IMMUNISATION OF PREGNANT WOMEN AGAINST INFLUENZA A H1N1(v)
INTRODUCTION
The purpose of this paper is to brief NHS Board Operational leads on the need
for further action to ensure all pregnant women have been offered the
opportunity of vaccination against influenza A H1N1v before 31st December
2009. As indicated in the CMO letter SGHD/CMO/CNO (2009)15, Health
Protection Scotland has been instructed by the Scottish Government to work
with NHS Boards to ensure that this is achieved.
RISK TO PREGNANT WOMEN FROM INFLUENZA A H1N1(v) INFECTION
1. WHO1 recently held a seminar to gather information on the experiences of 100
professionals who had managed cases of the infection.
Although the
overwhelming majority of those infected with the new virus have uncomplicated
influenza-like illness, concern was expressed about small subsets of patients
who rapidly develop very severe progressive pneumonia often associated with
failure of other organs. The participants agreed that the risk of severe or fatal
illness is highest in three groups: pregnant women, especially during the third
trimester of pregnancy, children younger than 2 years of age, and people with
chronic lung disease, including asthma. There is as yet no confirmed case of a
mother infected with influenza A H1N1v passing the virus onto her unborn child.
2. Early reports from the US2 indicated that pregnant women were more than four
times more likely to be admitted to hospital due to influenza A H1N1v infection
than the general population. In Australia3, about 5% of hospitalised confirmed
H1N1 cases have been reported as pregnant. In the UK, the ongoing review4
of hospitalised cases of laboratory confirmed pandemic influenza AH1N1v to
help guide clinical management, has identified 29 (19.6%) of 148 female cases
aged 16-45 years admitted to hospital who were pregnant at the time of
admission. The UK Obstetric Surveillance System5 reports that based on data
received up to 12 November, 18% of pregnant women admitted to hospital with
influenza A H1N1v infection had had an ITU admission.
3. In Scotland, of the 1280 confirmed hospitalised cases of influenza A H1N1v
infection reported to HPS by December 1st 2009, 48 (3.8%) were pregnant at
the time of admission, 8 of whom had other co-morbidities recognised as risk
factors for the disease. Over 50% of these pregnant women have been aged
less than 25 years. Of the 48, at least 5 received intensive care. Of the 52
deaths in confirmed cases, 3 (5.8%) were pregnant at the time of admission to
hospital.
4. Indicators for rates for influenza like illness in Scotland have remained relatively
stable over the last few weeks. Swab-positivity rates for influenza A H1N1v
infection in those presenting to GPs with symptoms have shown a similar
picture. Rates of transmission of the virus may therefore be at or near to their
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peak. However when they start falling, it is likely to take some weeks before
they cease to be a significant public health problem. With the winter starting,
the incidence of other respiratory pathogens (including bacterial) is likely to
increase which may lead to a worsening of the clinical spectrum.
5. Because of these factors, the influenza A H1N1v virus will continue to present a
risk to the health of pregnant women over the coming weeks. They remain a
priority for vaccination.
6. So far many thousands of women have been vaccinated with Pandemrix in the
UK. The MHRA has implemented a pharmaco-vigilance system. Up to and
including Thursday 29th October 2009, MHRA6 has received a total of 50 UK
reports of suspected adverse reactions to the H1N1 vaccines in pregnant
women. The most commonly reported are injection site reactions and other well
established adverse effects of many vaccines. The MHRA continues to
conclude that the benefit – risk balance for Pandemrix remains positive.
IMMUNISING PREGNANT WOMEN: CURRENT SITUATION
7. The estimated cumulative uptake rate among pregnant women as at week
ending 30 November is 28.5 %. These are preliminary figures only and are
derived from weekly compilation of information from 585 (57%) General
Practices where H1N1 vaccination uptake data was submitted and are
continuing to be scrutinised. Other information sought directly from individual
practices, for example in Borders on 1 December, indicates much higher
uptakes are being achieved by some practices usually over 50%. It is of note
that currently the number of women coded as pregnant by the practices is
about half that of the expected number of pregnant women. Steps are being
taken to support and inform practices around the identification and recording of
pregnancy status.
8. HPS has worked with NHS Boards to provide support and review progress in
the immunisation of pregnant women. NHS Boards have shown commitment to
achieving optimum uptake and have undertaken a number of important actions
to ensure that pregnant women are encouraged to come forward for
vaccination. Some of these actions are listed in Appendix 1 “Good Practice
Identified from NHS Boards in Scotland in Maximising Uptake in Pregnant
Women”.
9. There is considerable evidence of good practice in almost all Board areas, and
we would advise that we seek to extend this across all so as to contribute to the
maximisation of uptake in pregnant women.
10. We are aware that 7 Boards have developed a central register of pregnant
women and have organised the sending of a letter to each one identified either
inviting them for immunisation or informing that they will soon receive a letter
from their general practitioner doing so. Others have worked with local
practices to invite women.
11. Further information has emerged from Northern Ireland on practice that has
contributed to increasing uptake rates. This information is contained in
Appendix 2. The information for professionals in use in Northern Ireland
comes with this email.
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FURTHER ACTIONS TO ENHANCE UPTAKE
13. There is clearly scope for further action to ensure that the uptake of vaccination in
pregnant women is maximised.
National Actions
14. HPS is working with partner national agencies to:


Revise and improve the coding of pregnant women by General Practices;
Implement software to continue to extract uptake rates.
15. The Scottish Government with other UK Health Departments has taken forward a
media campaign to highlight the need for, and benefits of, immunisation for At
Risk groups including pregnant women. This will start today and feature over the
next two weeks.
The Swine Flu vaccination information leaflet for pregnant women comes with
this email. A Word version of the same leaflet also comes for incorporation into
any invitation letters if necessary. Further printed copies can also be ordered
from the Scottish Government.
Board Actions
16. Boards are asked to :
a) review their activity to date, and to consider implementation of good practice
where this is not already in place or completed, including close liaison with
midwifery leads/obstetrics staff;
b) if not already done, should ensure that all GP practices are provided with
complete lists of pregnant women receiving active antenatal care. Appropriate
information governance processes should be followed. Boards should also
ensure that robust arrangements are in place to notify practices of newly booked
pregnancies. This will allow practices to ensure that all registered pregnant
women have been completely identified. When these become available, lists
should be used as a final check by practices to ensure that no women have been
omitted.
c) by 10th December 2009, ensure that all pregnant women resident in the Board
area have been invited for vaccination. If this has not already been completed in
your area, you are asked to centrally organise the sending of a letter to all
pregnant women reminding them of the offer of the vaccine via their registered
GP. This should be done without delay. Boards which have not already done so,
should also encourage practices to invite for vaccination those who have not
already been vaccinated.
Appendix 3 gives further details on how this might be approached by Boards,
including a sample process and letter used by NHS Lanarkshire. An alternative
form of words for a letter, based on that used in Northern Ireland, is provided.
d) after 10th December 2009 and before the end of December 2009, liaise with
General Practices to encourage any pregnant woman who has been invited and
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has not directly refused the vaccine, but has not been vaccinated, to come
forward for immunisation or be offered the vaccine opportunistically;
e) liaise with midwifery leads/obstetrics staff to ensure that any pregnant woman
who has not directly refused the vaccine but has not been vaccinated, is advised
of the offer of vaccination.
f)
give a status update at the Board Operational Leads meeting on 9th December.
CONCLUSION
For the coming weeks influenza A H1N1 infection will continue to present a risk to
pregnant women in Scotland. All pertinent national and local actions should be taken
to protect them. This briefing is designed to ensure a consistent approach across the
country.
REFERENCES
1. World Health Organisation, “Clinical management of human infection with
pandemic (H1N1) 2009: revised guidance”, WHO, November 2009
2. Jamieson et al.., “H1N1 2009 Influenza Virus Infection during Pregnancy in the
USA”, Lancet 374:451-8, 2009
3. Australian Government, Department of Health and Ageing “Australian Influenza
Surveillance Summary Report 2009 - Period- 5 to 11 September 2009”,
Australian Government.
4. (Pandemic) Influenza Clinical Information Network - FLU-CIN, “Summary Report
No 6 Date: 20 /11 /2009 (based on data available to 18/11/2009 – 600 cases)”,
Presentation, November 2009
5. UK Obstetric Surveillance System, “H1N1 in Pregnancy Interim Report No.1Women admitted to hospital with laboratory confirmed H1N1v infection Date:
13/11/09 (based on data available to 12/11/09)”, Royal College of Obstetricians
and Gynaecologists and National Perinatal Epidemiology Unit, Presentation
November 2009.
6. Medicines and Healthcare Products Regulatory Agency “UK Suspected Adverse
Reaction Analysis - Swine Flu (H1N1) Vaccines 5 November 2009” MHRA,
November 2009.
Martin Donaghy
Medical Director
Jill Carson
Service Planning Manager
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APPENDIX 1
Good Practice Identified from NHS Boards in Scotland in Maximising Uptake in Pregnant Women
Good Practice……
Engaging directly with midwives and Obstetrics/Gynaecology staff.
Carried out by…..
Borders, Dumfries & Galloway, Western Isles.
GPs phoning pregnant women directly to invite for vaccination.
Some practices within Borders.
Occupational Health Consultant-led clinics for pregnant health and
social care workers.
GGC.
Support and encouragement to midwives from Obs/Gynae
Consultants.
Borders, GGC.
Active involvement of midwifery lead in planning structures for
vaccination.
Various Boards including Borders, GGC, Tayside, Western Isles.
Midwife-specific training sessions.
Lanarkshire, Dumfries & Galloway.
Letters and information sent out to all pregnant women.
Various boards including Lanarkshire, Lothian.
Specific arrangements for those with high-risk pregnancies.
Lothian.
Weekly H1N1 vaccination briefing cascaded to maternity services.
Borders
Jill Carson
Alison Smith-Palmer
HPS
1st December 2009 Version 1
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APPENDIX 2
INFLUENZA A H1N1 IMMUNISATION IN PREGNANT WOMEN IN NORTHERN
IRELAND (NI)
Uptake rates in pregnant women were discussed with colleagues from the Northern
Ireland Health Protection Agency.
Uptake Rates
So far the average uptake rate for NI is 52%. The programme is organised through
the 5 Acute Trusts operating in NI and the rates range from 40 to 65%.
The denominator for the uptake rate is all women booked with the Trusts for
antenatal care. It therefore does not include all pregnant women. NI has a register
of pregnant women (NIMAS) but this is only employed in a minority of the Trusts. It is
not essential to either the call of women or the recording of immunisation status or
the calculation of uptake. Indeed the Trust with the best uptake rates does not use
NIMAS. The differential in uptake rates partly reflects the varying start dates of the
Trust programmes.
The Programme
The NI Government and NI HPA decided after extensive consultation to run the
immunisation of pregnant women through the Trusts rather than GPs. The decision
was described as being 50:50.
Pregnant women are identified either through NIMAS or the routine antenatal
booking system. Special clinics in the hospitals were set up and run by midwives,
many at evenings and weekends. A special invitation letter was devised which gave
a number to book an appointment.
A specific information sheet on immunisation and pregnancy was developed which
was either sent with the letter or made available at the clinic prior to immunisation.
The Trust which made the sheet available on attendance has the highest uptake rate.
One Trust also sent out the GSK Patient information leaflet and this has the lowest
uptake leading to a preliminary conclusion that this may have backfired.
Immunisation is now being offered opportunistically at routine antenatal clinics in
most Trusts.
Reasons for the relatively high uptake rates
Colleagues from the Northern Ireland Health Protection Agency are of the view that
the main reason was the early engagement of midwives and their buy-in to the
programme. The NI HPA allocated a public health Specialist Registrar and a nurse
to develop this aspect of the pregnancy programme. Specific sessions to train
midwives as either immunisers and/or counsellors were arranged. Key opinion
formers in the profession were targeted and brought on board and served to reassure
their colleagues. Obstetricians were not involved in a major way.
Martin Donaghy
Medical Director
Health Protection Scotland
November 2009
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APPENDIX 3
EXAMPLE OF PROCESS FOR CENTRAL ORGANISATION FOR INVITING
PREGNANT WOMEN




Obtain lists of pregnant women from midwifery service/s.
Mail aggregated lists to individual practices for reconciliation with
practice lists.
Mail all pregnant women directly from the Board.
Ensure that there are robust arrangements in place to notify practices of
newly booked pregnant women.
NHS Lanarkshire Process











vaccination of pregnant women began with availability of vaccine in GP and
OH around end of Oct. The invite letter is the second phase.
we do not have centralised electronic records for pregnant women. Midwives
just had paper records but they had labels and CHI # (We considered using
electronic laboratory booking bloods data, but data quality not considered
good enough)
each midwife collated all their pt's labels with CHI #, ~5-10% did not have
CHI, in which case they hand wrote demographic details
admin persons entered ~3,000+ CHI numbers on to a spreadsheet with
forename (as a check) and code for their area of care (I think it took several
bank aid staff over about 4 days). They looked up CHI for those with just
demographics.
the spreadsheet was merged with CHI database to add demographics
electronically and checked with forename for accuracy (a small % were
discarded for lack of accuracy)
then the electronic CHI demographic data was used as mail merge
ideally we would have wished for a double check of pregnancy status before
letters issued, but risk balance favoured early distribution given the
consequences of H1N1 illness in pregnancy
mail merge letters auto stuffed with info leaflets in windowed envelopes with
private and confidential on it (NB no labels used to omit a further potential
source of error)
3,060 letters to be posted (over next few days)
key times were getting all midwives to collate all data, wait for printed leaflets,
then the envelope stuffer needed calibrated (manager for retinal screening off
unexpectedly) and letters posted.
midwives now issuing letters at booking.
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SAMPLE NHS LANARKSHIRE TEXT FOR LETTER TO PREGNANT WOMEN
Dear <first name> <surname>
Invitation for H1N1/Swine flu vaccination
I am writing to recommend vaccination against the H1N1/swine flu virus for all
pregnant women and invite you to contact your GP surgery to make an
appointment to be vaccinated.
Swine flu is a respiratory disease caused by a new strain of the influenza
virus. Swine flu is easily spread by coughing or sneezing and causes marked
fever, tiredness, cough and sore throat. Some people are more likely than
others to become very unwell with swine flu and pregnant women have been
particularly severely affected. These effects include being more likely to need
hospital treatment.
The vaccine against the virus is available from your GP surgery and is a very
good way of protecting you and your baby from the virus. Most people should
only require a single dose, but depending on your personal circumstances,
you may need two doses. Your GP will tell you whether you need to make a
follow-up appointment.
For more information about the vaccine, please see the attached leaflet or call
the NHS 24 vaccination information line on 08000 282 816.
If you are no longer pregnant, or have already made an appointment at the
surgery, or you have received your swine flu vaccination already, please
accept my sincere apologies and ignore this letter.
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ALTERNATIVE WORDING FOR BOARD LETTER BASED ON LETTER USED IN
NORTHERN IRELAND
Dear
SWINE FLU VACCINATION for PREGNANT WOMEN
We would like to invite you to be vaccinated against swine flu, if you have not
already received it. All pregnant women in Scotland are being offered a swine flu
vaccination. It may be that you have been contacted before by your general
practice, or have been advised by your midwife, or antenatal clinic to receive this
vaccine. If you are still undecided, we would ask you now to reconsider this
important invitation.
Why are pregnant women being vaccinated?
While swine flu is a mild illness for most people, it can be very serious. Pregnant
women who catch this flu are much more likely to develop serious complications,
including pneumonia and heart and lung problems, compared to women who are not
pregnant. They are more likely to become so ill that they need to be admitted to
hospital and they are ten times more likely to need intensive care compared to the
general population. Sadly, some pregnant women have died as a result of swine flu
infection. The vaccine can protect you and your unborn baby from the effects
of swine flu.
Is the vaccine safe for me and my baby?
The swine flu vaccine is a new vaccine because swine flu is a new virus. It has
undergone tests and has been certified as safe for use in pregnant women at all
stages of pregnancy. The swine flu vaccine is similar to the seasonal flu vaccine
which has been given safely to millions of women across the world. Studies looking
at the effects of giving pregnant women the seasonal flu vaccination found that it
caused no bad effects on pregnant women or their babies. The swine flu vaccine
does not contain live virus, and cannot give you or your baby the flu.
How do I get this vaccination?
If you wish to accept the vaccine, we urge you not to delay further and to
contact your general practice to receive it.
Please find enclosed a patient information leaflet on the swine flu vaccination.
Further information is available on the NHS 24 website: www.nhs24.com or its Flu
Helpline: 08000 282 816.
If you are no longer pregnant, or have already made an appointment at your general
practice, or you have received your swine flu vaccination already, please accept my
sincere apologies and ignore this letter.
Yours sincerely
Dr XXXXXX XXXXXX
3xx December 2009
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ALTERNATIVE WORDING FOR BOARD LETTER BASED ON LETTER USED IN
NORTHERN IRELAND
Dear
SWINE FLU VACCINATION for PREGNANT WOMEN
We would like to invite you to be vaccinated against swine flu. All pregnant women in
Scotland are being offered a swine flu vaccination. It may be that you have been
contacted before by your general practice, or have been advised by your midwife, or
antenatal clinic to receive this vaccine. If you are still undecided, we would ask you
now to reconsider this important invitation.
Why are pregnant women being vaccinated?
While swine flu is a mild illness for most people, it can be very serious. Pregnant
women who catch this flu are much more likely to develop serious complications,
including pneumonia and heart and lung problems, compared to women who are not
pregnant. They are more likely to become so ill that they need to be admitted to
hospital and they are ten times more likely to need intensive care compared to the
general population. Sadly, some pregnant women have died as a result of swine flu
infection. The vaccine can protect you and your unborn baby from the effects
of swine flu.
Is the vaccine safe for me and my baby?
The swine flu vaccine is a new vaccine because swine flu is a new virus. It has
undergone tests and has been certified as safe for use in pregnant women at all
stages of pregnancy. The swine flu vaccine is similar to the seasonal flu vaccine
which has been given safely to millions of women across the world. Studies looking
at the effects of giving pregnant women the seasonal flu vaccination found that it
caused no bad effects on pregnant women or their babies. The swine flu vaccine
does not contain live virus, and cannot give you or your baby the flu.
How do I get this vaccination?
If you wish to accept the vaccine, we urge you not to delay further and to
contact your general practice to receive it.
Please find enclosed a patient information leaflet on the swine flu vaccination.
Further information is available on the NHS 24 website: www.nhs24.com or its Flu
Helpline: 08000 282 816.
Yours sincerely
Dr XXXXXX XXXXXX
3rd December 2009
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