Synflorix is a 10-valent pneumococcal polysaccharide conjugate vaccine for Streptococcus pneumoniae.*1 The Pharmaceutical Benefits Advisory Committee recommended listing the vaccine on the National Immunisation Program as a 4-dose schedule (2, 4 and 6 months and a booster at either 12 or 18 months), concluding that it is equivalent to the standard 3-dose schedule of 7-valent pneumococcal conjugate vaccine (Prevenar).2 Either vaccine is recommended for immunising Australian infants and children from the age of 8 weeks to 2 years against pneumococcal disease (e.g. invasive disease, pneumonia and acute otitis media).3,4
* The 10-valent vaccine includes polysaccharide serotypes 1, 5 and 7F in addition to those in the 7-valent pneumococcal conjugate vaccine (Prevenar).
New information about prophylactic paracetamol use
Routine use of paracetamol at the time of vaccination is no longer recommended.4 However, a prophylactic antipyretic is recommended when administering pneumococcal vaccines to children with seizure disorders or with a prior history of febrile seizures.5,6
Paracetamol can be given after vaccination if an infant or child has a fever of > 38.5ºC. The dose is 15 mg/kg paracetamol liquid, up to a maximum daily dose of 90 mg/kg/day in 4–6 divided doses for up to 48 hours.4
Clinical trial data suggest that using prophylactic paracetamol might reduce the immune response to conjugate pneumococcal vaccines and some other paediatric vaccines, although it is unknown if the reduction is clinically relevant.1,7,8 An effect on antibody concentrations has been seen with both the 10-valent vaccine (Synflorix) and the 7-valent vaccine (Prevenar).7,8 Other antipyretics, such as ibuprofen, may have a similar effect, but there are no data.
Infants who received prophylactic paracetamol in 1 trial had lower antibody concentrations after the primary vaccination with the 10-valent vaccine than infants who did not receive paracetamol. The difference in antibody concentrations was larger for some serotypes than for others.7,8
The significance of the lower post-primary antibody response is unclear, but the data from 12–15 months after the booster dose suggest that any impact on efficacy should be limited. After receiving booster doses, similar proportions of children achieved target levels of anti-pneumococcal antibodies, regardless of whether they received paracetamol (with the exception of 1 measure of response to serotype 6B).7,8
Please note that this web version was updated after the December 2009 issue of NPS RADAR was printed. It contains more information from the PBAC Public Summary Document about the timing of the booster dose.
- GlaxoSmithKline Australia Pty Ltd. Synflorix product information. 2 July 2009.
- Australian Government Department of Health and Ageing. Public summary document for pneumococcal solysaccharide conjugate vaccine, turbid liquid suspension for injection (0.5 mL) in pre-filled syringe or vial, Synflorix July 2009. http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-pneumococcal-jul09 (accessed 1 November 2009).
- Australian Government Department of Health and Ageing. July 2009 PBAC outcomes: positive recommendations. http://www.health.gov.au/internet/main/publishing.nsf/Content/pbacrec-jul09-positive (accessed 7 October 2009).
- Australian Technical Advisory Group on Immunisation. The Australian Immunisation Handbook, 9th ed. Canberra: National Health and Medical Research Council, 2008. http://immunise.health.gov.au/internet/immunise/publishing.nsf/Content/handbook-home (accessed 7 October 2009).
- GlaxoSmithKline UK. Synflorix summary of product characteristics, 30 March 2009. http://www.emea.europa.eu/humandocs/PDFs/EPAR/synflorix/emea-combined-h973en.pdf (accessed 7 October 2009).
- Wyeth Australia Pty Limited. Prevenar product information. 15 June 2009.
- European Medicines Agency. European Public Assessment Report for Synflorix. EMEA/H/C/000973. 8 July 2009. Scientific Discussion. 2009. http://www.emea.europa.eu/humandocs/PDFs/EPAR/synflorix/H-973-en6.pdf (accessed 7 October 2009).
- 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\u201350.[PubMed]