2011 Handbook Changes including “Catch Ups”

1. 2011 Handbook Changes including “Catch Ups” Brief presentation

2. Outline • Eligibility for Public Funded Vaccines • Handbook Changes 2011 • NIR and PMS Data Entry • Planning Immunisation Catch Ups

3. Eligibility for Public Funded Vaccines • Vaccine available free of charge are: • Those on the National Schedule • Those eligible for the high risk programmes eg infants of hepatitis B carrier mothers, neonatal BCG, influenza, pneumococcal high risk • The immunisation benefit is paid by DHBs to providers for the administration of: • All childhood schedule vaccines • Influenza vaccine to eligible children and adults • Hepatitis B, Hib, IPV, pneumococcal conjugate and/or polysaccharide, MMR and meningococcal vaccines for eligible children and adults. • Currently the vaccines are available free of charge but there is no funding provided for the administration of Td boosters given at 45 and 65 years of age.

4. Eligibility for Public Funded Vaccines • The Health and Disability Services Eligibility Direction 2011 issued by Minister of Health sets out the eligibility criteria for publicly funded health and disability services in New Zealand. • Children ineligible for other health services are eligible to receive funded Schedule vaccines, and providers may claim the immunisation benefit for these children. This requires an NHI • The Health and Disability Services Eligibility Direction 2011 has been gazetted and took effect 16 April 2011. www.moh.govt.nz/eligibility. These changes  clarify that vaccinations on the Immunisation Schedule are publicly funded for all children. • Child means a person who is under the age of 18 years. http://www.moh.govt.nz/moh.nsf/pagesmh/10574/$File/eligibility-direction-2011.pdf

5. Eligibility for Public Funded Vaccines • For an NHI, Contact Sector Services Contact Centre on:Telephone 0800 855 151 Monday – Friday 8:00am – 5:00pm,(Except Wednesday when the Contact Centre’s hours are 9:30am – 5:00pm ) • All children are also eligible for Well Child/TamarikiOra services, regardless of immigration and citizenship status. (http://www.moh.govt.nz/eligibility). • Note that non-resident girls aged up to 16 years can only receive funded HPV vaccine if they are staying in New Zealand for longer than eight months. • Current eligibility for National Schedule vaccines is up to 16 years. There have been changes for eligibility for non resident children that covers up to 18 years. The MOH is currently addressing this.

6. Changes to the Handbook in 2011 • All chapters have been updated and revised since the 2006 edition, where necessary. • The stand-alone key points section has been removed, and key changes are inserted into the relevant disease chapters • The disease case definitions have been moved from the General Considerations chapter to a new appendix (Appendix 9: Notifiable Disease Case Definitions and Serological Tests) • The disease chapters have been reordered to match the order in which the vaccines are given on the Schedule (e.g., the pneumococcal chapter is before measles and after poliomyelitis)

7. Changes to the Handbook in 2011 • There are new, separate chapters for human papillomavirus and rotavirus • The appendix on meningococcal invasive disease has been removed • There is a new Measles Specimen Collection appendix (Appendix 10) • Planning Immunisation Catch-ups (Appendix 2), Immunisation Standards (Appendix 3) and Authorisation of Vaccinators (Appendix 4) appendices have been revised  

8. NIR/PMS Changes •  Pneumococcal conjugate vaccine will be scheduled as PCV without specifying which vaccine to use for the routine Schedule, catch-up and pneumococcal schedules.  Once you vaccinate you will be able to record in the PMS and NIR which vaccine was used. The options available will be: • PCV7 (Prevenar) • PCV10 (Synflorix) • PCV13 (Prevenar 13) • 23PPV (Pneumovax  23) •  There is now the ability to record electronically the result of the 5 month serology test for babies of HBsAg positive mothers and any additional hepatitis B vaccine doses (if required) at ages 6 and 7 months and a repeat serology test at age 8 months. • Note: There will be specific order process for PCV13 for High Risk. MOH will notify this.

9. NIR/PMS Changes • Recording vaccines given overseas. •  The responsibility of the vaccinator is to assess what a child needs to complete a course of immunisation and provide adequate protection.  If the vaccinator has documented evidence of an immunisation given overseas they can record that event in their PMS as ‘complete, given overseas’. • The only mandatory information required on the PMS will be the date given - the batch and vaccinator details are optional fields. •  If a child has received a dose of Hib after 1 year of age the NIR will not schedule a dose of Hib at age 15 months. • PMS vendors will advise their providers when their software has been updated and what changes have been made.

10. Payment Systems •  Two new pneumococcal conjugate vaccine codes have been added PCV10 (Synflorix) and PCV13 (Prevenar 13) to enable primary care providers to claim the immunisation benefit (including manually) when administering these vaccines to eligible individuals. •  Vaccinators will be able to claim for the additional hepatitis B vaccine doses when extra doses are needed to be given to babies of HBsAg positive mothers at ages 6 and 7 months.

11. Schedule Changes 2011 shorter presentation Brief presentation

12. Outline • Main changes to the schedule: 2011 • Pneumococcal disease • Pneumococcal vaccines • Impact of pneumococcal vaccines • New PCV vaccines • Synflorix (PCV10) • Prevenar 13(PCV13) • High risk programme • New Hib vaccine brand: Act-Hib™ • BCG • New brand • New eligibility criteria • Common Qs and As

13. 2011 NZ Immunisation Schedule

14. Schedule changes: summary Synflorix (PCV10) replaces Prevenar(PCV7) at 6 weeks, 3, 5 & 15 months High risk children only: Prevenar 13 (PCV13) followed by Pneumovax 23 (23PPV)

15. Summary cntd. • MeNZB vaccine is no longer available. • Change in BCG brand and eligibility criteria • Act-HIB™ replaces Hiberix ™ • The date the new vaccines are available will be later than 1 July while existing vaccine stocks are used up • The Immunisation Handbook 2011 will be available online during May and hardcopies will be sent to practices in June • Rubella antibody levels to indicate protection are now recommended to be ≥15IU/mL (previously it was ≥10 IU/mL)

16. Pneumococcal disease and vaccines

17. Pneumococcal disease is caused by Streptococcus pneumoniae • S. pneumoniae is a gram-positive diplococcus with a polysaccharide capsule1,2 • >90 serotypes with different polysaccharide chains1,2 • Normal inhabitant of human nasopharynx2 • not found in animals3 • Use of antibiotics has caused resistant strains to emerge1-3 1World Health Organization. Pneumococcal vaccines: 2003. 2US CDC. Epidemiology and prevention of vaccine preventable diseases. 2009. 3EU CDC. Factsheet for healthcare professionals. 2008. Photo credit: Image of pneumococcal serotype 19F; Rob Smith.

18. Streptococcus pneumoniae causes a spectrum of invasive and non-invasive disease Vaccination drivers Severity Deaths Invasive Pneumococcal Disease Hospitalisation Costs Volume of cases Economic costs Antibiotic use and resistance Adapted from Melegaro et al. J Infection 2006, 52(1):37–48. Silfverdal et al. Vaccine 2009; 27: 1601–1608. WHO. The global burden of disease. 2008. O’Brien et al. Lancet 2009;374:893–902.

19. The Vaccines PCV10: Synflorix - Routine childhood programme • Contains the 7 types and 3 extra • Conjugated to Protein D(non-typable H influenza) PCV13: Prevenar 13 - High risk children • Contains the 7 types and 6 extra • conjugated to CRM197 (non-toxin diphtheria) 23PPV: Pneumovax 23 - High risk adults /children • A polysaccharide vaccine • Less immunogenic, shorter duration of immunity • Poorly immunogenic in children under 2 years

20. String of sugars = polysaccharide Polysaccharide vaccines • Made from polysaccharide from the capsule surrounding the bacteria • Works in adults • Two major problems • Not immunogenic in babies • No immune memory

21. Polysaccharide And lipid (LPS) Pneumococcal bacterium Polysaccharide-protein conjugate Purification process Chemical Reaction CRM197 Protein Carrier Lipid Conjugate vaccine

22. PCV7 immunisation in New Zealand has reduced IPD Incidence of invasive pneumococcal disease in children younger than 2 years PCV7 serotypes Adapted from ESR. NZ Public Health Surveillance Report 2010; 8 (4) 4-5.

23. Incidence rates of invasive pneumococcal disease by serotype, in children aged less than five years, New Zealand, 1998 – 2007 (NB prior to introduction of PCV vaccine)

24. Composition of Synflorix – designed as a dual-pathogen vaccine Non-typeable H. influenzae S. pneumoniae Main carrier protein: Protein D Polysaccharides TT DT 4, 6B, 9V, 14, 18C, 19F, 23F 1, 5, 7F NTHi Protein D • 8 serotypes conjugated to protein D • 18C conjugated to tetanus toxoid (TT) • 19F conjugated to diphtheria toxoid (DT) GSK NZ. SynflorixData Sheet. 2010.

25. Global use of Synflorix(April 2011) National immunisation programmes: • First registered in December 2008 • Now approved in 83 countries 2 + 1 schedule • Colombia (Bogotá)    • Finland • Mexico • Sweden  (3 provinces) 3 + 1 schedule • Australia (Northern Territories) • Austria (high-risk groups) • Albania • Brazil • Bulgaria • Cyprus (high-risk groups) • Hong Kong • Taiwan  (Taipei) • The Netherlands 3 + 0 schedule • Kenya        • Prequalified by World Health Organization in October 2009 • Now available in some developing countries as part of “advance market commitment” — an agreement with the GAVI Alliance to improve access to pneumococcal vaccines 1GlaxoSmithKline.Data on file. 2010. 2WHO prequalification of Synflorix. 2009..

26. Synflorix is generally well tolerated Combined analysis of clinical studies of safety in more than 4,000 healthy infants1: • The most common adverse reactions observed after primary vaccination were pain, redness, and swelling at the injection site, irritability, fever, and drowsiness.1 • Most reactions were of mild to moderate severity and were not long-lasting.1 • No safety concerns were identified.1 The safety and tolerability profile of Synflorix is similar to that of PCV7 and commonly co administered vaccines.1 • Fever >38°C within same range as PCV7 post-primary and booster. • Fever >40C was infrequent: ≤1% of Synflorix doses and ≤2% of PCV7 doses.1 1Chevallier et al. Pediatr Infect Dis J 2009;28:S109–118.

27. Synflorix can be co administered with other vaccines available in NZ

28. Packaging and storage of Synflorix • Packs of 10 • No needles • Prefilled syringes • Store at 2–8°C • Do not freeze • 3-year shelf-life • Protect from light • Shake well before use GSK NZ. SynflorixData Sheet, 2010.

29. Administration of prefilled syringe Holding the syringe barrel (not the plunger) in one hand, unscrew the syringe cap by twisting anticlockwise. To attach the needle to the syringe, twist the needle clockwise into the syringe until you feel it lock. Remove the needle protector and administer the vaccine. GSK NZ. SynflorixData Sheet, 2010.

30. Prevenar 13 for high risk children • Same vaccine technology and composition as Prevenar, with six additional serotypes • Each dose of Prevenar 13 contains: • 2.2 μg of pneumococcal purified capsular polysaccharides for serotypes 1,3,4,5,6A,7F,9V,18C,19A,19F, 23F and 4.4 μg for serotype 6B • Each serotype is individually conjugated to non-toxic diphtheria CRM197 protein and adsorbed onto aluminium phosphate (0.565 mg). • Each dose contains succinic acid, polysorbate 80, aluminium phosphate and sodium chloride in water for injections. • Expected to have the same safety profile as Prevenar

31. Pneumococcal high risk children: 0 -16 yrs • Offer PCV13 followed by 23PPV • Up to 5 years of age: (59 months) • On immunosuppressive therapy or radiation therapy • Primary immune deficiencies • HIV • Renal failure or nephrotic syndrome • Immune suppressed following organ transplantation • Cochlear implants, intracranial shunts • CSF leaks • On corticosteroids at least 2mg/kg/day prednisone (or 20mg a day) >2 weeks • Chronic pulmonary disease • IDDM • Down Syndrome • Pre or post-splenectomy or functional asplenia • Preterm infants born at under 28 weeks • 6 – 16 years: • Pre or post-splenectomy or functional asplenia

32. Schedule for high risk children • As soon as the child is recognised as high risk, replace the next dose of PCV10 (Synflorix) with PCV 13 (Prevenar 13) at the same schedule visit times • If a child has already had a full course of PCV10 offer a single dose of PCV13 • 8 weeks after the final PCV dose (or at the age of 2 years if under 2) offer 23PPV (Pneumovax 23) • Offer a repeat 23PPV dose in 3-5 years time

33. Children/Adults high risk: pre or post splenectomy • The criteria remain unchanged • No longer need the recommendation of a secondary care specialist to given in primary care • Vaccines now being offered: • Prevenar 13 ( children up to 16 years only) • Act-HIB™ • Pneumovax 23 • Menomune ACYW135 NB Prevenar 13 and Act-HIB™ are only licensed to 5 years of age, giving to older children and adults is currently outside of licensure. While there are not expected to be any safety concerns, it is important to give full informed consent

34. Other vaccines changes

35. Act-HIB ™ • Haemophilus influenza type B vaccine conjugated to tetanus protein • Same conjugate as previous vaccine, Hiberix™ • Freeze-dried powder for reconstitution with diluent for injection • comes in a vial and separate syringe • Expected to act the same as Hiberix • Datasheet: http://www.medsafe.govt.nz/profs/datasheet/a/acthibinj.pdf

36. BCG key changes Neonatal BCG offered to infants at increased risk of TB. Those who: • Will be living in a house or family/whanau with a person with either currently TB or a past history of TB • Have one or both parents or household members or carers, who within the last five years lived for a period of six months or longer in countries with a rate ≥ 40 per 100,000 • During their first five years will be living for three months or longer in a country with a rate ≥ 40 per 100,000 and are likely to be exposed to those with TB • List of high-incidence countries: • www.moh.govt.nz/immunisation • www.bcgatlas.org/index.php The major change is that fewer Pacific countries are now considered high risk for TB

37. Common Qs and As Why was PCV10 introduced rather than PCV13? • “the extra components in PCV10(versus PCV7) provide extra cover against pneumococci” • “The NTHi protein may provide extra protection against otitis media” • “PCV10 is significantly less expensive than PCV13 and more cost-effective” Ref: NZ Immunisation Handbook 2011, Ministry of Health A child has started on Prevenar and now the practice has only got Synflorix available • Switch over to Synflorix

38. Qs & As cntd. What about when to use 23 PPV vaccine? • Pneumococcal polysaccharide (23PPV) vaccine is recommended, but not funded, for young people and adults aged 16 years and older at special risk, as per the high risk list in the NZ Handbook, and for HIV-infected people. Note that some specialists may recommend PCV13 prior to use of 23PPV (refer Immunisation Handbook 2011). Do you revaccinate with 23PPV? • “Revaccination with polysaccharide vaccine (23PPV) should be considered after three to five years in children aged less than 10 years of age when first immunised, and after five years in older children and adults belonging to particularly high-risk groups, who frequently exhibit a poor immune response. • Revaccination is recommended five years after the first vaccination post-splenectomy and at 65 years to complete three doses” Ref: NZ Immunisation Handbook 2011 p.196. Refer Table 9.3

39. Qs & As cntd. How to enter PCV10 and PCV13 on the PMS • PCV will be scheduled for the child • The new upgrades should have a drop down box identifying the different types of vaccine: PCV7,PCV10 and PCV13 A child who has started their immunisation programme and has already received some doses of Synflorix then becomes high risk • Once the high risk condition has been recognised switch over to PCV13 to complete the programme, and then offer 23PPV 8 weeks after the last dose of PCV13, or when the child reaches 2 years of age • If a child has already received 4 doses of PCV10, they should receive one dose of PCV13

40. Qs & As cntd. A family is wanting to purchase the private market Prevenar 13 rather than Synflorix to give their child additional protection. • Can switch from Synflorix to Prevenar 13, if they are partially through a schedule they may not get complete protection against the extra 3 serotypes. Why are conjugates not used routinely in adults? • The conjugates have been specifically designed for the serotypes that are most common in childhood disease, there is a broader spectrum of serotypes that adults are exposed to. • There is currently little data on the effectiveness of conjugates in adults. Conjugates are expected to be effective at preventing pneumococcal disease in adults but further data is needed before the precise role of these vaccines is defined in adults.

41. Qs and As cntd. What is the PCV programme for a child who needs catch up? • Children under 6 months of age need 3 doses at least a month apart • Children 6- 12 months need 2 doses at least a month apart • Children from 1 to 5 years of age who have never had any PCV need two doses 8 weeks apart Use of medication such as paracetamol for temperature or pain • Paracetamol or ibuprofen can be used for children who are in discomfort or pain following immunisation. It is not recommended routinely with immunisations as it may interfere with the immune response. Ref Prymula R et al Lancet 2009; 374: 1339–50

42. Further Information

43. More information on Synflorix • Phone the Immunisation Advisory Centre on: • 0800 IMMUNE (0800 466 863) • Go to www.immune.org.nz or www.moh.govt.nz/immunisation • Refer to the Synflorix Data Sheet and Consumer Medicine Information on the Medsafe website: http://www.medsafe.govt.nz/profs/Datasheet/dsform.asp • For GSK Medical Information in NZ, please call 0800 808 500 or +64 09 367 2900, and ask for the Medical Information Department. GSK NZ. SynflorixData Sheet, 2010.

44. More information on Prevenar 13 • Phone the Immunisation Advisory Centre on 0800 IMMUNE (0800 466 863) • Refer to Prevenar 13 datasheet http://www.medsafe.govt.nz/profs/datasheet/p/prevenar13inj.pdf • Contact Pfizer: • Phone 0800 734 076 • Fax 0800 735 045