Isabella Drew

age From Ben Gummer MP
Parliamentary Under Secretary of State for Care Quality

Department
of H ealth Richmond House
79 Whitehall
London
POGS000450192 SWIA 2NS
Tel: 020 7210 4850

Ms N. Mundy

Senior Coroner

Coroner’s Court and Office,

Crown Court 23 SEP 2015
College Road

Doncaster

DN1 3HS

23/9/2015

Dear Ms Mundy,

Thank you for your letter of 16 July 2015 following the inquest into the death of
Isabella Drew. I was extremely sorry to hear of baby Isabella’s death and wish to
extend my sincerest condolences to her family.

Your concerns in this case focus on the advice and support provided by ante-
natal healthcare services, to pregnant women, regarding the whooping cough
vaccination.

First you ask for consideration of whether there needs to be further and more
explicit guidance for local healthcare providers about how to meet their
responsibility to advise and offer whooping cough vaccination to pregnant
women and provide auditing and follow up procedures. You also ask whether
there needs to be further national guidance about the importance of effective
multi-agency communication between all ante-natal healthcare providers.

Immunisation programmes are the shared responsibility of the Department of
Health (DH), Public Health England (PHE) and NHS England (NHSE). All three
organisations have worked together to provide you with a response to your letter.

I can advise that Sir Bruce Keogh, National Medical Director of NHS England,
is responding to you on behalf of all three organisations. I have seen and agree
with the reply from Sir Bruce Keogh.

I am grateful to you for bringing the circumstances of Isabella’s death to my
attention.

Yours sincerely,

eT,

BEN GUMMER

H.M Senior Coroner for South Yorkshire

NHS)

England

Bruce Keogh

Medical Directorate

6" Floor, Skipton House
80 London Road

SE1 6LH

bruce.keogh@nhs.net

18" September 2015

(East District)

Ms N J Mundy

Coroner’s Court & Office Crown Court
College Road

Doncaster

DN1 3HS

Your Ref: NJM/Ib/tji/46385-2014
Dear Ms Munday,
RE: Isabella Rosa Drew (Deceased), DOB: 11.08.2014 — DOD: 09.09.2014

Thank you for your letter dated 16 July regarding Isabella Rosa Drew. Firstly may | say
that | was sorry to hear of Isabella’s death, as a result of whooping cough on 9"
September 2014 and wish to express my deepest sympathy to the Drew family.

Whooping cough (pertussis) is a disease that the Department of Health, Public Health
England (PHE) and NHS England take very seriously as it continues to be a life-
threatening illness in babies, particularly those who are too young to be protected by our
routine infant immunisation programme which begins at 2 months of age. As
immunisation programmes are the responsibility of this tripartite, | am writing on behalf
of the three organisations, each of which have contributed to this response.

As you are aware, we introduced pertussis vaccination for pregnant women in October
2012, in order to protect babies from birth through transplacental transfer of maternal
antibodies. This programme was introduced by the Department of Health as an outbreak
response measure following a rise in cases of infants too young to be vaccinated. The
programme introduction was based on expert, independent, scientific advice from the
Joint Committee on Vaccination and Immunisation (JCVI).

Acceptance of the programme has been high when compared with other countries
offering a similar programme, with the most recent recorded vaccine uptake at 63% for
women giving birth in December 2014 compared, for example, to 57% reported
coverage in Argentina in 2014 and state-based estimates of pertussis-containing
vaccine receipt during pregnancy in the US typically not exceeding 20%. Equity of
access is important for this programme and assessment of this is being undertaken. For
example, PHE has recently introduced collection of pertussis vaccination in pregnancy
uptake figures by ethnicity. In addition, the enhanced surveillance for pertussis that has
been in place nationally since 1994 (where every laboratory-confirmed case of pertussis
is followed up with the patient’s GP for additional information including; vaccination
history, hospitalisation and complications) has been extended to cover information on
maternal immunisation history, maternal ethnicity and gestational age at delivery for

High quality care for all, now and for future generations

babies born since the immunisation in pregnancy programme was introduced.

There were 14 deaths in infant cases in 2012. These infants were all born before the
introduction of the maternal pertussis immunisation programme and were too young to
be protected by their first infant dose of pertussis vaccine. Up to 14 August 2015, 12
deaths have been reported in infants with confirmed whooping cough who were born
after the introduction of the maternal programme. Eleven of these 12 babies were born
to unvaccinated mothers and only one infant had received their first dose of pertussis-
containing vaccine.

Whilst cases and deaths in young infants have fallen since the introduction of the
immunisation in pregnancy programme, PHE has been concerned that babies have
continued to die from pertussis. Most of these babies, as the figures above show,
appear to have been born to women who were not offered immunisation during their
pregnancy, despite the demonstrated protection against severe disease and death. As a
result, PHE has contacted all the Child Death Overview Panels (CDOP) in the areas
where these babies were resident to request a copy of the relevant CDOP report(s) to
develop further understanding and learn from the deaths that have arisen in infants
diagnosed with whooping cough with a view to collating findings and sharing learning at
a national level.

PHE has also put in place a number of other actions to support the improvement of
access, communication and health professional understanding. These include:

e Engagement with pregnant women.

° In addition to the materials prepared specifically for pregnant women,
PHE has shared information through social media and used pregnancy apps
to raise awareness of pertussis vaccine in pregnancy and when and how
pregnant women can get the vaccine.

¢ Improved communication with healthcare professionals. PHE has:

° Engaged with the Royal College of Midwives (RCM) and the Royal

College of Obstetricians and Gynaecologists to ensure they have clear

statements and links to clinical advice on immunisation in pregnancy on their

websites.

Published articles in professional journals highlighting to midwives the
importance of immunisation in pregnancy against both pertussis and
influenza.
fo) Attended four regional infectious diseases in pregnancy screening events
to highlight to midwives immunisation in pregnancy and will be presenting a
paper at the national maternity conference in Manchester in September.

Had a research paper on maternal attitudes to immunisation in pregnancy
accepted for publication in British Journal of Midwifery.
fo) Met with the RCM Heads of Midwifery and the NHS Heads of Midwifery at

national and local level.

° Undertaken attitudinal research amongst midwives, practice nurses and
health visitors on immunisation in pregnancy in collaboration with the RCM,
the Royal College of Nursing and the Institute of Health Visiting.

fc) Worked with NICE to have flu and pertussis immunisations in antenatal
Clinical guidance.

(e}

°

In addition, to better facilitate the vaccination of pregnant women by midwives, PHE
has ensured that its Patient Group Directions (PGDs) template for influenza and
pertussis immunisation (in pregnancy) includes midwives as nominated health

High quality care for all, now and for future generations

professionals. PGDs are written instructions for the supply or administration of
medicines (including vaccines) to groups of patients who may not be individually
identified before presentation for treatment.

PHE has also identified that a barrier to more effective implementation of the
vaccination programme is that GPs do not always know in a timely way when a
woman is pregnant and their expected date of delivery in order to schedule the
vaccination, ideally between 28 and 32 weeks. As part of the GP enhanced service
specification (contract), GPs have to compile a register of pregnant women and
contact them to offer vaccination. However, this is dependent on whether or not they
have been informed of pregnancies, and requires good communication between
primary care and maternity services.

Your area of particular concern relates to guidance available. As you rightly point out,
guidance from the Department places a responsibility on medical health practitioners to
discuss with and offer pertussis immunisation to all pregnant women. At the start of the
programme in 2012, the Department issued an alert about the announcement to the
NHS using the Central Alert System and pager messaging just before 7pm on 27
September 2012:

https:/Avww.cas.dh.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=101844

Primary Care Trusts (at the time) were asked to cascade the information to healthcare
professionals including general practitioners (GPs) urgently and within 24 hours. The
announcement stated that “we are writing to you about the introduction of a temporary
programme to vaccinate pregnant women against pertussis to protect their infants. This
programme should be implemented quickly following receipt of these letters.”

Since April 2013 the pertussis immunisation programme has been commissioned as part
of the Public Health Section 7a Agreement:
(https://www.gov.uk/government/publications/public-health-commissioning-in-the-nhs-
2015-to-2016) (s7a) — an agreement between the Secretary State for Health and NHS
England — delivered in partnership with PHE and DH.

PHE has published a range of information materials aimed at both expectant mothers
and healthcare professionals about the maternal immunisation programme. This is
available at:
https://www.gov.uk/government/publications/resources-to-support-whooping-cough-
vaccination

These. include:

e A leaflet aimed at expectant mothers that goes into detail about the vaccination
programme in a question and answer format;

e A flyer aimed at expectant mothers, explaining what they will need to know
before having the vaccination;

e A factsheet for healthcare professionals that gives the scientific background to
the need for, and development of, the vaccination programme;

e A training slide set for healthcare professionals;

e A poster to raise awareness in pregnant women.
You suggested that consideration should be given to:

High quality care for all, now and for future generations

e The need for further and more explicit guidance as to how local healthcare
providers ensure systems put in place effectively capture their responsibility to
advise all pregnant women of the importance of whooping cough vaccination with
provision for auditing and follow up procedures

e The need for further national guidance regarding the importance of effective
communication links between the various limbs of antenatal healthcare providers

Since the pertussis outbreak was declared in April 2012 this situation has been
managed as a level 3 (national level) incident by PHE. For such an incident there is a
nationally co-ordinated response that includes regular incident team meetings, regular
written situation reports and review and updating of all public health guidance for the
management of suspected cases and local outbreaks.

In addition, an independent review of maternity services in England was initiated in April
2015 chaired by Baroness Julia Cumberlege with Professor Sir Cyril Chantler as vice
chair. It will assess current maternity care provision and consider how services should be
developed to meet the changing needs of women and babies, and is expected to report
by the end of the calendar year. There are 5 working groups covering models of care,
choice, professional culture and accountability, levers and incentives, and quality
assessment. Your concerns about the need to better integrate the pertussis and other
immunisation services into routine maternity care and the need for additional guidance
will be taken into consideration as the review progresses.

| hope that this letter reassures you that we are taking appropriate action to ensure that
access, communication and health professional understanding of this programmes is
improved and that the need for additional guidance along the lines that you have
suggested will be given active consideration.

Yours sincerely, ~
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Bruce Keogh KBE, MD, DSc, FRCS, FRCP
National Medical Director
NHS England

High quality care for all, now and for future generations