Prevenar

pneumococcal saccharide conjugated vaccine, adsorbed

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This is a summary of the European public assessment report (EPAR) for Prevenar. 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.

What is Prevenar?

Prevenar is a vaccine. It is a suspension for injection that contains parts of the bacterium Streptococcus pneumoniae (S. pneumoniae).

What is Prevenar used for?

Prevenar is used to vaccinate infants and children aged between two months and five years against diseases caused by S. pneumoniae. These include sepsis (blood infection), meningitis (infection of the membranes that surround the brain and spine), pneumonia (infection of the lungs), otitis media (infection of the middle ear) and bacteraemia (bacteria detected in the blood).

The medicine can only be obtained with a prescription.

How is Prevenar used?

The vaccination schedule to be used depends on the age of the child and should be based on official recommendations.

  • Infants aged between two and six months need three doses. The first dose is usually given at two months of age with an interval of at least one month between doses. A fourth dose (booster) is recommended in the second year of life. Alternatively, when Prevenar is given as part of a ‘universal infant immunisation programme’ (when all infants in an area are vaccinated at around the same time), two doses can be given with an interval of at least two months, followed by a booster at 11 to 15 months of age.
  • Infants aged between seven and 11 months need two doses, with an interval of at least one month between doses. A third dose is recommended in the second year of life.
  • Children aged between 12 and 23 months need two doses, with an interval of at least two months between doses.
  • Children aged between 24 months and five years need one single dose.

The vaccine is given by injection into the thigh muscle in infants, or into the upper arm muscle in young children.

How does Prevenar 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 bacterium contained in the vaccine as ‘foreign’ and makes antibodies against it. The immune system will then be able to produce antibodies more quickly when it is exposed to the bacterium again. This helps to protect against the disease.

Prevenar 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 be better recognised by the immune system. The vaccine is also ‘adsorbed’ (fixed) onto an aluminium compound to stimulate a better response.

Prevenar contains the polysaccharides from different types of S. pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F). In Europe, it is estimated that these are responsible for about 54% to 84% of invasive infections (infections that have spread into the body) in infants and children under the age of two years, and for about 62% to 83% of invasive infections in children aged between two and five years.

How has Prevenar been studied?

The effectiveness of Prevenar in the prevention of S. pneumoniae invasive disease has been studied in almost 38,000 infants. Half of the infants received Prevenar, and the remainder received another vaccine that is not active against S. pneumoniae. Prevenar was given at two, four, six and 12 to 15 months of age. The study measured the number of children who developed an S. pneumoniae invasive disease during the 3.5 years of the study.

Additional studies looked at the effectiveness and safety of Prevenar in older infants and children, and at the development of antibodies in infants after the two-dose immunisation schedule followed by a booster injection.

What benefit has Prevenar shown during the studies?

Prevenar was effective in preventing S. pneumoniae invasive disease. During the main study, 49 cases of infection due to the serotypes 4, 6B, 9V, 14, 18C, 19F and 23F of S. pneumoniae were seen among the infants who received the control vaccine, compared with three cases among the infants vaccinated with Prevenar.

The additional studies showed that Prevenar was safe and effective in children up to the age of five years. In infants, the two-dose immunisation schedule led to the development of antibodies against S. pneumoniae, but to a lower level than the three-dose schedule. However, the CHMP concluded that this is unlikely to lead to a difference in the rate of protection against infection with S. pneumoniae following a booster injection, when Prevenar is used as part of a routine immunisation programme in which most infants are vaccinated.

What is the risk associated with Prevenar?

The most common side effects with Prevenar (seen in more than 1 patient in 10) are vomiting, diarrhoea, loss of appetite, reactions at the site of the injection (redness, hardening, swelling or pain), fever, irritability, drowsiness and restless sleep. For the full list of all side effects reported with Prevenar, see the package leaflet.

Prevenar should not be used in children who may be hypersensitive (allergic) to the Streptococcus vaccine, to any of the other ingredients or to the diphtheria toxoid (a weakened toxin from the bacterium that causes diphtheria). Vaccination should be postponed in children with a severe infection and high fever.

Why has Prevenar been approved?

The CHMP decided that Prevenar’s benefits are greater than its risks and recommended that Prevenar be given marketing authorisation.

Other information about Prevenar

The European Commission granted a marketing authorisation valid throughout the European Union for Prevenar to Wyeth Lederle Vaccines S.A. on 2 February 2001. The marketing authorisation is valid for an unlimited period.

For more information about treatment with Prevenar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Prevenar : EPAR - Summary for the public BG = bălgarski 17/03/2008 01/04/2011
Prevenar : EPAR - Summary for the public ES = español 17/03/2008 01/04/2011
Prevenar : EPAR - Summary for the public CS = čeština 17/03/2008 01/04/2011
Prevenar : EPAR - Summary for the public DA = dansk 17/03/2008 01/04/2011
Prevenar : EPAR - Summary for the public DE = Deutsch 17/03/2008 01/04/2011
Prevenar : EPAR - Summary for the public ET = eesti keel 17/03/2008 01/04/2011
Prevenar : EPAR - Summary for the public EL = elliniká 17/03/2008 01/04/2011
Prevenar : EPAR - Summary for the public EN = English 17/03/2008 01/04/2011
Prevenar : EPAR - Summary for the public FR = français 17/03/2008 01/04/2011
Prevenar : EPAR - Summary for the public IT = italiano 17/03/2008 01/04/2011
Prevenar : EPAR - Summary for the public LV = latviešu valoda 17/03/2008 01/04/2011
Prevenar : EPAR - Summary for the public LT = lietuvių kalba 17/03/2008 01/04/2011
Prevenar : EPAR - Summary for the public HU = magyar 17/03/2008 01/04/2011
Prevenar : EPAR - Summary for the public MT = Malti 17/03/2008 01/04/2011
Prevenar : EPAR - Summary for the public NL = Nederlands 17/03/2008 01/04/2011
Prevenar : EPAR - Summary for the public PL = polski 17/03/2008 01/04/2011
Prevenar : EPAR - Summary for the public PT = português 17/03/2008 01/04/2011
Prevenar : EPAR - Summary for the public RO = română 17/03/2008 01/04/2011
Prevenar : EPAR - Summary for the public SK = slovenčina 17/03/2008 01/04/2011
Prevenar : EPAR - Summary for the public SL = slovenščina 17/03/2008 01/04/2011
Prevenar : EPAR - Summary for the public FI = suomi 17/03/2008 01/04/2011
Prevenar : EPAR - Summary for the public SV = svenska 17/03/2008 01/04/2011

This EPAR was last updated on 15/07/2014 .

Authorisation details

Product details

Product details for Prevenar
NamePrevenar
Agency product numberEMEA/H/C/000323
Active substance

pneumococcal polysaccharide serotype 4 / pneumococcal polysaccharide serotype 6B / pneumococcal polysaccharide serotype 9V / pneumococcal polysaccharide serotype 14 / pneumococcal oligosaccharide serotype 18C / pneumococcal polysaccharide serotype 19F / pneumococcal polysaccharide serotype 23F

International non-proprietary name (INN) or common name

pneumococcal saccharide conjugated vaccine, adsorbed

Therapeutic area Pneumococcal InfectionsImmunization
Anatomical therapeutic chemical (ATC) code J07AL02

Publication details

Publication details for Prevenar
Marketing-authorisation holder

Pfizer Limited

Revision20
Date of issue of marketing authorisation valid throughout the European Union02/02/2001

Contact address:

Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Product information

Product information

06/05/2014  Prevenar -EMEA/H/C/000323 -N/0167

Name Language First published Last updated
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014
Prevenar : EPAR - Product Information SV = svenska 08/10/2009 15/07/2014

Contents

  • 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.


Name Language First published Last updated
Prevenar : EPAR - All Authorised presentations SV = svenska 25/04/2008  
Prevenar : EPAR - All Authorised presentations SV = svenska 25/04/2008  
Prevenar : EPAR - All Authorised presentations SV = svenska 25/04/2008  
Prevenar : EPAR - All Authorised presentations SV = svenska 25/04/2008  
Prevenar : EPAR - All Authorised presentations SV = svenska 25/04/2008  
Prevenar : EPAR - All Authorised presentations SV = svenska 25/04/2008  
Prevenar : EPAR - All Authorised presentations SV = svenska 25/04/2008  
Prevenar : EPAR - All Authorised presentations SV = svenska 25/04/2008  
Prevenar : EPAR - All Authorised presentations SV = svenska 25/04/2008  
Prevenar : EPAR - All Authorised presentations SV = svenska 25/04/2008  
Prevenar : EPAR - All Authorised presentations SV = svenska 25/04/2008  
Prevenar : EPAR - All Authorised presentations SV = svenska 25/04/2008  
Prevenar : EPAR - All Authorised presentations SV = svenska 25/04/2008  
Prevenar : EPAR - All Authorised presentations SV = svenska 25/04/2008  
Prevenar : EPAR - All Authorised presentations SV = svenska 25/04/2008  
Prevenar : EPAR - All Authorised presentations SV = svenska 25/04/2008  
Prevenar : EPAR - All Authorised presentations SV = svenska 25/04/2008  
Prevenar : EPAR - All Authorised presentations SV = svenska 25/04/2008  
Prevenar : EPAR - All Authorised presentations SV = svenska 25/04/2008  
Prevenar : EPAR - All Authorised presentations SV = svenska 25/04/2008  
Prevenar : EPAR - All Authorised presentations SV = svenska 25/04/2008  
Prevenar : EPAR - All Authorised presentations SV = svenska 25/04/2008  
Prevenar : EPAR - All Authorised presentations SV = svenska 25/04/2008  

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Active immunisation against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) in infants and children from two months up to five years of age.

The use of Prevenar should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as variability of serotype epidemiology in different geographical areas.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Prevenar : EPAR - Procedural steps taken before authorisation SV = svenska 21/10/2005  
Prevenar : EPAR - Scientific Discussion SV = svenska 21/10/2005  

Authorised

This medicine is approved for use in the European Union