Download Changes to MenC conjugate vaccine schedule

Changes to Childhood
Immunisation Schedule –
the introduction of
Rotavirus vaccine (Rotarix®)
and
Changes to the Meningococcal C
Schedule
Maureen McCartney
Mary Loughrey
Richard Smithson
Acknowledgment
This resource was prepared by Health Protection
Scotland (Rotavirus Vaccine) and the Vaccine
Preventable Disease Programme, Public Health Wales
(Men C Vaccine), and adapted for use in Northern
Ireland by the Public Health Agency.
We gratefully acknowledge their work and their permission
to adapt it for use in Northern Ireland.
Content of Presentation.
Rotavirus Vaccine
•
•
•
•
•
What is rotavirus?
Why vaccinate against rotavirus?
Vaccination against rotavirus – the use of Rotarix®
The role of registered healthcare practitioners
Resources
Men C Vaccine
What is Meningococcal serogroup C disease?
What, why and when are the changes happening?
Which vaccines are recommended?
The role of the HCP. Resources
Rotavirus Vaccine
Key Message
Rotavirus is the most common cause of gastroenteritis in
young children. Most children will experience at least one
infection with rotavirus by the time they are five years old,
with some requiring hospitalisation for dehydration.
•An oral vaccine against rotavirus is being introduced
into the infant immunisation programme at the 2 and 3
month appointments.
•Rotavirus vaccination should significantly reduce
rotavirus gastroenteritis in young children
Aims of resource
•To support staff involved in discussing vaccination
against rotavirus with parents/carers by providing
evidence based information.
•To raise awareness of rotavirus epidemiology and the
benefits of rotavirus vaccination for young infants.
•To provide guidance on the administration of this new
oral vaccine, including how to administer the vaccine,
contraindications, precautions and potential adverse
reactions.
Learning outcomes
After completing this resource registered healthcare
practitioners will be able to:
•Describe the aetiology and epidemiology of rotavirus
•Have an understanding of how rotavirus is transmitted and
the potential complications of infection in infants
•Discuss the importance of vaccination against rotavirus
•Have a knowledge of the contraindications for rotavirus
vaccination
•Safely administer the vaccine
•Have an understanding of potential adverse reactions and
how to report these
•Be aware of sources of additional information
What is rotavirus?
• Rotavirus
is a virus that causes gastroenteritis
in particular in infants and young children
• Estimated that all children will become infected
with rotavirus at least once by the time they are
five years old
• Estimated that rotavirus causes around half of
all gastroenteritis in children aged under five
years
What is rotavirus?
Incubation period
The incubation period is approximately 2 days
Infectious period
Shedding of the virus in faeces may begin before
the onset of major symptoms and may continue for
several days after symptoms have resolved.
Clinical presentation of rotavirus
Rotavirus gastroenteritis usually begins with the symptoms of
•Diarrhoea
•Vomiting
The child may also have
•A fever (high temperature) of 38ºC or above
•Abdominal pain
The symptoms of vomiting usually pass within one to two days.
In most children, vomiting will not last longer than three days.
The symptoms of diarrhoea usually pass within five to seven
days. Most children’s diarrhoea symptoms will not last longer
than two weeks.
Complications of rotavirus
Gastroenteritis can cause dehydration:
•This can be more serious than the rotavirus infection
itself – and can require hospitalisation for intravenous
rehydration
• Virtually all children get rotavirus infection by age 5 yrs
• 1 in 5 of these will need medical attention
• 1 in 10 of these will need hospital admission
•400 children are estimated to be admitted to hospital
each year with rotavirus in Northern Ireland
Transmission of rotavirus
Rotavirus is highly infectious
•As few as 10-100 virus particles may cause disease
•Transmission mainly via the faecal-oral route
•Poor hand washing by young children leads to easy
transmission, both by direct and indirect contact
(contamination of surfaces etc.).
•Small droplets of infected faeces can also be carried in
the air, which children can breathe in.
Why vaccinate infants against rotavirus?
Number of Laboratory Confirmed Rotavirus Cases per year,
2000-2012
800
700
Number of Cases
600
500
400
300
200
100
0
2000
2001
2002
2003
2004
2005
2006
Year
2007
2008
2009
2010
2011
Number of Cases
Only a very small proportion of cases are confirmed by
laboratory testing. These cases are just the tip of the iceberg.
2012*
Why vaccinate against rotavirus?
Epidemiology of rotavirus in Scotland
–who is most at risk?
Age of laboratory confirmed cases of rotavirus reported to HPS in 2012
600
Laboratory reports
500
400
300
200
100
0
<3
mth
3-5
mths
6-8
mths
9-11
mths
1y
2y
3y
4y
5 - 9y
10 14y
15 19y
20 29y
Age (m onths & years - note changing scale
Data HPS
30 39y
40 49y
50 59y
65+
Northern Ireland
5-year average number of Rotavirus Cases, 2008-2012
250
Average number of cases
200
150
Average
100
50
0
Age Band
Why vaccinate against rotavirus?
Recommendation from JCVI for
rotavirus vaccine
The Joint Committee on Vaccination and Immunisation
(JCVI) is the UK’s independent panel of immunisation
experts.
•JCVI
rotavirus
should
be experts.
The Jointrecommends
Committee on Vaccinationthat
and Immunisation
(JCVI) isvaccination
the UK’s independent panel
of immunisation
•JCVI recommends that rotavirus vaccination should be given to infants at two and three months of age i.e. two doses.
given
tovaccination
infants
atsignificantly
two and
monthsin young
of age
•Rotavirus
should
reduce three
rotavirus gastroenteritis
childreni.e. two
doses.
•Rotavirus vaccination should significantly reduce
rotavirus gastroenteritis in young children
Why vaccinate against rotavirus?
Effectiveness of the vaccine
•Very
effective at protecting against the most common
strains of rotavirus.
•Very effective in protecting against severe rotavirus
infection requiring hospitalisation.
Vaccination against rotavirus
The use of Rotarix®
Image courtesy of GSK
Vaccination against rotavirus –
use of Rotarix®
Rotarix®
•From July 1st 2013 Rotarix® will be used for rotavirus immunisation programme
•Generic name: Rotavirus vaccine, live
•Marketed by GlaxoSmithKline
•Licensed from 6 weeks to 24 weeks
•Oral suspension in a prefilled oral applicator
•Container dimensions 42x24x133mm
Image courtesy of GSK
Vaccination against rotavirus – use of Rotarix®
Rotarix® Composition
Active ingredient
–Human rotavirus RIX4414 strain
–Live attenuated
–Not less than 106.0 CCID50
Excipients
–Sucrose
–Di-sodium Adipate
–Dulbecco’s Modified Eagle Medium
–Sterile water
Vaccination against rotavirus – use of Rotarix®
Rotarix® presentation
•Prefilled oral applicator
•Oral suspension
•Each dose contains 1.5ml of clear colourless liquid
Vaccination against rotavirus – use of Rotarix®
Storage of Rotarix®
Rotarix® must be stored in accordance with manufacturer’s instructions
•Cold chain must be maintained
- Store between +2°C and +8°C
- Store in original packaging
- Protect from light
Vaccination against rotavirus – use of Rotarix®
Rotarix® dosage and schedule
2 dose schedule
•First dose of 1.5ml at 8 weeks (two months) of age
•Second dose of 1.5ml at least four weeks after the first (i.e. 12
week appointment)
- If interrupted resume course and no need to repeat first dose
Both doses ideally by 15 weeks (i.e.14 weeks and 6 days) and no
later than 24 weeks of age (i.e. 23 weeks and 6 days)
•The first dose must be given before 15 weeks of age. If infant
does not have first dose before 15 weeks then do not give
Rotarix®
•If infant spits out/regurgitates most of dose, one replacement dose
may be given at same visit
Important Message
Unlike other childhood vaccines
Rotarix® has an UPPER age limit
beyond which it should not be given.
First dose must not be given after 14 weeks 6
days of age
Second dose must not be given after 23 weeks 6
days of age
Vaccination against rotavirus – use of Rotarix®
Administration of Rotarix®
Rotarix is different from the other infant vaccines, as it is a
LIVE ORAL vaccine and must not be injected
Rotarix® can be administered at the same time as other
childhood vaccines – it should be given before injected
vaccines at same visit.
Administration of Rotarix®
If the infants spits out or regurgitates most of the
vaccine, a single replacement dose may be
given at the same vaccination visit.
There are no restrictions on infant’s feeding
before or after vaccination.
Breast-feeding does not reduce vaccine
effectiveness so can be continued.
Vaccination against rotavirus – use of Rotarix®
Contraindications
•Confirmed anaphylactic reaction to a previous rotavirus vaccine
•Confirmed anaphylactic reaction to component of vaccine
•Previous history intussusception
•Over 24 weeks of age
•Infants presenting for their first dose of Rotarix® over 15 weeks of
age
•Severe Combined Immunodeficiency (SCID) disorder
•Congenital malformation of GI tract that could predispose to
intussusception.
•Rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrose-isomaltose insufficiency
There are very few infants who cannot receive rotavirus vaccine
Vaccination against rotavirus – use of Rotarix®
Immunosuppression and HIV
Should not be administered to infants known to have
severe combined immunodeficiency disorder (SCID)
Other immuno-suppressive disorders should be considered
in relation to risks and benefits
Rotarix® vaccination is supported in HIV infected infants.
Additionally infants of unknown HIV status, but born to HIV
positive mothers should be offered vaccination
Vaccination against rotavirus – use of Rotarix®
Precautions
•Acute severe febrile illness
–Defer until recovered
•Acute diarrhoea or vomiting
–Defer until recovered
Minor illnesses without fever or systemic upset are not
valid reasons to postpone immunisation
Vaccination against rotavirus – use of Rotarix®
Precautions
Potential transmission of live attenuated vaccine virus
from infant but:
- Vaccination of the infant will offer protection to
household contacts from wild-type rotavirus
disease and outweigh any risk from transmission
of vaccine virus to any immunocompromised close
contacts
- Those in close contact with recently vaccinated
infants should observe good personal hygiene
Rotarix® - Adverse reactions
In 3 placebo controlled trials, in which Rotarix
was administered alone there was no
significant difference in incidence or severity
for:
Diarrhoea; vomiting; loss of appetite; fever;
irritability or cough/runny nose.
Vaccination against rotavirus – use of Rotarix®
Adverse reactions
The most common adverse reactions observed after Rotarix® are
•Diarrhoea
•Irritability
Other reactions commonly reported are
•Vomiting
•Abdominal pain
•Flatulence
•Skin inflammation
•Regurgitation of food
•Fever
•Loss of appetite
•Fatigue
Vaccination against rotavirus- Use of Rotarix®
Intussusception
•Intussusception is a naturally occurring condition of the
intestines – around 120 cases per 100,000 children under
1 year.
•Research from some countries suggests that Rotarix®
may be associated with a very small increased risk of
intussusception – possibly 2 cases per 100,000 first doses.
•Even with this small potential risk, the benefits of
vaccination in preventing the consequences of rotavirus
infection outweigh any possible side effects
Vaccination against rotavirus Use of Rotarix®
Reporting suspected adverse reactions
•Yellow card scheme
- Voluntary reporting system for suspected adverse
reaction to medicines/vaccines
- Success depends on early, complete and accurate
reporting
- Report even if uncertain about whether vaccine caused
condition
- http://yellowcard.mhra.gov.uk/
-See chapter 27a of Green book for details
Vaccination against rotavirus use of Rotarix®
Data management - Call and recall
Infants will be called for their immunisation against rotavirus
at the same time as for their other immunisations at two and
three months.
It is important to note that if an infant attends late for
appointments the first dose must not be given at 15 weeks
or later, or the second dose at 24 weeks or late.
All the other routine childhood vaccines can and should be
given even if the infant is late.
The registered healthcare practitioners’ key role
•To provide clear and concise information to parents/guardians
regarding vaccination against rotavirus
•To safely administer this new oral vaccine to young infants
according to the schedule.
Resources
Green Book
https://www.gov.uk/government/uploads/system/uploads/attachment_data/f
ile/193107/Green_Book_Chapter_27b_v1_0W.pdf
Incorporated into baby immunisation leaflet – will be available at:
http://www.publichealth.hscni.net/publications
Patient group direction
Q & A briefing – will be available at:
http://www.publichealth.hscni.net/publications
CMO letter
http://www.dhsspsni.gov.uk/hss-md-11-2013.pdf
Key Messages
•Rotavirus is the most common cause of gastroenteritis
in young children. Most children will experience at least
one infection with rotavirus by the time they are five
years old, some requiring hospitalisation for dehydration.
•An oral vaccine against rotavirus is being introduced
into the infant immunisation programme at the 2 and 3
month appointments
•Rotavirus vaccination should significantly reduce
rotavirus gastroenteritis in young children.
Meningococcal C Vaccine.
Key Message
The changes will make the overall
Meningococcal serogroup C conjugate
immunisation programme more effective and
offer greater protection by extending routine
protection to adolescents and young adults.
Aims of resource
•
•
•
To raise awareness of current Meningococcal
serogroup C epidemiology and the impact of
the vaccination programme to date
To support healthcare professionals (HCPs)
involved in discussing MenC vaccination with
parents and young persons by offering
evidence based information
To increase awareness of the changes among
HCPs to ensure a smooth and effective
transition to the new schedule
Learning outcomes
•
•
•
•
Describe the aetiology and epidemiology of
Meningococcal serogroup C disease
Understand the HCP’s role in implementing the
changes to the MenC vaccination schedule
To be able to advise and reassure parents and
young people of the changes in the MenC
vaccination schedule by providing evidence based
information
Be aware of useful resources
What is Meningococcal serogroup C disease?
•
•
•
•
•
•
Meningococcal disease occurs as a result of an invasive bacterial
infection caused by Neisseria meningitidis
Transmission is by aerosol, droplets or direct contact with
nasopharyngeal secretions and usually requires frequent or prolonged
close contact
Incubation period 2 – 7 days
Meningococcal infection most commonly presents as either meningitis
or septicaemia, or a combination of both
Meningococcal C is one of 12 serogroups of Neisseria meningitidis
In the UK serogroups B & Y are currently the most common, less
common include C & W
Clinical presentation of Meningococcal infection
Babies and toddlers
Children and young adults
Fever with poor peripheral perfusion
Fever with poor peripheral perfusion
Poor feeding, refusing food or vomiting
Vomiting
Tense, bulging fontanelle and photophobia
Severe headache and photophobia
Fretful, unusual cry, moaning or rapid
breathing
Confusion and irritability
Neck stiffness
Neck stiffness and muscle pain
Pale blotchy complexion & or non blanching
rash
Pale blotchy complexion &/or non blanching
rash
Drowsy & loss of consciousness
Drowsy & loss of consciousness
Neck stiffness & muscle pain
Symptoms can appear in any order, some may not appear at all.
The meningococcal rash
•The
rash starts as a cluster of pinprick
blood spots under the skin, spreading
to form bruises. It can appear
anywhere on the body.
•It
can be distinguished from other
rashes by the fact that it does not fade
when pressed under the bottom of a
glass (THE TUMBLER TEST).
•A
febrile illness and rash that does not
fade under pressure is a sign of
meningococcal septicaemia.
The ‘tumbler’ test picture courtesy of
Meningitis Research Foundation
http://www.meningitis.org/symptoms
Meningococcal disease,
potential complications
•
•
•
Overall mortality in the UK has reduced from 10% in 2005/6
to 5% in 2010/11
Mortality higher in cases with septicaemia than those with
meningitis alone
Most common long term effects:
– - Skin scarring
- Seizures
– - Limb amputation
- Brain Damage
– - Hearing loss
Background to MenC vaccination programme
•
•
•
In 1999 children and adolescents under the
age of 18 years were offered MenC vaccine
over a two-year period
January 2002 the campaign extended to
include all adults under 25 years
Following the campaign the number of cases
fell by over 90% in all age groups immunised
Impact of MenC vaccination programme
Number of laboratory confirmed serogroup C cases in England and Wales,
1998-2010. Source: Public Health England, Infectious Disease Epidemiological Data
http://www.hpa.org.uk/webw/HPAweb&HPAwebStandard/HPAweb_C/1234859709051?p=1201094595391
Reduction in capsular group C carriage following
introduction of meningococcal serogroup C
conjugate vaccines
Slide courtesy of Prof Ray Borrow
Meningococcal disease cases by group and epidemiological
year in England and Wales
Source: Public Health England, Meningococcal Reference Unit, Invasive meningococcal infections laboratory
reports, England and Wales, as at 14/09/2012
Risk Factors
•
•
•
•
Age
– Highest incidence in children under five years, peak incidence in
those under one year of age. A second peak in incidence is noted in
young people aged 15-19 years of age
Season
– Seasonal variation, peak levels in winter, declining to low levels by
late summer
Social
– Living in closed or semi – closed communities:
– university halls of residence
– military barracks
Smoking
– Exposure to tobacco smoke increases the risk
What are the changes to the UK schedule
for MenC vaccination
Adolescents
New starters at
university/fresher
students
Infants
© Leah Millinship
© Leah Millinship
© Leah Millinship
Revised MenC vaccination schedule
Age
Dose
3 months
(12 weeks)
1 dose - MenC vaccine
NeisVac-C®, Menjugate Kit® only
Just after 1st birthday 1 dose Hib/MenC vaccine
Menitorix®
From 14-15 years
1 dose MenC vaccine
Any MenC vaccine**
New starters at
university/freshers *
1 dose MenC vaccine
Any MenC vaccine **
*Temporary catch up for new starters entering university setting under 25 years
** Any MenC vaccine can be given, Meningitec advised to help balance vaccine stocks
Why is there a change to the MenC
vaccination schedule?
•
•
•
•
One dose MenC vaccine is now considered to offer sufficient
direct protection to infants with the 12m booster
Individual protection in young children wanes
A booster dose for adolescents will provide longer-term
protection and maintain herd protection to help protect infants
and younger children
To protect freshers (temporary catch up for new starters at
university setting under 25 years coomencing in 2014) because of
an increased risk of disease and sub-optimal protection from
vaccination under 10 years
When will the change to the schedule
be implemented?
Infant
•
•
•
•
•
Child Health systems will stop inviting infants for MenC
vaccination at 16 weeks from 1st June 2013
One dose in infancy has been shown to provide
sufficient protection until booster at 12/13 months
The infant will still be called for other primary
immunisations at 8, 12 and 16 weeks
Hib/MenC booster with MMR & PCV13 is still given just
after 1st birthday.
Rotavirus vaccination starts July 1st 2013
When will the change to the schedule
be implemented?
Adolescent
Begin in academic year starting September 2013
An adolescent booster dose of MenC vaccine to be given
at same time as the Td/IPV teenage booster vaccine
HPV and MMR vaccines can be given at same time
Delivered through school based delivery model
When will the change be implemented?
New starters at university/freshers,
•
•
•
•
•
•
From summer 2014
A time limited catch-up programme offering vaccine to freshers
entering university
Defined as new starters at university under 25 years i.e 24 years
and 364 days
Ideally provided by own GP at least 2 weeks before starting
university
Information provided with offer of university place
Those that have received a Men C vaccine over the age of 10
years will not require the booster dose
Which vaccines are recommended?
Age
Primary/Booster
Product
3 months
(12 weeks)
Primary
MenC
NeisVac-C® or
Menjugate Kit®only
12-13 months
Booster
Hib/MenC Vaccine
Menitorix®
From 14-15 years
Booster
MenC Vaccine
All can be given
New starters at
university
/freshers
Booster
MenC Vaccine
All can be given
Supply issues may dictate use of Meningitec® for teenagers and freshers
Vaccine products
Primary
Primary
under 1 year
under 1 year
X
Primary
under 1 year
© Docsimon
©Baxter
© Science photo library
USE THE CORRECT VACCINE
Meningitec® is less immunogenic, as a single dose in infancy than other vaccines
Different schedules
for MenC vaccines
Summary of Product Characteristics (SPC) for MenC conjugate
vaccines state that two doses should be given two months
apart in those under 1 year of age
This is superseded by the Green Book recommendation to give a
single dose of NeisVac-C® or Menjugate Kit® MenC vaccine in
infancy
Consideration should be given as to whether a quadrivalent
meningococcal vaccine should be used if protection is required
for travel
Contraindications and precautions
Contraindications
Confirmed anaphylactic reaction to a previous dose of the
vaccine
Confirmed anaphylactic reaction to any constituent of the
vaccine, including meningococcal polysaccharide,
diphtheria toxoid or the CRM197 carrier protein or tetanus
toxoid
Precautions
Acute febrile illness (defer until recovered)
Unstable/evolving neurological conditions
Adverse events
•
•
•
•
Pain, tenderness, swelling or redness at the
injection site and mild fever
Infants and toddlers: crying, irritability,
drowsiness, impaired sleep, reduced eating,
diarrhoea and vomiting
Older children and adults: headaches, myalgia
and drowsiness
Neurological reactions such as dizziness,
febrile/afebrile seizures, faints, numbness and
hypotonia are very rare
Reporting Adverse Events
Yellow card scheme
• Voluntary reporting system for suspected adverse
reaction to medicines/vaccines
• Serious adverse events in adults or all suspected
adverse reactions in children that may be attributable
to the vaccine should be reported to the Medicines
and Healthcare Products Regulatory Agency (MHRA)
using the yellow card system
• http://yellowcard.mhra.gov.uk/
• Chapter 8 of Green Book
for details
© MHRA
Supplies
•
Meningitis C conjugate:
– Menjugate® – manufactured by Novartis Vaccines
– NeisVac-C® – manufactured by Baxter Healthcare
– Meningitec® – manufactured by Pfizer
•
•
Supplies should be obtained in line with
routine ordering for childhood vaccines
Monitoring uptake
•
•
Vaccination against MenC should be recorded
in the GP, patient and child health computer
records as routine
Immunisation uptake data will be collected
using the Child Health Information System for
the infant and teenage doses
Resources
• Green Book
•
•
•
•
•
https://www.gov.uk/government/uploads/system/uploa
ds/attachment_data/file/195250/Green_Book_Chapte
r_22_v2_2A.PDF
Patient group direction (PGD)
Chief Medical Officer (CMO) Letter
http://www.dhsspsni.gov.uk/hss-md-12-2013.pdf
Leaflets/posters/factsheets/ – will be available at:
http://www.publichealth.hscni.net/publications
Key Message
The changes will make the overall
Meningococcal serogroup C conjugate
immunisation programme more effective and
offer greater protection by extending routine
protection to adolescents and young adults