Transcript A new possibility for the prevention of pneumococcal disease

2011 Handbook Changes
including “Catch Ups”
Brief presentation
Outline
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Eligibility for Public Funded Vaccines
Handbook Changes 2011
NIR and PMS Data Entry
Planning Immunisation Catch Ups
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.
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/eligibilitydirection-2011.pdf
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/Tamariki Ora
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.
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)
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
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.
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.
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.
Schedule Changes 2011
shorter presentation
Brief presentation
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
2011 NZ Immunisation Schedule
DTaP-IPVHepB/Hib
PCV
6 weeks
Infanrix Synflorix®
hexa®
3 months
Infanrix Synflorix®
hexa®
5 months
Infanrix Synflorix®
hexa®
15 months
4 years
11 years
12 years
Hib
MMR
DTaP-IPV
dTap
HPV
Td
Influenza
Synflorix® Act-HIB™ MMR II®
MMR II® Infanrix®
-IPV
Boostrix®
3 doses
Gardasil®
45 years
ADTBooster™
65 years
ADT Booster®
Fluvax®
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 and
vaccines
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.
Streptococcus pneumoniae causes a spectrum of
invasive and non-invasive disease
Vaccination drivers
Invasive
Pneumococcal
Disease
Severity
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.
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
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
Polysaccharide
And lipid (LPS)
Pneumococcal
bacterium
Polysaccharide-protein
conjugate
Purification
process
Lipid
Chemical
Reaction
CRM197 Protein Carrier
PCV7 immunisation in New Zealand has
reduced IPD
Rate per 100,000
Incidence of invasive pneumococcal disease in children
younger than 2 years
100
90
80
70
60
50
40
30
20
10
0
PCV7 serotypes
2007
2008
Year
Adapted from ESR. NZ Public Health Surveillance Report 2010; 8 (4) 4-5.
2009
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)
60
Average annual rate
per 100,000 population
50
15
40
10
30
20
5
Average annual rate
Serotype
3
6A
19A
5
1
7F
9V
4
23F
18C
19F
6B
14
0
Cumulative average annual rate
othe…
10
0
Cumulative average annual rate
per 100,000 population
additional
PCV-10
PCV-7
serotypes
20
additional
PCV-13
types
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.
Global use of Synflorix (April 2011)
•
First registered in December 2008
•
Now approved in 83 countries
National
immunisation
programmes:
2 + 1 schedule
•Colombia (Bogotá)
•Finland
•Mexico
•Sweden (3 provinces)
3 + 0 schedule
• Kenya
3 + 1 schedule
•Australia (Northern Territories)
•Austria (high-risk groups)
•Albania
•Brazil
•Bulgaria
•Cyprus (high-risk groups)
•Hong Kong
•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 >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.
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.
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
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 vaccines 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
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
Further Information
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.
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