1. 20 April 2011
Schedule Changes 2011

2. Outline Main changes to the schedule: 2011 Pneumococcal disease
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
PCV7 (Prevenar)
PCV10 (Synflorix)
PCV13 (Prevenar 13)
23PPV (Pneumovax23)
Thanks to GSK for their kind permission to use content from some of their slides.

3. 2011 NZ Immunisation Schedule
DTaP-IPV-HepB/Hib
PCV
Hib
MMR
DTaP-IPV
dTap
HPV Td
Influenza
6 weeks
Infanrix hexa®
Synflorix®
3 months
Infanrix hexa®
5 months
15 months
Act-HIB™
MMR II®
4 years
Infanrix® -IPV
11 years
Boostrix®
12 years
3 doses
Gardasil®
45 years
ADT-Booster™
65 years
ADT - Booster®
Fluvax®
or Fluarix®
Remember there are also the targeted programmes: infants of hepatitis B carrier mothers, BCG for high risk children at birth, pneumococcal vaccination programme for high risk children, influenza vaccination for high risk, vaccination programme for splenectomised individuals
From 1 July 2011 onwards , Synflorix  will replace Prevenar on the National Immunisation schedule for protection against pneumococcal disease This will occur over time as stocks of Prevenar run out the new vaccine Synflorix  will be distributed. Synflorix  will be offered at 6 weeks, and at 3, 5, and 15 months of age, at the same time as other routine vaccinations.1 Synflorix  should also be administered in the same way as Prevenar : 0.5mL given intramuscularly (thigh or deltoid).2,3
A seamless transition from PCV7 to Synflorix has been achieved in several countries (including Australia, Canada, Sweden, and Brazil) where infants were switched to Synflorix at any point in their PCV schedule.4,5
For any child under 5 years of age who is considered at higher risk of invasive pneumococcal disease they should be offered PCV13 (Prevenar13) followed by PPV23 (Pneumovax) instead of Synflorix, to offer them cover from a wider range of serotypes. PCV13 will be available from 1 July 2011.
Other minor changes to the schedule is a change in brand for the Hib conjugate, and BCG vaccine
1. Ministry of Health. Announcement – Changes to the National Immunisation Schedule for July 2011. Wellington: NZ Ministry of Health; Available at: Accessed 3 January
2. Wyeth. Prevenar® Data Sheet. Wyeth New Zealand; Available at: Accessed 3 January 2011.
3. GlaxoSmithKline. Synflorix® Data Sheet. GSK New Zealand; Available at: Accessed 3 January 2011.
4. Institut National De Santé Publique Du Québec. Assessment of the pertinence of a new pneumococcal conjugate vaccine in Québec. Available from: Accessed 3 January 2011.
5. Department of Health and Families. Memorandum: Change to Northern Territory Childhood Vaccination Schedule 1 October Darwin, Northern Territory Government Australia; 14 September 2009.

4. Schedule changes: summary
20 April 2011
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)
The most significant change to the schedule this year is:
Changing the 7 valent conjugate pneumococcal vaccine for a 10 valent vaccine for all children,
For children at particularly high risk, once they are identified as high risk, a 13 valent vaccine should be used rather than the 10 valent PCV10

5. Summary cntd. MeNZB vaccine is no longer available.
20 April 2011
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)
Nb MENZB is no longer available as the vaccine stock is now outside its expiry date and no more is being produced. This is because rates of meningococcal B disease have remained low. An IBS cannot now be claimed for MeNZB.

6. Pneumococcal disease

7. Pneumococcal disease is caused by Streptococcus pneumoniae
2 February 2011
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
Because there is no animal or insect vector for Streptococcus pneumoniae, immunisation programmes in the human population can reduce the prevalence of disease.1
S. pneumoniae is a gram-positive diplococcus with a polysaccharide capsule.1
Pneumococcal bacteria are categorised into serotypes on the basis of the different polysaccharide layers on their outer capsule. To date, 91 different serotypes have been defined, from type-specific antibodies.
The pneumococcal vaccine that has been in use since 1983 contains polysaccharides from 23 pneumococcal serotypes. However, it has limited immunogenicity in children younger than 2-3 years.1,2
Pneumococcal conjugate vaccines have been designed to protect children in this age-group by attaching polysaccharides to a carrier protein that triggers immune response and memory.1,2
Use of antibiotics has caused resistant strains to emerge.3 Immunisation can reduce the prevalence of antibiotic-resistant pneumococci by reducing both carriage and invasive disease.3
1US Centers for Disease Control and Prevention. Chapter 15: Pneumococcal Disease. The Pink Book - Epidemiology and prevention of vaccine preventable diseases. 11th ed. Atlanta: CDC; 2009: 217– Available at Accessed 10 January 2011.
2World Health Organization. Pneumococcal vaccines: WHO position paper Available at Accessed 10 January 2011.
3European Centre for Disease Prevention and Control. Factsheet for healthcare professionals. Available at: ssionals.aspx?MasterPage=1&PDF=true Accessed 10 January 2011.
1World Health Organization. Pneumococcal vaccines: US CDC. Epidemiology and prevention of vaccine preventable diseases EU CDC. Factsheet for healthcare professionals Photo credit: Image of pneumococcal serotype 19F; Rob Smith.

8. Pneumococcal bacteria cause disease when they spread beyond the nasopharynx
Larynx
Nasopharynx
Eustachian
tube
Nasal cavity
Trachea
Primary
bronchi
Lungs
S. pneumoniae
Colonisation
Meningitis
Upper
respiratory
tract
infections
Sinusitis
Otitis media
Invasive
disease
Lower
respiratory
tract
infections
Pneumococcal disease is caused by Streptococcus pneumoniae.1,2,3
These bacteria are benign when carried in the nasopharynx, but when they go beyond the nasopharynx they cause more severe pneumococcal disease such as pneumonia and invasive pneumococcal diseases such as septicaemia(blood poisoning), and meningitis.1,2,3
Bacterial spread within the respiratory tract causes non-invasive pneumonias, ear infections (otitis media), and sinusitis.1,2,3
Pneumococcal disease is most common in infants (<2 years) and the elderly (>65 years).1,2,3
1Ministry of Health. Chapter 16: Pneumococcal Disease. In: Immunisation Handbook. Wellington: New Zealand Government; Available at: Accessed 10 January 2011.
2US Centers for Disease Control and Prevention. Chapter 15: Pneumococcal Disease. The Pink Book - Epidemiology and prevention of vaccine preventable diseases. 11th ed. Atlanta: CDC; 2009: 217–230. Available at: Accessed 10 January 2011.
3European Centre for Disease Prevention and Control. Factsheet for healthcare professionals. Available at: ?MasterPage=1&PDF=true Accessed 10 January 2011.
Pneumonia
Bacteraemia/
septicaemia
Parapneumonic
empyema

9. 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
The World Health Organization has estimated that every year about a million children younger than 5 years die from pneumococcal diseases worldwide.1-4 Some invasive pneumococcal disease, such as meningitis, can also cause significant long-term damage such as hearing loss.5 The rationale for vaccination against invasive pneumococcal disease is clear – it can reduce severe morbidity and the resulting deaths.
Non-invasive pneumococcal diseases, such as some pneumonias, ear infections (otitis media), and sinusitis, are less severe but much more common.3,6 Therefore they also make a large contribution to the global burden of disease, and vaccination could reduce the healthcare costs of treating these diseases (e.g. acute otitis media is the most common reason for antibiotic prescriptions in developed countries).7
Every year in NZ, about 100 infants in every 100,000 are admitted to hospital because of severe pneumococcal disease, mainly pneumonia.8-12 Higher rates of severe pneumococcal disease are seen in Maori and Pacific Island populations in NZ.8-12
1World Health Organization. The global burden of disease: 2004 update. Geneva, Switzerland: WHO; 2008.
2Black RE et al. Global, regional, and national causes of child mortality in 2008: a systematic analysis. Lancet 2010;375(9730):1969–87.
3World Health Organization. Pneumococcal vaccines: WHO position paper Available at Accessed 10 January 2011.
4O’Brien K et al. Burden of disease caused by Streptococcus pneumoniae in children younger than 5 years: global estimates. Lancet 2009; 374: 893–902.
5Bedford H et al. Meningitis in infancy in England and Wales: follow up at age 5 years. Clin Vaccine Immunol. 2007;14(11):
6Melegaro A et al. The current burden of pneumococcal disease in England and Wales. J Infection 2006, 52(1):37-48.
7Silfverdal SA et al. The cost-burden of paediatric pneumococcal disease in Sweden and the potential cost-effectiveness of prevention using 7-valent pneumococcal vaccine. Vaccine 2009; 27: 1601–1608.
8Jackson C. Serious Pneumococcal Disease in New Zealand. Immunisation Advisory Centre (IMAC); 2007.
9Ministry of Health. Chapter 16: Pneumococcal Disease. In: Immunisation Handbook. Wellington: New Zealand Government; Available at: Accessed 10 January 2011.
10Drinkovic D et al. Pneumococcal bacteraemia and opportunities for prevention. NZ Med J. 2001;114(1136):
11Voss L et al. Invasive pneumococcal disease in a pediatric population, Auckland, New Zealand. Pediatr Infect Dis J ;13(10):
12Chambers S et al. Maori have a much higher incidence of community-acquired pneumonia and pneumococcal pneumonia than non-Maori: findings from two New Zealand hospitals. N Z Med J. 2006;119(1234):U1978. 
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 O’Brien et al. Lancet 2009;374:893–902.

10. Pneumonia and otitis media also cause a substantial burden of disease in NZ
Cases per 100,000* 23
295
808
S. pneumoniae can cause invasive disease such as meningitis, but most frequently presents in children with non-invasive infections such as otitis media and sinusitis.1
This slide shows the estimated hospital burden (i.e. severe disease) of pneumococcal disease and otitis media in NZ.3 Up to 80% of bacterial otitis media is caused by S. pneumoniae and non-typeable H. influenzae.1,2 In NZ, pneumonia accounts for approximately 10-fold more hospital admissions than invasive pneumococcal disease (IPD), and otitis media causes approximately 35-fold more hospital admissions for surgical and medical treatment than IPD.3
Acute otitis media causes a significant burden of disease worldwide.4 Otitis media includes acute infections and chronic conditions such as otitis media with effusion (glue ear). 80% of children are affected by AOM by 3 years of age.5 AOM represents the most common cause of GP visits for children, and the most common reason for prescription of antibiotics in developed countries.4 The WHO estimates that the global prevalence of hearing loss due to AOM is million people.4
Experts agree that the best approach for reducing the global burden of AOM is vaccination.4,6 Immunisation programmes for the different types of pneumococcal disease should deliver a range of benefits,6,7 reducing the overall burden on NZ’s healthcare system.3
1Ministry of Health. Chapter 16: Pneumococcal Disease. In: Immunisation Handbook. Wellington: New Zealand Government; Available at: Accessed 10 January 2011.
2Leibovitz E et al. Haemophilus influenzae: a significant pathogen in acute otitis media. Pediatr Infect Dis J 2004;23:1142–1152.
3Milne RJ, Vander Hoorn S. Burden and cost of hospital admissions for vaccine-preventable paediatric pneumococcal disease and non-typable Haemophilus influenzae otitis media in New Zealand. Appl Health Econ Health Policy 2010;8:281–300.
4Vergison A et al. Otitis media and its consequences: beyond the earache. Lancet Infect Dis 2010;10:195–203.
5Teele DW et al. Epidemiology of otitis media during the first seven years of life in children in greater Boston: a prospective, cohort study. J Infect Dis 1989;160(1):83–94.
6Schuerman L. Prevention of otitis media: Now a reality? Vaccine 2009;27:
7Silfverdal SA et al. The cost-burden of paediatric pneumococcal disease in Sweden and the potential cost-effectiveness of prevention using 7-valent pneumococcal vaccine. Vaccine 2009; 27: 1601–1608.
*Disease in children younger than 5 years before implementation of PCV7 immunisation in NZ.
Milne, Vander Hoorn. Appl Health Econ Health Policy 2010;8:281–300.

11. Impact of pneumococcal vaccines

12. IPD in children younger than 5 years worldwide by serotype
91 different serotypes of S. pneumoniae have been identified to date, but data from the Pneumococcal Global Serotype Project (GSP) show that most invasive pneumococcal disease worldwide in children younger than 5 years is caused by the 20 most common serotypes shown in the graph.1 However note that there are differences in this in every country.
10–15 pneumococcal serotypes account for 80–90% of all invasive pneumococcal disease in young children globally.1
Serotype 14 is the most prevalent in this age-group worldwide, and in every region of the world. 1,2
Pneumococcal conjugate vaccines have been designed to induce protection against the serotypes responsible for most severe disease in younger children, rather than all 91 serotypes.3
PCV7 was the first pneumococcal conjugate vaccine licensed for use – in 2000 in the USA.2,3,4
It contains serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F.5 When the vaccine was first introduced, these seven serotypes caused almost 90% of IPD in young children in the USA and Canada.6
1Pneumo-ADIP. Global Serotype Project Summary Report for SAGE Meeting. Geneva, Switzerland: WHO; Available at: 8%202007_Oct% pdf Accessed 10 January 2011.
2Johnson HL et al. Systematic evaluation of serotypes causing invasive pneumococcal disease among children under five: the Pneumococcal Global Serotype Project. PLoS Med 2010; 7 (10): e
3World Health Organization. Immunization, Vaccines and Biologicals. Pneumococcal vaccines. Available at: Accessed 10 January 2011.
4IMAC. Pfizer Receives FDA Approval for Prevnar February Available at: Accessed 10 January 2011.
5Wyeth. Prevenar® Data Sheet. Wyeth New Zealand; 2010.
6Hausdorff WP et al. Which pneumococcal serogroups cause the most invasive disease: implications for conjugate vaccine formulation and use, part I. Clin Infect Dis 2000;30:100–21.
Adapted from Pneumo-ADIP. Geneva: WHO; 2007.

13. PCV7 immunisation programmes in the USA have reduced IPD
Rate of invasive pneumococcal disease caused by PCV7 serotypes in the USA
Overall decline
in IPD >75%
PCV7 programme
Cases per 100,000 population
Adults ≥65 years
76% decrease
PCV7 has had a significant impact on invasive pneumococcal disease in countries where immunisation programmes have been implemented.
Routine immunisation with PCV7 was implemented in the USA in The graph shows results of a US CDC study that calculated the rates of IPD (n=1,312,144) by serotype over 6 years.1 The annual incidence of disease among children younger than 5 years caused by vaccine serotypes declined by 97%, but disease due to non-vaccine serotypes increased by 22%.1 Overall, invasive pneumococcal disease decreased by more than 75%, with a 39% decrease in hospital admissions for pneumonia among children younger than 2 years.2 The decline in rates of invasive pneumococcal disease in all age-groups revealed a ‘herd immunity’ effect, in which reduced carriage of pneumococcal serotypes by young children protected other members of the population.1,2
Data from Australia show similar reductions in IPD after the introduction of routine pneumococcal immunisation.3
Cochrane reviews of the effectiveness of PCV7 immunisation have found 88% reduction in IPD caused by PCV7 serotypes (73– 94%); 66% reduction in all serotypes (46-79%);4 22% reduction in pneumonia (11–31%);4 and 6% reduction in otitis media (-4–16%) .5
1Hicks LA et al. Incidence of pneumococcal disease due to non-pneumococcal conjugate vaccine (PCV7) serotypes in the United States during the era of widespread PCV7 vaccination, J Infect Dis. 2007;196:
2US Centres for Disease Control. Invasive pneumococcal disease in children 5 years after conjugate vaccine introduction — eight states, 1998– MMWR 2008;57(6):144–146.
3Roche PW et al. Invasive pneumococcal disease in Australia, Commun Dis Intell. 2008;32(1):18–30.
4Lucero MG et al. Pneumococcal conjugate vaccines for preventing vaccine-type invasive pneumococcal disease and pneumonia with consolidation on X- ray in children under two years of age. Cochrane Database Syst Rev 2004;4:CD DOI: / CD
5Jansen AG et al. Pneumococcal conjugate vaccines for preventing otitis media. Cochrane Database Syst Rev. 2009;2:CD
Children ≤5 years
97% decrease
Year
Adapted from Hicks et al. J Infect Dis. 2007;196:

14. PCV7 immunisation in New Zealand has reduced IPD
Incidence of invasive pneumococcal disease in children younger than 2 years
PCV7 serotypes
In NZ, routine pneumococcal vaccination was introduced in June 2008 as a 4-dose schedule of PCV7, with a catch-up programme for children born on or after January
The incidence of all invasive pneumococcal disease in children younger than 2 years was reduced from 96 cases per 100,000 in 2007 to 46 cases per 100,000 in For vaccine serotypes contained in PCV7, invasive pneumococcal disease in this age-group was reduced from 79 to 18 cases per 100,000.2
There is no evidence to date of serotype replacement
1Ministry of Health. Chapter 16: Pneumococcal Disease. In: Immunisation Handbook. Wellington: New Zealand Government; Available at: Accessed 10 January 2011.
2ESR. Invasive pneumococcal disease, New Zealand Public Health Surveillance Report 2010;8(4):4-5.
Adapted from ESR. NZ Public Health Surveillance Report 2010; 8 (4) 4-5.

15. 20 April 2011
Rates of invasive pneumococcal disease caused by serotypes 4,6B,9V,14,18C,19F,23F by age group 2004 – 2009, NZ
Ref: figure 9.2 NZ Immunisation Handbook 2011, Ministry of Health Wellington
This shows the occurrence of IPD in NZ from 2004 – It shows a decline in invasive disease in those aged less than 2 years, who comprise the population eligible for PCV7 from mid No decline isseen in older age groups so far, showing that the herd effect is not yet being seen in NZ. In the US the herd effect was seen 3 years after the introduction of PCV7 but this was in the context of a recommendation to vaccinate children up to 5 years of age. The NZ catch-up programme was limited to children born after Jan 2008 , so observation of a herd effect may be delayed. However note the herd effect has not been seen so strongly in European countries so other factors are involved such as a different spectrum of serotypes -
Although PCV7 covered almost 90% of IPD in young children in the USA and Canada when it was introduced, it covers only 45-60% of IPD in other regions.1-4 In New Zealand in 2009, it covered 71% of IPD in children younger than 5 years5
1Pneumo-ADIP. Global Serotype Project Summary Report for SAGE Meeting. Geneva, Switzerland: WHO; Available at: %202007_Oct% pdf Accessed 10 January 2011.
2Hausdorff WP et al. Which pneumococcal serogroups cause the most invasive disease: implications for conjugate vaccine formulation and use, part I. Clin Infect Dis 2000; 30: 100– 21.
3Wyeth. Prevenar® Data Sheet. Wyeth New Zealand; 2010.
4Johnson HL et al. Systematic evaluation of serotypes causing invasive pneumococcal disease among children under five: the Pneumococcal Global Serotype Project. PLoS Med 2010;7(10):e
5Institute of Environmental Science and Research. Invasive pneumococcal disease in New Zealand, Report for the Ministry of Health. Wellington, NZ: ESR; 2010.
Ref: Figure 9.2 NZ Immunisation Handbook 2011

16. Pneumococcal vaccines in NZ
20 April 2011
Pneumococcal vaccines in NZ

17. 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
PCV7: Prevenar 4,6b,9v,14,18c,19f,23f
PCV10: Synflorix + 1,5,7F
PCV13: Prevenar ,3,5,6A,7F,19A

18. Summary of pneumococcal vaccine serotype content
20 April 2011
Summary of pneumococcal vaccine serotype content
Vaccine
Serotypes
PCV7
4,6B,9V,14,18C,19F,23F
PCV10
All serotypes in PCV7 + 1,5,7F
PCV13
All serotypes in PCV10 + 3,6A,19A
23PPV
All serotypes in PCV ,8,9N,10A,11A,12F15B,17F,20,22F,33F
Table adapted from Table 9.1 NZ Immunisation Handbook 2011

19. Polysaccharide vaccines
Made from polysaccharide from the capsule surrounding the bacteria
Works in adults
Two major problems
Not immunogenic in babies
No immune memory
A polysaccharide is a string of saccharides, or sugars. Gram +ve bacteria have these polysaccharides on the outside of their cell wall. The polysaccharides are associated with lipids (lipopolysaccharide or LPS).
The immune system recognises these polysaccharides and makes antibody against them. This antibody has an important function in the elimination of the bacteria.
The immune systems of children under the age of about 2 years are not efficient at making these antibodies.
This is why polysaccharide vaccines are not used in young children and babies – they are not very effective.
String of sugars = polysaccharide

20. Conjugate vaccine Polysaccharide And lipid (LPS) Pneumococcal
bacterium
Lipid
CRM197 Protein Carrier
Chemical
Reaction
Purification
process
Polysaccharide-protein
conjugate
To overcome this problem the polysaccharides are coupled with an immunogenic protein. In this example ( Prevenar and Prevenar 13 vaccine) this protein is derived from the diphtheria toxin. It is called CRM197 (Cross Reactive Protein 197). Many other conjugates have also been designed

21. PCV10 (Synflorix)
This is a similar style of vaccine to PCV7 except if has 3 extra serotypes, and is conjugated to a different conjugate – non-typeable Hib which may offer extra protection against otitis media - extra slides below on OM if wish to discuss further

22. Synflorix increases coverage of IPD worldwide
IPD in children younger than 5 years worldwide by serotype
The WHO published a requirement that future vaccine formulations must include serotypes 1 and 5,1 which cause a large proportion of severe infections in other parts of the world,2 leaving a significant unmet need. Synflorix increases coverage of invasive pneumococcal disease by the addition of serotypes 1, 5, and 7F.3 In New Zealand in 2009, serotypes 1, 5, and 7F represented 17% of IPD in children younger than 5 years.4
Synflorix also induces cross-reactive immune responses to serotypes 6A and 19A.2,3,5. Synflorix is not indicated for protection against disease caused by serotypes not included in the vaccine.3
1World Health Organization. Target Product Profile for the Pneumococcal Advanced Market Commitment. Geneva: WHO; Available at: Accessed 10 January 2011.
2Pneumo-ADIP. Global Serotype Project Summary Report for SAGE Meeting. Geneva, Switzerland: WHO; Available at: 8%202007_Oct% pdf Accessed 10 January 2011.
3GlaxoSmithKline. Synflorix® Data Sheet. GSK New Zealand; Available at: Accessed 3 January 2011.
4Institute of Environmental Science and Research. Invasive pneumococcal disease in New Zealand, Report for the Ministry of Health. Wellington, NZ: ESR; 2010.
5Wyeth. Prevenar® Data Sheet. Wyeth New Zealand; 2010.
Adapted from: 1Pneumo-ADIP. Geneva: WHO; GSK. Synflorix Data Sheet

23. Serotypes that cause invasive pneumococcal disease can vary over time
Serotype 1 has increased in NZ in recent years1 and is one of the most prevalent serotypes in IPD globally2
In 2009 in NZ, serotype 1:
was the most prevalent cause of IPD (153 cases, 16%) in the total population1
was the most prevalent cause of IPD in children younger than 2 years (12 cases, 22%)1
was the second most prevalent serotype (15 cases, 16%) after serotype 14 (17 cases, 18%) in children under 5 years of age1
The incidence of 19A has been steady in NZ over recent years, with no increase observed since the introduction of PCV71,3,4
8 cases in children younger than 2 years in 20091
The prevalence of specific pneumococcal serotypes follows temporal trends, so it is important to evaluate the prevalence over time. Some changes may be associated with introduction of PCV7 and others may be independent of immunisation programmes. See backup slides for more detail.
IPD in children younger than 5 years is most often caused by serotype 14 – globally, and in every region, including NZ.1,2
Serotype 1 has risen in NZ in recent years.2-4 In 2009 serotype 1 was:
the most prevalent cause of invasive pneumococcal disease in 2009 in all ages and in children younger than 2 years2
the second most common cause of invasive pneumococcal disease in children younger than 5 years (after serotype 14)2
Increases in 19A IPD have been observed in some parts of the world, notably the USA.5-7 The reason is not yet understood – it could be caused by antibiotic use rather than PCV7 vaccination programmes. For example, serotype 19A has risen in countries without PCV7 immunisation (e.g. Korea), and has not risen in some regions that have high vaccine coverage (e.g. Northern California, Norway, Germany).5-7
In NZ, the incidence of 19A IPD is steady, representing 6.3% of cases in 0-4 year olds in 2008 (8-12 cases per year since 2005).2,3
1Pneumo-ADIP. Global Serotype Project Summary Report for SAGE Meeting. Geneva, Switzerland: WHO; Available at: 8%202007_Oct% pdf Accessed 10 January 2011.
2Institute of Environmental Science and Research. Invasive pneumococcal disease in New Zealand, Report for the Ministry of Health. Wellington, NZ: ESR; 2010.
3ESR. Invasive pneumococcal disease, New Zealand Public Health Surveillance Report 2010;8(4):4-5.
4Heffernan H et al. Invasive pneumococcal disease in New Zealand 1998–2005: capsular serotypes and antimicrobial resistance. Epidemiol. Infect. 2008;136:352–359.
5Hicks LA et al. Incidence of pneumococcal disease due to non-pneumococcal conjugate vaccine (PCV7) serotypes in the United States during the era of widespread PCV7 vaccination, J Infect Dis. 2007;196:
6Whitney CG et al. Effectiveness of seven-valent pneumococcal conjugate vaccine against invasive pneumococcal disease: a matched case-control study. Lancet 2006; 368:1495–1502.
7Park IH et al. Differential effects of pneumococcal vaccines against serotypes 6A and 6C. J Infect Dis 2008;198:1818– 1822.
1ESR. Invasive pneumococcal disease in New Zealand, Pneumo-ADIP. WHO; ESR. NZ Publ Health Surveill Rep 2010;8(4):4-5. 4Heffernan et al. Epidemiol. Infect 2008;136:352–359.

24. Synflorix extends coverage against IPD
The WHO required that future vaccines contain serotypes 1 and 5, since they cause a large proportion of severe disease.1
Serotypes 1, 5, and 7F together account for about 15% of global pneumococcal morbidity and mortality.2
In NZ in 2009, serotypes 1 and 7F caused 17% of IPD in children younger than 5 years.3
These serotypes were included in Synflorix because compared with other serotypes they cause more:
invasive disease (1 and 5)4
complicated pneumonias and empyemas (1, 5, and 7F)5
severe disease and deaths (7F)6
outbreaks of meningitis (1 and 5)7
Synflorix covers more serotypes that cause invasive pneumococcal disease than PCV7 does.1 The extra serotypes 1, 5, and 7F together account for approximately 15% of global pneumococcal morbidity and mortality.1
Not all serotypes are created equal. The additional serotypes chosen for inclusion in Synflorix are particularly prevalent and cause severe disease.
Some are more likely than others to cause invasive disease (e.g. serotypes 1 and 5 are 60 times more invasive than 3 and 6A,2 and more likely to cause invasive disease3) See back-up slides.
Some cause complicated pneumonia and empyema (serotypes 1 and 7F).4,6-9 The incidence of empyema has increased globally, and in New Zealand in recent years.6,10 See back-up slides.
Some serotypes cause more severe disease than others, or higher case-fatality rates (7F is the serotype most associated with deaths)5 See back-up slides.
Some are associated with outbreaks of meningitis (serotypes 1 and 5 in Indigenous Australian populations)11
1Pneumo-ADIP. Global Serotype Project Summary Report for SAGE Meeting. Geneva, Switzerland: WHO; Available at: Accessed 11 January 2011.
2Brueggemann AB et al. Temporal and geographic stability of the serogroup-specific invasive disease potential of Streptococcus pneumoniae in children. J Infect Dis 2004;190:1203–1211.
3Shouval DS et al. Site-specific disease potential of individual Streptococcus pneumoniae serotypes in pediatric invasive disease, acute otitis media and acute conjunctivitis. Pediatr Infect Dis J 2006;25(7):602–607.
4Hausdorff W et al. Epidemiological differences among pneumococcal serotypes. Lancet Infect Dis 2005;5:83–93.
5Ruckinger S et al. Association of serotype of Streptococcus pneumoniae with risk of severe and fatal outcome. Pediatr Infect Dis J 2009;28:118–22.
6Byington CL et al. Impact of the pneumococcal conjugate vaccine on pneumococcal parapneumonic empyema. Pediatr Infect Dis J 2006;25:
7Munoz-Almagro C et al. Emergence of invasive pneumococcal disease caused by nonvaccine serotypes in the era of 7-valent conjugate vaccine. Clin Infect Dis. 2008;46:
8Obando I et al. Molecular typing of pneumococci causing parapneumonic empyema in Spanish children using multilocus sequence typing directly on pleural fluid samples. Pediatr Infect Dis J 2006;25:962–3.
9Hausdorff W et al. Serotypes and pathogens in paediatric pneumonia. Vaccine 2007;25:2406–12.
10Mahon C. Parapneumonic effusion and empyema in South Auckland children : a retrospective review. Poster at 62nd Annual Meeting of Paediatric Society NZ; November 2010.
11Torzillo PJ et al. Changing epidemiology of invasive pneumococcal disease in central Australia prior to conjugate vaccine: a 16-year study. Vaccine 2007;25:2375–78.
1WHO. Target Product Profile for the Pneumococcal AMC Pneumo-ADIP. WHO; ESR. Invasive pneumococcal disease in New Zealand, Shouval et al. Pediatr Infect Dis J 2006;25(7):602– Hausdorff et al. Vaccine 2007;25:2406–12. 6Ruckinger et al. Pediatr Infect Dis J 2009;28:118–22. 7Torzillo et al. Vaccine 2007;25:2375–78.

25. Main carrier protein: Protein D
Composition of Synflorix – designed as a
dual-pathogen vaccine
Non-typeable
H. influenzae
Main carrier protein: Protein D
S. pneumoniae
Polysaccharides
4, 6B, 9V, 14, 18C, 19F, 23F DT TT
1, 5, 7F
NTHi Protein D
8 serotypes conjugated to protein D
18C conjugated to tetanus toxoid (TT)
19F conjugated to diphtheria toxoid (DT)
Synflorix contains the seven serotypes in PCV7, plus serotypes 1, 5, and 7F to increase coverage of IPD.1 Like other pneumococcal conjugate vaccines Synflorix uses a carrier protein to induce immune memory in infants.
8 serotypes are conjugated to Protein D from non-typeable H. influenzae (NTHi)
18C is conjugated to tetanus toxoid
19F is conjugated to diphtheria toxoid
Protein D from NTHi:
enhances the immunogenicity of S. pneumoniae polysaccharides, and triggers immune responses to conjugated serotypes even in young children with immature immune systems2-4
avoids interference with coadministered vaccines4
Synflorix has been designed not only to protect against pneumococcal disease, but also to stimulate immune responses against NTHi.5-8 This innovative design offers the potential to expand protection beyond pneumococcal disease.1,9 Data on immune responses against NTHi are reviewed in the Synflorix Data Sheet.1 Synflorix is only indicated for immunisation against pneumococcal disease.1
1GlaxoSmithKline. Synflorix® Data Sheet. GSK New Zealand; Available at: Accessed 3 January 2011.
2Wysocki J et al. Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae Protein D conjugate vaccine (PHiD-CV) when coadministered with different Neisseria meningitidis serogroup C conjugate vaccines. Pediatr Infect Dis J 2009;28:S77–S88.
3Vesikari T 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–S76.
4Knuf M et al. Immunogenicity of routinely used childhood vaccines when coadministered with the 10-valent pneumococcal non-typeable Haemophilus influenzae Protein D conjugate vaccine (PHiD-CV). Pediatr Infect Dis J 2009;28:S97–S108.
5Wysocki J et al. Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae Protein D conjugate vaccine (PHiD-CV) when coadministered with different Neisseria meningitidis serogroup C conjugate vaccines. Pediatr Infect Dis J 2009;28:S77–S88.
6Knuf M et al. Immunogenicity of routinely used childhood vaccines when coadministered with the 10-valent pneumococcal non-typeable Haemophilus influenzae Protein D conjugate vaccine (PHiD-CV). Pediatr Infect Dis J 2009;28:S97–S108.
7Prymula R et al. Pneumococcal capsular polysaccharides conjugated to protein D for prevention of acute otitis media caused by both Streptococcus pneumoniae and non-typable Haemophilus influenzae: a randomised double-blind efficacy study. Lancet 2006;367:740–748.
8Vesikari T 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–S76.
9Prymula R, Schuerman L. 10-valent pneumococcal nontypeable Haemophilus influenzae PD conjugate vaccine: Synflorix™. Expert Rev Vaccines 2009;8:1479–1500.
GSK NZ. Synflorix Data Sheet

26. Summary: the design of Synflorix
Synflorix protects against invasive pneumococcal disease, pneumonia, and acute otitis media1
Synflorix extends protection by inclusion of serotypes 1, 5, and 7F1
Additional design features:
Inclusion of 6B and 19F stimulates cross-reactive functional immune responses to pneumococcal serotypes 6A and 19A.1,2
Inclusion of Protein D enables immune responses against not only S. pneumoniae but also NTHi (these two bacteria cause up to 80% of acute otitis media)1-5
Note: Data on immune responses to cross-reactive serotypes and NTHi are reviewed in the Synflorix Data Sheet.1 Synflorix is only indicated against disease caused by vaccine serotypes.1 Large-scale effectiveness studies are ongoing.6,7
Synflorix is a next-generation vaccine with the potential to further reduce the burden of pneumococcal disease, including additional serotypes 1, 5, and 7F.1,2
Synflorix is not indicated against disease caused by serotypes 6A or 19A.2 Synflorix induces functional antibodies to 6A and 19A2-6 Post-licensure studies are ongoing to investigate the clinical significance of the functional 6A and 19A antibodies.7,8
Synflorix protects against S. pneumoniae, which is one of the two leading causes of bacterial otitis media. Post-licensure studies are ongoing to investigate whether use of Protein D from NTHi increases protection against this disease.7-9 Data on immune responses to Protein D and protection against otitis media are reviewed in the Synflorix Data Sheet, but Synflorix is not indicated against disease caused by non-typeable H. influenzae.2
1Dagan R et al. Clinical characteristics of a novel 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine candidate (PHiD-CV). Introduction. Pediatr Infect Dis J 2009;28(4):S63-65.
2GlaxoSmithKline. Synflorix® Data Sheet. GSK New Zealand; Available at: Accessed 3 January 2011.
3Vesikari T 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–S76.
4Prymula R et al. Pneumococcal capsular polysaccharides conjugated to protein D for prevention of acute otitis media caused by both Streptococcus pneumoniae and non-typable Haemophilus influenzae: a randomised double-blind efficacy study. Lancet ;367:740–748.
5Wysocki J et al. Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae Protein D conjugate vaccine (PHiD-CV) when coadministered with different Neisseria meningitidis serogroup C conjugate vaccines. Pediatr Infect Dis J ;28:S77–S88.
6Hausdorff W et al. Do pneumococcal conjugate vaccines provide any cross-protection against serotype 19A? BMC Pediatr ;10:4.
7GSK. COMPAS (Clinical Otitis Media & Pneumonia Study): Pneumonia & AOM Efficacy Study of the Pneumococcal Conjugate Vaccine Available at: Accessed 11 January 2011.
8GSK. Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine A Against Invasive Disease (FinIP) Available at: Accessed 11 January 2011.
9Schuerman L Prevention of otitis media: Now a reality? Vaccine 2009;27:
1GSK NZ. Synflorix® Data Sheet Wysocki et al. Pediatr Infect Dis J 2009;28:S77–88. 3Hausdorff et al. BMC Pediatr 2010;10:4. 4Prymula et al. Lancet 2006;367:740–748. 5Schuerman. Vaccine 2009;27: GSK. COMPAS (Clinical Otitis Media & Pneumonia Study) GSK. Pneumococcal Conjugate Vaccine A (FinIP)

27. National immunisation programmes:
Global use of Synflorix (April 2011)
First registered in December 2008
Now approved in 83 countries
3 + 1 schedule
Australia (Northern Territories)
Austria (high-risk groups)
Albania
Brazil
Bulgaria
Cyprus (high-risk groups)
Hong Kong
Taiwan  (Taipei)
The Netherlands
National immunisation programmes:
2 + 1 schedule
Colombia (Bogotá)   
Finland
Mexico
Sweden  (3 provinces)
3 + 0 schedule
Kenya       
Synflorix was first registered in Canada in December 2008, and is currently approved for use in 83 countries.1
Countries where Synflorix is being used in national immunisation programmes are shown.
Synflorix was also the first pneumococcal vaccine to receive WHO prequalification for global use.2 The prequalification process consists of transparent, scientifically sound assessments, based on standards of quality, safety, and efficacy, which include consistency testing and site visits.
In the past year, more than 7 million doses of Synflorix have been distributed worldwide, including those made available to developing countries such as Kenya.1
1GlaxoSmithKline. Data on file. November 2010.
2 World Health Organization. WHO prequalification of Synflorix: Pneumococcal (conjugate) 1 dose vial. Geneva, Switzerland: WHO; 30 October, Available at: GSK_1dose/en/ Accessed 2 January 2011.
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 WHO prequalification of Synflorix

28. 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
A combined analysis of clinical studies of safety in more than 4,000 healthy infants1,2,3 showed that the most common adverse reactions observed after primary vaccination were local site reactions (pain, redness and swelling) and the general reactions of drowsiness, irritability, loss of appetite and fever.1,2 Most reactions were of mild to moderate severity and were not long-lasting.1,2 No safety concerns were identified.1-3
During clinical studies, Synflorix was administered to over 3,500 healthy infants as primary vaccination and 2,000 infants as a booster vaccination.2-4
As with other vaccines, an increase in reactogenicity was reported following the booster vaccination compared to the primary course.1-3 The majority of these reactions were of mild to moderate severity and were not long-lasting.2,3
1Chevallier B et al. Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines. Pediatr Infect Dis J 2009; 28(4): S109-S118.
2Prymula R, Schuerman L. 10-valent pneumococcal nontypeable Haemophilus influenzae PD conjugate vaccine: Synflorix. Expert Rev Vaccines 2009;8:1479–1500.
3Knuf M et al. Immunogenicity of routinely used childhood vaccines when coadministered with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Pediatr Infect Dis J 2009;28:S97–108.
4GlaxoSmithKline. Synflorix® Data Sheet. GSK New Zealand; Available at: Accessed 3 January 2011.
5Jefferson T et al. Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence. Lancet Infect Dis 2004;4(2):84–90.
1Chevallier et al. Pediatr Infect Dis J 2009;28:S109–118.

29. Synflorix can be co administered with other vaccines available in NZ
Vaccines on the Immunisation Schedule:1
DTaP-IPV-HepB-/Hib2-6 (Infanrix-hexa, Infanrix-IPV)
MMR7
Vaccines approved but not funded 1
Hib MenC2,6
Rotavirus vaccine8 (e.g. Rotarix)
Varicella vaccine7 (e.g. Varilrix)
Synflorix can be given with any of the following monovalent or combination vaccines: diphtheria-tetanus-acellular pertussis vaccine (DTPa),1,2, hepatitis B vaccine,1,2 inactivated polio vaccine (IPV),1,2 Haemophilus influenzae type b vaccine (Hib),1,2 DTPa-HBV- IPV/Hib,1,2,6DTPw-HBV/Hib,1,2,6 diphtheria-tetanus-whole cell pertussis vaccine (DTPw),1,2 measles-mumps-rubella vaccine (MMR),5 varicella vaccine,5 meningococcal serogroup C conjugate vaccine (CRM197 and TT conjugates),1,2 and rotavirus vaccine.4,9
Specific clinical trials to assess coadministration of Synflorix with influenza vaccines have not been conducted. However, there are no known contraindications to administering Synflorix at the same time as vaccines for seasonal influenza, provided that they are administered in separate syringes at different injection sites.1,2,8
1Knuf M et al. Immunogenicity of routinely used childhood vaccines when coadministered with the 10-valent pneumococcal non- typeable Haemophilus influenzae Protein D conjugate vaccine (PHiD-CV). Pediatr Infect Dis J 2009;28:S97–S108.
2Wysocki J, et al. Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae Protein D conjugate vaccine (PHiD-CV) when coadministered with different Neisseria meningitidis serogroup C conjugate vaccines. Pediatr Infect Dis J 2009;28:S77–S88.
3Chevallier B et al. Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines. Pediatr Infect Dis J 2009; 28, S109– S118.
4Huang LM et al. Antibody responses and safety of a 10-valent pneumococcal nontypeable Haemophilus influenzae Protein D- conjugate vaccine (PHiD-CV) in Taiwanese infants (NA25). Bangkok: 7th International Symposium on Antimicrobial Agents and Resistance; 2009.
5Vesikari T. Immunogenicity and safety of a Measles-Mumps-Rubella-Varicella (MMRV) vaccine co-administered with pediatric vaccines in children aged months (ESPID ). Graz: 26th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID); 2008.
6Bermal N et al. Safety and immunogenicity of a booster dose of the 10-valent pneumococcal nontypeable Haemophilus influenzae Protein D conjugate vaccine coadministered with DTPw-HBV/Hib and poliovirus vaccines. Pediatr Infect Dis J 2010 Oct 26. [Epub ahead of print PMID: ]
7Bermal N et al. The 10-valent pneumococcal non-typeable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) coadministered With DTPw-HBV/Hib and poliovirus vaccines: assessment of immunogenicity. Pediatr Infect Dis J 2009;28:S89–S96.
8GlaxoSmithKline. Synflorix® Data Sheet. GSK New Zealand; Available at: Accessed 3 January 2011.
9Prymula R, Schuerman L. 10-valent pneumococcal nontypeable Haemophilus influenzae PD conjugate vaccine: Synflorix™. Expert Rev Vaccines 2009;8:1479–1500.

30. 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
Like PCV7, Synflorix is presented as a suspension in 0.5mL prefilled syringes, in packs of 10.1,2
Synflorix boxes should be refrigerated at 2–8°C (and not frozen).1 Store in the original package to protect from light.1
Shelf life is 3 years from date of manufacture.1
Shake well before use.1
1. GlaxoSmithKline. Synflorix® Data Sheet. GSK New Zealand; Available at: Accessed 3 January 2011.
2. Wyeth. Prevenar® Data Sheet. Wyeth New Zealand; Available at: Accessed 3 January 2011.
GSK NZ. Synflorix Data Sheet, 2010.

31. 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.
Synflorix should also be administered in the same way as PCV7: by intramuscular injection.1,4
The preferred sites are the vastus lateralis of the thigh in children younger than 1 year or the deltoid muscle of the upper arm in children older than 1 year.1
Each prefilled syringe contains one dose (0.5mL).1,4
There is no need to expel air from the syringe prior to use
1. GlaxoSmithKline. Synflorix® Data Sheet. GSK New Zealand; Available at: Accessed 3 January 2011.
2. Wyeth. Prevenar® Data Sheet. Wyeth New Zealand; Available at: Accessed 3 January 2011.
Remove the needle protector and administer the vaccine.
GSK NZ. Synflorix Data Sheet, 2010.

32. More information on Synflorix
Phone the Immunisation Advisory Centre on:
0800 IMMUNE ( )
Go to or
Refer to the Synflorix Data Sheet and Consumer Medicine Information on the Medsafe website:
For GSK Medical Information in NZ, please call or , and ask for the Medical Information Department.
GlaxoSmithKline. Synflorix® Data Sheet. GSK New Zealand; Available at: Accessed 3 January 2011.
GSK NZ. Synflorix Data Sheet, 2010.

33. Prevenar 13® and the Pneumococcal high risk programme

34. 20 April 2011
Incidence rates of invasive pneumococcal disease by serotype, in children aged less than five years, New Zealand, 1998 – (NB prior to introduction of PCV vaccine)
Ref: Figure 9.1 Immunisation Handbook 2001, Ministry of Health, Wellington
This graph shows the incidence of serotypes in NZ, and which type is covered by which vaccine note the small amount of extra protection offered by switching to PCV10, and further additional coverage from switching to PCV13. Hence for children who are at very high risk of pneumococcal disease there is a extra small gain in protection against broader serotypes by using Prevenar13

35. Prevenar 13 for high risk children
20 April 2011
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
Licensed to aged 5 years, if wanting to use to high risk children 5 years and above this is currently out of licensure and would need to be given with full informed consent that it is outside of licensure. There are not expected to be any safety concerns in giving to older children.

36. 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:
PCV13 replaces PCV10 once high risk is recognised. Secondary service specialist approval is no longer required.
Unimmunised: 2-5 years: 2 doses 8 weeks apart followed by 23PPV
PCV13 one dose followed by 23PPV for 5yrs and above
NB PCV13 is not licensed above 5 years of age, older children being offered conjugate PCV will need to be offered it outside of licensure. There are not expected to be any safety concerns with this, but full informed consent needs to be undertaken.

37. Schedule for high risk children
20 April 2011
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
Ordering PCV13: Do not hold supplies in fridge, order on a case by case basis as needed. There will be restrictions on ordering – awaiting further information from the Ministry

38. More information on Prevenar 13
20 April 2011
More information on Prevenar 13
Phone the Immunisation Advisory Centre on
0800 IMMUNE ( )
Refer to Prevenar 13 datasheet
Contact Pfizer:
Phone
Fax
Pfizer’s 0800 number for medical questions about vaccines. They will transfer our call to Medical Affairs in Australia. It’s worth remembering that Australia (NSW where Pfizer head Office is) is 2 hours behind NZ so no point ringing before /11am.
The other contact if needed is: 
Carmel Murphy
Associate Brand Manager - Vaccines
Pfizer New Zealand
Tel:
DDI:
Mob:
Fax:
 Level 3 Pfizer House
14 Normanby Road
Mt Eden
Auckland 1024
New Zealand

39. Children/Adults high risk: pre or post splenectomy
20 April 2011
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
The vaccines are fully funded for this programme and the Immunisation Benefit Subsidy can be claimed
PCV13 and Act-HIB are licensed to aged 5 years, if wanting to use to high risk children 5 years and above this is currently out of licensure and would need to be given with full informed consent that it is outside of licensure. There are not expected to be any safety concerns in giving to older children.
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

40. Other vaccine changes

41. 20 April 2011
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:
Currently is supplied in single packets
There may be slight differences in the amount of tetanus protein (toxoid) in Act-Hib cf to Hiberix
From datasheets:
Act-HIB: Haemophilus influenzae type b polysaccharide (10mcg) conjugated to tetanus protein (18-30mcg).
Hiberix: 10 mcg of purified capsular polysaccharide covalently bound to approximately 30 mcg tetanus toxoid.

42. 20 April 2011
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:
See TB section of the 2011 Handbook
BCG introduced in NZ in 1948, extended to all adolescents later. Discontinued in the South Island in 1963 and phased out in regions of the North island in the 1980s, and ceased by If population-specific rates rise over 10 per 100,000 in particular districts this would warrant reconsideration of this policy
Neonatal BCG introduced in 1976, initially in districts with high rates of active TB, now offered only to high risk groups. Given by gazetted vaccinators intradermal.
Nb the previous policy till 2011:
Infants eligible for BCG immunisation are those who:
Will be living in a house or with family or whânau where a person has TB or a history of TB
Have one or both parents who are of Pacific ethnicity
Have parents or household members who, within the past five years, lived for a period of six months or longer in a country with a high incidence of TB
During their first five years will be living for three months or longer in a country with a high incidence of TB
The major change is that fewer Pacific countries are now considered high risk for TB

43. BCG cntd.
As a general indication, the following global areas have rates of ≥ 40/ 100,000
Most of Africa
Much of South America
Russia and the former Soviet States
Indian Subcontinent
China including Hong Kong
South East Asia (except Singapore)
Pacific (except Cook Islands, Fiji, Niue, Samoa, Tokelau and Tonga)

44. Qs and As

45. Common Qs and As Why was PCV10 introduced rather than PCV13?
20 April 2011
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
Several countries have switched seamlessly from PCV7 to PCV10 including Australia, Canada, Sweden, Hong Kong (Ref NZ Immunisation Handbook 2011 pg 193)
NB: there is a possible concern that serotype 19A which is a relatively common serotype may take advantage of the niche created by relative lack of protection by PCV10 – so NZ is enhancing its surveillance to watch serotypes closely following the introduction of PCV10.

46. Qs & As cntd. What about when to use 23 PPV vaccine?
20 April 2011
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

47. 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

48. 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.

49. 20 April 2011
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 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

50. Qs and As cntd. Co administration of Influenza and PCV vaccines
Fevers are known to occur after influenza vaccines, and febrile convulsions are a recognised complication of fever.
Approximately 24% of all children have a febrile convulsion at some stage in their life.
In February 2011 the Center for Disease Control and Prevention (CDC) in the U.S.A. presented findings from the Vaccine Safety Datalink in the U.S.A., which identified there may be a small increase in the risk of fever, and febrile convulsion, in children aged 12 to 23 months of age when an inactivated influenza vaccine was administered at the same time as the pneumococcal conjugate vaccine Prevenar 13 (PCV13).
Out of prudence, parents should be advised that there may be a small increase in the risk of fever, and associated febrile convulsion in susceptible children when PCV vaccine is administered with influenza vaccine, over and above having the vaccines separately.
Ref: CDC Feb 2011

51. Back-up slides

52. 20 April 2011
Meningococcal disease rates for selected strains and all cases, by year Data provisional, ESR
Note the epidemic line showing the epidemic strain rates have dropped since and stayed at low levels over the past 3 years. The reason for the decline is a mixture of the fact that the epidemic was starting to decline anyway, but the vaccination programme started in 2004/2005 assisted in reducing numbers as well.
The number of total meningococcal disease notifications has not increased. Levels of meningococcal disease are now slightly less than the low reached in 2007; with 96 cases notified in 2010 (a rate of 2.2 per 100,000 population) compared to 104 notifications of meninogococcal disease in 2007.
The number of epidemic strain meningococcal disease has steadily decreased from its peak of 370 in 2001, to 47 in 2007, and 24 cases in Almost all of the cases in 2010 were in children less than five years of age (21). The yearly number of epidemic strain meningococcal disease in children less than five years of age has been stable since 2007 when there were 25 cases, 23 in 2008, 22 in 2009, and 21 in 2010 (see last Figure and Table, on page 4)

53. Synflorix and acute otitis media protection

54. Ear infections are debilitating, affect hearing, and can delay learning
Every year, otitis media in NZ children younger than 5 years accounts for:
83,000 GP consultations1 and 5,000 hospital admissions2
Antibiotics prescribed for at least 50% of cases1
Ethnic disparities in ear health:
Hospital admissions for Maori and Pacific Island children with otitis media are twice those for other children3,4
Maori and Pacific Island children are more than twice as likely as other children to fail new-entrant school hearing checks5,6
Otitis media constitutes a significant burden on NZ’s health system.1,2
Every year in NZ, there are at least:
83,000 GP consultations for new cases of OM in children younger than 5.2
5,000 hospital admissions for OM each year in NZ children under 5 years of age (average in 2000–2007).1
Antibiotics were prescribed for approximately 50% of GP visits for OM,2 despite the fact that empiric treatment with antibiotics provides only modest benefit.3 Therefore, prevention of OM by immunisation would reduce over-prescribing of antibiotics, which contributes to development of resistance.3
Ethnic disparities in ear health
Maori and Pacific Island children are disproportionately affected; their hospital admission rates for OM are twice those of European and other children, which suggests that they have more severe disease.4 Conversely, Maori and Pacific Island children with OM are less likely to have important surgical interventions, such as grommets.1,4
Maori children in rural areas have been found to have a higher incidence of ear disease with lower recovery rates than non-Maori children.5
A survey of Maori children with persistent middle ear effusion, cholesteatoma, or perforations demonstrated that 49/194 (25%) children suffered hearing loss.5
New entrant hearing-check failure rates: 11.2% Pacific; 10.3% Maori; and 4.4% European children.2
7.1% of 3-year-olds in NZ failed screening by serial tympanometry.3 Maori and Pacific Island children had higher failure rates at 16.8% and 17.1%, respectively.3
A study of hearing loss in NZ prisoners showed that 69% of prisoners had at least one ear with a hearing loss of 15dB or greater. 83% of Māori prisoners had at least one ear with a hearing loss of 15dB or greater, in comparison to 54% of European prisoners.6
1Milne RJ, Vander Hoorn S. An economic evaluation of replacement of 7-valent pneumococcal vaccine with either a 10-valent or a 13-valent pneumococcal vaccine on the New Zealand Childhood Immunisation Schedule. Report to the New Zealand Ministry of Health. Auckland, NZ: Health Outcomes Associates; November 2009.
2Gribben B. The incidence in primary care of acute otitis media in children <5 years of age in New Zealand. CBG Health Research. GSK Data on file; March 2010.
3Vergison A et al. Otitis media and its consequences: beyond the earache. Lancet Infect Dis 2010;10:195–203.
4Milne RJ, Vander Hoorn S. Burden and cost of hospital admissions for vaccine-preventable paediatric pneumococcal disease and non-typable Haemophilus influenzae otitis media in New Zealand. Appl Health Econ Health Policy 2010;8:281–300.
4Teele DW et al. Epidemiology of otitis media during the first seven years of life in children in greater Boston: a prospective, cohort study. J Infect Dis 1989;160(1):83–94
5Stanhope JM et al. Ear disease in rural New Zealand school children. NZ Med J 1978;88:5–8.
6Bowers M Hearing Impairment in Prisoners. Auckland: Deafness Research Foundation.
1Gribben. GSK Data on file; Milne, Vander Hoorn. Report to NZ Ministry of Health Milne, Vander Hoorn. Appl Health Econ Health Policy 2010;8:281– Stanhope et al. NZ Med J 1978;88:5–8. 5Ministry of Social Development. Wellington;MSD: NZ Health Technology Assessment. Wellington:NZHTA; 1998.

55. An 11-valent prototype for Synflorix was effective against AOM
100 80 60 40 20
-20
-40
-60
-80
-100
Vaccine efficacy against acute otitis media (95%CI) *
All pneumococcal serotypes
Cause of AOM:
All-cause
Non-vaccine serotypes
Evidence supporting the effectiveness of Synflorix for protection against acute otitis media is from an 11-valent Synflorix prototype vaccine.1,2 This vaccine contained serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F, plus 1, 5, 7F, and 3. All were conjugated to protein D from non- typeable H. influenzae. After this study, the prototype vaccine was refined; for example, serotype 3 was removed because it was not shown to be effective for protection against otitis media.3 See back-up slides.
The results showed efficacy against all-cause AOM and AOM caused by S. pneumoniae.1,2 Vaccine efficacy against all clinical AOM episodes was 33.6% (95% CI: 20.8–44.3).1 Vaccine efficacy against AOM episodes caused by pneumococcal serotypes contained in the vaccine was 57.6% (41.4– 69.3).1 These results are reviewed in the Synflorix Data Sheet.4 Two major clinical studies are currently ongoing (in South America and Finland) with the final formulation of Synflorix.5,6 They are event-driven trials, which should start to reach endpoints by late ,6 See back-up slides.
1Prymula R et al. Pneumococcal capsular polysaccharides conjugated to protein D for prevention of acute otitis media caused by both Streptococcus pneumoniae and non-typable Haemophilus influenzae: a randomised double-blind efficacy study. Lancet 2006;367:740–748.
2Schuerman L Prevention of otitis media: Now a reality? Vaccine 2009;27:
3Poolman J et al. Pneumococcal serotype 3 otitis media, limited effect of polysaccharide conjugate immunisation and strain characteristics. Vaccine 2009;27:3213–3222.
4GlaxoSmithKline. Synflorix® Data Sheet. GSK New Zealand; Available at: Accessed 3 January 2011.
5GSK. Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine A Against Invasive Disease (FinIP) Available at: Accessed 11 January
6GSK. COMPAS (Clinical Otitis Media & Pneumonia Study): Pneumonia & AOM Efficacy Study of the Pneumococcal Conjugate Vaccine Available at: Accessed 11 January 2011.
*Statistically significant effect
Adapted from: 1Prymula et al. Lancet 2006;367:740–748. 2GSK. Synflorix Data Sheet