Vaccination against pertussis (whooping cough) for pregnant women An update for healthcare...

Vaccination against pertussis (whooping cough) for pregnant women

An update for healthcare professionalsMay 2014

Key Message

• Infant cases of pertussis have been dramatically reduced by the introduction of the temporary maternal immunisation programme. However, the disease continues to circulate in older age groups

• Therefore it is important for all health professionals to encourage vaccination in pregnant women from 28 weeks, at the earliest opportunity

© NHS Scotland/Crown Copyright

2 Vaccination against pertussis for pregnant women

Aims of Resource

• To support staff involved in discussing vaccination against pertussis with pregnant women by providing evidence based information

• To raise awareness of current pertussis epidemiology and the impact of pertussis on young infants

• To promote uptake of vaccination against pertussis through increasing awareness amongst healthcare professionals

3



Learning OutcomesAfter completing this resource immunisers will be able to:

• Understand their role in raising the issue of vaccination against pertussis with all women in the antenatal period and providing women with evidence based information about this vaccination

• Describe the aetiology and epidemiology of pertussis

• Understand how pertussis is transmitted and the severity of it in young infants

• Discuss the important role of vaccination against pertussis during pregnancy for young infants

• Be aware of sources of additional information


Contents1. What is pertussis?

2. Why vaccinate pregnant women against pertussis?

3. Vaccination against pertussis and the use of Boostrix®

4. The role of the immuniser

5. Resources


What is pertussis?


What is pertussis?• Pertussis is an acute bacterial infection

caused by Bordetella pertussis

• It is highly contagious and can be passed from person to person through droplets from the nose and throat of infected individuals when coughing and sneezing

• Infants and young children have the highest rates of complications

• Infants are the most vulnerable group and almost all deaths from pertussis occur in this age group with most <3 months of age

Photo courtesy of CDC


What is pertussis? (cont’d)

Incubation period

• The incubation period is on average 7-10 days (range 5-21 days)

Infectious period

• Patients with pertussis are most infectious in the initial catarrhal stage and during the first three weeks after the onset of cough



Clinical presentation of pertussisInitial stage

Early symptoms are:

• similar to those of a cold

• can last for one to two weeks before becoming more severe

Second or Paroxysmal Stage

Characteristic symptoms:

• Intense bouts of coughing sometimes referred to as ‘paroxysms’ of coughing

• a ‘whoop’ sound with each sharp intake of breath after coughing (may not occur in infants)

• Vomiting after coughing



Clinical presentation of pertussis (cont’d)Convalescent stage

Symptoms:

• Slowly become less severe

• Generally last 2-6 weeks but can persist for months



Clinical presentation of pertussis in infants and young children Infants may not make the ‘whoop’ sound

after coughing, but they may start gagging or gasping and may temporarily stop breathing

Young children may also seem to choke or become cyanosed when they have a bout of coughing



Complications in infants and young children

Infants and young children are usually most severely affected and more likely to develop severe complications such as:

•Pneumonia

•Temporary pauses in breathing as a result of severe difficulty with breathing

•Weight loss due to excessive vomiting

•Seizures or brain damage

•Encephalitis (an acute inflammation of the brain)

In severe cases pertussis can be fatal in infants


Complications of pertussis in older children & adultsComplications in older children and adults are usually much less serious than those in infants and young children. These may include:

•nosebleeds and burst blood vessels in the whites of the eye from intense bouts of coughing

•bruised ribs as a result of intense coughing

•hernia due to intense coughing

•a swollen face

•ulcers on the tongue and mouth

•ear infections such as otitis media


Why vaccinate pregnant women against pertussis?


What did the epidemiology of pertussis in 2012 tell us?Incidence of confirmed pertussis cases at all ages, England & Wales

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

2011

2012

0

4

8

12

16

20

Rate per 100,000 popu-lation


Age distribution of laboratory confirmed pertussis cases and rate per 100,000 England and Wales 2012

16 Vaccination against pertussis in pregnancy

<3 months 3-5 months 6-11 months

1-9 years 10-14 years

15+ years0

50

100

150

200

250

300

0

1000

2000

3000

4000

5000

6000

7000

8000

9000

Total casesincidence per 100,000

Age group

Rate per 100,000 population

Total cases

Confirmed cases in infants under 1 year, by week of age at onset* (2011-end August 2012) England and Wales

0

10

20

30

40

50

60

70

80

0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52

Age in weeks

To

tal c

ases

* Where provided; specimen date used when onset not available

Dose 1

Dose 2

Dose 3


Reconciled deaths from pertussis in infants (England only)

0

2

4

6

8

10

12

14

16

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

<3M 3-5M 6-11M

Sources: lab confirmed cases, certified deaths, Hospital episode statistics, GP registration details

How can we help prevent pertussis?The childhood vaccination programme

• The main strategy for reducing the impact (morbidity and mortality) from pertussis is the current childhood vaccination programme

What does this current vaccination programme look like?

• Pertussis is part of the infant vaccination programme

• 5-in-1 vaccine (DTaP/IPV/Hib) is offered to infants at two, three and four months of age.

• This protects against pertussis, diphtheria, tetanus, polio and Haemophilus influenzae type b

• A booster dose of pertussis containing vaccine is given to children from about three years and four months of age


Immunity against pertussis

• Vaccination against pertussis does not give life-long immunity

• Individuals who have previously had pertussis can become re-infected and spread infection to others

• This spread of infection is important, particularly in children too young to be vaccinated


How can we protect children too young to be vaccinated against pertussis?

•One dose of pertussis containing vaccine from 28-38 weeks, with the ideal time being 28-32 weeks gestation

•The aim is to boost antibodies in vaccinated women in late pregnancy so that pertussis antibodies are passed from mother to baby

•This is considered the best way to provide passive protection to infants in the first weeks of life and offers women a safe way to protect their baby against this serious disease

•On the advice of the JCVI, the programme will continue into 2014

© NHS /Crown Copyright


In October 2012, the Department of Health recommended that pregnant women receive

Why vaccinate pregnant women?

The immunity acquired by vaccination will be passed across the placenta by antibodies and should help protect the baby in the first few weeks of life, when they are most at risk of serious complications if they become infected with pertussis



Why vaccinate pregnant women against pertussis (cont’d)?

Helps protect the baby

• Babies born to mothers vaccinated at the recommended time during pregnancy should have higher levels of antibodies than those born to unvaccinated mothers, which should help protect the infant until they start receiving their own immunisations

Helps protect the mother

• Reduces the risk of the mother catching pertussis and passing it on to the young infant © NHS Scotland/Crown Copyright


Is the pertussis vaccination in pregnancy programme proving effective?


Collected pertussis vaccine uptake in pregnant women Oct 2012- March 2014 (England only)

Source: Public Health England

Oct

-12

Nov-12

Dec-12

Jan-1

3

Feb-13

Mar-1

3

Apr-13

May-

13

Jun-1

3

Jul-1

3

Aug-13

Sep-13

Oct

-13

Nov-13

Dec-13

Jan-1

4

Feb-14

Mar-1

40

10

20

30

40

50

60

70

80

90

100

Month

Va

cc

ine

Co

ve

rag

e (

%)

http://www.hpa.org.uk/hpr/infections/immunisation.htm


http://www.hpa.org.uk/hpr/infections/immunisation.htm

Annual age specific laboratory confirmed pertussis incidence rates 1998 – 2013: England

19981999200020012002200320042005200620072008200920102011201220130

50

100

150

200

250

0

5

10

15

20

25

30<3 months 3-5 months 6-11 months

1-9 years 10-14 years 15+ years

Incidence per 100, 000 (<1 year age

groups)

Incidence per 100, 000 (>= 1 year age

groups)


Reconciled deaths from pertussis in infants England only

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014*0

2

4

6

8

10

12

14

16

<3M 3-5M 6-11M

Sources: lab confirmed cases, certified deaths, Hospital episode statistics, GP registration details *to end April


Vaccination against pertussis (whooping cough) - the use of Boostrix-IPV®


The recommended vaccine: Boostrix-IPV®

Brand name: Boostrix-IPV®

Generic Name: Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated vaccine) adsorbed (dTaP/IPV)

Marketed by GlaxoSmithkline UK

Inactivated (N.B. the vaccine cannot cause pertussis)

Presented as a prefilled syringe


Image courtesy of GlaxoSmithKline UK

30

All staff should be familiar with the BOOSTRIX-IPV packaging

XEnsure that all those administering the vaccine are

familiar with the product

Please ensure that you use the correct vaccine and that you accurately record the brand and batch number

Images courtesy of GlaxoSmithKline UK

Vaccination against pertussis for pregnant women

Composition of Boostrix-IPV®

Diphtheria

Toxoid not less

than 2IU

Tetanus Toxoid

not less than

20IU

Pertussis antigens

Pertussis Toxoid 8 micrograms

Filamentous Haemagglutinin 8 microgram

Pertactin 2.5 micrograms

Poliovirus (inactivated) Type 1 40 D antigen

units

Type 2 8 D antigen units

Type 3 32 antigen units


Composition of Boostrix-IPV® (Cont’d)

Excipients

Medium 199

Sodium Chloride

Water for injections

Adjuvant

Aluminium hydroxide 0.3mg

Aluminium phosphate (hydrated) 0.2mg

Residual substances

Neomycin

Polymyxin B


Administration of Boostrix-IPV®Licensing:

The Green Book states that:

“Pertussis-containing vaccines may be given to pregnant women when protection is required without delay. There is no evidence of risk from vaccinating pregnant women or those who are breast-feeding with inactivated viral or bacterial vaccines or toxoids (Plotkin & Orenstein 2004)”

• The vaccine marketing authorisation holder’s Summary of Product Characteristics (SPC) for Boostrix-IPV® states that the vaccine can be used in pregnancy when clearly needed.

• In a study of 20,000 women vaccinated with dTaP/IPV during pregnancy, the MHRA found no evidence of risk

• The advice from JCVI to use pertussis containing inactivated vaccines should be followed. There is no evidence of risk to pregnancy or the infant with inactivated vaccines such as Boostrix-IPV®


Administration of Boostrix-IPV® (Cont’d)• The vaccine comes as pre-filled suspension that must be shaken

before use to form a white suspension

• Given by intramuscular injection into the deltoid

• Can be given at the same time as other vaccines such as influenza

May only be administered:

• Against a prescription written manually or electronically by a registered medical practitioner or other authorised prescriber

• Against a Patient Specific Direction

• Against a Patient Group Direction


Contraindications and PrecautionsContraindications

• A confirmed anaphylactic reaction to a previous dose of diphtheria, tetanus, pertussis or poliomyelitis containing vaccine

• A confirmed anaphylactic reaction to any component of the vaccine, including neomycin and/or polymyxin

Precautions

• Acute illness- defer until recovered

• Recent immunisation against pertussis, diphtheria, tetanus and or polio- ensure an interval of 4 weeks

• Current neurological deterioration or encephalopathy of unknown origin within seven days of previous immunisation with pertussis- containing vaccine- follow advice in the Green Book


Possible adverse reactionsMost Common

• Erythema (redness), pain, swelling at the injection site

Less Common

• Pyrexia (>37.5C), haematoma, induration, pruritus and warmth at the injection site

Uncommon

• Swelling of vaccinated limb, pyrexia (>39.5), chills, pain


Reporting suspected adverse reactionsYellow 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://mhra.gov.uk/yellowcard

• See chapter 8 of Green Book for details


http://mhra.gov.uk/yellowcard



Recommendations• Women who become pregnant again while the programme is in

place should be offered immunisation during each pregnancy to maximise transplacental transfer of antibody

• One dose of Boostrix-IPV® is recommended for women carrying twins or multiple pregnancies

• Vaccination may be offered to new mothers who have never previously been vaccinated against pertussis, up to when their child receives their first vaccination. A single dose of Boostrix-IPV® is recommended in these circumstances

• New mothers who have never previously been vaccinated against pertussis are unlikely to have been fully vaccinated against diphtheria, tetanus and polio and should be assessed as to the need for further immunisations with Td/IPV vaccine


Data management• Health professionals are encouraged to accurately record the brand and

batch number of the vaccine in relevant data systems following the administration

• The delivery date of the baby should also be recorded in the mother’s medical records

• This information is essential to allow an assessment of vaccine uptake, safety and to inform any future public health actions, if required

• Vaccination against pertussis should be recorded in the women’s medical/maternity records and recorded in the relevant data system

• Vaccine uptake of Boostrix-IPV® for pregnant women will be monitored with a monthly data collection though ImmForm


Providing longer term protection against pertussis

• The protection the infant acquires from the mother by the transfer of antibodies across the placenta is short term

• It is very important that parents ensure their infants start their immunisation schedule at the recommended 8 weeks and complete all three doses to receive long lasting protection

• Parents should ensure older brothers and/or sisters are up to date with their immunisations © NHS Scotland/Crown Copyright


The healthcare professionals’ key role

To provide clear, concise and accurate information to every pregnant woman regarding vaccination against

pertussis

Every effort should be made by medical practitioners, midwives and others to maximise the uptake of pertussis-

containing vaccine


Resources• DH, PHE and NHS England Tripartite Letter (2013) Continuation of

temporary programme of pertussis vaccination of pregnant women [link]

• NHS Choices (2013). Whooping cough vaccination in pregnancy programme [link]

• Public Health England (2013). Immunisation against infectious diseases (Green Book). [link]

• Department of Health. Pertussis vaccine in pregnancy programme. [link]

• Public Health England (2014) Vaccination against pertussis for pregnant women: an update for health professionals training slide and advice for health professionals document [link]


https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/197839/130510_Pertussis_continuation_letter_FINAL.pdf

http://www.nhs.uk/conditions/pregnancy-and-baby/pages/whooping-cough-vaccination-pregnant.aspx

https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book

https://www.gov.uk/government/publications/resources-to-support-whooping-cough-vaccination

https://www.gov.uk/government/collections/immunisation

Key Message

• Infant cases of pertussis have been dramatically reduced by the introduction of the temporary maternal immunisation programme. However, the disease continues to circulate in older age groups

• It is important for all health professionals to encourage vaccination in pregnant women from 28 weeks, at the earliest opportunity



Acknowledgement

This resource was developed by NHS Education for Scotland as a national training template to support the temporary maternal pertussis vaccination programme. Their permission to adapt it for use in England is gratefully acknowledged.

Adaption for use in England undertaken by the

Immunisation, Hepatitis and Blood Safety Department

Public Health England-Colindale


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