Proposal to widen access to the PCV13 pneumococcal conjugate vaccine for immunisation against pneumococcal disease
What we're proposing
We propose to widen access to the PCV13 pneumococcal conjugate vaccine in the Pharmaceutical Schedule from 1 December 2022, for immunisation against pneumococcal disease.
Consultation closes at 5pm Thursday 6 October and feedback can be emailed to vaccines@pharmac.govt.nz
What would the effect be?
This proposal would mean that tāmariki in Aotearoa New Zealand would receive three doses of PCV13 instead of the current PCV10 pneumococcal conjugate vaccine, as part of their regular childhood immunisations. People at high risk of pneumococcal disease due to reduced immune function would continue to be eligible for additional doses of PCV13.
Funded vaccine supply would be available through ProPharma as with other funded vaccines. Further information on Pharmac’s role in vaccines is available on our website.
Who we think will be interested
- Parents and whānau of tamariki
- Vaccinators and other healthcare professional involved in childhood immunisations
- Te Whatu Ora hospitals
- Vaccine manufacturers, suppliers, wholesalers, and distributors
- Organisations with an interest in immunisation
About pneumococcal disease and pneumococcal conjugate vaccine
Pneumococcal disease describes a range of infections caused by the bacterium Streptococcus pneumoniae. There are over 90 identifiable serotypes of S. pneumoniae with some serotypes associated with more severe disease and antibiotic resistance. Local pneumococcal disease includes ear infections and sinusitis that are unpleasant and painful, but not life threatening.
Invasive pneumococcal disease (IPD) occurs if the pneumococcal bacteria pass into the blood, resulting in a severe form of pneumonia, bacteraemia, and meningitis. S. pneumoniae can also infect other sites around the body, including the heart muscle, joints, and abdomen. IPD can progress quickly, require hospitalisation and may be fatal or result in long-term disabilities. The rate of IPD for Māori is just over four times, and for Pacific peoples almost five times, higher than the rate for NZ Europeans.
IPD is a notifiable disease(external link) in Aotearoa New Zealand. Reports of notifications show that 19 people have died in the period from January to June 2022 with a diagnosis of IPD at the time of death, however, the main causes of death are not yet final for most cases. Six of these cases had serotype 19A which is associated with higher disease severity and antibiotic resistance.
Since the introduction of pneumococcal conjugate vaccine (PCV) to the National Immunisation Schedule in 2008, there have been dramatic reductions in the incidence of IPD in the vaccine-eligible age groups. Pneumococcal vaccination is generally given at 6 weeks and 5 months, with a booster at 12 months of age. People at high risk of pneumococcal disease may require additional doses. Current recommended immunisation schedules are described in the Ministry of Health’s Immunisation Handbook(external link).
The currently funded PCV10(external link) vaccine provides active immunisation against ten S. pneumoniae serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C and 23F, with some cross-reactive protection to 19A, in infants and children under 5 years of age. The PCV13 vaccine provides active immunisation against thirteen S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in children and adults more than 6 weeks of age. PCV13 is currently funded(external link) for (re‑)immunisation of people at high risk of pneumococcal disease, such as people with reduced immune function.
Why we’re proposing this
In August 2021, our Immunisation Advisory Committee considered a report from the Institute of Environmental Science and Research on the changing epidemiology of IPD in New Zealand. Trends in this report showed a recent increase in serotype 19A notifications. Based on their review of this report, and a further review in April 2022 of additional surveillance data from early 2022, our expert clinical advisors have now recommended that access to funded PCV13 be widened to provide additional protection against pneumococcal disease, including serotype 19A, with a high priority.
Pharmac has been working hard over several months with the suppliers of PCV13 and PCV10 vaccines to reach an agreement that would enable this proposed change to be progressed.
Links to published expert clinical advice are provided below.
- August 2021 Immunisation Advisory Committee meeting [PDF, 294 KB]
- February 2022 Pharmacology and Therapeutics Advisory Committee (PTAC) [PDF, 531 KB]
- April 2022 Immunisation Advisory Committee meeting [PDF, 160 KB]
Details about our proposal
The PCV13 pneumococcal conjugate vaccine (Prevenar 13) would continue to be listed in Section I and Part II of Section H of the Pharmaceutical Schedule from 1 December 2022 as follows:
| Chemical | Formulation | Brand | Pack size | Price* |
|---|---|---|---|---|
| Pneumococcal (PCV13) conjugate vaccine | Inj 30.8 mcg of pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in 0.5ml syringe | Prevenar 13 | 1 inj | $0.00* |
| Pneumococcal (PCV13) conjugate vaccine | Inj 30.8 mcg of pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in 0.5ml syringe | Prevenar 13 | 10 inj | $0.00* |
*Vaccine prices are listed with zero cost in the Pharmaceutical Schedule as Pharmac distributes them free of charge to vaccinators.
A confidential net price would apply to Prevenar 13.
PCV13 would be listed with the Xpharm restriction in Section I. An Xpharm listing means that community pharmacies cannot claim subsidy because Pharmac has made alternate distribution arrangements.
PCV13 would be listed in Section I of the Pharmaceutical Schedule with widened eligibility criteria as follows (new criteria in bold, deletions in strikethrough):
Any of the following:
- A course of three doses for previously unvaccinated individuals up to the age of 59 months inclusive; or
- Two doses are funded for high-risk children (over the age of 12 months and under 18 years) who have previously received two doses of the primary course of PCV10; or
- Up to an additional four doses (as appropriate) are funded for the (re)immunisation of for high-risk children aged under 5 years for (re-)immunisation of patients with any of the following:
- on immunosuppressive therapy or radiation therapy, vaccinate when there is expected to be a sufficient immune response; or
- with primary immune deficiencies; or
- with HIV infection; or
- with renal failure, or nephrotic syndrome; or
- who are immune-suppressed following organ transplantation (including haematopoietic stem cell transplant); or
- with cochlear implants or intracranial shunts; or
- with cerebrospinal fluid leaks; or
- receiving 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; or
- with chronic pulmonary disease (including asthma treated with high-dose corticosteroid therapy); or
- pre-term infants, born before 28 weeks gestation; or
- with cardiac disease, with cyanosis or failure; or
- with diabetes; or
- with Down syndrome; or
- who are pre-or post-splenectomy, or with functional asplenia; or
- Up to an additional four doses (as appropriate) are funded for the (re-)immunisation of patients 5 years and over with HIV, for patients pre or post haematopoietic stem cell transplantation, or chemotherapy; pre- or post splenectomy; functional asplenia, pre- or post- solid organ transplant, renal dialysis, complement deficiency (acquired or inherited), cochlear implants, intracranial shunts, cerebrospinal fluid leaks or primary immunodeficiency; or
- For use in testing for primary immunodeficiency diseases, on the recommendation of an internal medicine physician or paediatrician.
Note: please refer to the Immunisation Handbook for the appropriate schedule for catch up programmes
Similar funding criteria would also apply in Part II of Section H of the Pharmaceutical Schedule.
The PCV10 pneumococcal conjugate vaccine (Synflorix) would continue to be listed in the Pharmaceutical Schedule so it would still be funded if it was administered, but vaccinators could start using PCV13 for childhood immunisations immediately from 1 December 2022. Vaccinators would be able to return any unused PCV10 to ProPharma.
The National Immunisation Programme at Te Whatu Ora – Health New Zealand is responsible for supporting the implementation of changes to the National Immunisation Schedule.
The Ministry of Health’s Immunisation Handbook would be updated to reflect the changes to pneumococcal conjugate vaccines.
To provide feedback
Send us an email: vaccines@pharmac.govt.nz by 5pm Thursday 6 October.
All feedback received before the closing date will be considered by Pharmac’s Board (or its delegate) prior to making a decision on this proposal.
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