This is a summary of the European public assessment report (EPAR) for Prevenar 13. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Prevenar 13.
- What is Prevenar 13?
Prevenar 13 is a vaccine. It is a suspension for injection that contains parts from 13 different types of the bacterium Streptococcus pneumoniae (S. pneumoniae).
- What is Prevenar 13 used for?
Prevenar 13 is used to protect children aged between six weeks and 17 years against invasive disease, pneumonia (infection of the lungs) and acute otitis media (infection of the middle ear) caused by S. pneumoniae. It is also used to protect adults and the elderly against invasive disease caused by S. pneumoniae. Invasive disease occurs when the bacterium spreads through the body causing serious infections such as septicaemia (blood infection) and meningitis (infection of the membranes around the brain and spine).
When prescribing Prevenar 13, consideration should be given to the risk of invasive disease in the different age groups, other diseases the vaccinees may have and the type of bacteria in the different geographical areas.
The vaccine can only be obtained with a prescription.
- How is Prevenar 13 used?
Adults should receive one single dose of Prevenar 13 into the shoulder muscle.
In children, the vaccine is given by injection into the thigh muscle in children below two years of age, and into the shoulder muscle in children over two years of age. The vaccination schedule depends on the age of the child and should be based on official recommendations:
- children aged between six weeks and six months are normally given four doses. The first three doses are given with an interval of one month between each dose. The first dose is usually given at two months of age, but can be given as early as six weeks. The fourth dose, the booster, is given between 11 and 15 months of age. Alternatively, when Prevenar 13 is given as part of a routine immunisation programme, two doses can be given at the ages of two and four months, followed by a booster at 11 to 15 months of age;
- children aged between seven months and 11 months should first receive two doses with an interval of at least one month followed by a third dose in the second year;
- children between 12 and 23 months of age should receive two doses with an interval of at least two months;
- children between two and 17 years of age should receive a single dose.
Prevenar 13 can be used in children who have started vaccination with Prevenar (another vaccine authorised in the European Union for S. pneumoniae, which contains parts of seven of the 13 types of S. pneumoniae included in Prevenar 13). Further information on how to switch can be found in the summary of product characteristics.
- How does Prevenar 13 work?
Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. When a person is given the vaccine, the immune system recognises the parts of the bacterium contained in the vaccine as ‘foreign’ and makes antibodies against them. The immune system will then be able to produce antibodies more quickly when it is exposed to the bacterium. This helps to protect against the disease.
Prevenar 13 contains small amounts of polysaccharides (a type of sugar) extracted from the ‘capsule’ that surrounds the S. pneumoniae bacterium. These polysaccharides have been purified, then ‘conjugated’ (attached) to a carrier to help them to be recognised by the immune system. The vaccine is also ‘adsorbed’ (fixed) onto an aluminium compound to enhance the immune response.
Prevenar 13 contains the polysaccharides from 13 different types of S. pneumoniae (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). In Europe, it is estimated that these are responsible for between 73 and 100% of the cases of invasive disease in children under the age of five years, depending on the country. The six additional polysaccharides contained in Prevenar 13 (but not in Prevenar) are responsible for between 16 and 60% of the cases. In adults aged over 50 years, the pneumococcal serotypes in Prevenar 13 may be responsible for at least 50% to 76% of cases of invasive disease, depending on the country.
- How has Prevenar 13 been studied?
The ability of Prevenar 13 to trigger the production of antibodies (immunogenicity) in children was assessed in two main studies involving 1,266 healthy children who were vaccinated between the ages of two and 15 months and in a third study involving 598 children aged between five and 17 years old who had previously been vaccinated with Prevenar or who had never been vaccinated for invasive pneumococcal disease.
Prevenar 13 was compared with Prevenar. The studies compared the immune response for Prevenar 13 with that for Prevenar against the seven polysaccharides that they share in common. In the first two studies they were compared directly, and in the third study the results for Prevenar 13 were compared to those obtained for Prevenar in a previous study. The immune response to the additional six polysaccharides in Prevenar 13 was compared with the lowest immune response to any of the polysaccharides in Prevenar. Additional studies in children looked at the effects of giving booster vaccinations, switching from Prevenar to Prevenar 13 and using Prevenar 13 alongside other vaccines routinely given to children.
Prevenar 13 was also investigated in three main studies in adults. The first study involved 835 adults aged 50 to 64 years who had not previously been vaccinated against invasive disease caused by S. pneumoniae. The second study involved 938 adults aged 70 years or older who had already been vaccinated against invasive disease caused by S. pneumoniae at least five years earlier. In both studies, Prevenar 13 was compared with a similar vaccine containing the polysaccharides from 23 different types of S. pneumoniae (23-valent polysaccharide vaccine). The studies compared the immune responses one month after vaccination with the two vaccines.
A third study, which involved 900 adults aged 18 to 49, compared the immune response to Prevenar 13 with the response in adults aged 60 to 64.
- What benefit has Prevenar 13 shown during the studies?
In children under five years of age, Prevenar 13 produced a response that was at least as good as Prevenar for six of the seven S. pneumoniae polysaccharides they share in common in the first main study, and for five of the seven in the second. Where the response to Prevenar 13 was lower than the comparator, the differences were considered to be small. All six of the additional polysaccharides in Prevenar 13 produced a response at least as good as the lowest response seen with Prevenar in the first main study. This was true for five of the six additional polysaccharides in the second study.
In children aged between five and 17 years old, Prevenar 13 produced a response that was at least as good as Prevenar for all seven S. pneumoniae polysaccharides they share in common. All six of the additional polysaccharides in Prevenar 13 produced a response that was similar to the response seen with Prevenar.
The additional studies showed that Prevenar 13 led to an increase in antibody production following booster vaccinations and supported a switch to Prevenar 13 in children who had started vaccination with Prevenar. Prevenar 13 was not shown to affect the immunogenicity of other vaccines routinely given to children.
In adults aged 50 and older, in both the main studies Prevenar 13 produced an immune response that was at least as good as the 23-valent polysaccharide vaccine for all 12 of the S. pneumoniae polysaccharides they share in common, and for several of these serotypes the immune response was better with Prevenar 13.
Adults aged 18 to 49 had an immune response with Prevenar 13 that was as good as the response in adults aged 60 to 64.
- What is the risk associated with Prevenar 13?
The most common side effects with Prevenar 13 (seen in more than 1 patient in 10) in children are decreased appetite, fever (only very common in children aged six weeks to five years), irritability, reactions at the site of injection (reddening or hardening of the skin, swelling, pain or tenderness), somnolence (sleepiness) and poor-quality sleep. In adults and the elderly, the most common side effects (seen in more than 1 patient in 10) are decreased appetite, headaches, diarrhoea, fever (only very common in adults aged 18 to 29 years), vomiting (only very common in adults aged 18 to 49 years), rash, reactions at the site of injection, limitation of arm movement, arthralgia and myalgia (joint and muscle pain), chills and fatigue. For the full list of all side effects reported with Prevenar 13, see the package leaflet.
Prevenar 13 must not be used in people who are hypersensitive (allergic) to the active substances, to any of the other ingredients or to diphtheria toxoid (a weakened toxin from the bacterium that causes diphtheria). People who have a severe fever should not receive the vaccine until they have recovered, but they can still be given the vaccine if they have a mild infection such as a cold.
- Why has Prevenar 13 been approved?
The CHMP noted that in children the immune system’s response to Prevenar 13 was comparable to that of Prevenar, which is already authorised for the protection of children against S. pneumoniae in the EU. The Committee also noted that Prevenar 13 contains additional polysaccharides from the types of S. pneumoniae that are responsible for causing disease in children in Europe.
In adults and the elderly, the Committee noted that invasive pneumococcal disease may be an important health problem and that the benefit in terms of protection outweighed the risk of adverse reactions.
The CHMP decided that Prevenar 13’s benefits are greater than its risks and recommended that it be granted marketing authorisation.
- Other information about Prevenar 13:
The European Commission granted a marketing authorisation valid throughout the European Union for Prevenar 13 on 9 December 2009.
For more information about treatment with Prevenar 13, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This EPAR was last updated on 16/10/2013 .
09/07/2013 Prevenar 13 -EMEA/H/C/001104 -II/0071
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from six weeks to 17 years of age.
Active immunisation for the prevention of invasive disease caused by Streptococcus pneumoniae in adults aged 50 years and older.
See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.
Changes since initial authorisation of medicine
|Name||Language||First published||Last updated|
|Prevenar 13-H-C-1104-II-71: EPAR - Assessment Report - Variation||HR = Hrvatski||16/10/2013|
|Prevenar 13 : EPAR - Procedural steps taken and scientific information after authorisation||HR = Hrvatski||01/09/2010||16/10/2013|
|CHMP post-authorisation summary of positive opinion for Prevenar 13||HR = Hrvatski||30/05/2013|
|Prevenar 13-H-C-1104-II-55: EPAR - Assessment Report - Variation||HR = Hrvatski||28/02/2013|
|CHMP post-authorisation summary of positive opinion for Prevenar 13||HR = Hrvatski||16/11/2012|
|Prevenar 13-H-C-1104-II-28 : EPAR - Assessment Report - Variation||HR = Hrvatski||20/12/2011|
|CHMP summary of positive opinion for Prevenar 13||HR = Hrvatski||23/09/2011|
Initial marketing-authorisation documents
|Name||Language||First published||Last updated|
|Prevenar 13 : EPAR - Public assessment report||HR = Hrvatski||08/01/2010|
This medicine is approved for use in the European Union