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Prevenar 13

Common name:

PCV13, pneumococcal conjugate vaccine

Protects against pneumococcal disease caused by 13 types of Streptococcus pneumoniae.

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Overview

Prevenar 13® is funded for children and adults with a medical condition that increases their risk of invasive pneumococcal disease AND is listed on the Pharmaceutical Schedule, identified as 'special groups on the National Immunisation Schedule. In children with an eligible medical condition, Prevenar 13® replaces doses of the Synflorix® vaccine at 6 weeks, 3 months and 5 months and 15 months of age.

Prevenar 13® is available as a purchased vaccine for people with a medical condition that is not listed on the Pharmaceutical Schedule.

The vaccine is designed to protect people from severe forms of the 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

Prevenar 13 (PCV13)

Common Responses

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

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

  • Ministry of Health. Immunisation Handbook 2017 2nd Edition. Ministry of Health: Wellington. Available from http://www.health.govt.nz/publication/immunisation-handbook-2017
  • Plosker GL.13-valent pneumococcal conjugate vaccine: a review of its use in infants, children, and adolescents. Paediatric Drugs. 2013;15(5):403-23
  • Plosker GL.13-valent pneumococcal conjugate vaccine: a review of its use in adults. Drugs. 2015;75(13):1535-46
  • Weiss S, Falkenhorst G, van der Linden M, Imöhl M, von Kries R. Impact of 10- and 13-valent pneumococcal conjugate vaccines on incidence of invasive pneumococcal disease in children aged under 16 years in Germany, 2009 to 2012. Euro Surveill. 2015;20(10):pii=21057
In Depth

Other brands: Synflorix® (PCV10)

Vaccine type: subunit conjugate

Schedule and administration

Prevenar 13® is funded for children and adults with a medical condition that increases their risk of invasive pneumococcal disease AND is listed on the Pharmaceutical Schedule, identified as 'special groups on the National Immunisation Schedule. In children with an eligible medical condition, Prevenar 13® replaces doses of the Synflorix® vaccine at 6 weeks, 3 months and 5 months and 15 months of age.

Prevenar 13® is available as a purchased vaccine for people with a medical condition that is not listed on the Pharmaceutical Schedule.

Special groups

Prevenar 13 is recommended and funded as below.

One dose for high-risk children aged 18 months to under 18 years who have previously received four doses of PCV10, or up to an additional four doses (as appropriate) for (re-)immunisation of individuals:

Children aged under 5 years

  • Cardiac disease with cyanosis or failure
  • Cerebrospinal fluid leak
  • Chronic pulmonary disease, including asthma treated with high-dose corticosteroid therapy
  • Cochlear implant
  • Corticosteroid therapy for more than two weeks and who are on an equivalent daily dosage of prednisone of 2 mg/kg per day or greater, or children who weigh more than 10 kg on a total daily dosage of 20 mg or greater
  • Diabetes
  • Down syndrome
  • Functional asplenia
  • HIV-positive
  • Immunosuppressive therapy
  • Intracranial shunt
  • Nephrotic syndrome
  • Pre-or post-splenectomy
  • Pre-term infant born before 28 weeks gestation
  • Primary immune deficiency
  • Post-haematopoietic stem cell transplantation
  • Post-solid organ transplantation
  • Radiation therapy
  • Renal failure

Children aged 5 years or older, and adults

  • Cochlear implant
  • Complement deficiency (acquired or inherited)
  • Functional asplenia
  • HIV-positive
  • Post-haematopoietic stem cell transplantation
  • Post-chemotherapy
  • Pre- or post-splenectomy
  • Pre- or post-solid organ transplantation
  • Primary immunodeficiency
  • Renal dialysis

N.B. Pneumovax23 (pneumococcal polysaccharide vaccine) is also funded for these groups from 2 years of age, and should also be administered at least 8 weeks after Prevenar13.

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. Refer to Appendix 2 in the Immunisation Handbook 2017: Planning immunisation catch-ups.

For those people meeting special groups eligibility, Prevenar 13 should be administered at least 8 weeks before Pneumovax 23. However, missed doses of Prevenar 13 can be given even if the person has previously received one or more doses of Pneumovax23. There are no safety concerns expected, but it is possible for prior doses of Pneumovax23 to reduce an individual’s immune response to Prevenar 13.

For adults aged 18 years or older who received Pneumovax23 before a dose of Prevenar 13: Prevenar 13 should be given at least one year after Pneumovax23. 

For children aged 2 years to under 18 years who received Pneumovax23 before a dose of Prevenar 13: Prevenar 13 should be given at least eight weeks after Pneumovax23. 

Storage and preparation

Upon storage, the vaccine may separate into a white deposit and clear liquid. The vaccine should be well shaken to obtain a consistent white suspension. Do not use if the content appears otherwise.

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

Administration

Prevenar 13 can be administered concurrently with other vaccines, including all the National Immunisation Schedule vaccines except other pneumococcal vaccines, e.g. Synflorix, Pneumovax23, and Menactra. Separate syringes and different injection sites should be used. Where both Prevenar 13 and Menactra are to be given, administration of Menactra must be at least 4 weeks before or after a dose of Prevenar 13.

Systemic reactions (chills, rash and myalgia) may occur when Prevenar 13 and influenza vaccine are administered at the same time. If a child aged under 5 years needs both Prevenar 13 and influenza vaccines, separation of vaccines by two days can be offered. If the child has a history of febrile convulsions, separation of the vaccines is recommended.

The vaccine is administered intramuscularly, into the vastus lateralis or the deltoid mucle in older children and adults.

Vaccine safety

The benefit of vaccination in very premature infants and those with a previous history of respiratory immaturity is high. Vaccination should not be withheld or delayed in these babies, however, respiratory monitoring should be considered for 48–72 hours due to the potential risk of apnoea.

Prevenar 13 should not be given to:

  • Anyone with severe allergy (anaphylaxis) to a previous dose of this vaccine or other pneumococcal-containing vaccine, or a component of the vaccine
  • Administration of Prevenar 13 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

Specialist advice should be sought for the following groups:

  • Those with bleeding disorders, such as haemophilia The vaccine should be administered in accordance with the haematologist’s instructions. It may, in this situation only, be given subcutaneously

Vaccine effectiveness

There is good evidence that pneumococcal conjugate vaccines given in infancy help to protect non-vaccinated individuals from invasive pneumococcal disease caused by serotypes in the vaccines through community (herd) immunity.

A study in Germany showed a marked decrease in the incidence of non-meningitis invasive pneumococcal disease (IPD) caused by PCV13 serotypes following the introduction of Synflorix and Prevenar 13. This decrease was not only observed in infants younger than 2 years but also older children, indicating herd immunity. In this study, an overall decrease in meningitis was limited to vaccinated children aged 2–4 years.

Herd effects from Prevenar 13 result from the impact of this vaccine on pneumococcal nasopharyngeal carriage in vaccinated infants. In a French study, overall carriage was reported to be significantly lower among children who received at least one doses of Prevenar 13 compared with those who were exclusively vaccinated with Prevenar.

Data has shown a decline in otitis media (middle ear infection) following the routine introduction of pneumococcal conjugate vaccines to the schedule. However, otitis media also caused by other types of bacteria which are not protected against by this vaccine.

Last updated: Nov 2018