Pneumococcal vaccine products

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Question

What information should users have on different pneumococcal vaccine products (Prevenar 13 and Synflorix) before making the decision?

Answer

	Prevenar 13	Synflorix
Intended age group	6 weeks - 17 years	6 weeks - 5 years
Serotypes	1 3 4 5 6A 6B 7F 9V 14 18C 19A 19F 23F	1 4 5 6B 7F 9V 14 18C 19F 23F
Research done on age groups	1 266 children, 2-15 months 598 children, 5-17 years 835 adults, 50-64 years 938 adults, over 70 years 900 adults, 18-49 years	30 000 children, under 7 months 24 000 children, 6-16 weeks 5 000 children, 3 months 1 650 children, 6-12 weeks children, 2-5 years

Rationale

Prevenar 13 and Synflorix are vaccines. More precisely, they are a suspension for injection that contains parts from different types of the bacterium Streptococcus pneumoniae (S. pneumoniae). They are used to protect children against invasive disease, pneumonia (infection of the lungs) and acute otitis media (infection of the middle ear) caused by S. pneumoniae.

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.

How do vaccines 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 and Synflorix contain 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.

Research

Prevenar 13

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.

Synflorix

Synflorix was evaluated in a large study involving over 30,000 infants aged below 7 months of age who were given either Synflorix or a comparator vaccine which was not active against S. pneumoniae. The children were followed up for an average of around two years to see how effective Synflorix was in preventing invasive disease.

Synflorix was also investigated in a large study involving around 24,000 children aged between 6 and 16 weeks that focussed mainly on the vaccine’s benefit in preventing community acquired pneumonia. The children in this study were given either Synflorix or a comparator vaccine which was not active against S. pneumoniae and were followed up for an average of 30 months.

Another main study was carried out to determine whether Synflorix would prevent acute otitis media. The study involved almost 5,000 infants aged three months and compared an investigational vaccine that contains 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 up until the end of their second year of life.

The ability of Synflorix to trigger the production of antibodies (immunogenicity) was assessed in one main study involving 1,650 healthy infants aged between six and 12 weeks. Synflorix was compared with another vaccine that is authorised in the European Union (EU) to protect children against 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.

Additional studies looked at the effects of booster vaccinations and vaccinations in older infants and children. In particular, two clinical studies in children aged two to five years investigated the ability of Synflorix to produce antibodies in this age group compared with other age groups. The children received one dose of Synflorix in the first study and two doses in the second study.

Benefits

Prevenar 13

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 which was as good as the response in adults aged 60 to 64.

Synflorix

In the invasive disease study, Synflorix was shown to be effective in protecting against invasive disease: no cases were seen among the 10,000 children given three doses of Synflorix and a booster, one case was among the 10,000 children given two doses of Synflorix and a booster and 12 cases were seen in 10,000 children given the comparator vaccine.

Synflorix was also shown to reduce the occurrence of pneumonia. In the large study that focused mainly on pneumonia, the percentage of children who had bacterial pneumonia was 2.3% (240 out of over 10,000) among those given Synflorix compared with 3% (304 out of over 10,000) among those given the comparator.

In the study looking at otitis media, the investigational vaccine containing the same polysaccharides as Synflorix was more effective than the comparator in preventing otitis media. The occurrence of the first episode of acute otitis media caused by S. pneumoniae was approximately halved among children who were given the vaccine compared with those given the comparator. Based on a comparison of the immune response of Synflorix with the vaccine used in the study, it is expected that Synflorix would provide similar protection against acute otitis media caused by S. pneumoniae.

In the immunogenicity study, Synflorix produced a similar response to the comparator vaccine for the majority of the S. pneumoniae polysaccharides they share in common. Synflorix was as effective as the comparator in triggering the production of antibodies against five of the polysaccharides that the two vaccines shared in common (4, 9V, 14, 18C and 19F), but it was less effective than the comparator for two (6B and 23F). For the three additional polysaccharides (1, 5, 7F), Synflorix was effective in triggering the production of antibodies.

The additional studies in infants and older children showed that although Synflorix produced a lower antibody response than the comparator vaccine, it fulfilled pre-defined criteria and was considered acceptable in this group. Both Synflorix and the comparator showed an increase in antibody production following booster vaccinations.

When Synflorix was tested in two to five years olds, the response to Synflorix was similar to the younger age group, with better results in children who received two doses.

references

• Summary of the European public assessment report for Synflorix on the European Medicines Agency webpage.
• Summary of the European public assessment report for Prevenar13 on the European Medicines Agency webpage.