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What is Prevenar 13?
Prevenar 13 is a vaccine. It is a suspension for injection that contains parts of 13 different types of the bacterium Streptococcus pneumoniae (S. pneumoniae).
What is Prevenar 13 used for?
Prevenar 13 is used to protect children aged six weeks to five years from invasive disease, pneumonia (lung infections) and acute otitis media (inflammation of the middle ear) caused by S. pneumoniae. Invasive disease occurs when the bacterium spreads through the body causing serious infections such as septicemia (blood infection) and meningitis (infection of the membranes around the brain and spine).
The vaccine can only be obtained with a prescription.
How is Prevenar 13 used?
The vaccination schedule for Prevenar 13 depends on the age of the child and should be based on official recommendations:
• Children aged six weeks to six months are usually 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 the age of two months, 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 in the "As part of a routine immunization program (when all children in an area are given the vaccine at the same time), two doses can be given at the age of two months and four months, followed by a booster at a corresponding period between 11 and 15 months of age;
• infants aged seven to 11 months should first be given two doses at an interval of at least one month followed by a third dose in the second year;
• children between the ages of 12 and 23 months should be given two doses at an interval of at least two months;
• For children between the ages of two and five, only one dose should be given.
Prevenar 13 can be used in children who have started getting vaccinated with Prevenar (another vaccine authorized in the European Union [EU] for S. pneumoniae, which contains parts of seven of the 13 types of S. pneumoniae included in Prevenar 13). children can switch to Prevenar 13 at any time during the vaccination schedule Children aged one to two who have been vaccinated with Prevenar should receive two doses of Prevenar 13.
The vaccine is given by injection into the thigh muscle for children under two years of age or into the shoulder muscle for children over two years of age.
How does Prevenar 13 work?
Vaccines "teach" the immune system (the body's natural defense system) to defend itself against a certain disease. When a person is vaccinated, the immune system recognizes the bacterium contained in the vaccine as "foreign" and produces antibodies against it. In the event of exposure to the bacterium following vaccination, the immune system will be able to produce antibodies more quickly, thus helping 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 are purified and subsequently "conjugated" (bound) to a vector to favor a better recognition by the immune system. The vaccine is also "adsorbed" (fixed) to an aluminum-containing compound to stimulate a better response.
Prevenar contains polysaccharides from different types of S. pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19A, 19F and 23F). In Europe, they are believed to have caused between 73% and 100% of invasive disease cases in children under the age of five, depending on the country. The six additional polysaccharides contained in Prevenar 13 (but not in Prevenar) cause between 16 and 60% of cases.
How has Prevenar 13 been studied?
Before being studied in humans, the effects of the vaccine were tested in experimental models.
The ability of Prevenar 13 to trigger antibody production (immunogenicity) was investigated in two main studies involving 1,266 vaccinated healthy children between two and fifteen months of age. Prevenar 13 was compared with Prevenar. The study compared the immune responses of the two vaccines against the seven polysaccharides they share The immune responses to the six additional polysaccharides in Prevenar 13 were compared to the immune response to the polysaccharide in Prevenar which provided the lowest immune response.
Additional studies looked at the effects of giving booster vaccinations, switching from Prevenar to Prevenar 13 and using Prevenar 13 together with other vaccines regularly given to children.
What benefit has Prevenar 13 shown during the studies?
Prevenar 13 produced at least as effective a response as Prevenar for six of the seven S. pneumoniae polysaccharides they share with the first main study, and for five of the seven in the second. In cases where the response to Prevenar 13 was less effective than the reference drug, the differences were deemed minor. All the other six additional polysaccharides present in Prevenar 13 produced a response that was at least as effective as that of Provenar in the first main study. This turned out to be true for five of the six additional polysaccharides in the second study.
The additional studies showed that Prevenar 13 caused an increase in antibody production following booster vaccinations and supported a change to Prevenar 13 in children who started vaccination with Prevenar. Prevenar 13 does not appear to have affected the immunogenicity of other vaccines routinely administered to children.
What is the risk associated with Prevenar 13?
The most frequent side effects with Prevenar 13 (seen in more than 1 in 10 patients) are decreased appetite, pyrexia (fever), irritability, reactions at the injection site (redness or hardening of the skin, swelling, pain or tenderness) , sleepiness and poor quality sleep. For the full list of side effects reported with Prevenar 13, see the package leaflet.
Prevenar 13 must not be used in children who may be hypersensitive (allergic) to the active substance or to any of the other substances or to diphtheria toxoid (an attenuated toxin from the bacterium that causes diphtheria). Children in severe fever should not be given the vaccination until they have recovered; however, vaccination can still be given in the presence of a "mild infection, such as a" flu.
Why has Prevenar 13 been approved?
The Committee for Medicinal Products for Human Use (CHMP) noted that the immune system response to Prevenar 13 is comparable to that of Prevanar, already authorized in the EU for the protection of children against S. pneumoniae. The Committee also noted that Prevenar 13 contains additional polysaccharides taken from the types of S.pneumoniae responsible for the disease in Europe. The CHMP decided that Prevenar 13's benefits are greater than its risks and recommended that it be given a "marketing authorization" for the medicine. .
Other information about Prevenar 13
On 9 December 2009, the European Commission issued Wyeth Lederle Vaccines S.A. a "marketing authorization" for Prevenar 13, valid throughout the European Union. The "marketing authorization" is valid for five years, after which it can be renewed
For the full version of Prevenar 13 EPAR, click here.
Last update of this summary: 12-2009
The information on Prevenar 13 published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
