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Schedule Changes 2011
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 Thanks to GSK for their kind permission to
• Common Qs and As use content from some of their slides.
2011 NZ Immunisation Schedule
DTaP-IPV- PCV Hib MMR DTaP-IPV dTap HPV Td Influenza
HepB/Hib
6 weeks Infanrix Synflorix®
hexa®
3 months Infanrix Synflorix®
hexa®
5 months Infanrix Synflorix®
hexa®
15 months Synflorix® Act-HIB™ MMR II®
4 years MMR II® Infanrix®
-IPV
11 years Boostrix®
12 years 3 doses
Gardasil®
45 years ADT-
Booster™
65 years ADT - Fluvax®
Booster® or
Fluarix®
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)
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)
Pneumococcal disease
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
1WorldHealth 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.
Pneumococcal bacteria cause disease when
they spread beyond the nasopharynx
S. pneumoniae
Meningitis
Upper Nasal cavity
respiratory Sinusitis
tract Otitis media Eustachian
tube
infections
Nasopharynx
Invasive
Pharynx
disease
Larynx
Trachea
Lower Primary
respiratory Pneumonia bronchi
Bacteraemia/
tract septicaemia
infections Lungs
Parapneumonic
empyema
Streptococcus pneumoniae causes a spectrum of
invasive and non-invasive disease
Vaccination drivers
Invasive
Pneumococcal Severity
Disease Deaths
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.
Pneumonia and otitis media also cause
a substantial burden of disease in NZ
Cases per 100,000*
23
295
808
*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.
Impact of pneumococcal
vaccines
IPD in children younger than 5 years
worldwide by serotype
Adapted from Pneumo-ADIP. Geneva: WHO; 2007.
PCV7 immunisation programmes in the USA
have reduced IPD
Rate of invasive pneumococcal disease caused by
PCV7 serotypes in the USA
PCV7 programme Overall decline
Cases per 100,000 population
in IPD >75%
Adults ≥65 years
76% decrease
Children ≤5 years
97% decrease
Year
Adapted from Hicks et al. J Infect Dis. 2007;196:1346-54.
PCV7 immunisation in New Zealand has
reduced IPD
Incidence of invasive pneumococcal disease in children
younger than 2 years
100
PCV7 serotypes
90
80
Rate per 100,000
70
60
50
40
30
20
10
0
2007 2008 2009
Year
Adapted from ESR. NZ Public Health Surveillance Report 2010; 8 (4) 4-5.
Rates of invasive pneumococcal disease caused by
serotypes 4,6B,9V,14,18C,19F,23F
by age group 2004 – 2009, NZ
100
80
Rate per 100,000
60
40
20
0
<2 years 2-4 years 5-64 years 65+ years
Age group
2004 2005 2006 2007 2008 2009
Ref: Figure 9.2 NZ Immunisation Handbook 2011
Pneumococcal vaccines in NZ
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
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 PCV13 + 2,8,9N,10A,11A,12F15B,17F,20,22F,33F
Polysaccharide vaccines
• Made from polysaccharide from the capsule
surrounding the bacteria
• Works in adults
• Two major problems
– Not immunogenic in babies
– No immune memory
String of sugars = polysaccharide
Conjugate vaccine
Pneumococcal Polysaccharide Polysaccharide-protein
bacterium And lipid (LPS) conjugate
Purification
process Chemical
Reaction
CRM197 Protein Carrier
Lipid
PCV10 (Synflorix)
Synflorix increases coverage of IPD worldwide
IPD in children younger than 5 years worldwide by serotype
Adapted from: 1Pneumo-ADIP. Geneva: WHO; 2007. 2GSK. Synflorix Data Sheet. 2010 .
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
1ESR. Invasive pneumococcal disease in New Zealand, 2009. 2010. 2Pneumo-ADIP. WHO; 2007. 3ESR. NZ Publ Health Surveill Rep
2010;8(4):4-5. 4Heffernan et al. Epidemiol. Infect 2008;136:352–359.
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
1WHO. Target Product Profile for the Pneumococcal AMC. 2008. 2Pneumo-ADIP. WHO; 2007. 3ESR. Invasive pneumococcal disease in
New Zealand, 2009. 2010. 4Shouval et al. Pediatr Infect Dis J 2006;25(7):602–607. 5Hausdorff 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.
Composition of Synflorix – designed as a
dual-pathogen vaccine
Non-typeable
S. pneumoniae H. influenzae
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.
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
1GSK NZ. Synflorix® Data Sheet. 2010. 2Wysocki 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;27:5748-5754. 6GSK. COMPAS (Clinical Otitis Media & Pneumonia
Study). 2007. 7GSK. Pneumococcal Conjugate Vaccine 1024850A (FinIP). 2009.
Global use of Synflorix (April 2011)
• First registered in December 2008
• Now approved in 83 countries
2 + 1 schedule 3 + 1 schedule
•Colombia (Bogotá) •Australia (Northern Territories)
•Finland •Austria (high-risk groups)
National •Mexico •Albania
•Sweden (3 provinces) •Brazil
immunisation •Bulgaria
programmes: •Cyprus (high-risk groups)
3 + 0 schedule •Hong Kong
• Kenya
•Taiwan (Taipei)
•The Netherlands
• 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..
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 >40C was infrequent: ≤1% of Synflorix doses and
≤2% of PCV7 doses.1
1Chevallier et al. Pediatr Infect Dis J 2009;28:S109–118.
Synflorix can be co administered
with other vaccines available in NZ
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.
Administration of prefilled syringe
1. Holding the syringe barrel (not the plunger) in one hand,
unscrew the syringe cap by twisting anticlockwise.
2. To attach the needle to the syringe, twist the needle clockwise
into the syringe until you feel it lock.
3. Remove the needle protector and administer the vaccine.
GSK NZ. Synflorix Data Sheet, 2010.
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.
Prevenar 13® and the
Pneumococcal high risk
programme
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)
additional
PCV-7 additional PCV-13
20 PCV-10 types 60
serotypes
Cumulative average annual rate
50
per 100,000 population
per 100,000 population
15
Average annual rate
40
10 30
20
5
10
othe…
0 0
6A
6B
19F
23F
9V
14
19A
18C
7F
4
1
5
3
Serotype
Average annual rate Cumulative average annual rate
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
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
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
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
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
Other vaccine changes
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
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
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)
Qs and As
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
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
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
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.
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
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
Back-up slides
Meningococcal disease rates for selected
strains and all cases, by year
Data provisional, ESR
Meningococcal disease rates, all ages, by year
Rate per 100,000
18 Total cases
B other
16
C
Epidemic
14
12
10
8
6
4
2
0
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Year
Synflorix and
acute otitis media protection
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
1Gribben. GSK Data on file; 2010. 2Milne, Vander Hoorn. Report to NZ Ministry of Health. 2009. 3Milne, Vander Hoorn. Appl Health
Econ Health Policy 2010;8:281–300. 4Stanhope et al. NZ Med J 1978;88:5–8. 5Ministry of Social Development.
Wellington;MSD:2007. 6NZ Health Technology Assessment. Wellington:NZHTA; 1998.
An 11-valent prototype for Synflorix
was effective against AOM
100
acute otitis media (95%CI) 80
Vaccine efficacy against
60
*
40 *
20
0
-20
-40
-60
-80
-100
All
Cause of All-cause Non-vaccine
pneumococcal
AOM: serotypes
serotypes
*Statistically significant effect
Adapted from: 1Prymula et al. Lancet 2006;367:740–748. 2GSK. Synflorix Data Sheet. 2010.
