DRAFT ONLY - Please see the disclaimer text on slide 1

DRAFT ONLY - Please see the disclaimer text on slide 1
The national flu immunisation programme 2014/ 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 2014/15 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 This resource is designed to be used for 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 the actual administration techniques involved in vaccinating with any other flu vaccine. If staff are required to deliver these vaccinations they should refer to their line manager for alternative 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 2014/15

Aims of resource This training resource aims to:
Develop the knowledge base of healthcare practitioners regarding the 2014/15 seasonal flu vaccination programme Support healthcare practitioners involved in discussing flu vaccination with those eligible by providing evidence based information Promote high uptake of flu vaccination in those eligible by increasing the knowledge of those involved in delivering the vaccination programme Provide information on the administration of flu vaccines Key roles of healthcare practitioners in relation to the flu programme are as follows: To understand the evidence base for the administration of the flu vaccination. To advise individuals and parents/carers of children who are eligible to receive the flu vaccination that it is strongly recommended that they/their children are vaccinated against flu. To safely administer the appropriate flu vaccine To ensure any adverse effects are managed and reported appropriately. The national flu immunisation programme 2014/15

Learning Outcomes On completion of this resource healthcare practitioners will be able to: Describe the cause of flu Understand how flu is transmitted and the possible effects of flu Understand the evidence base for the administration of flu vaccination to those aged 65 years and over and those in clinical risk groups Explain which vaccines will be used and the precautions and contraindications to the administration of flu vaccines Explain the sequence of steps in flu vaccine administration Explain the possible side effects from flu vaccines Understand the importance of their role in promoting and providing evidence based information about flu vaccination to patients Identify sources of additional information The national flu immunisation programme 2014/15

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 2014/15

Influenza (flu) viruses
DRAFT ONLY - Please see the disclaimer text on slide 1 Influenza (flu) viruses There are 3 types of influenza (flu) 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 2014/15

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 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 2014/15

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: minor changes which tend to occur from season to season Antigenic shift: major changes and the emergence of new subtype Immunity from previous virus may not protect against new subtype thus leading to widespread epidemic or pandemic in a non-immune population 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 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 In most recent years, the vaccines have closely matched the influenza A viruses circulating during the subsequent influenza season. However, if a new influenza A subtype were to emerge with epidemic or pandemic potential (as occurred in 2009 with influenza A(H1N1)v), it is unlikely that the influenza vaccine will be well matched to the emerging strain. In these circumstances, as was done during the 2009 pandemic, a monovalent vaccine against that strain will be developed and implemented. However, because two lineages of B strain can circulate, and in some seasons co-circulate, mismatches of the trivalent vaccine-type and the circulating B strain can occur more frequently. The use of quadrivalent influenza vaccines containing a B strain from each lineage are expected to improve the matching of the vaccine to the circulating B strain(s). The national flu immunisation programme 2014/15

Features of flu 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, myalgia & 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 days1. The national flu immunisation programme 2014/15

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 Influenza during pregnancy may be associated with perinatal mortality, prematurity, smaller neonatal size and lower birth weight In healthy individuals, flu is usually unpleasant but self-limiting with recovery within 2-7 days2. However, the illness may be complicated by (and may present as) bronchitis, secondary bacterial pneumonia or, in children, otitis media. Influenza can be complicated more unusually by meningitis, encephalitis or meningoencephalitis. Although primary influenza pneumonia is a rare complication that may occur at any age and carries a high case fatality rate, it was seen more frequently during the 2009 pandemic and the following influenza season. The national flu immunisation programme 2014/15

Flu epidemiology Flu activity usually between weeks 37 and 15 (September to March) Impact of flu varies from year to year 2013/14 saw low levels of circulating flu Estimated 11,000 deaths attributable to flu in the 2012/13 season 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 per 100,000 consultations in primary care from 2008/9 flu season to 2013/14 season. The data show that flu viruses circulate each winter season, but the degree of activity varies substantially. 2013/14 saw low levels of circulating flu but we cannot be complacent as there were an estimated 11,000 deaths attributable to flu in the 2012/13 season3. Rate of influenza/influenza-like illness episodes in England (weekly returns to Royal College of General Practitioners), 2008–09 to 2013–14 The national flu immunisation programme 2014/15

Flu vaccination programme
DRAFT ONLY - Please see the disclaimer text on slide 1 Flu vaccination programme Late 1960s: annual flu immunisation recommended in the UK with the aim of directly protecting 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 extension to offer annual flu vaccination to all children aged 2-17y began with the inclusion of children aged 2 and 3 years in the routine programme and 7 geographical pilots of primary school aged children 2014: phased introduction of childhood flu vaccination programme continues with the vaccine to be offered to all children aged 2, 3 and 4 years and geographical pilots in primary and secondary school aged children In the 2014/15 flu season, all children aged 2-4 years old on or before 1 September 2014 will be offered vaccination. The pilot programme will extended to include 12 pilot areas for secondary school aged children (11 and 12 year olds) and the 7 pilots in primary school aged children that took place in 2013/14 will continue. In 2015/16 it is expected (subject to negotiations) that the programme will be extended to all 2-6 year olds, with the expectation that 5 and 6 year olds will be vaccinated predominantly in primary school settings. Subject to the outcome of the Spending Review, the programme will extend to all children of primary school age in 2016/17, reaching secondary school aged children in 2017/18. These plans will be kept under review4. 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 2014/15

Flu vaccine eligibility 2014/15
For the 2014/15 flu season, the following people are eligible for flu vaccination: those aged 65 years and over on or before 31 March (born on or before 31 March 1950) those aged six months to under 65 years in clinical risk groups pregnant women at any stage of pregnancy all children aged two, three and four years on or before 1 Sept (DOB on or after 2/9/09 and on or before 1/9/12) school-aged children in pilot areas those in long-stay residential care homes carers 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 2014/15

Clinical risk groups who should receive flu vaccine
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. Immunisers are advised to look at this table in the Green Book Influenza chapter2]. The national flu immunisation programme 2014/15

Clinical risk groups who should receive flu vaccine (cont)
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 2014/15

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 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 2014/15

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 that a patient may have, 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 Consideration should also be given to the vaccination 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 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 the clinical risk groups specified above. 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 2014/15

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 ( ) 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 ( ) Chronic respiratory disease 59 (16.6) 2.4 7.4 ( ) Chronic liver disease 15.8 48.2 ( ) Diabetes 26 (7.3) 2.2 5.8 ( ) Immunosuppression 71 (19.9) 20.0 47.3 ( ) Chronic neurological disease (excluding stroke/transient ischaemic attack) 42 (11.8) 14.7 40.4 ( ) 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 2014/15

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 2014/15: request to prioritise the improvement of vaccine uptake in those with chronic liver and neurological disease, including those 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 For 2014/15, GP practices and other providers are asked to prioritise the improvement of vaccine uptake in those with chronic liver and neurological disease, including those with learning disabilities who are at the highest risk of mortality from flu but have lowest rate of vaccine uptake. The national flu immunisation programme 2014/15

Flu vaccine uptake by clinical risk group in 2012/13
The national flu immunisation programme 2014/15

Flu vaccine uptake rates 2011/12 – 2013/14
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. However, the overall uptake is still below the 75% aspiration and this therefore remains a priority area for improvement. 2014/15 aim: all eligible individuals offered flu vaccine and a minimum 75% uptake for those aged 65 years and over and for health and social care workers The national flu immunisation programme 2014/15

Pregnant women 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 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 flu5,6 .In addition, there is evidence that having flu during pregnancy may be associated with premature birth and smaller birth size and weight7,8 and that flu vaccination may reduce the likelihood of prematurity and smaller infant size at birth associated with an influenza infection during pregnancy9.Furthermore, a number of studies show that flu vaccination during pregnancy provides passive immunity against flu to infants in the first few months of life10-13. 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 vaccine14. All pregnant women are recommended to receive the inactivated flu vaccine irrespective of their stage of pregnancy. When to stop offering the vaccine to pregnant women The ideal time for flu vaccination is between September and early November before flu starts circulating. However flu can circulate considerably later than this and it may therefore be necessary to continue offering the vaccine to groups such as newly pregnant women. Clinicians should apply clinical judgement to assess the needs of an individual patient, taking into account the level of flu-like illness in their community and the fact that the immune response following flu vaccination takes about two weeks to develop fully. The national flu immunisation programme 2014/15

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: Child to child Child to adult Child 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 Extending flu vaccination to children will reduce the impact of flu by directly averting many cases in children. The Joint Committee on Vaccination and Immunisation also concluded that, by reducing flu transmission in the community, it will avert many cases of severe flu and flu-related deaths in older adults and people with clinical risk factors15. In July 2012, the JCVI recommended extending the programme to healthy children. This programme will lower the potentially serious impact of influenza on those children but should also have a more profound effect on influenza transmission. Children are the main source of transmission in the population, and this programme will therefore reduce the spread of infection from children to other children, to adults and to those in clinical risk groups of any age. The Secretary of State accepted this recommendation, and the implementation of the extension commenced in September 2013 with a general practice roll-out to children aged two and three years and seven geographic pilots in children aged 5-11 years. This year, the programme in general practice will continue and there will be 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 two to 16. 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 2014/15

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 that it significantly lowers rates of flu-like illness, hospitalisation and mortality in older people in 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 health and social care workers can also help 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. In 2013/14 there was a very encouraging and marked improvement in flu vaccination of health care workers, with a final overall uptake rate of 54.8% compared to 45.6% the previous year. However, the overall level of uptake is still below the 75% aspiration. Flu outbreaks can arise 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 significantly lowers rates of flu-like illness, hospitalisation and mortality in older people in healthcare settings16-19.Vaccination of staff in social care settings may provide similar benefits. Flu immunisation of healthcare workers with direct patient contact and social care staff is likely to reduce the transmission of infection to vulnerable patients, some of whom may have impaired immunity that may not respond well to immunisation. Vaccination of health and social care workers can also help reduce the level of sickness absences and will contribute to keeping the NHS and care services running. This is particularly important in the face of winter pressures. The national flu immunisation programme 2014/15

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 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 2013/14: marked improvement in flu vaccination of health care workers with final overall uptake rate 54.8% compared to 45.6% previous year. However, overall level of uptake is still below the 75% aspiration See NHS Employers flu fighter campaign 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, with a final overall uptake rate of 54.8% compared to 45.6% the previous year. However, the overall level of uptake is still below the 75% aspiration3. The national flu immunisation programme 2014/15

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 important2. The national flu immunisation programme 2014/15

Which flu vaccine should be used?
The national flu immunisation programme 2014/15

Types of flu vaccines Two main types of vaccine available: Inactivated – by injection Live - by nasal application None of the influenza vaccines can cause clinical influenza in those that can be vaccinated Trivalent: most inactivated flu vaccines contain two subtypes of Influenza A and one type B virus Quadrivalent: an inactivated vaccine containing 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, a quadrivalent live intranasal vaccine will be offered to children aged 2yrs and over in the 2014/15 flu season *Quadrivalent inactivated influenza vaccine only authorised for children aged 3 years and older For many years only inactivated flu vaccines given by intramuscular injection have been available in the UK. These give 70 to 80% protection when the vaccine strains are well matched to those circulating. They are less protective in the elderly but still significantly reduce bronchopnemumonia, hospitalisations and mortality. Trivalent live attenuated influenza vaccine has been shown to provide a higher levels of protection for children than trivalent inactivated flu vaccine20 a recent meta-analysis suggested an efficacy against confirmed disease of 83% (95% confidence interval 69-91)21-23 Quadrivalent flu vaccines: an inactivated vaccine containing two subtypes of Influenza A and both B virus types was made available for the first time in For the 2014/15 flu season, this inactivated quadrivalent vaccine will be available for those aged 3 years and older. The live attenuated intranasal flu vaccine being given to children will also be a quadrivalent vaccine (a trivalent live vaccine was used in 2013/14 season). The national flu immunisation programme 2014/15

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 and a very similar trivalent vaccine has an established history of use in the United States The 2014/15 flu season is the first season in which Fluenz Tetra® will be used. This vaccine is the same as the Fluenz® vaccine used in the UK in the 2013/14 season and used in the US for many years but with the addition of the other B virus type. The majority of published literature is about Fluenz® but most of this will apply to Fluenz Tetra® The live attenuated influenza vaccine (LAIV) has been shown to be more effective in children compared with inactivated influenza vaccines20-22 and 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. This should mean it also offers better long-term protection to children than they may get from the inactivated vaccines. The live intranasal vaccine has a good safety profile in children aged two years and older and has been used for about 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 in the UK where hundreds of thousands of children were successfully vaccinated24. As with all vaccines and medicines, MHRA will closely monitor the safety of Fluenz Tetra®. Fluenz Tetra®) contains live viruses that have been attenuated (weakened) and adapted to cold so that they cannot replicate efficiently at body temperature. This means they cannot cause clinical flu in immunocompetent children. The national flu immunisation programme 2014/15

Inactivated flu vaccines
A number of different manufacturers produce flu vaccines Those available for 2014/15 season are listed in Green Book Influenza chapter 19 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 Green Book 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 influenza 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 influenza vaccines available in the UK for the 2014/15 influenza season are listed in the Green Book Influenza chapter 19 The national flu immunisation programme 2014/15

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 It is highly likely that all the Fluenz Tetra® supplied centrally will have expired by February It is therefore important to ensure that efforts are made to vaccinate children before the Christmas holidays 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 2014/15

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® 9µg Adults aged 18 years to 59 years Single injection of 0.1ml Inactivated intradermal vaccine - Intanza® 15µg Adults aged 60 years and older 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 before25,26 . Live attenuated influenza vaccine has been shown to provide greater protection for children than inactivated influenza vaccine20-22 and studies have also shown meaningful efficacy after a single dose of live attenuated influenza vaccine in previously unvaccinated children27,28. Given this, JCVI has advised the use of different dosage schedules of influenza 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 2014/15

Flu vaccine composition 2014/15 Trivalent vaccines will contain the following three viruses: A/California/7/2009 (H1N1)pdm09-like virus A/Texas/50/2012 (H3N2)-like virus B/Massachusetts/2/2012-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 2014/15 season contain thiomersal as an added preservative More detailed information on the characteristics of the available vaccines, including age indications and ovalbumin (egg) content 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 2014/15 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 2014/15 season contain any preservatives such as thiomersal. The national flu immunisation programme 2014/15

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. 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 influenza 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 children2. 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 2014/15

Vaccine administration
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 IM and ID 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 Both inactivated and live flu vaccines can be given at the same time as, or at any interval before or after, other vaccines 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. 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 vaccines2. The national flu immunisation programme 2014/15

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 Fluenz Tetra® can be given at the same time as other vaccines, including live vaccines2. The national flu immunisation programme 2014/15

Administration of flu vaccines
Flu vaccines may only be administered: Against a prescription written manually or electronically by a registered medical practitioner or other authorised prescriber Against a Patient Specific Direction Against a Patient Group Direction The national flu immunisation programme 2014/15

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 There are very few individuals who cannot receive any influenza 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 2014/15

Contraindications to flu vaccines Confirmed anaphylactic reaction to a previous dose of flu vaccine Confirmed anaphylactic reaction to any component of the vaccine The live attenuated flu vaccine should not be given to children who are: Severely immunodeficient due to conditions or immunosuppressive therapy: Acute and chronic leukaemias Lymphoma HIV positive patient not on highly active antiretroviral therapy Cellular immune deficiencies High dose steroids Receiving salicylate therapy Known to have egg allergy 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 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®. There are no data on the use of live attenuated vaccine (Fluenz Tetra® in children with egg allergy and at the current time Fluenz Tetra® should not be given to children with an egg allergy. See Green Book Influenza chapter 19 and subsequent slide for specific detailed information about flu immunisation for egg allergic children Safety data for the live attenuated influenza vaccine (Fluenz Tetra®) is limited . Whilst there is no evidence of risk with live attenuated influenza vaccine, inactivated influenza 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 2014/15

Precautions to flu vaccines
DRAFT ONLY - Please see the disclaimer text on slide 1 Precautions to flu vaccines Acute severe febrile illness: 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 the vaccination may be deferred until they have recovered - this is to avoid confusing the differential diagnosis of acute illness by wrongly attributing the signs or symptoms as 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 vaccine2. The national flu immunisation programme 2014/15

Severe asthma or active wheezing
The live attenuated influenza vaccine (Fluenz Tetra®) is not recommended for those children: • with a history of active wheezing at the time of vaccination (until at least 7 days after wheezing has stopped) or • who are currently taking or have been prescribed oral steroids in the last 14 days or • who are currently taking a high dose inhaled steroid - Budesonide >800 mcg/day or equivalent* (e.g. Fluticasone > 500 mcgs/day) because of limited safety data in these groups * In children aged 5-12 years, the definition of severe asthma corresponds to the British Thoracic Society BTS Sign Step 5 The national flu immunisation programme 2014/15

Egg allergy Most flu vaccines are prepared from flu viruses grown in embryonated hens eggs and the final vaccine products contains varying amounts of egg (as ovalbumin) Fluenz Tetra® contains traces of egg and is therefore not suitable for children with any degree of egg allergy Patients with egg allergy should be immunised in primary care using either an egg-free flu vaccine (licensed from 18yrs of age) or an inactivated flu vaccine with an ovalbumin content less than 0.12 µg/ml (equivalent to µg for 0.5 mL dose) Vaccines with ovalbumin content more than 0.12 µg/ml or where content is not stated should not be used in egg-allergic individuals Ovalbumin content of flu vaccines is given in the Green Book Influenza chapter Patients with either confirmed anaphylaxis to egg or egg allergy and severe uncontrolled asthma should be referred to specialists for immunisation in hospital In recent years, inactivated influenza vaccines that are egg-free or have a very low ovalbumin content have become available and studies show they may be used safely in individuals with egg allergy30. Vaccines with ovalbumin content more than 0.12 μg/ml (equivalent to 0.06 μg for 0.5 ml dose) or where content is not stated should not be used in egg-allergic individuals. There are insufficient data on the use of the live attenuated vaccine (Fluenz Tetra®) in children with egg allergy and therefore, at the current time, Fluenz should not be given to children with any degree of egg allergy. Most children (under the age of 18 years) with egg allergy should be immunised in primary care 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). Children with either confirmed anaphylaxis to egg or with egg allergy and severe uncontrolled asthma should be referred to specialists for immunisation in hospital. The ovalbumin-free influenza vaccine Optaflu®, if available can be used in primary care patients from the age of 18 years, regardless of the severity of the allergy. If there is no egg-free vaccine available, adult patients with either confirmed anaphylaxis to egg or with egg allergy and severe uncontrolled asthma should be referred to specialists for immunisation in hospital. Other adult patients can be immunised in primary care 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). The national flu immunisation programme 2014/15

Risk of transmission of vaccine virus Theoretical potential for transmission of live attenuated virus to very severely immunocompromised contacts (e.g. bone marrow transplant patients requiring isolation) 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 individuals is likely or unavoidable (e.g. household members) consider an appropriate inactivated flu vaccine instead There is a potential for transmission of live attenuated influenza virus in Fluenz Tetra® to very severely immunocompromised contacts (e.g. bone marrow transplant patients requiring isolation) 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 exposed21. Where close contact with very severely immunocompromised patients (for example household members) is likely or unavoidable, appropriate alternative inactivated influenza vaccines should be considered. The national flu immunisation programme 2014/15

Exposure of healthcare professionals to live attenuated influenza vaccine (LAIV)
There may be some low level exposure to the vaccine viruses for those administering LAIV In the US, where there has been extensive use of LAIV, no reported instances of illness or infections from the vaccine virus among HCPs or immunocompromised patients 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 take reasonable precautions 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. 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 ever has 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 unknown but is probably low31. As a precaution, very severely immunosuppressed individuals should not administer live attenuated influenza vaccine. Other healthcare workers who have less severe immunosuppression or are pregnant, should take reasonable precautions to avoid inhaling the vaccine and ensure that they themselves are appropriately vaccinated2. The national flu immunisation programme 2014/15 The national flu immunisation programme 2014/15

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. The national flu immunisation programme 2014/15

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 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 As with all vaccines and other medicines registered healthcare practitioners and patients are encouraged to report suspected adverse reactions using the yellow card reporting scheme. All serious suspected reactions following influenza vaccines should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card scheme at The influenza vaccine Fluenz Tetra® and quadrivalent 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. The national flu immunisation programme 2014/15

Vaccine ordering General Practices are responsible for ordering sufficient flu vaccine for 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 delivery of the vaccine PHE has centrally procured both live and inactivated flu vaccine for all children aged from 6 months to less than 18 years old for children who are part of the extension of the programme (2,3,4yrs and pilots) and those children in clinical risk groups who are not part of the extension 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 ( General practices are responsible for ordering sufficient flu vaccine for eligible patients in 2014/15 directly from manufacturers, apart from children less than 18 years of age as this has been centrally procured. Ordering from more than one supplier is recommended in case of supplier delays or difficulties in delivery of the vaccine. Practices should also order appropriate vaccines for those with egg allergy. PHE has centrally procured both live and inactivated flu vaccine for all children aged from 6 months to less than 18 years old for children who are part of the extension of the programme (2,3,4yrs and pilots) and those children in clinical risk groups who are not part of the extension 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 More information about flu vaccine supply and ordering is available in Appendix H in the letter detailing the 2014/15 flu programme3 (available at: ) The national flu immunisation programme 2014/15

Inactivated Influenza Vaccine (TIV) for children contraindicated to receive Fluenz Tetra®
Children for whom Fluenz Tetra® is contraindicated should be offered a suitable alternative influenza 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 FluenzTetra ® can be found in the Green Book influenza chapter Fluarix Tetra® is the preferred vaccine for children aged three years and over who cannot receive Fluenz Tetra® For those children for whom Fluenz Tetra® is unsuitable, a suitable inactivated influenza vaccine should be offered. Some inactivated influenza vaccines have been associated with high rates of febrile convulsions (Fluvax by CSL marketed in the UK by Pfizer as Enzira® or CSL Biotherapies) or in children under five years of age in other countries. The SPC for Enzira® also indicates that an increased number of reports of fever were also 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 2014/15

Beware of product confusion!
Fluarix Tetra® is an inactivated vaccine licensed from three years of age that can be purchased for 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 Fluarix Tetra (quadrivalent inactivated influenza vaccine administered by injection) will also be available as one of the several flu vaccines that can be purchased locally for the rest of the flu vaccination programme – 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, 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’s 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 2014/15

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. As in previous years, flu vaccine uptake data collections will be managed using the ImmForm website ( Monthly data collections will take place over four months during the 2014/15 flu immunisation programme, starting in November for October’s uptake. These collections will enable performance to be reviewed at Area 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 2014/15 is available in Appendix J in the letter detailing the 2014/15 flu programme3 (available at: ) The national flu immunisation programme 2014/15

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 checklist3 highlights good practice and is based upon the findings from a study examining the factors associated with higher vaccine uptake in general practiceii. GP practices are encouraged to review their systems in the light of the checklist. 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 ( 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. Robust call and recall arrangements 6. Patients recommended to receive the flu vaccine will be directly contacted (for example through letter, , 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: 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 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. The national flu immunisation programme 2014/15

Achieving high uptake (GP Practice checklist cont’d)
6. Patients recommended to receive the flu vaccine should be directly contacted (e.g. letter, , 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 in the practice so 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 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, , 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: 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. 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 2014/15

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 Foundation 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 Some recommendations will apply to other areas where flu vaccine is given iDexter L 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/e 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 GP Practice Checklist is in Appendix D in the letter detailing the 2014/15 flu programme3 (available at: ) The national flu immunisation programme 2014/15

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 The national flu immunisation programme 2014/15

Resources Letter detailing 2014/15 flu programme: Department of Health, Public Health England, NHS England. The national flu immunisation programme 2014/ April Available at: to-2015 Green Book Influenza chapter updated July Available at: green-book Leaflets, posters, Q&As and other resources to support the annual flu programme Available at: A video for health professionals on how to administer the Fluenz Tetra® vaccine produced by NHS Education for Scotland is available at health/health-protection/seasonal-flu.aspx Summary of Product Characteristics (SPC) for flu vaccines are available at References Wilde JA, McMillan JA, Serwint J et al. (1999) Effectiveness of influenza vaccine in health care professionals: a randomised trial. JAMA 281: 908–13. Immunisation against infectious disease (‘the Green Book’) Chapter 19 ‘Influenza’. Updated July Available at: Department of Health, Public Health England, NHS England. The national flu immunisation programme 2014/ April Available at: Department of Health, Public Health England, NHS England. Childhood flu immunisation programme:update and provisional roll-out schedule. 15 July Available at: Neuzil KM, Reed GW, Mitchel EF et al. (1998) Impact of influenza on acute cardiopulmonary hospitalizations in pregnant women. Am J Epidemiol. 148: Pebody R et al. (2010) Pandemic influenza A (H1N1) 2009 and mortality in the United Kingdom: risk factors for death, April 2009 to March Eurosurveillance 15(20): Pierce M, Kurinczuk JJ, Spark P et al. (2011) Perinatal outcomes after maternal 2009/H1N1 infection: national cohort study. BMJ. 342: d3214. 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. 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) e iBenowitz 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: 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: Zaman K, Roy E, Arifeen SE et al. (2008) Effectiveness of maternal influenza immunisation in mothers and infants. N Engl J Med. 359: 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. Tamma PD, Ault KA, del Rio C, Steinhoff MC et al. (2009) Safety of influenza vaccination during pregnancy. Am. J. Obstet. Gynecol. 201(6): Joint Committee on Vaccination and Immunisation. JCVI statement on the annual influenza vaccination programme – extension of the programme to children. 25 July Available at: 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. 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. 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: /bmj 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: 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): 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): 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): Osterholm, M. T., Kelley, N. S., Sommer, A., and Belongia, E. A. (2012) Efficacy and effectiveness of influenza vaccines: a systematic review and meta-analysis (1. 1), 36-44The Lancet Infectious Diseases Public health England. Childhood flu immunisation programme from September 2014 to 2015: information for parents and schools. July Available at: Allison MA Daley MF, Crane LA et al. (2006) Influenza vaccine effectiveness in healthy 6 to 21 month-old children during the season. The Journal of Pediatrics 149: 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): 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: 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: Immunisation against infectious disease (‘the Green Book’) Chapter 6 ‘Contraindications and special considerations ’. Updated January Available at: 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): Centers for Disease Control and Prevention (2012) Persons Who Should Not Be Vaccinated Influenza Prevention and Control Recommendations. The national flu immunisation programme 2014/15

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