13-Valent pneumococcal polysaccharide conjugate vaccine (Prevenar 13) listed on the National Immunisation Program

Published in NPS RADAR

Date published: About this date

Clinical content may change after this date. This information is not intended as a substitute for medical advice from a qualified health professional. Health professionals should rely on their own expertise and enquiries when providing medical advice or treatment.

Immunisation schedule and catch-up program | Switching from Prevenar to Prevenar 13 | Use an antipyretic only when indicated | Differences between the pneumococcal conjugate vaccines | Evidence of herd immunity from widespread infant immunisation | Serotype replacement | References


Prevenar 13 is a 13-valent pneumococcal polysaccharide conjugate vaccine for Streptococcus pneumoniae. It is registered for immunising Australian infants and children against pneumococcal disease (e.g. invasive disease, pneumonia and acute otitis media).1

Prevenar 13 replaced the 7-valent vaccine Prevenar on the ACT and all State vaccination schedules from1 July 2011. The Northern Territory vaccination schedule currently includes Synflorix, a 10-valent pneumococcal polysaccharide conjugate vaccine. The Northern Territory Department of Health expects to change to the 13-valent vaccine later in 2011.

The Pharmaceutical Benefits Advisory Committee recommended Prevenar 13 for the same listing on the National Immunisation Program as the previously listed 7-valent vaccine, Prevenar.2

Immunisation schedule and catch-up program

The immunisation schedule is the same as that for 7-valent Prevenar, that is, at 2 months, 4 months and 6 months, with a fourth booster dose at 12 months for children who are medically at risk.1,3

For children aged between 12 months and 35 months who have already received three doses of the 7-valent vaccine, there will be a catch-up program from 1 October 2011 to 30 September 2012. These children will be eligible for a single booster dose of the 13-valent vaccine.4

At the time of publication, the Australian Immunisation Handbook and National Immunisation Schedule have not been updated with information about the 13-valent vaccine.3

Switching from Prevenar to Prevenar 13

Infants and children who have received one or more doses of 7-valent vaccine may complete their immunisation schedule using the 13-valent vaccine, including the booster dose. This should provide adequate coverage of the seven serotypes in the 7-valent vaccine. However, it is not known if infants and children who receive fewer than three doses of the 13-valent vaccine will have adequate coverage for the six new serotypes.1

Switching information is not yet available for infants and children who have received one or more doses of 10-valent vaccine.

Use an antipyretic only when indicated

Routine use of paracetamol at the time of vaccination is no longer recommended. Paracetamol can be given after vaccination if an infant or child has a fever > 38.5ºC.3 A pooled analysis of antipyretic use on the day of vaccination in Prevenar 13 trials found a negligible reduction in antibody response that the European regulator did not judge to be medically relevant.5

Prophylactic antipyretic treatment is recommended for children with seizure disorders or a history of febrile seizures, or when children simultaneously receive the 13-valent vaccine and a vaccine containing whole-cell pertussis.1 In clinical trials, prophylactic paracetamol was associated with a reduced antibody response to both 10-valent pneumococcal vaccine (Synflorix) and 7-valent vaccine.6,7

Differences between the pneumococcal conjugate vaccines

The 13-valent vaccine includes serotypes 1, 3, 5, 6A, 7F and 19A in addition to those in the 7-valent vaccine. As with the 7-valent vaccine, the S. pneumoniae polysaccharides are individually covalently conjugated to diphtheria toxoid cross-reactive material 197 protein.8 Serotypes 1, 5 and 7F are also included in the 10-valent vaccine Synflorix (see the December 2009 NPS RADAR in brief New pneumococcal polysaccharide conjugate vaccine (Synflorix) added to the national immunisation schedule).

The 13-valent vaccine was approved on the basis of trials that compared its immunogenicity with that of the 7-valent vaccine, rather than comparing pneumococcal disease incidence.8–10 The World Health Organization recommended that regulators take this approach to the licensing of pneumococcal conjugate vaccines after the 7-valent vaccine demonstrated a high level of efficacy in reducing rates of invasive pneumococcal disease.5 The 10-valent vaccine was approved on basis of the same approach.6

It is uncertain how well immunogenicity data will predict the efficacy of the 13-valent vaccine for the six new serotypes. In addition, some measures of the functional immune response against serotypes 1, 3 and 5 did not reach the reference value.5 Long-term antibody persistence data are not available for the 13-valent or the 10-valent vaccine.6,8

Evidence of herd immunity from widespread infant immunisation

The incidence of invasive pneumococcal disease fell substantially in several countries, including Australia, after the introduction of 7-valent pneumococcal conjugate vaccine.11–17 In Australia, the vaccine was funded nationally for all infants from 2005, and in the period from 2002 to 2006, rates of vaccine-serotype invasive pneumococcal disease fell 90% in children aged under 2 years. In the same period, rates of disease caused by the vaccine strains fell 46% in the 65 years-and-over age group.14 A model based on US data also suggests that the pneumococcal conjugate vaccine has induced herd immunity there.18

Serotype replacement

The additional coverage of the 13-valent vaccine is intended to counter any shift towards serotypes not included in the 7-valent vaccine.8 In Australia the incidence of invasive pneumococcal disease caused by serotypes not covered by the 7-valent vaccine has increased in some regions and in some Indigenous populations.14,19,20 In the US, vaccination with the 7-valent vaccine has decreased overall pneumococcal disease prevalence, but there are observations of increased disease from non-vaccine serotypes (i.e. possible serotype replacement).21,22

References

  1. Wyeth Australia Pty Limited. Prevenar 13 product information. 27 May 2011.
  2. Australian Government Department of Health and Ageing. July 2010 PBAC outcomes: positive recommendations. http://www.health.gov.au/internet/main/publishing.nsf/Content/pbacrec-jul10-positive (accessed 30 June 2011).
  3. Australian Technical Advisory Group on Immunisation. The Australian Immunisation Handbook, 9th edn. Canberra: National Health and Medical Research Council, 2008. http://immunise.health.gov.au/internet/immunise/publishing.nsf/Content/handbook-home (accessed 30 June 2011).
  4. Victoria Department of Health. Transition to Prevenar 13 on the National Immunisation Program. http://docs.health.vic.gov.au/docs/doc/EC2A346DFCE9FBA4CA2578B200123F36/$FILE/Transition%20to%20Prevenar%2013%20fact%20sheet%2013.pdf (accessed 30 June 2011).
  5. European Medicines Agency. European Public Assessment Report for Prevenar 13. EMEA/H/C/001104. 8 January 2010. Scientific Discussion. 2010. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/001104/WC500057250.pdf (accessed 30 June 2011).
  6. European Medicines Agency. European Public Assessment Report for Synflorix. EMEA/H/C/000973. 8 July 2009. Scientific Discussion. 2009. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000973/WC500054349.pdf (accessed 30 June 2011).
  7. Prymula R, Siegrist C-A, Chlibek R, et al. Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: two open-label, randomised controlled trials. Lancet 2009;374:1339-50. [PubMed]
  8. Therapeutic Goods Administration. Australian Public Assessment Report for Pneumococcal Polysaccharide Conjugate Vaccine. Proprietary product name: Prevenar 13. 2010. http://www.tga.gov.au/pdf/auspar/auspar-prevenar13.pdf (accessed 30 June 2011).
  9. Kieninger DM, Kueper K, Steul K, et al. Safety, tolerability, and immunologic noninferiority of a 13-valent pneumococcal conjugate vaccine compared to a 7-valent pneumococcal conjugate vaccine given with routine pediatric vaccinations in Germany. Vaccine 2010;28:4192-203. [PubMed]
  10. Yeh SH, Gurtman A, Hurley DC, et al. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Pediatrics. [PubMed]
  11. Bettinger JA, Scheifele DW, Kellner JD, et al. The effect of routine vaccination on invasive pneumococcal infections in Canadian children, Immunization Monitoring Program, Active 2000-2007. Vaccine 2010;28:2130-6. [PubMed]
  12. Harboe ZB, Valentiner-Branth P, Benfield TL, et al. Early effectiveness of heptavalent conjugate pneumococcal vaccination on invasive pneumococcal disease after the introduction in the Danish Childhood Immunization Programme. Vaccine 2010;28:2642-7. [PubMed]
  13. Lexau CA, Lynfield R, Danila R, et al. Changing epidemiology of invasive pneumococcal disease among older adults in the era of pediatric pneumococcal conjugate vaccine. JAMA 2005;294:2043-51. [PubMed]
  14. Roche PW, Krause V, Cook H, et al. Invasive pneumococcal disease in Australia, 2006. Commun Dis Intell 2008;32:18-30. [PubMed]
  15. Rodenburg GD, de Greeff SC, Jansen AG, et al. Effects of pneumococcal conjugate vaccine 2 years after its introduction, the Netherlands. Emerg Infect Dis;16:816-23. [PubMed]
  16. Vestrheim DF, Hoiby EA, Bergsaker MR, et al. Indirect effect of conjugate pneumococcal vaccination in a 2+1 dose schedule. Vaccine 2010;28:2214-21. [PubMed]
  17. Whitney CG, Farley MM, Hadler J, et al. Decline in invasive pneumococcal disease after the introduction of protein-polysaccharide conjugate vaccine. N Engl J Med 2003;348:1737-46. [PubMed]
  18. Haber M, Barskey A, Baughman W, et al. Herd immunity and pneumococcal conjugate vaccine: a quantitative model. Vaccine 2007;25:5390-8. [PubMed]
  19. Easton M, Veitch M, Strachan J. The impact of infant pneumococcal vaccination on the serotypes of invasive pneumococcal disease in Victoria, 2003-2007. Victorian Infectious Diseases Bulletin 2008;11:38-43.
  20. Lehmann D, Willis J, Moore HC, et al. The changing epidemiology of invasive pneumococcal disease in aboriginal and non-aboriginal western Australians from 1997 through 2007 and emergence of nonvaccine serotypes. Clin Infect Dis 2010;50:1477-86. [PubMed]
  21. Centers for disease control and prevention. Invasive pneumococcal disease in young children before licensure of 13-valent pneumococcal conjugate vaccine - United States, 2007. MMWR 2010;59:253-7. [PubMed]
  22. O'Brien KL, Millar EV, Zell ER, et al. Effect of pneumococcal conjugate vaccine on nasopharyngeal colonization among immunized and unimmunized children in a community-randomized trial. J Infect Dis 2007;196:1211-20. [PubMed]