code
- J07BC01
Pharmacotherapeutic group
VaccinesTherapeutic indication
Heplisav B is indicated for the active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The use of Heplisav B should be in accordance with official recommendations.
It can be expected that hepatitis D will also be prevented by immunisation with Heplisav B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
News on Heplisav B
This page was last updated on