DRAFT ONLY - Please see the disclaimer text on slide 1 The national flu immunisation programme 2015/16 Training for healthcare practitioners Rationale of resource This resource is designed to educate health care practitioners involved in delivering the national flu immunisation programme for the 2015/16 flu season. Although it includes slides on the childhood flu programme and the live attenuated intranasal vaccine being used for children for those that will deliver the programme to all age groups (e.g. Practice Nurses), a separate set of slides and a Q&A document focusing solely on the childhood programme is available at https://www.gov.uk/government/collections/annual-flu-programme This resource is designed to be used by anyone involved in the flu programme. Not all slides will be required for training – trainers should select slides depending on audience background, role in the programme and length of training session. This resource does not cover vaccine administration technique. If staff are required to deliver flu vaccinations they should refer to their line manager for additional training. Note: For the purposes of this resource, the term ‘influenza’ will be replaced by the term ‘flu’ unless it relates to a specific virus/strain.

Key messages Flu immunisation is one of the most effective interventions immunisers can provide to reduce harm from flu and pressures on health and social care services during the winter Increasing flu vaccine uptake in clinical risk groups is important because of increased risk of death and serious illness if people in these groups catch flu For a number of years only around half of patients aged six months to under 65 years in clinical risk groups have been vaccinated Influenza during pregnancy may be associated with perinatal mortality, prematurity, smaller neonatal size, lower birth weight and increased risk of complications for the mother Vaccination of health and social care workers protects them & reduces risk of spreading flu to their patients, service users, colleagues and family members The national flu immunisation programme 2015/16

DRAFT ONLY - Please see the disclaimer text on slide 1 What is flu? Flu is an acute viral infection of the respiratory tract (nose, mouth, throat, bronchial tubes and lungs) Highly infectious illness which spreads rapidly in closed communities Even people with mild or no symptoms can infect others Most cases in the UK occur during an 8-10 week period during the winter The national flu immunisation programme 2014/15 The national flu immunisation programme 2015/16

DRAFT ONLY - Please see the disclaimer text on slide 1 Influenza viruses There are 3 types of influenza viruses: A viruses Cause outbreaks most years and are the usual cause of epidemics Animal reservoir – wildfowl, also carried by other mammals B viruses Tend to cause less severe disease and smaller outbreaks Burden of disease mostly in children Predominantly found in humans C viruses Minor respiratory illness only The national flu immunisation programme 2015/16

Flu A virus Genetic material (RNA) in the centre Two surface antigens: Haemagglutinin (H) Neuraminidase (N) Schematic model of a flu A virus. There are two antigens on the surface, as illustrated. The role of the H antigen is to bind to the cells of the host. There are 16 different types of H. The role of the N antigen is to release the virus from the cell surface. There are nine different types of N. The different types of H and N are identified by numbers, hence H1N1 or H3N2 for example. There are 16 different types of H and 9 different types of N The blue protuberances represent haemagglutinin and the red spikes neuraminidase The national flu immunisation programme 2015/16

Genetic changes in the flu virus – what this means DRAFT ONLY - Please see the disclaimer text on slide 1 Genetic changes in the flu virus – what this means Changes in the surface antigens (H & N) result in the flu virus constantly changing Antigenic drift: refers to minor changes (natural mutations) in the genes of flu viruses that occur gradually over time Antigenic shift: when two different strains combine. This abrupt major change results in a new subtype. Immunity from previous flu infections/vaccinations may not protect against the new subtype, potentially leading to a widespread epidemic or pandemic Because of the changing nature of flu viruses, WHO monitors their epidemiology throughout the world Each year WHO makes recommendations about the strains of influenza A and B which are predicted to be circulating in the forthcoming winter These strains are then included in the influenza vaccine developed each year The WHO convenes a group that reviews the global influenza situation (once each year for the northern hemisphere and once for the southern hemisphere) and recommends which flu strains should go in the seasonal vaccine to be produced by manufacturers for the following season six to eight months later. This recommendation is based on information about the circulating viruses and epidemiological data from around the world at that time. Most current influenza vaccines are trivalent, containing two subtypes of influenza A and one B virus. Quadrivalent vaccines with an additional B virus have been developed and the first authorised quadrivalent influenza vaccine was made available for use in the UK in 2013. The use of quadrivalent influenza vaccines containing a B strain from each of the two B strain lineages is expected to improve the matching of the vaccine to the circulating B strain(s). The national flu immunisation programme 2015/16

Flu vaccine effectiveness Efficacy calculated at between 50-60% for adults aged 18-65yrs, Lower efficacy in elderly although immunisation shown to reduce incidence of severe disease including bronchopneumonia, hospital admissions and mortality In 2014/15 the flu vaccine only provided limited protection against infection caused by one particular strain of flu A (H3N2) Caused by a mismatch between the A(H3N2) strain selected for the vaccine and the main A(H3N2) strain that circulated Throughout the last decade, there has generally been a good match between the strains of flu in the vaccine and those that subsequently circulated Flu vaccination remains the best way to protect people from flu It is crucial the mismatch in winter 2014/15 does not discourage at-risk groups from having flu vaccination in future flu seasons A recent meta-analysis (2012), which included studies when the influenza virus strains in the vaccine were drifted or mismatched with those in circulation, suggested an overall efficacy against confirmed disease of 59% (95% confidence interval 51-67) in adults aged 18 to 65 years.1 In the elderly, protection produced by the vaccine may be lower2, although immunisation has been shown to reduce the incidence of severe disease including bronchopneumonia, hospital admissions and mortality.3, 4 A PHE study5 found that the 2014/15 mid-season estimates of flu vaccine, which is used primarily in adults, provided low protection against flu infection due to one particular subtype, H3N2. This was because a drifted strain of flu A(H3N2) emerged in 2014/15 after the 14/15 A(H3N2) vaccine strain had been selected in February 2014. This resulted in a mismatch between the vaccine strain and the main A(H3N2) strain that circulated in the UK. The study was based on the results from 1,314 patients presenting in primary care across the UK and found that vaccine effectiveness in preventing laboratory confirmed influenza was estimated to be 3% overall (with an upper 95% confidence interval of 35%). This compares to approximately 50% vaccine effectiveness that has typically been seen in the UK over recent years. The national flu immunisation programme 2015/16

Features of flu Common symptoms include: Easily transmitted by large droplets, small-particle aerosols and by hand to mouth/eye contamination from an infected surface or respiratory secretions of infected person People with mild or no symptoms can still infect others Incubation period 1-5 days (average 2-3 days) though may be longer especially in people with immune deficiency Common symptoms include: Sudden onset of fever, chills, headache, muscle and joint pain and extreme fatigue Dry cough, sore throat and stuffy nose In young children gastrointestinal symptoms such as vomiting and diarrhoea may be seen Serological studies in healthcare professionals have shown that approximately 30 to 50% of influenza infections can be asymptomatic1 but the proportion of influenza infections that are asymptomatic may vary depending on the characteristics of the influenza strain. In healthy individuals, flu is usually unpleasant but self-limiting with recovery within 2-7 days6. The national flu immunisation programme 2015/16

Possible complications of flu DRAFT ONLY - Please see the disclaimer text on slide 1 Possible complications of flu Common: Bronchitis Otitis media (children), sinusitis Secondary bacterial pneumonia Less common: Meningitis, encephalitis, meningoencephalitis Primary influenza pneumonia Risk of most serious illness higher in children under 6 months, pregnant women, older people and those with underlying health conditions such as respiratory disease, cardiac disease, chronic neurological conditions or immunosuppression Flu during pregnancy may be associated with perinatal mortality, prematurity, smaller neonatal size and lower birth weight The risk of serious illness from flu is higher among children under six months of age, older people and those with underlying health conditions such as respiratory disease, cardiac disease or immunosuppression, as well as pregnant women. These groups are at greater risk of complications from flu such as bronchitis or pneumonia. The national flu immunisation programme 2015/16

Flu epidemiology Flu activity usually between September to March (weeks 37 and 15) Impact of flu varies from year to year Moderate levels of influenza activity seen in 2014/15 season ICU/HDU admissions in 2014/15 higher than seen in the previous few seasons The impact of flu on the population varies from year to year and is influenced by changes in the virus that, in turn, influence the proportion of the population that may be susceptible to infection and the severity of the illness. The graph shows the rate of influenza/influenza-like illness episodes in England and Wales per 100,000 consultations in primary care from 2008/9 flu season to 2014/15 season. The data show that flu viruses circulate each winter season, but the degree of activity varies substantially. Moderate levels of influenza activity were seen in the community in the UK in the 2014 /15 flu season, with influenza A(H3N2) the predominant virus circulating for the majority of the season, with influenza B circulating towards the end of the season. The health impact was predominantly seen in the elderly, with numerous outbreaks in care homes and levels of excess mortality significantly higher than the last notable significant H3N2 season of 2008 to 2009. Admissions to hospital and intensive care were observed, with peak ICU/HDU numbers higher than seen in the previous few seasons, but lower than the recent notable season of 2010 to 2011, which affected mainly younger adults7. Rate of influenza/influenza-like illness episodes in England (weekly returns to Royal College of General Practitioners), 2008–09 to 2014–15 The national flu immunisation programme 2015/16

UK flu vaccination programme DRAFT ONLY - Please see the disclaimer text on slide 1 UK flu vaccination programme Late 1960s: annual flu immunisation recommended to directly protect those in clinical risk groups who are at a higher risk of influenza associated morbidity and mortality 2000: flu vaccine policy extended to include all people aged 65 years or over 2010: pregnancy added as a clinical risk category for routine influenza immunisation 2013: phased introduction of an annual childhood flu vaccination programme for all children aged 2-16y began with vaccine offered to all children aged 2 and 3 years and seven geographical pilots in primary school aged children 2014: phased introduction of childhood flu vaccination programme continued with vaccine offered to all children aged 2, 3 and 4 years and geographical pilots in primary and secondary school aged children 2015: offer to all 2, 3 & 4 year old children and children of school year 1 & 2 age In the 2015/16 flu season, all children aged 2, 3 and 4 years old on 31st August 2015 (i.e. date of birth on or after 1 September 2010 and on or before 31 August 2013) will be offered vaccination through general practice. All children of school years 1 (5-6yrs) and 2 (6-7yrs) age will be offered vaccine through locally commissioned arrangements. Primary school-aged children in areas that participated in primary school pilots in 2014/15 will also be offered flu vaccine. The principle for the future extension of the programme beyond 2015/16 will be to extend upwards through the age cohorts. Plans are subject to the outcome of the Spending Review, and the annual agreement between the Department of Health and NHS England regarding public health functions (Section 7A agreement). JCVI will continue to monitor the impact of the programme on an annual basis, and the detail for each flu season will be confirmed on a yearly basis. The national flu immunisation programme 2015/16

Flu vaccine eligibility: 2015/16 flu season those aged 65 years and over on or before 31 March 2016 those aged six months to under 65 years with a serious medical condition all pregnant women (including those who become pregnant during flu season) all children aged two, three and four years on 31 Aug 2015 all children of school years 1 and 2 age primary school-aged children in areas that participated in primary school pilots in 2014/15 those in long-stay residential care homes or other long-stay care facilities carers and household contacts of immunocompromised individuals Health and social care workers who are in direct contact with patients or service users should be offered flu vaccination by their employer The national flu immunisation programme 2015/16

Morbidly obese patients JCVI has advised morbidly obese patients (BMI 40+) could benefit from flu vaccination Those with morbid obesity (BMI>40) found to be at higher risk of hospitalisation and death following pandemic influenza infection Many in this patient group already eligible due to complications of obesity that place them in another risk category Practices need to use clinical judgement to decide whether to vaccinate this group of patients However, flu vaccinations for morbidly obese patients with no other recognised risk factor will not attract a payment in 2015/16 The inclusion of this patient group into the flu programme from 2016/17 is currently under consideration Individuals with morbid obesity (BMI>40) were found to be at higher risk of severe outcome (both hospitalisation and death) following pandemic influenza infection compared to individuals with obesity and to normal weight individuals 8,9,10. The national flu immunisation programme 2015/16

Clinical risk groups who should receive flu vaccine (1) Clinical risk category Examples (this list is not exhaustive and decisions should be based on clinical judgement) Chronic respiratory disease Asthma that requires continuous or repeated use of inhaled or systemic steroids or with previous exacerbations requiring hospital admission. 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. see precautions section on live attenuated influenza vaccine 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 kidney disease Chronic kidney disease at stage 3, 4 or 5, chronic kidney failure, nephrotic syndrome, kidney transplantation. Chronic liver disease Cirrhosis, biliary atresia, chronic hepatitis Chronic neurological disease (included in the DES directions for Wales) Stroke, transient ischaemic attack (TIA). Conditions in which respiratory function may be compromised due to neurological disease (e.g. polio syndrome sufferers). Clinicians should offer immunisation, based on individual assessment, to clinically vulnerable individuals including those with cerebral palsy, learning difficulties, multiple sclerosis and related or similar conditions; or hereditary and degenerative disease of the nervous system or muscles; or severe neurological disability Diabetes Type 1 diabetes, type 2 diabetes requiring insulin or oral hypoglycaemic drugs, diet controlled diabetes. Flu vaccine should be offered to the eligible groups set out in the table. [Although difficult to read the detail on this slide in a lecture theatre/classroom situation, this table is presented here in order to show immunisers that under each risk group category, individual conditions are listed and detailed. Healthcare practitioners should refer to the Green Book influenza chapter6 for further detail about clinical risk groups included in the national flu immunisation programme. This chapter is regularly updated, sometimes during the flu season, and can be found at: www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book] The national flu immunisation programme 2015/16

Clinical risk groups who should receive flu vaccine (2) Clinical risk category Examples (this list is not exhaustive and decisions should be based on clinical judgement) Immunosuppression (see contraindications and precautions section on live attenuated influenza vaccine) Immunosuppression due to disease or treatment, including patients undergoing chemotherapy leading to immunosuppression, bone marrow transplant, HIV infection at all stages, multiple myeloma or genetic disorders affecting the immune system (e.g. IRAK-4, NEMO, complement disorders) 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. It is difficult to define at what level of immunosuppression a patient could be considered to be at a greater risk of the serious consequences of influenza and should be offered influenza vaccination. This decision is best made on an individual basis and left to the patient’s clinician. Some immunocompromised patients may have a suboptimal immunological response to the vaccine. Asplenia or dysfunction of the spleen This also includes conditions such as homozygous sickle cell disease and coeliac syndrome that may lead to splenic dysfunction. Pregnant women Pregnant women at any stage of pregnancy (first, second or third trimesters). (see precautions section on live attenuated influenza vaccine) The national flu immunisation programme 2015/16

Flu immunisation should also be offered to: Those living in long-stay residential care homes or other long-stay care facilities where rapid spread is likely to follow introduction of infection and cause high morbidity and mortality (this does not include prisons, young offender institutions, university halls of residence etc.) Those who are in receipt of a carer’s allowance, or those who are the main carer of an elderly or disabled person whose welfare may be at risk if the carer falls ill Household contacts of immunocompromised individuals, specifically those who expect to share living accommodation on most days over the winter and therefore for whom continuing close contact is unavoidable. Health and social care staff in direct contact with patients/service users (they should be vaccinated by their employer as part of an OH programme) Immunisation should be provided to healthcare and social care workers in direct contact with patients/clients to protect them and to reduce the transmission of flu within health and social care premises, to contribute to the protection of individuals who may have a suboptimal response to their own immunisations, and to avoid disruption to services that provide their care. This includes: health and social care staff directly involved in the care of their patients or clients those living in long-stay residential care homes or other long-stay care facilities where rapid spread is likely to follow introduction of infection and cause high morbidity and mortality (this does not include prisons, young offender institutions, university halls of residence etc.) those who are in receipt of a carer’s allowance, or those who are the main carer of an elderly or disabled person whose welfare may be at risk if the carer falls ill. others involved directly in delivering health and social care such that they and vulnerable patients/clients are at increased risk of exposure to influenza (further information is provided in guidance from UK health departments) The national flu immunisation programme 2015/16

Other groups who should receive flu vaccine The list of clinical risk groups is not exhaustive Healthcare practitioners should apply clinical judgement to take into account the risk of flu exacerbating any underlying disease as well as the risk of serious illness from flu itself Flu vaccine should be offered to such patients even if the individual is not in the clinical risk groups specified in the risk groups list Child contacts of very severely immunocompromised individuals should be given inactivated vaccine The list of clinical risk groups is not exhaustive, and the healthcare practitioner should apply clinical judgement to take into account the risk of influenza exacerbating any underlying disease that a patient may have, as well as the risk of serious illness from flu itself. Flu vaccine should be offered in such cases even if the individual is not in one of the specified clinical risk groups. Consideration should also be given to the vaccination (with inactivated vaccine), of household contacts or carers of immunocompromised individuals, i.e. individuals who expect to share living accommodation on most days over the winter and therefore for whom continuing close contact is unavoidable. Child contacts of very severely immunocompromised individuals should be given inactivated vaccine rather than the live vaccine that would normally be recommended for children under 18 years. The national flu immunisation programme 2015/16

Why vaccinate these risk groups? Influenza-related population mortality rates and relative risk of death among those aged six months to under 65 years by clinical risk group in England, September 2010 – May 2011   Number of fatal flu cases (%) Mortality rate per 100,000 population Age-adjusted relative risk In a risk group 213 (59.8) 4.0 11.3 (9.1-14.0) Not in any risk group 143 (40.2) 0.4 Baseline Chronic renal disease 19 (5.3) 4.8 18.5 Chronic heart disease 32 (9.0) 3.7 10.7 (7.3-15.7) Chronic respiratory disease 59 (16.6) 2.4 7.4 (5.5-10.0) Chronic liver disease 15.8 48.2 (32.8-70.6) Diabetes 26 (7.3) 2.2 5.8 (3.8-8.9) Immunosuppression 71 (19.9) 20.0 47.3 (35.5-63.1) Chronic neurological disease (excluding stroke/transient ischaemic attack) 42 (11.8) 14.7 40.4 (28.7-56.8) Total 378 0.8 Increasing flu vaccine uptake in clinical risk groups is important because of the increased risk of serious illness should people in these groups catch flu. The table above shows flu mortality by clinical risk group and demonstrates the increased risk of death. The national flu immunisation programme 2015/16

Vaccination of clinical risk groups Increasing flu vaccine uptake in clinical risk groups important because of increased risk of death and serious illness if people in these groups catch flu For a number of years only around half of patients aged six months to under 65 in clinical risk groups have been vaccinated Despite those with liver disease and chronic neurological disease having some of the highest mortality rates, they have the lowest flu vaccine uptake rate amongst those in clinical risk groups Vaccine uptake for all those in clinical risk groups needs to improve, but particularly in those with chronic liver and neurological disease, and people with learning disabilities. For a number of years only around half of patients aged six months to under 65 in clinical risk groups have been vaccinated Vaccine uptake for those in clinical risk groups needs to improve, particularly for those who are at the highest risk of severe disease and mortality from flu but have low rates of vaccine uptake, including those with chronic liver and neurological disease, and people with learning disabilities. The national flu immunisation programme 2015/16

Flu vaccine uptake by clinical risk group in 2014/15 Vaccine uptake varies widely between disease groups and by age category for those with an underlying clinical risk factor. The diabetes disease group continues to have the highest uptake rate at just under 70%. For clinical risk groups such as chronic heart and respiratory disease, uptake levels continue to remain at 50 to 52% in recent seasons. By the end of the 2014 to 2015 winter season, just over 50% of people aged six months to under 65 years in a clinical risk group, had been vaccinated against flu11. Despite continued efforts to improve uptake and a sustained drive over the past couple of years, the remaining half of the clinical risk group population eligible to receive the vaccine, are still not getting immunised. Vaccine uptake is particularly low in the younger age groups with clinical conditions that put them at most risk of complications from flu. GPs and practice staff managing the influenza programme should make sure that all at-risk children have the opportunity to receive influenza vaccine. The national flu immunisation programme 2015/16

Flu vaccine uptake rates 2012/13 – 2014/15   2014/15 2013/14 2012/2013 Patients aged 65 years or older 72.7% 73.2% 73.4% Patients aged six months to under 65 years in risk groups (excluding pregnant women without other risk factors) 50.3% 52.3% 51.3% Pregnant women 44.1% 39.8% 40.3% Health care workers 54.9% 54.8% 45.6% Carers 45.1% 44.8% 46.3% Children aged two years old (including those in risk groups) 38.5% 42.6% N/A Children aged three years old ( including those in risk groups) 41.3% 39.5% Children aged four years old ( including those in risk groups) 32.9% Flu vaccine uptake rates for the last three years are shown in the table above. In 2013/14 there was a marked improvement in vaccine uptake of frontline health care workers which was sustained in 2014/15. However, the overall uptake is still below the 75% aspiration and this therefore remains a priority area for improvement. The national flu immunisation programme 2015/16

Pregnant women All pregnant women are recommended to receive the inactivated flu vaccine irrespective of their stage of pregnancy Pregnant women at increased risk from complications if they contract flu Having flu during pregnancy may be associated with premature birth and smaller birth size and weight Flu vaccination during pregnancy provides passive immunity against flu to infants in the first few months of life Studies on safety of flu vaccine in pregnancy show that inactivated flu vaccine can be safely and effectively administered during any trimester of pregnancy No study to date has demonstrated an increased risk of either maternal complications or adverse fetal outcomes associated with inactivated flu vaccine Women should be offered the vaccine every time they are pregnant All pregnant women are recommended to receive the inactivated flu vaccine irrespective of their stage of pregnancy. There is good evidence that pregnant women are at increased risk from complications if they contract flu12,13 .In addition, there is evidence that having flu during pregnancy may be associated with premature birth and smaller birth size and weight14,15 and that flu vaccination may reduce the likelihood of prematurity and smaller infant size at birth associated with an influenza infection during pregnancy16.Furthermore, a number of studies show that flu vaccination during pregnancy provides passive immunity against flu to infants in the first few months of life17-21. A review of studies on the safety of flu vaccine in pregnancy concluded that inactivated flu vaccine can be safely and effectively administered during any trimester of pregnancy and that no study to date has demonstrated an increased risk of either maternal complications or adverse fetal outcomes associated with inactivated influenza vaccine22. When offer the vaccine to pregnant women The ideal time for flu vaccination is before flu starts circulating. However, even after flu is in circulation, vaccine should continue to be offered to groups such as newly pregnant women. If a woman becomes pregnant after the usual vaccinating period of October to January, it is still worth considering offering the vaccine if flu is still circulating in the community. Women should be offered the vaccine every time they are pregnant as the flu virus constantly mutates and therefore the strains included in the vaccine are reviewed annually23. The national flu immunisation programme 2015/16

Why vaccinate children against flu? DRAFT ONLY - Please see the disclaimer text on slide 1 Why vaccinate children against flu? Extension of the seasonal flu vaccination programme to all children aims to appreciably lower the public health impact of flu by: Providing direct protection thus preventing a large number of cases of flu in children Providing indirect protection by lowering flu transmission from children: to other children to adults to those in the clinical risk groups of any age Reducing flu transmission in the community will avert many cases of severe flu and flu-related deaths in older adults and people with clinical risk factors Annual administration of flu vaccine to children is expected to substantially reduce flu-related illness, GP consultations, hospital admissions and deaths In July 2012, the JCVI24 recommended extending the annual flu programme to include healthy children in order both to lower the potentially serious impact of flu in vaccinated children and also to have a more profound effect on flu transmission. Children are the main source of transmission in the population, and extending the flu programme to include healthy children should therefore reduce the spread of infection from children to other children, to adults and to those in clinical risk groups of any age. Implementation of the extension to the flu programme to include healthy children commenced in September 2013 with children aged 2 and 3 years being vaccinated in general practice and seven geographic pilots in children aged 5-11 years. In 2014/15, vaccination of 2,3, and 4 year olds was undertaken in general practice and there were further pilots in primary and secondary schools designed to help understand how best to vaccinate large numbers of children in a very short period of time. Using this information, it may prove possible to offer the vaccination to all children aged between two years and less than 17 years. Exactly how the programme will roll out year by year, and for how long, will be guided by the experience of the previous years’ programmes. The national flu immunisation programme 2015/16

Health and social care workers Frontline health and social care workers have a duty of care to protect their patients and service users from infection. Vaccination of health and social care workers protects them & reduces risk of spreading flu to their patients, service users, colleagues and family members Evidence vaccination significantly lowers rates of flu-like illness, hospitalisation and mortality in elderly in long-term healthcare settings Reduces transmission of flu to vulnerable patients, some of whom may have impaired immunity that may not respond well to immunisation Vaccination of frontline workers also helps reduce sickness absences and contributes to keeping the NHS and care services running through winter pressures Frontline health and social care workers have a duty of care to protect their patients and service users from infection. This includes getting vaccinated against flu. Flu outbreaks can occur in health and social care settings with both staff and their patients/service users being affected when flu is circulating in the community. It is important that health and social care workers protect themselves by having the flu vaccine, and, in doing so, they reduce the risk of spreading flu to their patients, service users, colleagues and family members. Vaccination of healthcare workers against flu has been shown to significantly lower rates of flu-like illness, hospitalisation and mortality in the elderly in long-term healthcare settings25-28. Vaccination of staff in acute care settings may provide similar benefits. Flu immunisation of frontline health and social staff care staff may reduce the transmission of infection to vulnerable patients, some of whom may have impaired immunity, increasing their risks of flu and who may not respond well to immunisation. Vaccination of health and social care workers also helps reduce the level of sickness absenteeism that can jeopardise the NHS and care services. This is essential in the winter when pressures on these services increase. and will contribute to keeping the NHS and care services running. This is particularly important when responding to winter pressures. The national flu immunisation programme 2015/16

Health and social care workers (cont) NHS and social care bodies have responsibility to ensure, as far as is reasonably practicable, that health and social care workers are free of, and are protected from exposure to infections that can be caught at work Responsibility for funding and administering seasonal flu vaccine to staff lies with employers Trusts/ employers must ensure that health and social care staff directly involved in delivering care are encouraged to be immunised and that processes are in place to facilitate this Overall level of flu vaccine uptake in health care workers is still below the 75% aspiration See NHS Employers flu fighter campaign www.nhsemployers.org/flu It is the responsibility of the NHS and social care bodies to ensure, as far as is reasonably practicable, that health and social care workers are free of, and are protected from exposure to infections that can be caught at work. Trusts/ employers should ensure that health and social care staff directly involved in delivering care are encouraged to be immunised and that processes are in place to facilitate this. Responsibility for funding and administering the seasonal flu vaccine to staff (other than those in clinical risk groups) lies with employers. This includes GP practices who need to have arrangements in place. In 2013/14 there was a very encouraging and marked improvement in flu vaccination of health care workers that was sustained (but not improved) in 2014/15 with a final overall uptake rate of 54.9%. The overall level of uptake is therefore still below the 75% aspiration. However, 13% of trusts did achieve the 75% aspiration in 2014/15 highlighting that this is possible. The national flu immunisation programme 2015/16

Key messages to health and social care workers Duty of care as professionals to patients or residents to do everything in your power to protect them against infection, including being immunised against flu Getting vaccinated against flu can help protect you, your patients and family Everyone is susceptible to flu, even if you are in good health and eat well You can be infected with the virus and have no symptoms but can still pass flu virus to others including patients or residents Good infection control measures reduce spread of flu and other acute respiratory infections in healthcare settings but are not sufficient alone to prevent them Impact of flu on frail and vulnerable patients can be fatal and outbreaks can cause severe disruption in communities, care homes and hospitals Flu vaccine has a good safety record and will help protect you. It cannot give you flu. Having the vaccination can encourage your colleagues to do likewise Throughout the last ten years there has generally been a good to moderate match between the strains of flu virus in the vaccine and those that subsequently circulated Staff act as positive role models for patients aged 65 and over, those with long-term health conditions and pregnant women to take up the offer too Misconceptions about flu vaccine are common, including amongst health and social care workers. The above key messages should be promoted to frontline staff in acute, primary, community and social care services. The national flu immunisation programme 20154/16

When to vaccinate As early as possible between September and early November before flu starts circulating in the community Flu can circulate considerably later than this however so clinical judgement should be applied to assess needs of individual patients for vaccination beyond this time period This should take into account level of flu-like illness in community and fact that the immune response following flu vaccination takes about two weeks to develop fully Protection afforded by the vaccine thought to last at least one influenza season However, as antibody levels likely to reduce in subsequent seasons and may be changes to circulating strains from one season to next, annual revaccination is important Although influenza activity is not usually significant in the UK before the middle of November, the influenza season can start early (as it did in 2003–04), and therefore the ideal time for immunisation is between September and early November. After immunisation, protective immune responses may be achieved within 14 days. Protection afforded by the vaccine is thought to last for at least one influenza season. However, as the level of protection provided in subsequent seasons is likely to reduce and there may be changes to the circulating strains from one season to the next, annual revaccination is important6. The national flu immunisation programme 2015/16

Which flu vaccine should be used? The national flu immunisation programme 2015/16

DRAFT ONLY - Please see the disclaimer text on slide 1 Types of flu vaccines Two main types of vaccine available: Inactivated – by injection Live - by nasal application None of the flu vaccines can cause clinical influenza in those that can be vaccinated Trivalent: flu vaccines contain two subtypes of Influenza A and one type B virus Quadrivalent vaccines contain two subtypes of Influenza A and both B virus types* As quadrivalent vaccines may be better matched and therefore may provide better protection against the circulating B strain(s) than trivalent flu vaccines, the live intranasal vaccine offered to children aged 2yrs and over is a quadrivalent vaccine *Quadrivalent inactivated flu vaccine only authorised for children aged 3 years and older Inactivated flu vaccines given by intramuscular injection have been used in the UK for many years. The live intranasal flu vaccine was introduced into the UK schedule in 2013. However, a live intranasal flu vaccine called Flumist (same vaccine as Fluenz, different trade name) was introduced in the US schedule in 2003 so although the live vaccine is newer, there is over 11 years experience of widespread use of the vaccine in the US. Most current inactivated flu vaccines are trivalent, containing two subtypes of influenza A and one B virus. However, quadrivalent vaccines, containing two subtypes of influenza A and both B virus types have more recently been developed. The live intranasal vaccine is a quadrivalent vaccine (hence the ‘Tetra’ part of the name Fluenz Tetra). An inactivated quadrivalent vaccine was made available for the first time in 2013 and is the preferred vaccine for children aged 3 years and over who are contraindicated to receive the live Fluenz Tetra vaccine (quadrivalent inactivated flu vaccine is only authorised for children aged 3 years and older). NB The Fluenz vaccine used in the 2013/14 flu season was a trivalent live vaccine. Fluenz Tetra® was first used in the 2014/15 flu season and will be used subsequently. The national flu immunisation programme 2015/16

Live attenuated influenza vaccine (LAIV) A live attenuated intranasal spray called Fluenz Tetra® is the recommended vaccine for the childhood flu programme The live attenuated influenza vaccine (LAIV) has been shown to be more effective in children compared with inactivated influenza vaccines It may offer some protection against strains not contained in the vaccine as well as to those that are Since this vaccine is comprised of weakened whole live virus, it replicates natural infection which induces better immune memory (thereby offering better long-term protection to children than from the inactivated vaccines) In addition to being attenuated (weakened), the live viruses in Fluenz Tetra® have been adapted to cold so that they cannot replicate efficiently at body temperature Fluenz Tetra® has a good safety profile in children aged two years and older Fluenz Tetra® is a quadrivalent live attenuated intranasal flu vaccine. The majority of published literature is about Fluenz® (a trivalent vaccine used prior to the addition of the other B strain) but most of this will apply to Fluenz Tetra® LAIV has been shown to be more effective in children compared with inactivated flu vaccines29-31 and it may offer some protection against strains not contained in the vaccine as well as to those that are and has potential to offer better protection against strains that have undergone antigenic drift compared to the original virus strains in the vaccine6 Since this vaccine is comprised of weakened whole live virus, it replicates natural infection which induces better immune memory. This should mean it also offers better long-term protection to children than they may get from the inactivated vaccines. Fluenz Tetra® contains live viruses that have been attenuated (weakened) and adapted to cold so that they cannot replicate efficiently at body temperature. The vaccine viruses replicate in the cooler nasal mucosa but not at body temperature in the lungs. This means they cannot cause clinical flu in immunocompetent children. The live intranasal vaccine has a good safety profile in children aged two years and older and has been used for over a decade in the United States. The Fluenz vaccine was extensively tested prior to it’s launch in the Unites States market. Since then there has been extensive post launch surveillance in the USA, involving millions of doses in children with no evidence found of any safety concerns. It was also used in 2013/14 and 2014/15 in the UK where hundreds of thousands of children were successfully vaccinated. As with all vaccines and medicines, MHRA closely monitors the safety of Fluenz Tetra®. The national flu immunisation programme 2015/16

Inactivated flu vaccines A number of different manufacturers produce flu vaccines. Those available for 2015/16 season are listed in the June 2015 Vaccine Update Most of the inactivated vaccines are administered by intramuscular injection, although one vaccine (Intanza®) is administered by the intradermal route Most flu vaccines are prepared from viruses grown in embryonated hens eggs – details of ovalbumin content available in Vaccine Update June 2015 and product SPC Some flu vaccines are restricted for use in particular age groups. The SPC for individual products should always be referred to when ordering vaccines for particular patients All but one of the flu vaccines available in the UK are inactivated and do not contain live viruses. They therefore cannot cause clinical influenza in those that can be vaccinated. Most of the inactivated vaccines are administered by intramuscular injection, although one vaccine (Intanza®) is administered by the intradermal route. Most of the vaccines are prepared from viruses grown in embryonated hens eggs. The flu vaccines available in the UK for the 2015/16 influenza season are listed on the PHE website at https://www.gov.uk/government/publications/influenza-vaccines-2015-to-2016-flu-season Vaccine Update Issue 230 June 2015 The national flu immunisation programme 2015/16

DRAFT ONLY - Please see the disclaimer text on slide 1 Storage of flu vaccine Efficacy, safety and quality may be adversely affected if vaccines are not stored at the temperatures specified in the licence Flu vaccines must be stored in accordance with manufacturer’s instructions: Store between +2°C and +8°C Do not freeze Store in original packaging Protect from light Check expiry dates regularly: Fluenz Tetra® has an expiry date 18 weeks after manufacture – this is much shorter than inactivated flu vaccines Vaccines should be stored in the original packaging at +2°C to +8°C and protected from light. All vaccines are sensitive to some extent to heat and cold. Heat speeds up the decline in potency of most vaccines, thus reducing their shelf life. Efficacy, safety and quality may be adversely affected if vaccines are not stored at the temperatures specified in the licence. Freezing may cause increased reactogenicity and loss of potency for some vaccines and can also cause hairline cracks in the container, leading to contamination of the contents. Vaccines are expensive and it is important to minimise wastage through inappropriate storage. Fluenz Tetra® has a shelf life of 18 weeks that starts at the point of release from the manufacturer. This is a shorter shelf life than other influenza vaccines and some of this time will have passed when the vaccine reaches the place where it is to be administered. It is important that the expiry date on the nasal spray applicator is checked before use. If the expiry date has passed, arrangements should be made to have the vaccine disposed safely. The national flu immunisation programme 2015/16

Flu vaccines for patients in clinical risk groups Age Which vaccine? How many doses? Children aged six months to less than two years of age in clinical risk groups These children should be offered inactivated trivalent influenza vaccine Those who have not received flu vaccine before should receive a second dose of vaccine at least four weeks later. Children aged two to less than 18 years of age in clinical risk groups These children should be offered the live intranasal vaccine Fluenz Tetra® unless it is medically contraindicated For those children for whom Fluenz Tetra® is medically contraindicated, a suitable inactivated flu vaccine should be offered. The quadrivalent inactivated influenza vaccine (Fluarix™ Tetra) is authorised for children from the age of three years and is preferred because of the additional protection offered. The quadrivalent vaccine has both lineages of influenza B and may therefore provide better protection against the circulating B strain(s) than trivalent inactivated influenza vaccines. Children aged two years should be given an inactivated trivalent vaccine. Those aged two to less than nine years who have not received flu vaccine before should receive a second dose of vaccine at least four weeks later Over 18 years Any of the inactivated vaccines A single dose Studies suggest that two doses of inactivated influenza vaccine may be required to achieve adequate antibody levels in younger children who have not received influenza vaccine before32,33. Live attenuated influenza vaccine has been shown to provide greater protection for children than inactivated influenza vaccine29-31 and studies have also shown meaningful efficacy after a single dose of live attenuated influenza vaccine in previously unvaccinated children34,35. Given this, JCVI has advised the use of different dosage schedules of flu vaccine for children depending on their age, the clinical indications, whether they have received influenza vaccine previously and on the type of vaccine offered (see table above). This advice differs from some of the SPCs. The national flu immunisation programme 2015/16

Which vaccine and how many doses? Vaccine type Authorised age indication Dose Live attenuated intranasal vaccine - Fluenz Tetra® Children aged two to under 18 years (if no contraindications) Single application in each nostril of 0.1ml Children NOT in clinical risk groups only require one dose of this vaccine. Children in clinical risk groups aged two to under nine years who have not received influenza vaccine before should receive a second dose of vaccine at least four weeks later. N.B Follow Green Book not SPC Inactivated intramuscular vaccine (number of different brands) Children aged six months and older and adults (N.B some of the vaccines are not authorised for young children) Single injection of 0.5ml Children aged six months to under nine years who have not received influenza vaccine before should receive a second dose of vaccine at least four weeks later. Inactivated intradermal vaccine - Intanza® 15µg Adults aged 60 years and older Single injection of 0.1ml Studies suggest that two doses of inactivated influenza vaccine may be required to achieve adequate antibody levels in younger children who have not received influenza vaccine before32,33. Live attenuated influenza vaccine has been shown to provide greater protection for children than inactivated influenza vaccine29-31 and studies have also shown meaningful efficacy after a single dose of live attenuated influenza vaccine in previously unvaccinated children34,35. Given this, JCVI has advised the use of different dosage schedules of flu vaccine for children depending on their age, the clinical indications, whether they have received influenza vaccine previously and on the type of vaccine offered (see table above). This advice differs from some of the SPCs The national flu immunisation programme 2015/16

DRAFT ONLY - Please see the disclaimer text on slide 1 Flu vaccine composition 2015/16 Trivalent vaccines will contain the following three viruses: an A/California/7/2009 (H1N1)pdm09-like virus an A/Switzerland/9715293/2013 (H3N2)-like virus a B/Phuket/3073/2013-like virus In addition to the above, the quadrivalent vaccine will also contain: B/Brisbane/60/2008-like virus None of the influenza vaccines for the 2015/16 season contain thiomersal as an added preservative More detailed information on the characteristics of the available vaccines, including age indications can be found in the Influenza chapter of the Green Book The live and inactivated flu vaccines contain the same strains (with additional B strain in quadrivalent vaccines) and comply with the WHO recommendation (Northern Hemisphere) and EU decision for the 2015/16 season as to which strains of influenza they should contain. The virus strains were produced in Vero Cells (monkey cell line) and grown in fertilised hens’ eggs from healthy chicken flocks. None of the influenza vaccines for the 2015/16 season contain any preservatives such as thiomersal. The national flu immunisation programme 2015/16

Flu vaccine presentation and dosage DRAFT ONLY - Please see the disclaimer text on slide 1 Flu vaccine presentation and dosage Inactivated flu vaccines for intramuscular (IM) administration supplied as suspensions in pre-filled syringes containing a 0.5ml dose If SPC for IM inactivated flu vaccine states young children can be given either a 0.25ml or a 0.5ml dose, give 0.5ml dose Intanza®, the intradermal vaccine, is supplied in a micro-needle injection system Fluenz Tetra®, the intranasal vaccine, is supplied as a nasal spray suspension in a special single use, pre-filled, nasal applicator. No reconstitution or dilution required. Each applicator contains 0.2ml (administered as 0.1 ml per nostril) Inactivated flu vaccines for intramuscular (IM) administration is supplied as suspensions in pre-filled syringes. They should be shaken well before they are administered Some SPCs for IM inactivated flu vaccines indicate that young children can be given either a 0.25ml or a 0.5ml dose. JCVI has advised that where these alternative doses are indicated in the SPC, the 0.5ml dose should be given to infants aged six months or older and young children because there is evidence that this dose is effective in young children6. Fluenz Tetra® is supplied as a single use prefilled nasal applicator that is ready to use. No reconstitution or dilution is required. The national flu immunisation programme 2015/16

Vaccine administration (inactivated vaccines) Intramuscular flu vaccines should be given into the upper arm (or anterolateral thigh in infants) Individuals with a bleeding disorder should be given vaccine by deep subcutaneous injection to reduce the risk of bleeding   Intradermal: Intanza® is supplied in a micro-needle injection system that should be held at right-angles to the skin. The device allows intradermal vaccination to be performed without the need for additional training Both inactivated and live flu vaccines can be given at the same time as, or at any interval before or after, other live and inactivated vaccines Different vaccines should be given at separate sites, preferably in a different limb. If given in the same limb, they should be given at least 2.5cm apart Inactivated influenza vaccines can be given at the same time as other vaccines. The live attenuated vaccine can also be given at the same time as other live or inactivated vaccines. Although it was previously recommended that, where vaccines cannot be administered simultaneously, a four-week interval should be observed between live viral vaccines, JCVI have now advised that no specific intervals need to be observed between the live attenuated intranasal influenza vaccine and other live vaccines6. Intramuscular (and intradermal) vaccines should be given at separate sites, preferably in a different limb. If given in the same limb, they should be given at least 2.5cm apart. The national flu immunisation programme 20154/16

Administration of Fluenz Tetra® DRAFT ONLY - Please see the disclaimer text on slide 1 Administration of Fluenz Tetra® Fluenz Tetra® is a live nasal vaccine and must not be injected Fluenz Tetra® can be administered at the same time as, or at any interval from other vaccines including live vaccines Patient should breathe normally - no need to actively inhale or sniff The vaccine is rapidly absorbed so no need to repeat either half of dose if patient sneezes, blows their nose or their nose drips following administration Image courtesy of AstraZeneca The national flu immunisation programme 2015/16

Supply and administration of flu vaccines A range of mechanisms can be used for the supply and administration of vaccines, including : Patient specific prescription written manually or electronically by a registered medical practitioner or other authorised prescriber Patient Specific Direction (PSD) Patient Group Direction (PGD) The following PGD templates are available on the PHE website: Administration of intramuscular inactivated influenza vaccine in accordance with the national immunisation programme The national influenza (Fluenz Tetra®) vaccination programme: September 2015 to August 2016 https://www.gov.uk/government/collections/immunisation-patient-group-direction-pgd N.B Local authorisation is required before PHE PGD templates can be used The national flu immunisation programme 2015/16

DRAFT ONLY - Please see the disclaimer text on slide 1 Contraindications There are very few individuals who cannot receive any flu vaccine Where there is doubt, expert advice should be sought promptly so that the period the individual is left unvaccinated is minimised For children aged 2-18 years, where live flu vaccine cannot be given, it is likely that inactivated vaccine could be given instead The SPCs for individual products should always be referred to when deciding which vaccine to give. There are very few individuals who cannot receive any flu vaccine. When there is doubt, appropriate advice should be sought promptly from the screening and immunisation team in the NHS England area team, a consultant in communicable disease control or a consultant paediatrician, so that the period the individual is left unvaccinated is minimised. The national flu immunisation programme 2015/16

DRAFT ONLY - Please see the disclaimer text on slide 1 Contraindications to flu vaccines None of the influenza vaccines should be given to those who have had: Confirmed anaphylactic reaction to a previous dose of the vaccine Confirmed anaphylactic reaction to any component of the vaccine The live attenuated flu vaccine should not be given to children who are: Clinically severely immunodeficient due to conditions or immunosuppressive therapy: Acute and chronic leukaemias Lymphoma HIV infection not on highly active antiretroviral therapy Cellular immune deficiencies High dose corticosteroids Receiving salicylate therapy Known to be pregnant Confirmed anaphylaxis is rare. Other allergic conditions such as rashes may occur more commonly and are not contraindications to further immunisation. A careful history of the event will often distinguish between true anaphylaxis and other events that are either not due to the vaccine or are not life threatening. In the latter circumstance, it may be possible to continue the immunisation course. Specialist advice must be sought on the vaccines and the circumstances in which they could be given. The risk to the individual of not being immunised must be taken into account.   The live attenuated influenza vaccine (Fluenz Tetra®) should not be given to children or adolescents who are clinically severely immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; HIV infection not on highly active antiretroviral therapy (HAART); cellular immune deficiencies; and high dose corticosteroids. It is not contraindicated for use in children or adolescents with stable HIV infection receiving antiretroviral therapy; or who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency. Chapter 6 of the Green Book on contraindications and special precautions contains gives further advice on the use of live vaccines in individuals who are severely immunosuppressed. It states that the definition of “systemic high doses steroids” (and until at least three months after treatment has stopped) would include children who receive prednisolone, orally or rectally, at a daily dose (or its equivalent) of 2mg/ kg/day for at least one week, or 1mg/kg/day for one month. Occasionally, individuals on lower doses of steroids may be immunosuppressed and at increased risk from infections. In those cases, live vaccines should be considered with caution, in discussion with a relevant specialist physician29. The live attenuated vaccine (Fluenz Tetra® is contraindicated in children and adolescents receiving salicylate therapy (other than for topical treatment of localised conditions) because of the association of Reye's syndrome with salicylates and wild-type influenza infection as described in the SPC for Fluenz Tetra®. Safety data for the live attenuated flu vaccine (Fluenz Tetra®) when given in pregnancy is limited . Whilst there is no evidence of risk with live attenuated flu vaccine, inactivated flu vaccines are preferred for those who are pregnant. There is no need, however, to specifically test eligible girls for pregnancy or to advise avoidance of pregnancy in those who have been recently vaccinated. The national flu immunisation programme 2014/15 The national flu immunisation programme 2015/16

Precautions to flu vaccines DRAFT ONLY - Please see the disclaimer text on slide 1 Precautions to flu vaccines Acutely unwell: defer until recovered Heavy nasal congestion: defer live intranasal vaccine until resolved or consider inactivated flu vaccine Use with antiviral agents against flu: The live intranasal vaccine (Fluenz Tetra®) should not be administered at the same time or within 48 hours of cessation of treatment with flu antiviral agents Administration of flu antiviral agents within two weeks of administration of Fluenz Tetra® may adversely affect the effectiveness of the vaccine Minor illnesses without fever of systemic upset are not valid reasons to postpone vaccination. If the individual is acutely unwell, immunisation may be postponed until they have recovered. This is to avoid confusing the differential diagnosis of acute illness by wrongly attributing any signs or symptoms to the adverse effects of the vaccine. There are no data on the effectiveness of Fluenz Tetra® when given to children with heavily blocked or runny nose (rhinitis) attributable to infection or allergy. As heavy nasal congestion might impede delivery of the vaccine to the nasopharyngeal mucosa, deferral of administration until resolution of the nasal congestion should be considered or an appropriate alternative intramuscularly administered influenza vaccine should be considered. There is a potential for influenza antiviral agents to lower the effectiveness of the live attenuated influenza vaccine (Fluenz Tetra®). Therefore, influenza antiviral agents and Fluenz Tetra® should not be administered concomitantly. Fluenz Tetra® should be delayed until 48 hours following the cessation of treatment with influenza antiviral agents. Administration of influenza antiviral agents within two weeks of administration of Fluenz Tetra® may adversely affect the effectiveness of the vaccine6. The national flu immunisation programme 2015/16

Severe asthma or active wheezing Live flu vaccine not recommended for children and adolescents with severe asthma or active wheezing, e.g. those who are currently taking or have been prescribed oral steroids for respiratory disease in the last 14 days Children currently taking a high dose inhaled steroid - Budesonide >800 mcg/day or equivalent (e.g. Fluticasone > 500 mcgs/day) should only be given live flu vaccine on the advice of their specialist As these children are a defined flu risk group, those who cannot receive LAIV should receive an inactivated flu vaccine Vaccination with Fluenz Tetra® should be deferred in children with a history of active wheezing in the past 72 hours or those who have increased use of bronchodilators in the previous 72 hours. If condition not improved after a further 72 hours then inactivated flu vaccine should be offered to avoid delaying protection in this high risk group The national flu immunisation programme 2015/16

Egg allergy - adults Most flu vaccines are prepared from flu viruses grown in embryonated hens eggs- the final vaccine products contains varying amounts of egg (as ovalbumin) Adults with egg allergy can be immunised in any setting using either an ovalbumin-free flu vaccine (Optaflu® - licensed from 18yrs of age) or an inactivated flu vaccine with an ovalbumin content less than 0.12 µg/ml (equivalent to <0.06 µg for 0.5 ml dose) Adults with severe anaphylaxis to egg which has previously required intensive care should be referred to specialists for immunisation in hospital (if Optaflu vaccine is not available) Inactivated influenza vaccines that are egg-free or have a very low ovalbumin content (<0.12 μg/ml - equivalent to <0.06 μg for a 0.5 ml dose) are available and studies show they may be used safely in individuals with egg allergy36. Vaccines with ovalbumin content more than 0.12 µg/ml or where content is not stated should not be given to egg-allergic individuals. The ovalbumin content of the flu vaccines available in the UK for the 2015 to 2016 flu vaccination season has been published in a table available at: https://www.gov.uk/government/publications/influenza-vaccines-2015-to-2016-flu-season   Adults The ovalbumin-free influenza vaccine Optaflu®, if available, can be used in any setting in patients from the age of 18 years, regardless of the severity of the egg allergy. Adult patients can also be immunised in any setting using an inactivated influenza vaccine with an ovalbumin content less than 0.12 μg/ml (equivalent to 0.06 μg for 0.5 ml dose), excepting those with severe anaphylaxis to egg which has previously required intensive care who should be referred to specialists for immunisation in hospital (if Optaflu vaccine is not available) . The national flu immunisation programme 2015/16

Egg allergy - children Children with an egg allergy can be safely vaccinated with Fluenz Tetra® in any setting (including primary care and schools) Those with both egg allergy and clinical risk factors* that contraindicate Fluenz Tetra® (e.g. immunosuppression) should be offered an inactivated flu vaccine with a very low ovalbumin content (less than 0.12 μg/ml) Children with a history of severe anaphylaxis to egg which has previously required intensive care, should be referred to specialists for immunisation in hospital LAIV is not otherwise contraindicated in children with egg allergy. Egg- allergic children with asthma can receive LAIV if their asthma is well- controlled (see previous slide on severe asthma) *Children in a clinical risk group and aged under nine years who have not been previously vaccinated against influenza will require a second dose whether given LAIV or inactivated vaccine Children JCVI has advised that, except for those with severe anaphylaxis to egg which has previously required intensive care, children with an egg allergy can be safely vaccinated with Fluenz Tetra® in any setting (including primary care and schools); those with clinical risk factors that contraindicate Fluenz Tetra® should be offered an inactivated influenza vaccine with a very low ovalbumin content (less than 0.12 μg/ml). Children with a history of severe anaphylaxis to egg which has previously required intensive care, should be referred to specialists for immunisation in hospital. LAIV is not otherwise contraindicated in children with egg allergy. Egg-allergic children with asthma can receive LAIV if their asthma is well-controlled (see previous slide on severe asthma). Children in a clinical risk group and aged under nine years who have not been previously vaccinated against flu will require a second dose whether given LAIV or inactivated vaccine. The national flu immunisation programme 2015/16

Flu vaccines with low or no ovalbumin content The following vaccines, available for the 2015/16 flu season, are egg-free or have a very low ovalbumin content (<0.12 μg/ml - equivalent to <0.06 μg for a 0.5 ml dose) They may be used safely in individuals with egg allergy LAIV Fluenz Tetra®, which has an upper ovalbumin limit of 1.2 μg/ml, has recently also been shown to be safe for use in most egg allergic children Supplier Name of product Vaccine type Age indication Ovalbumin content per dose ( μg/dose) Novartis Vaccines Optaflu Surface antigen, inactivated virus, prepared in cell cultures From 18 years No ovalbumin GSK Fluarix Tetra Split virion, inactivated virus From three years ≤0.05/0.5ml MASTA Inactivated Influenza Vaccine (Split Virion) BP From six months Sanofi Pasteur MSD Inactivated influenza vaccine (split virion) BP Intanza 15 micrograms 60 years of age and over ≤0.024/0.1ml The ovalbumin content of the flu vaccines available in the UK for the 2015 to 2016 flu vaccination season has been published in a table available at: https://www.gov.uk/government/publications/influenza-vaccines-2015-to-2016-flu-season The national flu immunisation programme 2015/16

DRAFT ONLY - Please see the disclaimer text on slide 1 Risk of transmission of live vaccine virus Theoretical potential for transmission of live attenuated virus to immunocompromised contacts Risk is for one to two weeks following vaccination Extensive use of the live attenuated influenza vaccine in United States - no reported instances of illness or infections from the vaccine virus among immunocompromised patients inadvertently exposed to vaccinated children However, where close contact with very severely immunocompromised patients (e.g. bone marrow transplant patients requiring isolation) is likely or unavoidable (e.g. household members) consider an appropriate inactivated flu vaccine instead There is a theoretical potential for transmission of live attenuated influenza virus in Fluenz Tetra® to immunocompromised contacts for one to two weeks following vaccination. In the US, where there has been extensive use of the live attenuated influenza vaccine, there have been no reported instances of illness or infections from the vaccine virus among immunocompromised patients inadvertently exposed. Where close contact with very severely immunocompromised patients (e.g. bone marrow transplant patients requiring isolation) is likely or unavoidable (for example, household members), however, appropriate alternative inactivated influenza vaccines should be considered. The national flu immunisation programme 2015/16

Exposure of healthcare workers to live attenuated influenza vaccine viruses There may be some low level exposure to the vaccine viruses for those administering LAIV and/or from recently vaccinated patients In the US, where there has been extensive use of LAIV, no reported instances of illness or infections from the vaccine virus among HCWs inadvertently exposed Risk of acquiring vaccine viruses from the environment is unknown but probably low The vaccine viruses are cold-adapted and attenuated and therefore unlikely to cause symptomatic influenza As a precaution, very severely immunosuppressed individuals should not administer LAIV Other healthcare workers who have less severe immunosuppression or are pregnant, should follow normal clinical practice to avoid inhaling the vaccine and ensure that they themselves are appropriately vaccinated In theory, healthcare workers may have low level exposure to live attenuated influenza vaccine viruses during administration of the vaccine and/or from recently vaccinated patients. Data indicate that both children and adults vaccinated with LAIV can shed vaccine viruses after vaccination, although in lower amounts than occur typically with shedding of wild-type influenza viruses. Rarely, shed vaccine viruses can be transmitted from vaccine recipients to unvaccinated persons. However, serious illnesses have not been reported among unvaccinated persons who have been infected inadvertently with vaccine viruses37. The vaccine viruses are cold-adapted and attenuated, and are unlikely to cause symptomatic influenza. In the US, where there has been extensive use of the live attenuated influenza vaccine, no transmission of vaccine virus in healthcare settings have been reported and there have been no reported instances of illness or infections from the vaccine virus among healthcare professionals inadvertently exposed. Thus, the Centers for Disease Control and Prevention has considered that the risk of acquiring vaccine viruses from the environment is probably low6. As a precaution however, very severely immunosuppressed individuals should not administer live attenuated influenza vaccine. Other healthcare workers who have less severe immunosuppression or are pregnant, should follow normal clinical practice to avoid inhaling the vaccine and ensure that they themselves are appropriately vaccinated6. The national flu immunisation programme 2015/16

Inadvertent administration of Fluenz Tetra® If an immunocompromised individual receives LAIV, the degree of immunosuppression should be assessed If patient is severely immunocompromised, antiviral prophylaxis should be considered Otherwise they should be advised to seek medical advice if they develop flu-like symptoms in the 4 days following administration of the vaccine If antivirals are used for prophylaxis or treatment, patient should also be offered inactivated flu vaccine in order to maximise their protection in the forthcoming flu season (this can be given straight away) If an immunocompromised individual receives LAIV then the degree of immunosuppression should be assessed. If the patient is severely immunocompromised, antiviral prophylaxis should be considered, otherwise they should be advised to seek medical advice if they develop flu-like symptoms in the four days (the usual incubation period) following administration of the vaccine. If antivirals are used for prophylaxis or treatment, then in order to maximise their protection in the forthcoming flu season, the patient should also be offered inactivated influenza vaccine. This can be given straight away. The national flu immunisation programme 2015/16

Commonly reported adverse reactions Following inactivated flu vaccine: Pain, swelling or redness at the injection site, low grade fever, malaise, shivering, fatigue, headache, myalgia and arthralgia A small painless nodule (induration) may also form at the injection site These symptoms usually disappear within one to two days without treatment Following live attenuated flu vaccine: Nasal congestion/rhinorrhoea, reduced appetite, weakness and headache Rarely, after live or inactivated vaccine, immediate reactions such as urticaria, angio-oedema, bronchospasm and anaphylaxis can occur Pain, swelling or redness at the injection site, low grade fever, malaise, shivering, fatigue, headache, myalgia and arthralgia are among the commonly reported symptoms after intramuscular or intradermal vaccination. A small painless nodule (induration) may also form at the injection site. These symptoms usually disappear within one to two days without treatment. Nasal congestion/rhinorrhoea, reduced appetite, weakness and headache are common adverse reaction following administration of the live attenuated intranasal vaccine (Fluenz Tetra®).   Immediate reactions such as urticaria, angio-oedema, bronchospasm and anaphylaxis can occur rarely. The national flu immunisation programme 2015/16

Reporting suspected adverse reactions All serious suspected reactions following flu vaccination should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card scheme at http://yellowcard.mhra.gov.uk/ Fluenz Tetra® and Fluarix™ Tetra carry a black triangle symbol (▼) (as do all vaccines during the earlier stages of their introduction) This is to encourage reporting of all suspected adverse reactions Fluenz Tetra® and Fluarix™ Tetra carry a black triangle symbol (▼). This is a standard symbol added to the product information of a vaccine during the earlier stages of its introduction, to encourage reporting of all suspected adverse reactions. All serious suspected reactions following flu vaccines should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card scheme at http://yellowcard.mhra.gov.uk/.   The national flu immunisation programme 20154/16

Vaccine ordering All flu vaccines for children (both live and inactivated) are purchased centrally by PHE All children aged 2, 3 and 4yrs, and in school years 1 & 2 and All children in clinical risk groups aged 6 months to 18 years i.e. PHE will supply Fluenz Tetra® for those who can receive it and inactivated flu vaccine for those children for whom Fluenz Tetra® is contraindicated Flu vaccines for children can be ordered through the ImmForm website as for other centrally purchased vaccines (www.immform.dh.gov.uk) Providers are responsible for ordering sufficient flu vaccine for all other eligible patients aged 18 years and older directly from manufacturers Ordering from more than one supplier is recommended in case of supplier delays or difficulties in the manufacture or delivery of the vaccine All flu vaccines for children are purchased centrally by PHE. This includes vaccine for the national offer to all children aged two to four years and children of school years 1 and 2 age, and for children in risk groups aged six months to less than 18 years. For children in risk groups under 18 years of age where Fluenz Tetra is contraindicated, suitable inactivated influenza vaccines will be provided centrally and should be offered. The quadrivalent inactivated influenza vaccine (Fluarix™ Tetra®) is authorised for children aged from three years and is preferred because of the additional protection offered. Children aged from six months to less than three years should be given inactivated influenza vaccine (Split Virion) BP®. Fluenz Tetra and inactivated injectable vaccines can be ordered through the ImmForm website: www.immform.dh.gov.uk. For all other eligible populations apart from children, providers remain responsible for ordering vaccines directly from manufacturers. It is recommended that orders are placed with more than one manufacturer in case of supplier delays or difficulties in the manufacture or delivery of the vaccine. The vaccines that will be available for the 2015/16 flu immunisation programme are listed in The national flu immunisation programme 2015 to 2016: supporting letter .This letter also provides more information about flu vaccine supply and ordering in Appendix E. The national flu immunisation programme 2015/16

Inactivated Influenza Vaccine for children contraindicated to receive Fluenz Tetra® Children for whom Fluenz Tetra® is contraindicated should be offered a suitable alternative inactivated flu vaccine Some inactivated flu vaccines have been associated with high rates of febrile convulsions in children Some inactivated flu vaccines contain too much ovalbumin for egg allergic children Check SPC for vaccine suitability before administration Guidance on which vaccines to use for those children who cannot receive Fluenz Tetra ® can be found in the Green Book influenza chapter Fluarix Tetra® is the preferred vaccine for children aged ≥ 3years who cannot receive Fluenz Tetra® Children 6m to <3yrs should be given inactivated influenza vaccine (Split Virion) BP® For those children for whom Fluenz Tetra® is unsuitable, a suitable inactivated flu vaccine should be offered. One inactivated flu vaccine has been associated with high rates of febrile convulsions (Fluvax by CSL marketed in the UK by Pfizer as Enzira® or CSL Biotherapies) in children under five years of age in other countries. The SPC for Enzira® also indicates that a high rate of fever was reported in the age group aged five to under nine years. Due to the risk of febrile convulsions, the indication for Enzira is restricted to use in adults and children aged five years and older. If no suitable alternative vaccines are available, clinicians should ensure parents are aware of the risk and give advice on the management of vaccine-induced fever. There remains no evidence that other trivalent influenza vaccines used in the UK are associated with a similar risk of febrile convulsions in children The inactivated influenza vaccines are interchangeable; the second dose, if required, should be given at least four weeks after the first dose in accordance with the manufacturer’s SPC for that vaccine. The national flu immunisation programme 2015/16

Beware of product confusion! Fluarix Tetra® is an inactivated vaccine licensed from three years of age that can be given to children who cannot receive the live intranasal flu vaccine, the 65 and overs, the under 65s at risk, pregnant women and healthcare workers Care must be taken not to confuse the two ‘Tetra’ brands One way of remembering which vaccine is which is: • Fluenz is the nazal flu vaccine • Fluarix is the arm injected vaccine Care must be taken not to confuse the two ‘Tetra’ brands, especially as Fluarix Tetra is not licensed for use in children under three years of age and both vaccines will be in the fridge at the same time. It is essential that the correct vaccine is chosen for the patient. This will also have implications for data recording – immunisers need to make sure that the correct vaccine is entered on the ImmForm documentation. The national flu immunisation programme 2015/16

Recording of flu vaccine given As a wide variety of influenza vaccines are on the UK market each year, it is especially important that the following information be recorded: ● vaccine name, product name, batch number and expiry date ● dose administered ● date immunisation given ● route/site used ● name and signature of vaccinator This information should be recorded in: Patient's GP record (or other patient record, depending on location) Personal Child Health Record (the ‘Red Book’) if a child Practice computer system Child Health Information System As a wide variety of influenza vaccines are on the UK market each year, it is especially important that the exact brand of vaccine, batch number and site at which each vaccine is given is accurately recorded in the patient records. Where the vaccine is given for occupational reasons, it is recommended that the employer keep a vaccination record. It is important that vaccinations given either at a general practice or elsewhere (for example, at community pharmacies, or antenatal clinics) are recorded on appropriate health records for the individual (using the appropriate clinical code) in a timely manner, including the relevant Child Health Information System. If given elsewhere, a record of vaccination should be returned to the patient’s general practice to allow clinical follow up and to avoid duplicate vaccination. The national flu immunisation programme 2015/16

Data collection Flu vaccine uptake data is collected via the web-based ImmForm system (www.immform.dh.gov.uk) where it is managed and published by PHE Over 90% GP practices are able to make automated data returns where the number of their patients vaccinated is directly extracted from their IT system and put into ImmForm For data to be accurate and complete, it is critical that vaccines given outside the surgery e.g. in antenatal clinics, pharmacies etc. are reported to the patient’s GP Uptake data for school years 1 & 2 and pilot areas will be manually submitted by Area Teams onto ImmForm Uptake data for HCWs is manually submitted by Trusts and Area Teams via ImmForm Data is collected and published monthly on all the groups for whom flu vaccine is indicated at national level and local NHS England team level to enable performance to be reviewed and time to take action if needed As in previous years, flu vaccine uptake data collections will be managed using the ImmForm website (www.immform.dh.gov.uk). Monthly data collections will take place over four months during the 2015/16 flu immunisation programme, starting in November for October’s uptake. These collections will enable performance to be reviewed at local NHS England Team level during the programme, with time to take action if needed, and for the uptake from the completed programme to be measured. More detail about data collection in 2015/16 is available in Appendix F The national flu immunisation programme 2015 to 2016: supporting letter The national flu immunisation programme 2015/16

Achieving high uptake (GP Practice checklist) In order to obtain high vaccine uptake, it is recommended that GP practices: Should have a named individual within the practice who is responsible for the flu vaccination programme Have a register that can identify all pregnant women, patients in the under 65 years at risk groups, those aged 65 years and over and those aged 2 to 4 years Update patient registers throughout the flu season paying particular attention to the inclusion of women who become pregnant during the flu season Submit accurate data on the number of its patients eligible to receive flu vaccine and the flu vaccinations given to its patients on ImmForm Order sufficient flu vaccine taking into account past and planned performance, expected demographic increase, and to ensure that everyone at risk is offered the flu vaccine The GP practice checklist (in Appendix E in the Flu Plan 2015/1623) highlights good practice and is based upon the findings from a study examining the factors associated with higher vaccine uptake in general practice. GP practices are encouraged to review their systems in the light of the checklist. Most recommendations will apply to other areas where flu vaccine is given General 1. The GP practice has a named individual within the practice who is responsible for the flu vaccination programme. Registers and information The GP practice has a register that can identify all pregnant women and patients in the under 65 years at risk groups, those aged 65 years and over, and those aged two to four years. The GP practice will update the patient registers throughout the flu season paying particular attention to the inclusion of women who become pregnant during the flu season. The GP practice will submit accurate data on the number of its patients eligible to receive flu vaccine and the flu vaccinations given to its patients on ImmForm (www.immform.dh.gov.uk), ideally using the automated function, and on uptake amongst healthcare workers in primary care using the ImmForm data collection tool. Meeting any public health targets in respect of such immunisations 5. The GP practice will/has ordered sufficient flu vaccine taking into account past and planned performance, expected demographic increase, and to ensure that everyone at risk is offered the flu vaccine. It is recommended that vaccine is ordered from more than one supplier and from PHE central supplies through the ImmForm website in respect of children. The national flu immunisation programme 2015/16

Achieving high uptake (GP Practice checklist cont’d) 6. Patients recommended to receive the flu vaccine should be directly contacted (e.g. letter, e-mail, phone call, text or other) inviting them to a flu vaccination clinic or to make an appointment 7. The practice should follow-up patients who do not respond or fail to attend scheduled clinics or appointments 8. Flu vaccination should start as soon as practicable after receipt of the vaccine so maximum number of patients are vaccinated as early as possible to ensure they are protected before flu starts to circulate 9. The GP practice should collaborate with midwives to offer and provide flu vaccination to pregnant women and to identify, offer and provide to newly pregnant women as the flu season progresses Robust call and recall arrangements 6. Patients recommended to receive the flu vaccine will be directly contacted (for example through letter, e-mail, phone call, text or otherwise although such strategies are for GP practices to determine) inviting them to a flu vaccination clinic or to make an appointment. PHE has produced a flu vaccination invitation template letter which can be found at: www.gov.uk/government/publications/flu-vaccination-invitation-template-letter 7. The GP practice will follow-up with patients who do not respond or fail to attend scheduled clinics or appointments. Maximising uptake in the interests of at-risk patients 8. Flu vaccination will start as soon as practicable after receipt of the vaccine in the practice so that the maximum number of patients are vaccinated as early as possible prior to the flu season (ie by the end of October), to ensure they are protected before flu starts to circulate. 9. The GP practice will collaborate with midwives to offer and provide flu vaccination to pregnant women and to identify, offer and provide to newly pregnant women as the flu season progresses. The national flu immunisation programme 2015/16

Achieving high uptake (GP Practice checklist cont’d ) 10.The GP practice should offer flu vaccination in clinics and opportunistically. 11.The GP practice and/ or CCG should collaborate with other providers such as community or health and social care trusts to identify and offer flu vaccination to residents in care homes, nursing homes and house-bound patients The GP practice checklist highlights good practice It is based upon the findings from a study examining the factors associated with higher vaccine uptake in general practicei GP practices are encouraged to review their systems in the light of the checklist Most recommendations will apply to other areas where flu vaccine is given iDexter LJ et al (2012) Strategies to increase influenza vaccination rates: outcomes of a nationwide cross-sectional survey of UK general practice. bmjopen.bmj.com/content/2/3/e000851.full Maximising uptake in the interests of at-risk patients 10.The GP practice will offer flu vaccination in clinics and opportunistically. 11.The GP practice and/ or CCG will collaborate with other providers such as Foundation Trusts to identify and offer flu vaccination to residents in care homes, nursing homes and house-bound patients. The national flu immunisation programme 2015/16

Key messages Flu immunisation is one of the most effective interventions immunisers can provide to reduce harm from flu and pressures on health and social care services during the winter Increasing flu vaccine uptake in clinical risk groups is important because of increased risk of death and serious illness if people in these groups catch flu For a number of years only around half of patients aged six months to under 65 years in clinical risk groups have been vaccinated Influenza during pregnancy may be associated with perinatal mortality, prematurity, smaller neonatal size, lower birth weight and increased risk of complications for mother Vaccination of health and social care workers protects them & reduces risk of spreading flu to their patients, service users, colleagues and family members Flu is unpredictable. It is not possible to fully predict the strains that will circulate in any given season, and there is always a risk of a drift occurring as was seen last flu season (2014/15). However, it is important to be aware that this does not occur every season. Flu vaccine is still the best protection we have against an unpredictable virus which can cause severe illness and deaths each year. The national flu immunisation programme 2015/16

Resources Flu Plan and Supporting Letter detailing 2015/16 flu programme: Department of Health, Public Health England, NHS England. Published 27 March 2015. Available at: https://www.gov.uk/government/publications/flu-plan-2015-to-2016 Green Book Influenza chapter updated August 2015 Available at: https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the- green-book Leaflets, posters, Q&As and other resources to support the annual flu programme Available at: https://www.gov.uk/government/collections/annual-flu-programme A video for health professionals on how to administer the Fluenz Tetra® vaccine produced by NHS Education for Scotland is available at http://www.nes.scot.nhs.uk/education-and-training/by-theme-initiative/public- health/health-protection/seasonal-flu.aspx Summary of Product Characteristics (SPC) for flu vaccines are available at http://www.medicines.org.uk/emc/ References Fleming DM, Watson JM, Nicholas S et al. (1995) Study of the effectiveness of influenza vaccination in the elderly in the epidemic of 1989/90 using a general practice database. Epidemiol Infect 115: 581–9 Osterholm, MT, Kelley, NS, Sommer, A, and Belongia, EA (2012) Efficacy and effectiveness of influenza vaccines: a systematic review and meta-analysis. Lancet Infect Dis. 12(1.1), 36-44. Pebody, R et al. (2015) Low effectiveness of seasonal influenza vaccine in preventing laboratory-confirmed influenza in primary care in the United Kingdom: 2014/15 mid-season results. Eurosurveillance. 20. Issue 5. www.eurosurveillance.org/ViewArticle.aspx?ArticleId=21025 Mangtani P, Cumberland P, Hodgson CR et al. (2004) A cohort study of the effectiveness of influenza vaccine in older people, performed using the United Kingdom general practice research database. J Infect Dis 190(1): 1–10. Wright PF, Thompson J, Vaughn WK et al. (1977) Trials of influenza A/New Jersey/76 virus vaccine in normal children: an overview of age-related antigenicity and reactogenicity. J Infect Dis 136 (suppl): S731–41. Public Health England. Surveillance of influenza and other respiratory viruses in the United Kingdom: winter 2014 to 2015. Published May 2015. Available at: https://www.gov.uk/government/statistics/annual-flu-reports Immunisation against infectious disease (‘the Green Book’) Chapter 19 ‘Influenza’. Updated 21 May 2015. Available at: https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book Van Kerkhove MD, WHO Working Group for Risk Factors for Severe H1N1pdm Infection. Risk factors for severe outcomes following 2009 influenza A (H1N1) infection: a global pooled analysis. PLoS Med. 2011 Jul;8(7):e1001053 Fezeu L, Julia C, Henegar A, Bitu J et al. Obesity is associated with higher risk of intensive care unit admission and death in influenza A (H1N1) patients: a systematic review and metaanalysis. Obes Rev. 2011 Aug;12(8):653-9 Morgan OW, Bramley A, Fowlkes A, et al. Morbid obesity as a risk factor for hospitalization and death due to 2009 pandemic influenza A(H1N1) disease PLoS One. 2010 Mar 15;5(3) Neuzil KM, Reed GW, Mitchel EF et al. (1998) Impact of influenza on acute cardiopulmonary hospitalizations in pregnant women. Am J Epidemiol. 148:1094-102 Public Health England. Influenza immunisation programme for England GP patient groups. Data collection survey. Season 2014 to 2015. Available at: https://www.gov.uk/government/statistics/seasonal-flu-vaccine-uptake-in-gp-patients-in-england-winter-season-2014-to-2015 McNeil SA, Dodds LA, Fell DB et al. (2011) Effect of respiratory hospitalization during pregnancy on infant outcomes. Am J Obstet Gynecol. 204: (6 Suppl 1) S54-7. Pierce M, Kurinczuk JJ, Spark P et al. (2011) Perinatal outcomes after maternal 2009/H1N1 infection: national cohort study. BMJ. 342:d3214. Pebody R et al. (2010) Pandemic influenza A (H1N1) 2009 and mortality in the United Kingdom: risk factors for death, April 2009 to March 2010. Eurosurveillance 15(20): 1957 Benowitz I, Esposito DB, Gracey KD et al. (2010) Influenza vaccine given to pregnant women reduces hospitalization due to influenza in their infants. Clin Infect Dis. 51: 1355-61. Omer SB, Goodman D, Steinhoff MC et al. (2011) Maternal influenza immunization and reduced likelihood of prematurity and small for gestational age births: a retrospective cohort study. PLoS Med. 8: (5) e1000441. Poehling KA, Szilagyi PG, Staat MA et al.(2011) Impact of maternal immunization on influenza hospitalizations in infants. Am J Obstet Gynecol. 204:(6 Suppl 1) S141-8. Zaman K, Roy E, Arifeen SE et al. (2008) Effectiveness of maternal influenza immunisation in mothers and infants. N Engl J Med. 359: 1555-64. Eick AA, Uyeki TM, Klimov A et al. (2010) Maternal influenza vaccination and effect on influenza virus infection in young infants. Arch Pediatr Adolesc Med. 165: 104-11. Tamma PD, Ault KA, del Rio C et al. (2009) Safety of influenza vaccination during pregnancy. Am. J. Obstet. Gynecol. 201(6): 547-52. Dabrera G, Zhao H, Andrews N et al. (2014) Effectiveness of seasonal influenza vaccination during pregnancy in preventing influenza infection in infants, England, 2013/14. Eurosurveillance. Nov 13;19. www.eurosurveillance.org/ViewArticle.aspx?ArticleId=20959 Potter J, Stott DJ, Roberts MA et al. (1997) The influenza vaccination of health care workers in long-term-care hospitals reduces the mortality of elderly patients. Journal of Infectious Diseases 175: 1-6. Joint Committee on Vaccination and Immunisation. JCVI statement on the annual influenza vaccination programme – extension of the programme to children. 25 July 2012. Available at: https://www.gov.uk/government/publications/jcvi-statement-on-the-routine-annual-influenza-vaccination-programme Department of Health, Public Health England, NHS England. Flu Plan Winter 2015/16. Published March 2015. Available at: https://www.gov.uk/government/publications/flu-plan-2015-to-2016 Hayward AC, Harling R, Wetten S et al. (2006) Effectiveness of an influenza vaccine programme for care home staff to prevent death, morbidity, and health service use among residents: cluster randomised controlled trial. British Medical Journal doi:10.1136/bmj.39010.581354.55 Carman WF, Elder AG, Wallace LA et al. (2000) Effects of influenza vaccination of healthcare workers on mortality of elderly people in long term care: a randomised control trial. The Lancet 355: 93-7. Ashkenazi S, Vertruyen A, Aristegui J et al. (2006) Superior relative efficacy of live attenuated influenza vaccine compared with inactivated influenza vaccine in young children with recurrent respiratory tract infections. The Pediatric Infectious Disease Journal 25(10): 870-9. http://www.ncbi.nlm.nih.gov/sites/entrez/17006279 Belshe RB, Edwards KM, Vesikari T et al. (2007) Live attenuated versus inactivated influenza vaccine in infants and young children. New England Journal of Medicine 356(7): 685-96. http://www.ncbi.nlm.nih.gov/sites/entrez/17301299 Lemaitre M, Meret T, Rothan-Tondeur M et al. (2009) Effect of influenza vaccination of nursing home staff on mortality of residents: a cluster randomised trial. Journal of American Geriatric Society 57:1580-6. Fleming DM, Crovari P, Wahn U et al. (2006) Comparison of the efficacy and safety of live attenuated cold-adapted influenza vaccine, trivalent, with trivalent inactivated influenza virus vaccine in children and adolescents with asthma. The Pediatric Infectious Disease Journal 25(10): 860-9. http://www.ncbi.nlm.nih.gov/sites/entrez/17006278 Block S L, Toback SL, Yi T et al. (2009) Efficacy of a single dose of live attenuated influenza vaccine in previously unvaccinated children: a post hoc analysis of three studies of children aged 2 to 6 years. Clin Ther. 31: 2140-7. Des Roches A, Paradis L, Gagnon R, et al. (2012). Egg-allergic patients can be safely vaccinated against influenza. J Allergy Clin Immunol. 130(5):1213-6. Bracco Neto H, Farhat CK, Tregnaghi MW, et al. (2009) Efficacy and safety of 1 and 2 doses of live attenuated influenza vaccine in vaccine-naive children. Pediatr Infect Dis J. 28: 365-71. Neuzil KM, Jackson LA, Nelson J et al. (2006) Immunogenicity and reactogenicity of 1 versus 2 doses of trivalent inactivated influenza vaccine in vaccine-naive 5-8-year-old children. Journal of Infectious diseases 194(8): 1032-9. http://www.ncbi.nlm.nih.gov/sites/entrez/16991077 Allison MA Daley MF, Crane LA et al. (2006) Influenza vaccine effectiveness in healthy 6 to 21 month-old children during the 2003--2004 season. The Journal of Pediatrics 149: 755-62. Department of Health, Public Health England, NHS England. The national flu immunisation programme 2015 to 2016: supporting letter. 27 March 2015. Available at: https://www.gov.uk/government/publications/flu-plan-2015-to-2016 Centers for Disease Control and Prevention. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2013–2014. MMWR September 20, 2013 / 62(RR07);1-43 http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6207a1.htm#LiveAttenuatedInfluenzaVaccines The national flu immunisation programme 2015/16

Flu immunisation e-learning A new interactive flu immunisation elearning programme, written by PHE, and produced by Health Education England’s eLearning for Healthcare (e-LfH) (see http://www.e-lfh.org.uk/programmes/flu- immunisation/ ) has been developed The programme consists of a core knowledge and accompanying assessment session, followed by knowledge and assessment sessions on the live and inactivated flu vaccines. After completing the core knowledge session, practitioners can choose to complete one or both of the vaccine specific sessions depending on which session(s) is relevant to their role. This programme has been made ‘Open access’ for everyone so that those not employed by the NHS, or eligible to register for e-LfH learning programmes, will also be able to undertake the programme if they wish to. Presentation title - edit in Header and Footer

Pneumococcal disease

Pneumococcal infections Pneumococcal infections are caused by the Streptococcus pneumoniae (S. pneumoniae) bacterium. They can be mild or severe. There are more than 90 different strains of S. pneumoniae bacteria, which are known as serotypes.

Streptococcus pneumoniae There are more than 90 different strains of S. pneumoniae and some are much more likely to cause serious infection (virulent) than others Some strains can be easily killed by infection-fighting white blood cells, while others are resistant and likely to cause a more serious infection It is thought that between eight and 10 strains are responsible for two-thirds of cases of serious infections in adults, and most cases in children

How the bacteria is spread? S. pneumoniae enter the human body through the nose and mouth, and an infection can be spread in the same way as a cold or the flu This can be through: direct contact, for example, when someone sneezes or coughs, tiny droplets of fluid that contain the bacteria are launched into the air and can be breathed in by others indirect contact, for example, if infected droplets of fluid are transferred from someone's hand to a door handle, someone else who touches the handle may become infected with the bacteria if they then touch their mouth or nose

Types of pneumococcal infections Pneumococcal infections usually fall into one of two categories: non-invasive pneumococcal infections – these occur outside the major organs or the blood and tend to be less serious invasive pneumococcal infections – these occur inside a major organ or the blood and tend to be more serious

Non-invasive pneumococcal infections Non-invasive pneumococcal infections include: bronchitis – infection of the bronchi, the tubes that run from the windpipe down into the lungs otitis media – ear infection sinusitis – infection of the sinuses

Invasive pneumococcal infections Invasive pneumococcal infections include: bacteraemia – a relatively mild infection of the blood septicaemia (blood poisoning) – a more serious blood infection osteomyelitis – infection of the bone septic arthritis – infection of a joint pneumonia – infection of the lungs meningitis – infection of the meninges, the protective membranes surrounding the brain and spinal cord Cases of invasive pneumococcal infection usually peak in the winter during December and January

Symptoms The symptoms of a pneumococcal infection can vary depending on the type of infection you have. Common symptoms include a high temperature (fever) of 38°C or above chills sweats aches and pains headache a general sense of feeling unwell

Spread It is important to emphasise that pneumococcal infections are far less contagious than a cold or flu. This is because most people's immune systems are able to kill the bacteria before they have the opportunity to cause an infection Outbreaks of pneumococcal infections can sometimes occur in environments where there are many people who have poorly functioning immune systems, such as in children's nurseries, care homes for the elderly and shelters for people who are homeless

Treatment Non-invasive pneumococcal infections are usually mild and go away without the need for treatment. More invasive types of pneumococcal infections can be treated with antibiotics, either at home or in hospital

Prevention Pneumococcal polysaccharide vaccines (23-valent) licensed in 1989 1992 until 2003 recommended for risk groups ≥2 year olds In 2003, pneumococcal polysaccharide (PPV) immunisation was recommended for all people aged 65 and over April 2003: recommended for all aged 80 and above April 2004: recommended for all aged 75 and above April 2005: recommended for all aged 65 and above

Vaccination coverage for patients who received PPV anytime up to 31 March 2015 Organisation Aged 65 and over (%) Aged 65 only (%) Aged 66-74 (%) Aged 75+ (%) Derbyshire and Nottinghamshire Area Team 73.3 40.1 67.7 84.0 Bassetlaw 71.4 33.7 64.6 85.3 Mansfield and Ashfield 73.1 40.0 68.3 83.4 Newark and Sherwood 77.6 46.0 73.5 87.0 Nottingham City 71.6 65.2 82.1 Nottingham North and East 71.1 32.3 64.2 Nottingham West 73.2 32.2 66.4 85.8 Rushcliffe 74.9 42.9 68.9 85.4 ENGLAND 69.8 35.1 63.0 81.7 For the fifth consecutive year, PPV coverage among people over the age of 65 remains stable at just under 70% of the eligible cohort.

Vaccination coverage for patients who received PPV between 1 April 2014 and 31 March 2015 Organisation Aged 65 and over (%) Aged 65 only (%) Aged 66-74 (%) Aged 75+ (%) Derbyshire and Nottinghamshire Area Team 4.22 18.56 5.31 1.03 Bassetlaw 5.4 16.9 7.3 1.3 Mansfield and Ashfield 3.7 19.6 4.1 1.0 Newark and Sherwood 4.5 22.8 0.9 Nottingham City 16.0 6.1 1.5 Nottingham North and East 12.4 5.8 1.2 Nottingham West 4.4 13.9 6.7 Rushcliffe 24.1 ENGLAND 4.67 16.15 6.07 1.62 Almost a fifth (19.0%) of patients in the 65 years only group had already received the vaccine any time up to and including 31 March 2015 as they were eligible due to their inclusion in specific clinical risk groups, and an additional 16.1% received the vaccine in the previous 12 months (ie 1 April 2014 to 31 March 2015). The data presented indicate that many of those eligible for PPV vaccination do not receive the vaccine in the first year that they become eligible. However, increasing vaccine coverage in the older age groups demonstrates that vaccination continues to be offered opportunistically in primary care to those aged over 65 years.

At-risk groups Influenza (annual immunisation) Pneumococcal disease (single dose except where indicated) Age 65 and over Chronic respiratory disease Chronic heart disease Chronic kidney disease Chronic kidney disease* Chronic liver disease Diabetes Immunosuppression Asplenia or splenic dysfunction Asplenia or splenic dysfunction*

At-risk groups Influenza (annual immunisation) Pneumococcal disease (single dose except where indicated) Chronic neurological disease Individuals with cochlear implants Pregnancy Individuals with cerebrospinal fluid leaks Morbid Obesity Health and Social Care staff Those living in long stay care facilities Carers Healthy children aged 2-7 years (eventually up to 17 yrs)

Shingles

Herpes Zoster (Shingles) Shingles is a viral infection of the nerve cells and surrounding skin. It is caused by the (herpes) varicella zoster virus that also causes chickenpox After a person recovers from chickenpox infection, the virus remains dormant in the nerve cells and can reactivate at a later stage when the immune system is weakened Reactivation can be associated with older age, immunosuppressant therapy or HIV infection An estimated 50,000 cases of shingles occur in people aged 70 years and above each year in E&W Of these, 14,000 develop a very painful and long lasting condition called Post Herpetic Neuralgia (PHN) 1,400 cases of shingles result in hospitalisation 1 in 1,000 cases of shingles are estimated to result in death Infection with varicella zoster (chickenpox) is a pre-requisite for the development of shingles You do not develop shingles from being in contact with chickenpox Increasing incidence of shingles infection amongst older age groups is thought to be associated with a decline in cell mediated immunity to varicella zoster virus2 shingles can not be transmitted from one person to another, although it can cause chickenpox in individuals who have not previously had the disease and who have direct contact with the fluid from the shingles vesicles   Although rare, it is possible to have shingles more than once Shingles is not caused by the same virus that causes genital herpes

Shingles Epidemiology of shingles in England and Wales The above graph shows the estimated annual age-specific incidence of shingles per 100, 000 per year in the immunocompetent population (Y- axis) against the age quinqennia (x-axis). The graph shows a continued increase in age related shingles, outlining that the incidence of shingles is largely associated with older age who are more at risk of developing the disease. Age-specific incidence rates of shingles have been estimated using a number of different primary care derived data sources3 including: the Royal College of General Practitioners (RCGP) Weekly Returns Service9 ; the fourth Morbidity Survey in General Practice (MSGP-4)10 , and the General Practice Research Database11 These are estimates (based on available data sources) as shingles is only clinically diagnosed, thus no lab confirmation of this is available- so actual figures may be much higher2.

Shingles prevention The epidemiology of the disease shows that individuals over 70 years of age are not only at an increased risk of developing the disease, but they also suffer a more severe form of the illness resulting in complications such as PHN and an increase in hospital admissions Analytical studies show that the most cost-effective age for offering vaccination to prevent and/ or reduce the disease burden is for those aged 70 to 79 Shingles vaccine introduced for all adults age 70 with a catch up programme to include adults aged 78 and 79 years in September 2013 Vaccination for individuals over the age of 80 years is not recommended due to the decreased efficacy of the vaccine in this age group and the economic analysis suggested that the vaccine would not be cost effective in individuals over the age of 80 years

Shingles vaccine eligibility From 1 September 2015 shingles vaccine should be offered to: 􀁸 Patients aged 70 years on 1 September 2015; and 􀁸 Patients aged 78 years on 1 September 2015. In addition, patients who were eligible for immunisation in the first two years of the programme but have not been vaccinated against shingles remain eligible until their 80th birthday. These cohorts are: 􀁸 Patients aged 71 and 72 on 1 September 2015; and 􀁸 Patients aged 79 on 1 September 2015. Presentation title - edit in Header and Footer

Shingles vaccine eligible cohorts Presentation title - edit in Header and Footer