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Product Information

Breaking news:
Prevenar 13 is now indicated for adults aged 50 and older. It is the first and only pneumococcal conjugate vaccine available for adults.


 

Prevenar 13®(Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)) is a suspension for injection supplied in a pre-filled syringe.425

Each 0.5ml dose contains the following pneumococcal polysaccharide serotypes425

Serotype 1

2.2 µg

Serotype 3

2.2 µg

Serotype 4

2.2 µg

Serotype 5

2.2 µg

Serotype 6A

2.2 µg

Serotype 6B

4.4 µg

Serotype 7F

2.2 µg

Serotype 9V

2.2 µg

Serotype 14

2.2 µg

Serotype 18C

2.2 µg

Serotype 19A

2.2 µg

Serotype 19F

2.2 µg

Serotype 23F

2.2 µg


All serotypes are conjugated to CRM197, an immunologic carrier protein, and adsorbed on aluminium phosphate (0.125 mg aluminium).

Prevenar 13 contains the 7 pneumococcal capsular polysaccharides that are in Prevenar (4, 6B, 9V, 14,
18C, 19F, 23F) plus 6 additional polysaccharides (1, 3, 5, 6A, 7F, 19A) and offers the broadest available coverage against pneumococcal disease in children and adults aged 50 and older. The six additional serotypes were selected to fit the epidemiology patterns observed in various global regions.425


Use of Prevenar and Prevenar 13 in the UK

In September 2006, the 7-valent pneumococcal conjugate vaccine (Prevenar), the world's first conjugate vaccine for the prevention of pneumococcal disease, was added to the national childhood immunisation programme in the UK.

In the UK, the Department of Health implemented a 2+1 immunisation schedule for Prevenar in September 2006 with an additional catch up programme for all children up to 2 years of age. Following this decision, the UK has observed a decrease in vaccine-serotype IPD, in both vaccinated and unvaccinated populations. The Health Protection Agency (HPA) is responsible for monitoring the prevalence of infectious diseases in the UK. Up-to-date information on pneumococcal serotypes that cause IPD can be found on the HPA website.422

By the end of 2009, more than 250 million doses of Prevenar had been distributed worldwide and, as of November 2009, 43 countries had adopted Prevenar into their national immunisation programmes.588

Prevenar 13 was licensed in the European Union for active immunisation for the prevention of invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks to 5 years of age.425

In Spring 2010, Prevenar 13 replaced Prevenar in the UK’s national immunisation programme. Prevenar 13 has been designed to provide the broadest pneumococcal coverage of any available conjugate vaccine.429

Prevenar 13 is expected to sustain the impact on pneumococcal disease created by Prevenar, but further extend these benefits to include serotypes of significant clinical importance.

Use of Prevenar 13 in adults is under consideration by the Joint Committee on Vaccination and Immunisation.

The vaccine should be given by intramuscular injection.

Summary of Product Characteristics can be found on electronic Medicines Compendium (eMC) click here to view the Prevenar13 SmPC.

Pneumococcal disease

Pneumococcal diseases are caused by Streptococcus pneumoniae and are a major cause of morbidity and mortality...

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