Andrew Johnson (ad.johnson@ntlworld….)

9^th November 2009

The following documents were e-mailed to me by a doctor who works for a large mental health trust in England. He has become concerned about the level of persuasion there seems to be to get both patients and staff vaccinated for Swine Flu. I have met this person and he has expressed to me the conflict he has in providing the best care for his patients, when he feels that the vaccine may cause them harm. This is not just because of the “bad wrap” the vaccine gets regarding its contents, but, for example, even one of the documents below warns that the vaccine contains egg albumen, which some people are allergic to. The doctor treats patients who, for example, may have dementia and so they cannot tell him what allergies they may have. Similarly, they are unable, mentally, to understand the issue to properly give their consent to be vaccinated.

So why is the vaccine being promoted so heavily within the NHS? When I wrote to the DoH, they could only describe a potential flu-pandemic threat – they could not provide evidence of a real one.

1.    “Mythbuster”. 1

2.    Section from Trust’s “Team Briefing” Document 4

3.    E-mail sent to various staff 5

4.    Document Attached with Above e-mail 6

5.    Document sent to NHS Doctors from Dept of Health. 7 – Link:  NHS-Clinical Professionals Brief on Swine Flu Vaccination.pdf    (3.6 MB)

6.    “1st Wave Swine Flu Vaccination – Vulnerable patients list”. 22

1.    “Mythbuster”

Sent: 08 October 2009

SWINE FLU MYTHBUSTER

MYTH: Swine flu is a mild illness, so I don’t really need the vaccine

Yes, swine flu is generally mild for healthy people, but for pregnant women and those with health problems it can be much more serious. So vaccination isn’t just about keeping you safe and well – it’s about protecting your patients and your colleagues, who may be more susceptible to the virus. It’s also worth remembering that in a number of cases swine flu can kill otherwise healthy people. Don’t underestimate the virus, get yourself protected!

MYTH: The effect on the NHS is being overplayed – swine flu won’t cause us any problems

Actually, this could be the toughest ever winter for the NHS, as swine flu combines with other seasonal pressures, including seasonal flu. Getting yourself vaccinated is a simple way of helping to make sure you’re fit and healthy, and able to play your part in the months ahead.

MYTH: I’ve already had swine flu so I don’t need the vaccine

Many people think they’ve had swine flu when they haven’t. Unless lab testing confirmed that you definitely had swine flu, you should still have the vaccination. When it comes to protecting you and your patients, it’s better to be safe than sorry.

MYTH: The vaccine will give me the flu

The vaccines contain inactivated flu viruses so they can’t give you flu. There is a small chance, you may get a mild fever and a few aches and pains immediately after the jab, but any side effects are usually very mild and will pass within 48 hours. Most people suffer nothing worse than a slightly sore arm.

MYTH: I don’t treat anyone who has swine flu, so I don’t need the vaccine

Health professionals are more likely to be exposed to the virus. If you catch it and pass it on to your patients, then they may become seriously ill. So don’t take the risk – for yourself and your patients’ sake, it’s best to get the jab.

MYTH: You’re infectious after having the jab, so you can’t treat patients during that period

The vaccine won’t make you infectious to anyone, so it is safe to carry on with your normal duties.

MYTH: The vaccine contains mercury so it’s dangerous for pregnant women

There are traces of thiomersal, a preservative containing mercury, in the GSK vaccine (‘Pandemrix’). Thiomersal is used in other vaccines and has been given a clean bill of health by the World Health Organisation and the many research teams who have looked into its use. Pandemrix has been approved as safe for use in pregnant women.

MYTH: The vaccines have been rushed out and haven’t been properly tested – you simply don’t know it’s safe.

The vaccine had to pass stringent tests before being granted a licence by the European Medicines Agency. On top of this extensive trials involving thousands of people have been done on very similar H5N1 flu vaccines. This means we are very confident that the new vaccine is low risk.

MYTH: The vaccine causes Guillain Barré Syndrome

There’s absolutely no reason to suggest the swine flu vaccine is linked with Guillain Barré Syndrome (GBS). The swine flu vaccine used in the United States in the 1970s did carry a small risk of GBS, but this was different to the vaccines used today. Checks on similar seasonal flu vaccines have revealed no association with the disease.  However, a link has been shown between having a flu-like illness and developing GBS. 

MYTH: I don’t need the swine flu vaccine if I’ve already had the seasonal flu one

No, you should have both vaccines because swine flu is a completely different virus to the normal seasonal flu. It is safe to have both vaccinations at the same time.

MYTH: I never catch normal flu, so I can’t see me getting swine flu

Many of us have built up resistance to seasonal flu but swine flu is a new virus, meaning that those of you who are lucky enough to avoid normal flu may find you get sick from swine flu.

2.    Section from Trust’s “Team Briefing” Document

3.    E-mail Sent to Various Staff

From: 

Sent: 20 October 2009 17:19

To: Trust Bulletin

Subject: FW: Swine flu information and guidance update

20 October 2009

Dear Colleagues

Rates of influenza-like illness continue to increase in the UK, but steadily rather than dramatically. The majority of cases continue to be mild, although there have been some hospitalisations and a low, if tragic, number of deaths.

General measures to prevent swine flu

You can reduce, but not eliminate, the risk of catching or spreading swine flu by:

• Always covering your nose and mouth with a tissue when coughing or sneezing

• Throwing away dirty tissues promptly and carefully

• Maintaining good basic hygiene, for example washing hands frequently with soap and warm water to reduce the spread of the virus from your hands to face, or to other people

• Cleaning hard surfaces, such as door handles, frequently using a normal cleaning product

For up-to-date information about swine flu and how to protect yourself and your family please go the NHS Choices website via the link below:

www.nhs.uk/AlertsEme…

You can do a lot of things to help keep you and your family healthy during the winter months by making sure you eat well, take some exercise and get enough rest.

During the winter months seasonal flu will also be more prevalent, so do please look out for opportunities to get your seasonal flu vaccine. This can be given alongside the swine flu vaccine and both of these will be available shortly.

Licensing approval has been granted for both of the pandemic flu vaccines. The vaccine will initially be prioritised to those groups of people who are at highest risk of severe illness, as well as frontline health and social care workers. The first batches of licensed vaccine are now in the NHS distribution network. Groups of staff will be prioritised for the swine flu vaccine to ensure we have enough supplies. We will be letting you know when both the seasonal flu and swine flu vaccines will be available in your area, so please keep any eye out for notices of dates, venues and times.

Staff who are pregnant, or think they might be pregnant, should seek advice from their midwife, GP or Occupational Health (OH) both in terms of vaccination and their working conditions. For more general advice go to the NHS Choices website via the link below:

www.nhs.uk/condition…

If you are a pregnant member of staff and a patient you are treating/having contact with in hospital, or in the community, is suspected of having swine flu, you should take immediate advice from your line manager.

You should avoid contact until you have received the appropriate advice from your GP/Midwife/OH and line manager even if this means staying at home.

Inpatients

If you suspect an inpatient may have swine flu, a swab should still be taken and sent for analysis to check whether or not the individual is a confirmed case. Antivirals will be prescribed if the patient is suspected of having symptoms of the H1N1 swine flu virus.  

These patients should be cared for following strict infection control procedures for pandemic flu and by staff using the appropriate personal protective equipment (PPE). PPE covers items used to control infection, such as masks, gloves, aprons etc. Hand hygiene is extremely important, as always, in preventing the spread of infection.

Community team guidance on managing the flu pandemic can be accessed on:

_____________

More guidance and detailed information on the vaccination programme will be issued by the pandemic flu working group as soon as it is available.

Some more detailed information supplied by NHS Choices, such as how to recognise symptoms, is attached. Please do share this information with colleagues who may not have easy access to a computer and the links contained in this e mail.

If you have any queries in the meantime please do not hesitate to contact Assistant Director of Nursing ____________

4.    Document Attached with Above e-mail

Swine Flu information (supplied by NHS Choices)

It is important that as swine flu spreads, you know the symptoms of the disease so you can recognise it in yourself and others at an early stage.

Please read this page and consider your symptoms carefully before using the National Pandemic Flu Service mentioned below. 

So far, most swine flu cases have been mild, with symptoms similar to those of seasonal flu. Only a small number of people have had more serious symptoms.

If you or a member of your family has a fever or high temperature (over 38°C/100.4°F) and two or more of the following symptoms, you may have swine flu:

• unusual tiredness, 

• headache,

• runny nose,

• sore throat,

• shortness of breath or cough,

• loss of appetite, 

• aching muscles,

• diarrhoea or vomiting.

Checking symptoms

It makes sense to have a working thermometer at home, as an increase in temperature is one of the main symptoms.

If you are still concerned you may have swine flu, stay at home and check your symptoms using the online National Pandemic Flu Service on www.pandemicflu.dire…

Call your GP directly if: 

• you have a serious existing illness that weakens your immune system, such as cancer

• you are pregnant

• you have a sick child under one

• your condition suddenly gets much worse, or

• your condition is still getting worse after seven days (five for a child).

Note: the National Pandemic Flu Service is a new online service that will assess your symptoms and, if needed, provide an authorisation number that can be used to collect antiviral medication from a local collection point. For those who do not have internet access, the same service can be accessed by telephone on:

• Telephone: 0800 151 3100

• Minicom: 0800 151 3200

High-risk groups

For most people, swine flu is a mild illness. Some people get better by staying in bed, drinking plenty of water and taking over-the-counter flu medication.

However, some groups of people are more at risk of serious illness if they catch swine flu, and will need to start taking antiviral medication as it is confirmed that they have it.

It is already known that you are particularly at risk if you have:

• chronic (long-term) lung disease

• chronic heart disease

• chronic kidney disease

• chronic liver disease

• chronic neurological disease (neurological disorders include motor neurone disease, multiple sclerosis and Parkinson’s disease)

• immunosuppression (whether caused by disease or treatment) or

• diabetes mellitus.

Also at risk are: 

• patients who have had drug treatment for asthma within the past three years

• pregnant women

• people aged 65 and older, and

• young children under five.

It is vital that people in these higher-risk groups who catch swine flu get antivirals and start taking them as soon as possible.

5.    Document sent to NHS Doctors from Dept of Health

Sent: 28 October 2009 15:43

To: Email-Addresses@dh.g…

Subject: From the Department of Health: (GatewayReference) –

Issued by the Department of Health

28 October 2009

Gateway Reference 12855

TO:

Medical Directors in all Acute Trusts in England Medical Directors in

all NHS Foundation Trusts in England Medical Directors in all Primary

Care Trusts in England Clinical Directors in all Strategic Health

Authorities in England

CC:

Flu Leads in all Strategic Health Authorities in England Monitor

Dear Colleague,

Please see the attached Briefing from Prof Sir Bruce Keogh, NHS Medical

Director, Department of Health

(See attached file: Clinical Professionals Brief on Swine Flu

Vaccination.pdf)

Departmental Publications

You can order many Department of Health publications at

www.orderline.dh.gov.uk

It is important that our contacts database is always as up-to-date as

possible so that we can produce accurate e-mailing lists.  In the event

of a forthcoming personnel change, please reply to Contact Details inbox

with the name and full contact details for the new person and the date

of the change.  Also, if there are any changes to your own contact

details, please reply to Contact_Details@dh.g…

– – Disclaimer – –

This e-mail and any files transmitted with it are confidential. If you

are not the intended recipient, any reading, printing, storage,

disclosure, copying or any other action taken in respect of this e-mail

is prohibited and may be unlawful. If you are not the intended

recipient, please notify the sender immediately by using the reply

function and then permanently delete what you have received.

Incoming and outgoing e-mail messages are routinely monitored for

compliance with the Department of Health’s policy on the use of

electronic communications. For more information on the Department of

Health’s e-mail policy click here www.dh.gov.uk/terms

==============================

DH INFORMATION READER BOX

Clinical Professionals Brief on Swine Flu Vaccination

I encourage all clinical staff to consider carefully the evidence for swine flu vaccination in order to protect their patients, colleagues, families and themselves. This is particularly important at a time when demand on clinical services within the NHS may be high. Vaccination of frontline healthcare workers against swine flu remains a key aspect of the NHS swine flu resilience plan.

This document provides details of the swine flu vaccines, as well as the vaccination programme and explores some of the surrounding issues which may be of particular interest to clinicians.

Wherever possible, the sources of the information have been referenced so that those who wish to explore the evidence further can do so.

Please circulate this document as widely as possible among the clinical professionals within your organisation.

Additional information about the swine flu vaccination programme can be found on the Department of Health website:

www.dh.gov.uk/en/Pub… mme/index.htm

==============

Contents

Contents………………………………………………………………………………………………………………………………. 4

Introduction…………………………………………………………………………………………………………………………… 5

Influenza A H1N1v (swine flu)………………………………………………………………………………………………… 5

The role of swine flu vaccination……………………………………………………………………………………………. 6

Healthcare workers as a target population……………………………………………………………………………. 6

Composition of the vaccines…………………………………………………………………………………………………. 7

Potential side effects……………………………………………………………………………………………………………. 7

Guillain Barré Syndrome (GBS)……………………………………………………………………………………………. 8

Adjuvants……………………………………………………………………………………………………………………………… 8

Squalene……………………………………………………………………………………………………………………………… 9

Thiomersal……………………………………………………………………………………………………………………………. 9

Pregnancy and lactation……………………………………………………………………………………………………… 10

Timeline for vaccination programme……………………………………………………………………………………. 11

Vaccination schedule………………………………………………………………………………………………………….. 11

Seasonal flu vaccine…………………………………………………………………………………………………………… 12

Licensing procedure…………………………………………………………………………………………………………… 12

Monitoring for adverse events…………………………………………………………………………………………….. 12

Conclusion…………………………………………………………………………………………………………………………. 13

References………………………………………………………………………………………………………………………… 14

==============

Introduction

This paper aims to provide clinicians with further information about the swine flu vaccination programme. It combines information about the vaccines and the proposed programme for their administration from the Department of Health with evidence from a variety of peer-reviewed sources. Should you have any further queries, please contact your Trust flu lead who should be able to direct you further.

Influenza A H1N1v (swine flu)

The first cases of swine flu emerged in Mexico in April 2009. The first cases were reported in the UK later that month. On 11^th June 2009 the WHO declared a pandemic¹. This is a new strain of influenza, different from any strain previously affecting humans. For this reason, the majority of people will not have immunity to it².

==============

The role of swine flu vaccination

Vaccinating healthcare workers is a key aspect of the NHS swine flu resilience plan³. It is estimated that, in addition to the usual winter pressures faced by the NHS, up to 5% of the NHS workforce may be unable to work because of swine flu in the peak weeks of a surge⁴. With high uptake of vaccination it is likely that this proportion can be reduced.

Healthcare workers as a target population

Healthcare workers, with their high levels of exposure, are at high risk of occupational^ acquired infections⁵. The Government has therefore decided that frontline health and social care staff should be offered the swine flu vaccination. The definition of which healthcare staff are included is the same as those who are offered the seasonal flu vaccine. Advice on this is set out in the Green Book⁶. Frontline healthcare workers who provide direct patient care will be offered swine flu vaccination at the same time as the priority groups⁷.

As well as this personal risk, healthcare workers may transmit infections to vulnerable patients. Patients with existing co-morbidities (those who would be routinely offered seasonal flu vaccine) are at increased risk from swine flu. As of 1^st October 2009, across all age groups, 81% of those who have died in England from swine flu had an underlying health condition⁸. Flu- Clinical Information Network (FLU-CIN) data suggest that across all age groups 60% of those hospitalised with swine flu have at least one co-morbidity⁸. This rate is high as 85% in some age groups. There are an estimated 9.36 million people in England whose health status makes them a priority for vaccination⁹.

Composition of the vaccines

The UK has contracts for the supply of vaccine from two different manufacturers. The core characteristics of the vaccines are outlined in Table 1 below:

==============

Table 1: Characteristics of the swine flu vaccines— —

==============

Potential side effects

Very common side effects for Pandemrix® are likely to include headache, myalgia, arthralgia and injection site pain, redness or bruising. Common side effects are likely to include influenza like illness and lymphadenopathy¹⁰.

Very common side effects for Celvapan® are likely to include injection site pain. Common side effects are likely to include headache, myalgia, arthralgia dizziness, vertigo, and nasopharyngitis¹¹.

7

==============

Guillain Barré Syndrome (GBS)

GBS is a rare, immune-mediated disease characterised by acute, rapidly-evolving, bilateral, ascending neuromuscular paralysis. Although it can be fatal, it usually resolves, but may require a period of intensive care¹². GBS is a naturally occurring condition so it is inevitable that cases may occur and be reported not long after vaccination.

In 1976 in the US a pandemic swine flu vaccine programme was suspended after a significant increase in the number of cases of GBS were reported with concerns about an association with the vaccine¹³. It is thought that one extra case of GBS occurred with every 100,000 doses of vaccine given¹⁴. The exact mechanism behind this association is not known. Several studies in the US and elsewhere have looked at possible links between influenza vaccines used since 1976 and GBS. No convincing evidence of an increased risk has been demonstrated¹⁵.

A recent UK study that used GP data showed the relative incidence of GBS within 90 days influenza vaccination was 0.76 (95% CI 0.41 to 1.40). The same study concludes that the risk of GBS within 90 days of an influenza-like illness is 7.35 (4.36 to 12.38)¹⁶.

Adjuvants

Adjuvants are substances added to vaccines to improve their immunogenicity and efficacy¹⁷. They work by promoting a more potent immunological response than would be generated by the antigen alone. There are different types of adjuvants including oil-in-water emulsions and aluminium based compounds.

The main advantages of adjuvants are that they are antigen sparing and that they help to produce broader protection¹⁸: Adjuvants permit a smaller amount of antigen to be used in each dose of vaccine thus enabling a greater number of doses to be made in a limited time. In trials looking at H5N1 vaccines that used the same adjuvant as in Pandemrix®, the inclusion of the AS03 adjuvant was shown to induce broader, cross-clade protection¹⁹.

A study using H5N1 vaccine (Prepandrix® by GSK) has shown significantly more injection site pain with AS03 adjuvanted vaccine (90%) than non-adjuvanted vaccine (38%) (P<0.0001)¹⁹. Approximately 40,000 people have been vaccinated with AS03 containing vaccines in clinical trials since the late 1990s with no serious adverse events thought to be caused by the vaccine¹⁸.

==============

Squalene

One of the components of the AS03 adjuvant system is squalene. Squalene is a naturally occurring substance that is found in humans, other animals and plants. It is commercially extracted from fish (shark liver) oil. Since 1997, more than 25 million doses of one squalene containing vaccine (FLUAD by Novartis) have been administered²⁰. There have been no associated severe adverse events thought to be caused by the vaccine.

It has been postulated that the use of squalene was linked to ‘Gulf-war syndrome’ as anti-squalene antibodies were identified in some veterans who received anthrax vaccine. It is now known that squalene was not added to the vaccines administered to these veterans, and that there were technical deficiencies in the reports²¹.

The WHO Global Advisory Committee on Vaccine Safety (GACVS) has concluded that "The absence of significant vaccine-related adverse events following this number of doses suggests that squalene in vaccines has no significant risk."²²

Thiomersal

Thiomersal is a mercury containing preservative. Pandemrix® contains small amounts of this¹⁰. Both the GACVS²³ and the UK Commission on Human Medicines (CHM) have issued statements that there is no evidence of neurodevelopmental adverse effects caused by such levels of thiomersal in vaccines. The CHM goes on to say that "The only evidence of harm due to thiomersal is a small risk of hypersensitivity reactions (that typically include skin rashes or local swelling at the site of the injection). The CHM advises that the balance of risks and benefits of thiomersal-containing vaccines is overwhelmingly positive."²⁴

9

Pregnancy and lactation

Pregnant women are at higher risk of serious consequences of H1N1 infection. A review article by MacDonald et al. from this year cites evidence that vaccinating this population against seasonal flu reduces rates of potentially severe influenza and influenza-like illness in both mothers and infants. There is no evidence of increased vaccination-related adverse events in this group²⁵.

The Summary of Product Characteristics for Pandemrix® states¹⁰: "There are currently no data available on the use of Pandemrix® in pregnancy. Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not suggest malformations or fetal or neonatal toxicity. Animal studies with Pandemrix® do not indicate reproductive toxicity (see section 5.3).

The use of Pandemrix® may be considered during pregnancy if this is thought to be necessary, taking into account official recommendations.

Pandemrix® may be used in lactating women."

The Summary of Product Characteristics for Celvapan® states¹¹:

"Data from vaccinations with interpandemic trivalent vaccines in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine. Therefore, for pregnant women, administration of the pandemic influenza vaccine is recommended, irrespective of their stage of pregnancy.

The vaccine CELVAPAN® may be used during lactation."

The Joint Committee on Vaccination and Immunisation has advised that pregnant women should be given Pandemrix® since a one-dose schedule with this vaccine confers more rapid protection that would be afforded by a two-dose schedule with Celvapan®. There is no evidence that thiomersal-containing vaccines present a risk to pregnant women or their offspring²⁶.

10

Timeline for vaccination programme

The first deliveries of vaccine arrived in Acute Trusts on 21st October 2009. Vaccine supplies are being delivered to GPs from 26^th October 2009. It is likely to take up to "4 weeks to complete the distribution of first supplies to all GP practices"²⁷. It is expected that vaccination programmes will begin as soon as deliveries are received.

Vaccination schedule

Following advice from the Joint Committee on Vaccination and Immunisation, the following vaccination schedule is recommended in the UK²⁶‘²⁸:

Pandemrix® (manufactured by GSK)

For all children aged from 6 months of age to less than 10 years of age:

•    Two half doses (0.25ml) of Pandemrix® should be given with a minimum of three weeks
between doses.

For individuals aged from 10 years to less than 60 years of age:

•    One dose (0.5ml) of Pandemrix®

For individuals aged 60 years and over:

•    One dose (0.5ml) of Pandemrix® (this advice will be reviewed when more data become
available).

For immunocompromised individuals aged 10 years and over:

•    Two doses (0.5ml) of Pandemrix® should be given with a minimum of three weeks between
doses

Celvapan® (manufactured by Baxter)

For children from 6 months of age and adults:

•    Two doses (0.5ml) of Celvapan® should be given with a minimum of three weeks between
doses.

The two vaccine products are not interchangeable and the same brand of vaccine must be used for both doses if two doses are needed.

This dosage advice may change in the light of new clinical data and any such changes will be made public if and when they are made.

These recommendations are based on initial trials of the vaccines, such as a trial of Pandemrix® that was carried out in Germany. This study of 130 healthy adults aged 18-60 years showed that one dose of adjuvanted vaccine achieved >98% seroconversion at 3 weeks²⁹.

11

==============

Seasonal flu vaccine

The seasonal flu vaccine provides immunity against three different strains of influenza. Those people who are eligible for both the seasonal and the swine flu vaccinations (including all frontline healthcare workers) are advised to get both³⁰. The two vaccines can be administered at the same time.

Licensing procedure

Within the EU "all medicinal products for human and animal use derived from biotechnology and other hightechnology processes must be approved (by the European Medicines Agency (EMEA))"³¹ prior to a marketing authorisation (known as a licence) being issued by the European Commission.

The EMEA assessment of the swine flu vaccines is based on a mock-up dossier process. Vaccines have been developed, tested and licensed so that once a pandemic strain is identified, it can be substituted into a vaccine that is of proven safety and efficacy. Quality and non-clinical data are then assessed prior to a variation to the licence being permitted.

The mock-up dossiers for the swine flu vaccines are based on the H5N1 (avian flu) vaccines that have previously been developed³².

Monitoring for adverse events

The Medicines and Healthcare Regulatory Agency (MHRA) has developed a specific pharmacovigilance strategy for pandemic vaccines and antivirals³³. There are three main elements:

•    Increased passive surveillance

A separate, parallel, passive reporting system has been in place since 6^th July 2009.

The web-based Pandemic ADR reporting Portal is available via www.mhra.qov.uk/swineflu . It

is largely based on the existing web-based Yellow Card Scheme.

•    Active Surveillance

Two parallel studies will be carried out amongst 9000 individuals of the first vaccinated cohorts for each vaccine.

This process aims to estimate the incidence of any medically-attended adverse events in vaccinated subjects.

©    Data mining

GP data and electronic records will be assessed.

12

==============

Conclusion

It is hoped that the information presented here will reassure individual clinicians about swine flu vaccines and enable them to promote their take up amongst frontline healthcare staff and high risk patients.

References

¹ WHO. What is Phase 6?

www.who.int/csr/dise… asked questions/levels pandemic alert/en/ index.html Accessed 06/10/2009

² WHO. What is the new influenza A (H1N1) ?

www.who.int/csr/dise… asked questions/about disease/en/index.ht ml Accessed 06/10/2009

³ CMO. Further details about the H1N1 swine flu vaccination programme 2009-2010.
www.dh.qov.uk/en/Pub…

104267 Accessed 06/10/2009

⁴  Department of Health. Swine Flu Guidance for planners. Issued 22 October 2009.
www.dh.gov.uk/en/Pub…
/DH 107413 Accessed 22/10/2009

⁵  Sepkowitz, K.A. Occupational^ Acquired Infections in Health Care Workers: Part 1. Ann
Intern Med. 1996; 125: p826-834.

⁶  Salisbury D.M. et al. (Eds) Immunisation Against Infectious Disease. Chapter 12:
Immunisation of healthcare and laboratory staff. The Stationery Office. 2006.
http.7/www.dh.qov.uk/en/Publichealth/Healthprotection/lmmunisation/Greenbook/DH 4097254
Accessed 07/10/2009

⁷  CMO. Further details about the H1N1 swine flu vaccination programme 2009-2010. Annex
>A.www.dh.gov.uk/en/Pub…
H  104267 Accessed 06/10/2009

⁸  CMO. Pandemic Influenza. Weekly Situation Report- Press Conference 01/10/2009.

⁹  CMO. Pandemic Influenza. Weekly Situation Report- Press Conference 17/09/2009.

¹⁰  EMEA. Pandemrix, INN-Pandemic influenza vaccine (H1N1) (split virion, inactivated,
adjuvanted) www.emea.europa.eu/h…
17-en.pdf Accessed 06/10/2009

¹¹   EMEA. Celvapan, INN-Pandemic influenza vaccine (H5N1 whole virion, Vero cell derived,
inactivated) www.emea.europa.eu/h…
Accessed 06/10/2009

¹² Hughes, A.C. and Cornblath, D. R. Guillain Barre Syndrome. The Lancet 2005; 366: p1653-
1666

¹³ Evans, D et al.  "Prepandemic" Immunization for Novel Influenza Viruses, "Swine Flu"
Vaccine, Guillain Barre Syndrome, and the Detection of Rare Severe Adverse Events. JID
2009; 200: p321-327

¹⁴ Schonberger, L.B. et al. Guillain Barre Syndrome Following vaccination in the National
Influenza Program, United States, 1976- 1977. Am J Epidemiol 1979; 110(2): p105-123

¹⁵ Stratton K. etal. (Eds) Immunization Safety Review. Influenza Vaccines and Neurological
Complications. The National Academies Press, 2004

¹⁶ Stowe J. etal. Investigation of the Temporal Association ofGuillain-Barré Syndrome with
influenza vaccine and influenza-like illness using the United Kingdom General Practice
Research Database. Am J Epidemiol 2009; 169: p382-388

¹⁷ WHO Global Advisory Committee on Vaccine Safety. Adjuvants.
www.who.int/vaccine safetv/topics/adjuvants/en/index.html. Accessed 21/9/2009

¹⁸ GSK. Pandemic (H1N1) 2009 influenza FAQ www.qsk.com/media/fl… faq.htm.
Accessed 21/09/2009

¹⁹ Baras et al. A vaccine manufacturer’s approach to address medical needs related to
seasonal and pandemic influenza viruses. Influenza and other Respiratory viruses 2008; 2:
p251-260.

²⁰ Novartis. Novartis MF59-adjuvanted influenza vaccine (FLUAD®) data demonstrate
significant protective benefits in adults at risk for post-influenza complications
www.novartisvaccines… MF59-
adiuvanted influenza vaccine FLUAD data demonstrate siqnificant protective benefits in
adults at risk for post-influenza complications.pdf Accessed 19/10/2009

²¹ Anthrax Vaccine Immunization Program.  The Facts on Squalene.
www.anthrax.osd.mil/… Accessed 07/10/2009

²² WHO Global Advisory Committee on Vaccine Safety. Squalene-based adjuvants in
vaccines.

www.who.int/vaccine safetv/topics/adiuvants/squalene/questions and answers/en/index .html Accessed 21/09/2009

²³ WHO Global Advisory Committee on Vaccine Safety. Statement on Thiomersal

www.who.int/vaccine safetv/topics/thiomersal/statement ¡ul2006/en/index.html Accessed 04/10/2009

²⁴ CHM. Thiomersal (ethylmercury) containing vaccines.

www.mhra.qov.uk/Safe…specificinformationandadvice/Vaccinesafety/Thiomersal(ethvlmercurv)containinqvaccines/CON 026254 Accessed 07/10/2009

²⁵ Macdonald NE et al. Influenza immunisation in pregnancy. Obstet Gynecol 2009; 114(2 Pt
1): p365-8

²⁶ CMO, CNO, CPO.  The H1N1 swine flu vaccination programme 2009-2010
www.dh.qov.uk/en/Pub…

107169 Accessed 16/10/2009

²⁷ Dalton I. A (H1N1) Swine Influenza: Vaccination Programme Update
www.dh.qov.uk/en/Pub… 107156 Accessed 16/10/2009

²⁸ Salisbury DM. et al. (Eds) Immunisation Against Infectious Disease. Chapter 23a:
Pandemic influenza A(H1N1)v (swine flu).

www.dh.qov.uk/prod consum dh/qroups/dh diqitalassets/@dh/@en/documents/diqitalas set/dh 107361.pdf Accessed 21/10/2009

²⁹ GSK. Pandemic (H1N1) 2009 Influenza Update: Initial results form first clinical trial of GSK’s
H1N1 adjuvanted vaccine.

www.qsk.com/media/pr… pressrelease 10087.htm. Accessed 21/9/2009.

³⁰ CMO, CNO, CPHO. PL CMO (2009)1, PL CNO (2009)1, PL CPHO (2009)1: the influenza
immunisation programme 2009/10

www.dh.qov.uk/en/Pub… medicalofficerletters/DH 097550 Accessed 07/10/2009

³¹ EMEA. About EMEA – Structure.
www.emea.europa.eu/h… Accessed 06/10/2009

³²  EMEA. Pandemic influenza A(H1N1)v vaccines authorised via the core dossier procedure.
Explanatory note on scientific considerations regarding the licensing of pandemic A(H1N1)v
vaccines
www.emea.europa.eu/p…

Accessed 08/10/2009

³³ Bryan, P and Seabroke S. Update on MHRA Pharmacovigilance Strategy for Influenza Pandemic Vaccines and Antivirals. MHRA. 2009.

Prepared by DH NHS Medical Directorate

© Crown copyright 2009

First published October 2009

Published to DH website, in electronic PDF format only.

www.dh.qov.uk/public…

6.    “1st Wave Swine Flu Vaccination – Vulnerable patients list”

From: ____
Sent: 29 October 2009 12:38
To: Management Team _____
Cc: _____
Subject: 1st Wave Swine Flu Vaccination -Vulnerable patients list

_______

Re: Identifying Vulnerable Patients List for the 1st Wave Swine Flu Vaccination Programme

Following the Flu Lead meeting this morning, we have agreed that as we move to make preparations for the first wave of our Swine Flu Vaccination Programme to commence from the week beginning the 9th November.

We will need you to identify vulnerable patients from the following clinical areas;

1.       Prison 

2.       PICU 

3.       Shaftesbury 

4.       Phoenix and long term patients in Rehab hostels not covered by GP 

5.       Older Peoples Wards -long stay patients 

The responsible ward manager and consultant will need to identify patients in the following criteria who are;

·         immunocompromised  

·         considered as vulnerable due to serious underlying physical health conditions  

·         any patient in the above group with a known allergy to egg 

·         patients who are pregnant 

Please have this data ready and sent to you by the 4th November 2009 

Thank you for your assistance

Kind regards

Document attached to e-mail Above

Chronic respiratory disease and asthma:

• Chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema; bronchiectasis, cystic fibrosis, interstitial lung fibrosis, pneumoconiosis and bronchopulmonary dysplasia (BPD)

• Children who have previously been admitted to hospital for lower respiratory tract disease

Chronic heart disease

• Congenital heart disease

• Hypertension with cardiac complications

• Chronic heart failure

• Individuals requiring regular medication and/or follow-up for ischaemic heart disease

Chronic renal disease

• Chronic renal failure

• Nephrotic syndrome

• Renal transplantation

• Chronic liver disease

• Cirrhosis

• Biliary artesia

• Chronic hepatitis

• Chronic neurological disease, including stroke and transient ischaemic attack (TIA)

• Diabetes

• Immunosuppression 

• Immunosupression due to disease or treatment

• Patients undergoing chemotherapy leading to immunosuppression

• Asplenia or splenic dysfunction

• HIV infection

• Individuals treated with or likely to be treated with systemic steroids for more than a month at a dose equivalent to prednisolone at 20mg or more per day (any age) or for children under 20kg a dose of 1mg or more per kg per day

• Some immunocompromised patients may have a suboptimal immunological response to the vaccine