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Synflorix

Common name:

PCV10, pneumococcal conjugate vaccine

Protects against pneumococcal disease caused by at least 10 types of Streptococcus pneumoniae.

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Overview

From 1 July 2020, Synflorix® will be administered on the routine National Immunisation Schedule as a primary course at 6 weeks and 5 months of age followed by a booster dose at 15 months of age. Infants who have received Synflorix at 6 weeks and 3 months under the previous Immunisation Schedule will receive Synflorix at 5 months of age followed by a booster dose at 15 months of age. Healthy children who missed these events can catch up at any time up to their 5th birthday.

Children with a medical condition that increases their risk of invasive pneumococcal disease AND is listed on the Pharmaceutical Schedule will be funded to receive Prevenar® 13 vaccine at 6 weeks, 3 months, 5 months and 15 months in place of Synflorix.

Synflorix is designed to protect people from severe forms of pneumococcal disease e.g.bacteraemia (blood infection) and meningitis, but children may also be protected from less severe forms of the disease such at acute otitis media (middle ear infection, glue ear). In addition there is good evidence that vaccinating young children reduces the amount of carriage (people who carry the bacteria in their nose and throat but do not get sick from it) in the population. This means that people not vacinated may be protected from the groups of disease covered by the vaccine. This is called herd, or community, immunity.

Responses to vaccine

Synflorix (PCV10)

Common Responses

  • Mild pain, redness and swelling around injection site
  • Decreased appetite
  • Increased or decreased sleep
  • Fever

Rare Responses

  • Hives
  • Hypotonic, hyporesponsive episode (HHE) in infants
  • Convulsion associated with fever

As with any medicine, very rarely a severe allergic reaction (anaphylaxis) can occur following immunisation.

References

  • Bryant KA, Block SL, Baker SA, Gruber WC, Scott DA, for the PCV13 Infant Study Group. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine. Pediatrics. 2010;125(5):866-75
  • Croxtall JD, Keating GM. Pneumococcal polysaccharide protein D-conjugate vaccine (Synflorix; PHiD-CV). Paediatr Drugs. 2009;11(5):349-57
  • Immunisation Advisory Centre. Antigen Literature Review for the New Zealand National Immunisation Schedule, 2016: Pneumococcal disease: ten-valent pneumococcal conjugate vaccine. The University of Auckland, Auckland. Available from: http://www.immune.org.nz/antigen-literature-review-new-zealand-national-immunisation-schedule-2016-pneumococcal-disease-ten
  • Medical Advisory Committee of Haemophilia Foundation of New Zealand. National guidelines management of haemophilia - treatment protocols. Christchurch: Haemophilia Foundation of New Zealand; 2005
  • Medsafe. New Zealand data sheet: Synflorix [Internet]. Wellington: New Zealand Medicines and Medical Devices Safety Authority; 2009 [updated 2018 November 21; cited 2020 July 1]. Available from: http://www.medsafe.govt.nz/profs/Datasheet/s/synflorixinj.pdf
  • Ministry of Health. Immunisation Handbook 2017 2nd Edition. Wellington: Ministry of Health; 2017 [updated March 2018 ]. Available from: http://www.health.govt.nz/publication/immunisation-handbook-2017.
  • Prymula R, Schuerman L. 10-valent pneumococcal nontypeable Haemophilus influenzae PD conjugate vaccine: Synflorix. Expert Rev Vaccines. 2009;8(11):1479 -500
  • Vesikari TM, Wysocki J, Chevallier B, Karvonen A, Czajka H, Arsene J-P, et al. Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) compared to the licensed 7vCRM vaccine. Pediatr Infect Dis J. 2009;28(4):S66-76
In Depth

Other brands: Prevenar 13® (PCV13)

Vaccine type: subunit conjugate

Schedule and administration

From 1 July 2020,

  • Synflorix® will be administered on the routine National Immunisation Schedule as a primary course at 6 weeks and 5 months of age followed by a booster dose at 15 months of age.
  • Infants aged under 12 months who have received Synflorix at 6 weeks and 3 months under the previous Immunisation Schedule will receive Synflorix at 5 months of age followed by a booster dose at 15 months of age.
  • Infants aged under 12 who have received two doses of Synflorix with at least 8 weeks between the doses under the previous Immunisation Schedule only need a booster dose of Synflorix at 15 months of age.

Healthy children who missed these events can catch up at any time up to their 5th birthday. 

Special groups

The Schedule for Prevenar 13 for infants with a medical condition that increases their risk of invasive pneumococcal disease AND is listed on the Pharmaceutical Schedule continues as a primary course at 6 weeks, 3 months and 5 months of age followed by a booster dose at 15 months of age in place of Synflorix.

Prevenar 13 is also recommended and funded for children and adults with a medical condition that increases their risk of invasive pneumococcal disease AND is listed on the Pharmaceutical Schedule.

Prevenar 13 is available for purchase by people with a medical condition that is not listed on the Pharmaceutical Schedule.

Catch-up doses

Healthy children under 5 years who have not completed a course of PCV vaccine are eligible to receive age-appropriate catch up doses. The required number of doses are determined by the age of the child and whether they completed a course of PCV in their first year of life. Refer to Appendix 2 in the Immunisation Handbook 2017: Planning immunisation catch-ups.

Note: Two catch-up doses of Synflorix are required for children aged 2–5 years. This is different to the number of catch-up doses of Prevenar 13 for this age group (one dose).

 Table 1: Synflorix (PCV10) catch up schedule

  Age now

  Number of doses required

  ≥ 6 weeks– ≤ 7 months

  2a + 1b

  7 – 11 months

  2c + 1b,d

  12 months – < 5 years

  1 + 1e,f

  a Primary course with at least 8 weeks between doses
  b The ‘+ 1’ dose is a booster given in the second year of life (at the 15 month
    immunisation event)
  c Primary course with at least 4 weeks between doses
  d Preferably 8 weeks after previous dose but can be given 4 weeks after previous
   dose if this brings the child in line with the next Immunisation Schedule event
  e If a primary course was completed in the first year only one dose is required

Storage and preparation

Store as per cold chain between 2°C to 8°C. Protect from light.

Administration

Synflorix can be administered concurrently with other vaccines, including all the National Immunisation Schedule vaccines except other pneumococcal vaccines, e.g. Prevenar 13, Pneumovax 23. Separate syringes and different injection sites should be used.

Administration of Synflorix is by intramuscular injection into the vastus lateralis muscle in infants and the deltoid muscle in toddlers and children. No data are available on subcutaneous administration of Synflorix.

Vaccine safety

Synflorix should not be given to:

  • Anyone with severe allergy (anaphylaxis) to a previous dose of this vaccine or other pneumococcal conjugate vaccines, or a component of the vaccine
  • Administration of Synflorix should be postponed in individuals suffering from a fever over 38°C. The presence of a minor infection is not a reason to delay immunisation

Vaccine effectiveness

Invasive pneumococcal disease

Finland FinIP, the largest study to be conducted on PCV-10, found vaccine effectiveness (VE) against culture-confirmed vaccine-serotype IPD was 92% following a two-dose primary series and a booster in the second year of life (2+1 schedule). Rates of invasive pneumococcal disease casued by a vaccine-serotype decreased by 92% and by serotype 19A (not in the vaccine) decreased by 62% in vaccinated children aged under 5 years compared with unvaccinated children.  non-laboratory confirmed IPD in children aged 3–42 months declined by two-thirds following the introduction of PCV10.

Canada At least one dose of PCV10 was shown to be 97% effective against vaccine-type IPD in children aged under 5 years, 72% effective against any IPD, and had a 71% cross-reactive VE against serotype 19A IPD. When comparing at least two doses of PCV7, PCV10 or PCV13, VE did not differ against vaccine-type IPD.

Pneumonia

Decreases in pneumonia hospitalisation in infants were observed in Finland following the introduction of PCV10. VE against all infant pneumonia hospitalisations was calculated to be around 29% in infants who followed a 2+1 schedule starting before 7 months of age. For infants following a 2+1 schedule starting aged 7–11 months, VE agaoinst hospitalisation for pneumonia was around 33%, and for chidlren receiving two doses aged 12–18 months, VE was around 22%.

Otitis media

PCV 10 has been shown to provide protection against pneumococcal acute otitis media (AOM) in Latin American and Indigenous Australian children. In New Zealand, a decline in incidence of otitis media in children aged under 6 years has been observed since the introduction of PCV to the childhood immunisation schedule from 2006 in special groups and 2008 universally. During the PCV7 usage time period OM incidence declined by 55%, then by 66% during the PCV10 period and 81% during the PCV13 period. These declines were greatest in the children of Māori and Pacific ethnicity, resulting in little ethnic disparity in disease incidence between the main ethnic groups. Following the introduction of PCVs in New Zealand, the dominant pathogen associated with otitis media became NTHi, which was detected in 95% of children requiring surgery for otitis media. Due to conjugation of eight of the ten vaccine-type polysaccharides with NTHi protein D, it has been suggested that PCV10 may also protect against this major cause of AOM in children. However, the data is not conclusive.

There is evidence from the FinIP study that PCV10 immunisation initiated prior to 12 months of age may reduce the frequency of tympanostomy tube placements (TTP, grommets). The FinIP study also found that there were fewer outpatient prescriptions for antimicrobial drugs used to treatment AOM following immunisation with PCV10 (VE ranging from 3–8% across study cohorts) 

Nasopharyngeal carriage

Vaccination with PCV10 reduces nasopharyngeal carriage (NPC) of vaccine-type pneumococci. The FinIP study found that NPC was reduced by 19-56% in infants aged under 2 years immunised with PCV10 (as 3+1 schedule). The COMPAS study showed a 25.6% (reduction in NPC for vaccine-serotypes. Following a three-dose primary series in Brazil, NPC was reduced by 44%. Carriage of vaccine-type pneumococci declined from 34% to 13% in vaccinated Kenyan children following the introduction of PCV10 to the childhood schedule. The reductions in NPC were shown to persist for at least 28 months following a 3+1 infant schedule of PCV10 in the Czech Republic.

PCV10 immunisation was not found to reduce NTHi carriage in the COMPAS, FinIP and other studies. A Dutch study also found that effect of PCV10 on NTHi NP colonisation in healthy children was no greater than that from PCV7 vaccination.

In New Zealand, the carriage of PCV10 serotypes, but not NTHi, declined in children aged under 3 years following the introduction of the vaccine to the childhood schedule. There was an increase in NP carriage of non-vaccine type 19A in New Zealand children.

Herd immunity

PCV10 immunisation has been shown to have indirect population-wide effects (herd immunity) on vaccine-specific disease, including in New Zealand. A reduction in IPD cases of 48% among unvaccinated children aged 2–5 years was observed following the introduction of the PCV10 vaccination programme in Finland. In Kenya, the PCV10 had 66% effectiveness among unvaccinated individuals aged ≥5 years against NP carriage of pneumococcal vaccine-serotypes. This reduction in transmission may lead to a reduction in vaccine-type IPD in all age groups.

In New Zealand, significant reductions of 60% and 70% were observed in vaccine-serotype IPD notifications in those aged 5–64 years and over 65 years, respectively, between 2006 and 2014. However, no corresponding decline was seen in the overall IPD rate for the non-target age groups.

Although antibody response to diphtheria toxoid, tetanus toxoid and Protein D (Protein D is highly conserved in all Haemophilus influenzae strains including NTHi) occurs, immunisation with Synflorix does not substitute routine immunisation with diphtheria, tetanus or Haemophilus influenzae type b vaccines.

Last updated: Jul 2020