Important changes to the childhood immunisation programme
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Important changes to the childhood immunisation programme. The addition of a pneumococcal conjugate vaccine (PCV) at 2, 4 and 13 months of age; A dose of MenC vaccine at 3 and 4 months; A booster dose of Hib and MenC vaccine (given as a combined Hib/MenC vaccine) at 12 months of age.

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Changes from 4 th september 2006

The addition of a pneumococcal conjugate vaccine (PCV) at 2, 4 and 13 months of age;

A dose of MenC vaccine at 3 and 4 months;

A booster dose of Hib and MenC vaccine (given as a combined Hib/MenC vaccine) at 12 months of age.

Changes from 4th September 2006


The childhood immunisation schedule 4 and 13 months of age;


Why are these changes being made

to protect children < 2 years of age who are at increased risk of pneumococcal disease

to boost children’s protection against Hib and MenC infections through their early childhood years

Why are these changes being made?


Facts about pneumococcal disease

Facts about pneumococcal disease risk of pneumococcal disease


What is pneumococcal disease

Describes infections caused by the bacterium risk of pneumococcal diseaseS.pneumoniae

Over 90 serotypes identified

20 – 30 serotypes responsible for majority of disease

7 serotypes responsible for 82% of disease in children under 5 years of age

What ispneumococcal disease?


Pneumococcal infection

Major cause of serious disease: risk of pneumococcal disease

meningitis, septicaemia and severe pneumonia (invasive pneumococcal disease - IPD)

Less serious, but commoner diseases:

otitis media, milder pneumonia and bronchitis (non invasive)

Pneumococcal infection


Severity of disease

Severity of disease risk of pneumococcal disease

dependent on which part of the body is affected



Pneumococcal infection1

Most common in: 4

the very young – babies and children under 2 years of age

the very old – over 65 years of age

younger age groups with concurrent medical conditions

Pneumococcal infection



Pneumococcal infection2

5000 cases of invasive pneumococcal disease (IPD) per year population per year

530 children IPD < 2 years (England & Wales)

Around 50 children < 2yrs die from IPD per yr1

2 thirds from pneumococcal meningitis

50% who survive pneumococcal meningitis have disabilities2

Pneumococcal infection

1. IspahaniP, Slack RC, Donald FE, et al (2004) Twenty-year surveillance of invasive pneumococcal disease in Nottingham: serogroups

responsible and implication for immunisation. Arch Dis Child 89: 757-62

2. Bedford H, de Louvois J, Halket et al (2001) Meningitis in infancy in England and Wales: follow-up at 5 years. BMJ 323: 533-6



Evidence for changes

Regular reviews of immunisation programmes to ensure all children have the best possible protection against preventable diseases

Research shows that longer-term protection against Hib and meningococcal C disease is achieved by modifying the existing programme

Evidence for changes


Meningococcal disease
Meningococcal Disease children have the best possible protection against preventable diseases


Meningococcal infection

Serogroups: children have the best possible protection against preventable diseases B and C account for majority of disease in the UKA, W135, Y, 29E and Z in other countries

Prior to MenC (1999/2000)vaccine campaign group C, disease accounted for 40% of cases – now < 10%

High overall fatality rate

Serious sequelae in survivors

Meningococcal infection


Meningococcal disease cont

Most common presentation of meningococcal disease is meningitis and septicaemia

Disease onset is sudden

1 in 8 people who recover are left with long term complications

Case fatality rate is high but varies with age, serogroup, clinical presentation and prompt treatment

Meningococcal disease (cont)


Symptoms of meningitis or septicaemia
Symptoms of Meningitis or Septicaemia meningitis and septicaemia

  • Rash

  • Fever/ Vomiting

  • Cold hands and feet

  • Rapid breathing

  • Joint/ stomach/ muscle ache

  • Drowsiness/ LOC

  • Stiff neck

  • Dislike of bright lights

Photo courtesy of CDC


Meningococcal c disease in england and wales

Throughout the last 80 years irregular upsurges of meningococcal disease have occurred

Historically approximately 60-70% of all meningococcal infections were serogroup B

In 1998/99 a significant increase in incidence of group C disease was noted in infants, teenagers and young adults.

Meningococcal C disease in England and Wales


Introduction of men c conjugate vaccine in the uk

Development and evaluation of MenC vaccine accelerated in response to increase in disease

Phased introduction between November 1999 to September 2000

Routine immunisation of infants (with DTP-Hib)

Catch-up for all under 18 years

targeting of the vaccine supplies against the highest risk groups

given with other routine vaccines where possible

Since 2002 inclusion of all under 25 years

Introduction of Men C conjugate vaccine in the UK


Evidence for changes1

Studies show two doses of MenC in the first year of life provides the same level of protection as three doses

No additional or increased protection from giving three doses of MenC in the first year of life

An additional dose in the second year of life gives longer-term protection against meningococcal C disease

Evidence for changes


Hib disease
Hib Disease provides the same level of protection as three doses


Features of hib disease

Most common presentation of invasive Hib is meningitis, frequently accompanied by bacteraemia (60%)

15% of cases present with epiglottitis

Septicaemia without any other concomitant infection, occurs in 10% of cases

Remainder made up of cases of septic arthritis, osteomyelitis, cellulitis, pneumonia, and pericarditis

Features of Hib disease


Complications of hib meningitis
Complications of Hib meningitis frequently accompanied by bacteraemia (60%)

  • Deafness

  • Convulsions

  • Intellectual impairment

  • Case fatality rate 2-5% in spite of effective antimicrobial therapy

Courtesy of Children’s Immunization Project, St. Paul, Minnesota


Hib disease in england and wales

Before 1992: frequently accompanied by bacteraemia (60%)

1 child in 600 developed some form of Hib disease by 5th birthday

Hib Meningitis caused 30 deaths each year

Approximately 80 children a year were left with deafness or permanent brain damage

Hib disease in England and Wales


Introduction of hib conjugate vaccine in the uk

Pure polysaccharide vaccines (1985-1989) not effective in infants under 18 months in whom risk of disease was highest

October 1992

Hib conjugate vaccine introduced into routine routine infant vaccination at 2, 3 and 4 months of age

October 1992-1993

Catch-up vaccination offered to all children under four years of age

Three doses under 13 months of age

One dose for 13 months and older

Introduction of Hib conjugate vaccinein the UK


Invasive hib disease
Invasive Hib disease infants under 18 months in whom risk of disease was highest


Reasons for increase

Short term exacerbation of the problem related to lower efficacy vaccine

Infanrix-Hib used in response to vaccine shortage

Accelerated schedule without booster

1993 Catch-up programme contributed to control of Hib

Effect was probably temporary

Protection from infant vaccination declines rapidly

Efficacy of vaccine higher when given over age of 1 year

Action in response: Booster programme for children aged 6 months – 4 years (2003)

Reasons for increase


Evidence for changes2

Studies show an additional booster dose of Hib vaccine is needed in the second year of life to ensure that:

Hib disease levels remain low

protection given to children continues well into their childhood

Evidence for changes


What do the changes mean

No additional visits in the first year of life needed in the second year of life to ensure that:

Infants will be offered different combinations of vaccines at the 2, 3 and 4 month visits

Three injections will be offered to infants at 4 months of age

A new 12 month vaccination visit will be introduced

What do the changes mean?


Three injections for infants

It’s been done before during the Hib booster campaign 2003 needed in the second year of life to ensure that:

Infant anterolateral thigh can accommodate two injections along the length of the thigh

At least 2.5cms (1 inch) apart so that reactions don’t overlap

Record which vaccine was injected at which point on limb

Common practice in United States where e.g. DTaP, Hep B, Hib and PCV may all be given in same visit

Three injections for infants


Simultaneous administration
Simultaneous administration needed in the second year of life to ensure that:

DTaP/IPV/Hib

PCV

MenC

World Health Organisation (2004)


Why keep pcv separate

To allow any localised reaction to be easily linked to the particular vaccine

Why keep PCV separate?


Order of injections given

Prepare all 3 injections immediately prior to immunising particular vaccine

2 in 1 leg, PCV in other

DH do not specify which leg

Local decisions - may consider recommending always using the same leg

Order of injections given


Can the deltoid be used

It is not recommended that immunisations be given in the arm of infants under one year of age because:

Risk of hitting radial nerve

Muscle mass not properly developed

Can the deltoid be used?


Can one vaccine be delayed

DH recommends all three vaccines be given at the same time to ensure children are fully protected from serious disease as early as possible

Parents have the right to refuse one or all injections

HCW should never recommend delaying

Could leave HCW open to criticism if relevant vaccine preventable infection occurred in the interim

Can one vaccine be delayed?


12 month visit

A single dose of Hib/MenC to ensure children are fully protected from serious disease as early as possible

No catch-up for Hib/MenC booster

Cannot be administered (at the moment) with PCV & MMR at 13 months as no data to show compatibility

12 month visit


13 month visit

1 to ensure children are fully protected from serious disease as early as possiblest MMR and booster PCV

Cannot be administered (at the moment) with combined Hib/MenC vaccine as no data to show compatibility

PCV catch-up for all children aged > 2 months and < 2 years of age

13 month visit


Pneumococcal catch up programme

Pneumococcal catch-up programme to ensure children are fully protected from serious disease as early as possible


Children over 2 months and under 8 months of age at the start of the programme

Children born 04.02.06 - 03.07.06 to ensure children are fully protected from serious disease as early as possible

(> 2 months but < 8 months of age)

Two doses of PCV two months apart with booster at 13 months

Children over 2 months and under 8 months of age at the start of the programme.


Children over 8 months of age at the start of the programme

Children born 04.08.05 - 03.02.06 to ensure children are fully protected from serious disease as early as possible(8 months – 13 months of age)

A single dose of PCV at 13 months of age

Children over 8 months of age at the start of the programme.


Children over 12 months of age at the start of the programme

Children born 05.09.04-03.08.05 to ensure children are fully protected from serious disease as early as possible(> 13 months - < 2 years of age)

A single dose of PVC

Children over 12 months of age at the start of the programme.


At risk children

Asplenia or dysfunction of the spleen to ensure children are fully protected from serious disease as early as possible

Chronic respiratory disease

Chronic heart disease

Chronic renal disease

Chronic liver disease

Diabetes

Immunosuppression

Cochlear implants

CSF leaks

< 5s with previous history of invasive disease

At-risk children


At risk children1

It is important that at-risk children of any age up to 5 years receive a complete course of PCV vaccination as soon as possible (regardless of catch-up scheduling)

At-risk children


At risk children2

PCV routinely at 2, 4 and 13 months of age years receive a complete course of PCV vaccination as soon as possible (regardless of catch-up scheduling)

At-risk children < 12 months of age2 doses of PCV (one month apart if necessary) before 12 months and one at 13 months of age

At-risk children > 12 months and < 5 years of age should be offered a single dose of PCV

All at-risk children should be offered a single dose of pneumococcal polysaccharide vaccine (PPV) when they are two years of age or over and at least 2 months after the final dose of PCV

At-risk children


At risk children3

Children aged 2 months and under 5 years of age with asplenia, splenic dysfunction or who are immunocompromised, require a second dose 2 months after the first dose as they may have a sub-optimal immunological response to the first dose of vaccine

All children > 5 years with previous history of IPD should have PCV irrespective of previous vaccination history

At-risk children presenting for first pneumococcal immunisation aged 5 years and over should be offered a single dose of PPV

At-risk children


Vaccination of children with unknown or incomplete vaccination status

Following completion of the catch-up programme, children who have not completed the routine programme require:

Children < 12 months of age

2 doses of PCV, 2 months apart and further dose at 13 months of age

Children > 12 months and < 2 years of age

should be offered a single dose of PCV

Vaccination of children with unknown or incomplete vaccination status


Supplies

Week commencing 7 who have not completed the routine programme require:th and 14th August 2006first allocated delivery of two week supply on usual delivery date

Week commencing 21st and 28th Augustno deliveries

Week commencing 4th September 2006 – campaign starts

Week commencing 4th and 11th September 2006second allocated delivery of two week supply

“Free” ordering from midday 13th September 2006

Supplies


When will manchester introduce the changes

11 September 2006 who have not completed the routine programme require:– Start new childhood immunisation schedule

Early 2007 Date to be confirmed - Start catch up programme

When will Manchester Introduce the changes?


Child health support

Will generate appointments for children in line with new schedule

Will generate appointments for those children to be included in the catch up dependant on age of child and where they will fit into the catch up programme

If you wish to amend your appointments contact Child Health: 958 4090/4099

Child health support


Practical considerations

Bulky presentation of vaccine schedule

Fridge capacity

Extra 12 month immunisation visit plus extra visit for those children over 2 months and under 8 months at start of the programme

Prevenar and Menitorix vaccines both carry black triangle for adverse reaction reporting ▼

Practical Considerations


In summary

The routine childhood vaccination programme continues to deliver significant public health benefits.

The proposed new primary changes will protect babies as early as possible from serious diseases such pneumococcal meningitis.

The proposed booster doses in the second year of life will extend protection against Hib, meningococcal and pnumococcal meningitis further.

In Summary


Further information

CMO Letters deliver significant public health benefits.

www.dh.gov.uk/PublictionsAndStatistics/LettersAndCirculars/DearColleagueLetters/fs/en

www.dh.gov.uk/AboutUs/MinistersAndDepartmentLeaders/ChiefMedicalOfficer/CMOPublications/CMOLetters/fs/en

NHS Immunisation website

www.immunisation.nhs.uk

The ‘Green Book’

www.dh.gov.uk/PolicyAndGuidance/HealthAndSocialCareTopics/GreenBook/fs/en

Further information


Acknowledgements: deliver significant public health benefits.

Rosemary McCann GMHPU

Judith Moreton and David Salisbury DH

Additional slides:

Julie Annakin and Leasa Benson


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