HNZ: PCV13 Immunisation Schedule Change

 Kia ora Practice Managers,

FYI and for you to share with your wider networks as relevant:

You may be aware Pharmac has made a change to the immunisation schedule. From 1 December 2022 Prevenar 13 (PCV13) will replace Synflorix (PCV10) as the funded vaccine used to protect tamariki against pneumococcal disease.

Prevenar 13 (PCV13) provides broader protection against strains of the virus currently circulating in the community. For more information please visit Pharmac’s website.

The National Immunisation Programme is working closely with Te Whatu Ora Districts, the Immunisation Advisory Centre (IMAC) and other health organisations to ensure a smooth transition between the two vaccines. Health providers administering childhood immunisations will be given access to a webinar and operational guidance over the coming weeks. Please keep a look out for more information.

In the meantime, if you have questions please email immunisations@health.govt.nz

FAQ:

Information for health professionals 

Why are we switching from Synflorix (PCV10) to Prevenar (PCV13)? What is the difference? 

In 2021 the Pharmac Immunisation Advisory Committee considered a report from the Institute of Environmental Science and Research on the changing epidemiology of Invasive Pneumococcal Disease in New Zealand. The report noted an increase in pneumococcal serotype 19A notifications. 

Following this report, and a further review in April 2022, the committee recommended access to funded Prevenar (PCV13) vaccine which protects against three serotypes (3, 6A and 19A) that are not covered by Synflorix (PCV10).  

Will there be a change in the schedule to introduce PCV13 at 3 months? Why not? 

No, at this time a 3 dose schedule of PCV13 is expected to provide sufficient protection for healthy infants and children. An extra dose at three months is only required for high-risk infants. 

What are the gaps between doses/timing period for all PCV13 vaccinations? 

There is no change to the timing of doses. PCV13 should be administered at 6 weeks (all), 3 months (high risk), 5 months (all), and 12 months (all). 

If a child has started their pneumococcal course with one or two doses of PCV10 do they continue the rest of their course with PCV13? 

Yes, from 1 December 2022 all children under five years would be able to receive PCV13 as part of their regular childhood immunisations, including those who were given PCV10 at previous milestones. For example, if PCV10 has been given at 6-week and/or 5 month milestone, the next pneumococcal event would have PCV13 instead of PCV10. This will mean some children have a combination of PCV10 and PCV13 to complete their childhood immunisations.

Do we need to re-vaccinate the children we’ve already given a full course of PCV10 to?  

No, the decision announced by Pharmac on 7 November 2022 does not include a catch-up programme for children who have were previously vaccinated with a full course of PCV10. Pharmac is seeking further clinical advice on a proposal for a catch-up programme 

If parents/caregivers request it, can children who have received PCV10 at 6 weeks, 5 months or 12 months repeat that dose with PCV13?  

Funding is not available to replace already given PCV10 vaccination events with PCV13 vaccine.  A maximum of three doses in total (all PCV10, all PCV13, or a combination) is funded, unless the child meets the high-risk criteria for four doses of PCV13.

If parents or caregivers wish their child to have the PCV13 instead of PCV10 before 1 December, they will need to pay for it. The cost is variable as general practices determine the final amount charged as it may also include courier and administration charges. 

Would children who have both PCV10 and PCV13 vaccines in their record be considered a ‘mixed schedule’ like COVID-19 vaccines and require a script?  

A script is not required if the vaccine is being given by an authorised vaccinator.  

If a primary course of PCV10 is not completed by the age of 12 months, should two 2 doses of PCV13 be given as a catch-up? Yes, for those who have not completed a primary course of PCV vaccine and are now aged 12 months or older, an appropriate catch up is required. Consult with 0800 IMMUNE or refer to Appendix 2 of Immunisation Handbook.  

Are there any extra considerations needed for high-risk children? 

There is no change to the criteria used to confirm who is deemed to be ‘high risk’ (see the Pharmac schedule). Those who meet the criteria should have a fourth primary course dose – this is administered at 3 months of age.  

How do we manage high-risk children who haven’t completed their primary course of PCV10 (four doses) when PCV13 is introduced? 

Please contact 0800 IMMUNE to discuss. 

Are fourth doses of Prevenar (PCV13) for high-risk patients only?  

Yes  

Will all children require 23PPV at 2 years then? (potential for vaccinators to think those on PCV13 will need to continue with 23PPV instead of checking for special group criteria).  

No, 23PPV vaccination is only a follow on for those children who meet the high risk criteria.  

What should vaccinators do if they administer PCV10 after 1 December 2022? Is this a medication error and will the patient need to be revaccinated with PCV13?  

Yes, this is considered a medication error as PCV10 is not part of the Immunisation Schedule from 1 December 2022. Please contact 0800 IMMUNE to discuss each case for specific advice and follow usual medication error processes. PCV10 would still be funded if administered but clinical advice should still be sought regarding revaccination.

If a practice runs out of PCV10 vaccine before 1 December and has PCV13 in stock, can PCV13 be used instead?  

If a provider runs out of PCV10 before 1 December 2022, they will need to obtain more PCV10. Providers should have a minimum of two weeks stock available at any one time. PCV13 for tāmariki not classified as high-risk, is only funded from 1 December 2022. 

Logistics 

Do providers have to change to PCV13? 

Yes. From 30 November 2022 PCV10 will not be available for order through ProPharma. 

What happens to entries of PCV13 (non-high risk schedule) added before 1 Dec? Will payment be made still?  

PCV13 is funded for administration from 1 December 2022.  

Is PCV13 coming in boxes of 1 or 10s? 

Pharmac have advised that initially stock may arrive in either single dose packs or 10 dose packs. Providers are reminded to check fridge capacity prior to ordering and to take particular care when ordering stock as to what box size is available. 

Do we need to use PCV10 stock or will this be returned?  

PCV10 stock is not to be used after 30 November 2022. Excess stock should be returned  

to ProPharma for destruction. These packs can be placed inside the returnable ProPharma boxes that are used to deliver vaccine orders to your practice. Full instructions for that return process are printed on the outside of the shipping carton. If that is not practical, then stock can also be sent back in separate parcels that are labelled with a Vaccines For Destruction label; these labels are available under the ‘Resources’ section of www.fundedvaccines.co.nz. Call the phone number on this label to arrange collection by a courier. 

When can we order PCV13 stock?  

21 November 2022. Check ProPharma website for updates if available earlier depending on stock arrival to warehouse. Backorders of PCV13 will not be released.

Information for parents, caregivers and consumers 

What is changing? 

To increase your child’s protection from pneumococcal infections Pharmac is now funding a vaccine called Prevenar 13 (replacing Synflorix) which protects from more strains of the infection. 

If my child has had one or two doses of PCV10 do they continue the rest of their course with PCV13? 

Yes, from 1 December 2022 all children under five years will receive PCV13 as part of their regular childhood immunisations, including those who were given PCV10 at previous immunisation events. For example, if PCV10 has been given at 6-week and 5 month milestones, the next pneumococcal event at 12 months would have PCV13 instead of PCV10.

Do we need to re-vaccinate my child who has already received three doses of PCV10?  

No, the decision announced by Pharmac on 7 November 2022 does not include a catch-up programme for children who have were previously vaccinated with a full course (three doses) of PCV10. PCV10 provides active protection against ten strains of bacteria that can lead to pneumococcal disease.

Should parents delay immunisation so that they can receive Prevenar instead of Synflorix? 

No, don’t delay. To get the best protection it’s important children receive their vaccines on time. Delaying would put your child at risk. Synforix (PCV10) still offers a very good level of protection. 

How long has Prevenar-13 (PCV13) been used? 

Prevenar (PCV13) is used in many countries. It was approved for use in the European Union in 2009 and was used in New Zealand between 2014 and 2017. This vaccine is formulated and filled in Ireland, with labelling and packaging completed in Belgium. 

Can a parent choose to pay for Prevenar before 1 December? 

From 1 December Prevenar (PCV13) will be available for free as part of a child’s regular childhood immunisations. 

If parents or caregivers want their child to have the PCV13 vaccine before 1 December, they will need to pay for it. The cost is approximately $200 (general practices determine the final amount charged at their practice as it may also include courier and administration charges). 

Will there also be a change in eligibility criteria? For example, will high-risk adults now be funded?  

No, this is only a vaccine change. There is no change to any eligibility criteria. =

Ngā mihi nui,

Sandy

Please  note:  As I am WFH from overseas at the moment, and due to the time difference, my hours of work is altered.  I will endeavour to get back to you as soon as I can, but sometimes it may not be until the next day when I respond. Thank you so much for your understanding and patience. 

Sandy Thambiah

Senior Adviser, Engagement

National Immunisation Programme

waea pūkoro: +64 21 248 1288| īmēra: sandy.thambiah@health.govt.nz

133 Molesworth Street, Te Whanganui-a-Tara

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Te Whatu Ora – Health New Zealand

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