What is Synflorix?
Synflorix is a vaccine. It is a suspension for injection containing parts of the bacterium Streptococcus pneumoniae / em> ( S. pneumoniae ).
What is Synflorix used for?
Synflorix is used to vaccinate infants and children aged between six weeks and two years against invasive diseases and acute otitis media (middle ear infection) caused by S. pneumoniae . Invasive disease develops when the bacterium spreads through the body causing serious infections such as septicemia (blood infection), meningitis (infection of the membranes surrounding the brain and spine) and pneumonia (infection of the lungs).
The medicine can only be obtained with a prescription.
How is Synflorix used?
The Synflorix vaccination program depends on the age of the child and must be based on official recommendations.
- Infants aged between six weeks and six months are given three doses with an interval of at least one month between each dose. The administration of a fourth dose as a 'booster' is recommended at least six months after the third dose, preferably when the child is between 12 and 15 months of age.
- Infants aged between seven and 11 months receive two doses at an interval of at least one month from each other. A third dose is recommended as a 'booster' at least two months after the second dose, during the child's second year of life.
- Infants aged 12 to 23 months receive two doses at an interval of at least two months from each other. The need for a booster dose in this age group has not been established.
The vaccine is given by injection into the thigh muscle in the case of newborns or in the shoulder muscle in young children. It is recommended that all children receiving the first dose of Synflorix complete the entire vaccination cycle.
How does Synflorix work?
Vaccines act by 'teaching' the immune system (the body's natural defenses) to defend itself against a disease. When a person receives the vaccine, the immune system recognizes the parts of the bacterium contained in the vaccine as 'foreign' and produces specific antibodies. The immune system
he will therefore be able to produce antibodies more quickly if he is exposed to the bacterium again. This helps protect against the disease.
Synflorix contains small amounts of polysaccharides (a type of sugar) extracted from the 'capsule' that surrounds the bacterium S. pneumoniae . These polysaccharides have been purified, then 'conjugated' (attached) to a vector that helps to make them recognizable by the immune system. The vaccine is also 'adsorbed' (fixed) on an aluminum compound to stimulate a better response.
Synflorix contains polysaccharides derived from 10 different types of S. pneumoniae (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). In Europe, it is estimated that these are responsible for approximately 56 - 90% of invasive disease cases in children under five years of age.
What studies have been carried out on Synflorix?
The effects of Synflorix were first tested in experimental models before being studied in humans.
The ability of Synflorix to activate antibody production (immunogenicity) was tested in only one main study involving 1 650 healthy newborns aged between six and 12 weeks. Synflorix has been compared with another vaccine authorized in the European Union (EU) to protect children from S. pneumoniae infection, and which contains seven of the 10 polysaccharides included in Synflorix. The study compared the immunogenicity of the two vaccines against the different polysaccharides.
Another main study was conducted to establish whether Synflorix guaranteed the prevention of acute otitis media. The study included almost 5, 000 newborns of three months of age and compared an experimental vaccine containing the same polysaccharides as Synflorix with another vaccine that is not active against S. pneumoniae infection (in this case, a vaccine against hepatitis A virus). The children were followed until the end of their second year of life.
Further studies looked at the effects of booster vaccinations and vaccinations in older infants and children.
What benefit has Synflorix shown during the studies?
In the immunogenicity study, Synflorix produced a similar response to that of the comparator vaccine for most of the S. pneumoniae polysaccharides they have in common. Synflorix had an efficacy equivalent to that of the comparator vaccine in activating antibody production against five of the polysaccharides that the two vaccines had in common (4, 9V, 14, 18C and 19F), but was less effective than the comparator for two (6B and 23F). For the other three polysaccharides (1, 5, 7F), Synflorix was effective in activating antibody production.
In the study that observed otitis media, the experimental vaccine containing the same polysaccharides as Synflorix was more effective than the comparator vaccine in preventing otitis media. The onset of the first episode of acute otitis media was roughly halved in children receiving the vaccine compared to those receiving the comparison product. Based on a comparison of the immune response of Synflorix with that of the vaccine used in the study, Synflorix is expected to provide similar protection against acute otitis media caused by S. pneumoniae.
Other studies showed that although Synflorix produced a lower antibody response in infants and older children than the comparison vaccine, it met established criteria and was considered acceptable in this group. Both Synflorix and the comparison vaccine showed increased antibody production after booster vaccinations.
What is the risk associated with Synflorix?
The most common side effects of Synflorix (seen in more than 1 patient in 10) are pain, redness and swelling of the injection site, drowsiness, loss of appetite, fever and irritability. For the full list of all side effects reported with Synflorix, see the Package Leaflet.
Synflorix should not be used in children who may be hypersensitive (allergic) to the active substances or any of the other substances. Children with high fever should not receive the vaccine until they have recovered, but they can receive the vaccine if they have a mild infection, eg. a cold.
As with all vaccines, if Synflorix is used in very premature newborns, there is a risk that children go into apnea (short interruptions in breathing). Their breathing should be monitored for up to three days after vaccination.
Why has Synflorix been approved?
The Committee for Medicinal Products for Human Use (CHMP) noted that the immune system's response to Synflorix was comparable to that of the comparator vaccine, already authorized for the protection of children against the S. pneumoniae bacterium in the EU. The committee also took into account the fact that Synflorix contains other polysaccharides derived from the types of S. pneumoniae that are responsible for diseases in Europe. The CHMP therefore decided that Synflorix's benefits are greater than its risks for active immunization against invasive diseases and acute otitis media caused by S. pneumoniae in infants and children from six weeks to two years of age. age. The Committee recommended that Synflorix be given marketing authorization.
More information on Synflorix:
On 30 March 2009, the European Commission issued a marketing authorization for Synflorix, valid throughout the European Union, to GlaxoSmithKline Biologicals SA.
For the full EPAR for Synflorix, click here.
Last update of this summary: 03-2009.
