Childhood influenza vaccination programme

Transcription

1 Childhood influenza vaccination programme Questions and Answers Background In 2012 the Joint Committee on Vaccination and Immunisation (JCVI) recommended that the seasonal influenza (flu) programme should be extended to all children aged 2 to 16 years. 1 In Wales, there is an annual vaccination programme which aims to reduce the impact (morbidity and mortality) of flu particularly in high risk groups e.g. those aged 65 and over or in clinical risk groups. The flu vaccine programme for children will be rolled out gradually over several years and the age groups offered flu vaccine will expand each year until the programme is fully implemented. In September 2016 the seasonal flu vaccination programme will include all children aged 2-7 years old (age on 31 August 2016). 2 Why vaccinate children? Extending the current flu vaccination programme to more children aims to lower the public health impact of flu by: providing direct protection to children thus reducing a large number of cases of flu in children; reducing the risk of children spreading flu to other children, family and friends, this may include people at increased risk of flu complications due to age, pregnancy or those in the clinical risk groups of any age. This will prevent many cases of severe flu disease and flu-related deaths that mostly occur in older adults and those of any age with clinical risk factors. It is estimated that up to 1 in 10 children present to their GP with flu each year. 3 Death from influenza is uncommon in children. However it is estimated around 50 children died from flu each year in England between Around 40% of these children did not have any risk factors for flu. 4 For children with some pre-existing medical conditions, getting flu can be very serious as it is likely to make their condition much worse. Studies suggest that, despite the high cost, extending the flu vaccination programme to children is highly likely to be cost effective and well below the established cost effectiveness threshold when indirect protection to the whole population is taken into account, particularly over the longer-term Public Health Wales 1

2 What is Influenza? Influenza, more commonly known as flu, is a highly infectious acute respiratory illness, affecting the lungs and airways, and is the result of an infection caused by an influenza virus. Flu viruses are usually spread in the small droplets of saliva coughed or sneezed into the atmosphere by an infected person. Direct contact with hands or surfaces contaminated with the virus can also spread infection. The incubation period is 1-5 days (average 2-3 days) though it may be longer especially in children and immunocompromised people. There are 3 types of influenza viruses: Type A - Causes epidemics and pandemics. This virus is also found in many different animals and may spread between them. This is mainly in wildfowl and pigs but it also carried by other mammals Type B - May cause epidemics. Predominantly found in humans Type C Causes minor respiratory illness only Who is does it affect? Flu can affect anyone but is a more likely to cause complications and be a serious illness in neonates, pregnant women, older people and those with underlying disease. What are the features of Flu? In healthy individuals it is usually an unpleasant but self limiting illness with recovery within 5-7 days. Common symptoms include sudden onset of fever, chills, headache, myalgia (muscle aches) and severe fatigue. Sufferers can also experience a dry cough, sore throat and stuffy nose. In young children gastrointestinal symptoms such as vomiting and diarrhoea are common. Possible complications of Flu Common complications may include bronchitis, otitis media (middle ear infection) especially in children, and sinusitis. Less common complications include secondary bacterial pneumonia, meningitis, encephalitis and primary influenza pneumonia Public Health Wales 2

3 Extension of seasonal flu vaccination programme to children Types of vaccines There are two main types of flu vaccine: Live attenuated influenza vaccine (LAIV), a nasal spray vaccine, is the vaccine of choice as this is more effective in children Inactivated vaccine given by injection for those unable to receive LAIV due to clinical contraindications Use of LAIV The flu vaccine being used for most children in the UK is Fluenz Tetra. This is a live attenuated cold-adapted intranasal (nasal spray) influenza vaccine (LAIV). It contains a weakened form of the virus to protect against flu, which cannot cause disease. Being cold-adapted it cannot multiply at normal body temperature in the lungs. Fluenz Tetra is licensed from 24 months to 17 years of age (inclusive). As LIAV is a live vaccine not all children are able to receive it, this is covered later in this resource (under contraindications). For children in whom LAIV is clinically contraindicated, an inactivated flu vaccine by injection will be offered as an alternative. How is the children s flu programme being rolled out in Wales? The following children will be offered the flu vaccine in 2016/17: all children aged two or three years old on 31 August 2016 (children born from 1 September 2012 to 31 August 2014) will be offered vaccination through their GP surgery all children in reception class, year 1, year 2 or year 3 in primary school in September 2016 will be offered vaccination as part of a school based programme children with a date of birth from 31 August 2012 to 1 September 2008 who do not attend a school where school based flu immunisation is offered can obtain their vaccine from their GP surgery. This includes a small number of four year olds who may not have started school, some independent schools and home schooled children It is anticipated that the programme will be extended over the coming years to include other age groups Public Health Wales 3

4 Why are only some children being offered the vaccine now? The childhood flu vaccination programme is being phased in gradually so that adequate local arrangements can be put in place for annual vaccination of children. Two to seven year olds are being offered flu vaccine as younger children are more vulnerable to flu and are more likely to require hospital admission. Is Wales the only country introducing the childhood flu vaccination programme? The childhood flu vaccination programme is being introduced throughout the United Kingdom (UK) but until the programme is fully in place the implementation of the programme will differ in each home country. In 2016 all two to seven year olds are included in the programme universally across the UK. Is LAIV more effective for children than injectable flu vaccine? LAIV provides greater protection for children than existing inactivated flu vaccines particularly against flu B strains and studies have shown that the vaccine may also provide additional cross protection against other flu strains. 6 Is LAIV safe? LAIV nasal spray flu vaccines have been used in USA for many years, and have been used in the UK since Millions of doses have been given and it has a good safety profile in children aged 2 years and older. Parents, children and nurses prefer the nasal spray vaccine to the injectable vaccine. The vaccine cannot cause flu. How should LAIV be stored? LAIV must be stored in accordance with the manufacturer s instructions maintaining the cold chain. LAIV should be stored in a refrigerator between +2 C and +8 C in the original packaging. Do not freeze. Protect from light. Before use, LAIV may be taken out of the refrigerator, for a maximum period of 12 hours at a temperature not above +25 C. If the vaccine has not been used after this 12 hour period, it should be disposed of. LAIV has an expiry date 18 weeks after manufacture this is much shorter than inactivated influenza vaccines. Expiry dates should be checked regularly and any expired vaccine disposed of according to local policy Public Health Wales 4

5 How many doses are required? Children not in clinical risk groups only require one dose of this vaccine. A single dose of Fluenz Tetra LAIV is 0.2ml (administered as 0.1ml per nostril). The marketing authorisation holder s Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL) state that all children under nine years old receiving flu vaccine for the first time require two doses, with second at least four weeks after the first. The JCVI have considered this issue and have advised that for children who are not in a clinical risk group, a single dose of Fluenz Tetra LAIV is recommended because one dose is highly effective. Healthcare practitioners are reminded that in some circumstances the recommendations regarding vaccines given in the Green Book 7 may differ from those in the SPC for a particular vaccine. When this occurs, the recommendations in the Green Book are based on current expert advice received from the JCVI and this advice should be followed. The Green Book recommendations and/or further advice from the Department of Health is reflected in the template LAIV Patient Group Direction (PGD). Children aged from 2 years to less than 9 years, who are in clinical at risk groups, who have not received seasonal influenza vaccine before should receive two doses of LAIV with the second dose at least 4 weeks after the first. How is LAIV given? LAIV is administered by the nasal route and is supplied in an applicator that allows a divided dose of to be administered in both nostrils (total dose of 0.2ml) with 0.1ml in each nostril. What happens if the child sneezes, blows their nose or has nasal dripping following administration? Administration of either dose does not need to be repeated. Reassurance should be given that the vaccine will still be effective if any of these occur. Does LAIV contain latex? There is no latex in the raw materials of LAIV or in any components of the applicator. 8 The vaccine is supplied in a single use nasal applicator (type 1 glass), with nozzle (polypropylene with polyethylene transfer valve), nozzle tipprotector (synthetic rubber), plunger rod, plunger stopper (butyl rubber) and dose divider clip. Does LAIV contain thiomersal? No, LAIV does not contain any thiomersal Public Health Wales 5

6 Does LAIV contain gelatine? Yes. LAIV contains gelatine that comes from pork (porcine gelatine). Gelatine is commonly used in a range of medicines, including many capsules and some other vaccines. The gelatine used in LAIV is a highly purified product used to stabilise this live vaccine. For children who are not in an at risk group an alternative vaccine is not available in NHS Wales. LAIV is the recommended vaccine for the childhood influenza vaccination programme as it provides the greatest protection for children in the recommended age groups. 6 7 What is the view of faith communities? Public Health England has consulted with the Kashrut and Medicines Information Service, who said It should be noted that according to Jewish laws, there is no problem with porcine or other animal derived ingredients in non-oral products. This includes vaccines, including those administered via the nose, injections, suppositories, creams and ointments. 9 However it is acknowledged that there is diversity within the British Muslim and Jewish communities and they, and some other groups, may consider medicines and vaccines containing porcine products to be forbidden. In these circumstances it is likely that the individual would be unable to accept many pharmaceutical products unless there was no alternative or the product was considered life-saving. 9 What are the recommendations for children who have an egg allergy? Apart from children who have needed intensive care following a severe allergic reaction to eggs, who should be referred to specialist hospital services for vaccination, LAIV can safely be given to those with allergy to egg or egg proteins in any setting including schools and primary care. 7 Can LAIV be administered at the same time as other vaccines? LAIV can be given at the same time as other vaccines or with any interval between different vaccines including other live vaccines. Can LAIV be administered with antiviral agents? There is a potential for flu antiviral agents (such as osetamivir) to lower the effectiveness of LAIV. Therefore influenza antiviral agents and LAIV should not be administered at the same time. LAIV should not be administered within 48 hours after stopping treatment with flu antiviral agents. Administration of flu antiviral agents within two weeks of administration of LAIV may adversely affect the effectiveness of the vaccine Public Health Wales 6

7 What are the contraindications to LAIV? LAIV should not given to a person who: is under 24 months or over 17 years of age has had a confirmed anaphylactic reaction to a previous dose of flu vaccine has had a confirmed anaphylactic reaction to any component of the vaccine has previously needed intensive care following a severe allergic reaction to eggs or egg products is clinically severely immunocompromised 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. have severe asthma or active wheezing defined as: o history of active wheezing at the time of vaccination or in the previous 72 hours (reassess after 72 hours) o Increased use of bronchodilators in previous 72 hours (reassess after 72 hours) o currently taking or have been prescribed oral steroids in the last 14 days o currently taking a high dose inhaled steroid Budesonide >800mcg day or equivalent (e.g. Fluticasone >500 mcg/day) because of limited safety data in these groups.7 is receiving salicylate (including aspirin) therapy is pregnant Chapter 6 of the Green Book 7 on Contraindications and special considerations gives further advice on the use of live vaccines in individuals who are severely immunosuppressed. In cases of contraindication such as immunosuppression, severe asthma, wheezing at time of immunisation, pregnancy or salicylate therapy, consideration should be given to the use of inactivated (i.e. injectable) flu vaccine. LAIV is not contraindicated for use in children or adolescents with HIV infection receiving stable antiretroviral therapy; or who are receiving topical/inhaled corticosteroids (less than 800mcg/day Budesonide or equivalent) or low-dose systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency. There are very few individuals who cannot receive any flu vaccine. When there is any doubt, appropriate advice should be sought from an immunisation 2016 Public Health Wales 7

8 coordinator or other appropriate person such as a GP or a specialist caring for the child rather than withholding vaccination. Can LAIV be given when the child has a blocked or runny nose? There are no data on the effectiveness of LAIV when given to children with a heavily blocked or heavily runny nose caused by infection or allergy (rhinitis). 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 intramuscularly administered flu vaccine should be considered. The vaccine will still work in those with a simple runny nose or those who sneeze straight after it. Can LAIV be given in pregnancy? No. Inactivated flu vaccines should be given instead to those aged under 18 years who are pregnant. However, there is no need to specifically test girls for pregnancy or to avoid pregnancy in those who have been recently vaccinated. What if the child is unwell on the day of vaccination? If the child has an acute febrile illness, LAIV administration should be deferred until recovered. Minor illnesses without fever or systemic upset are not valid reasons to postpone vaccination. If the child has already had influenza infection should they still receive the vaccine? If a child has had confirmed or suspected influenza they should still receive flu vaccine as scheduled, to provide protection against other strains of the influenza virus. Although if the child is still unwell with an acute febrile illness, administration should be deferred until the child has recovered. As LAIV is a live vaccine, can people who have had it then pass flu on to others? There is the potential for transmission of live attenuated virus to very severely immunocompromised contacts (e.g. bone marrow transplant patients requiring isolation). The risk is for the period of one to two weeks following vaccination. Where close contact is likely or unavoidable (e.g. household members) consideration should be given to using inactivated flu vaccine. Can healthcare staff in clinical risk groups administer the vaccine? There may be some inadvertent low level exposure of those administering LAIV to the vaccine viruses. In the US, where there has been extensive use of LAIV, there have been no reported instances of transmission of vaccine virus in healthcare settings or of illness or infections from the vaccine virus among those 2016 Public Health Wales 8

9 healthcare practitioners inadvertently exposed. Thus, the Centers for Disease Control and Prevention (CDC) has considered that the risk of acquiring vaccine viruses from the environment is unknown but is probably low. 7 The vaccine viruses are cold-adapted and attenuated, and are unlikely to cause symptomatic flu. However, as a precaution, very severely immunosuppressed individuals should not administer LAIV. Other healthcare workers who are immunosuppressed or pregnant, should follow normal clinical practice to avoid inhaling the vaccine and ensure that they themselves are appropriately vaccinated. How will the practice or school nurse recognise if someone is severely immunocompromised? An individual may be considered severely immunocompromised if they fall into one of the following groups: treated within the last 6 months with immunosuppressive drugs, chemotherapy or radiotherapy acute or chronic leukaemia lymphoma HIV positive but not on highly active antiretroviral therapy cellular immune deficiencies taken high dose systemic steroids within the last 3 months 7 bone marrow transplant until 12 months after finishing treatment What are the potential side effects of LAIV? LAIV has a similar adverse reaction profile to inactivated flu vaccines. Nasal congestion/runny nose (rhinorrhoea), reduced appetite, muscle aches, tiredness and headache are common adverse reactions following administration of LAIV. Immediate reactions such as urticaria, angioedema, bronchospasm and anaphylaxis can occur rarely. All health care practitioners responsible for vaccination are trained to recognise and treat anaphylaxis. What should be done if an individual experiences a side effect? As with all vaccines and other medicines, healthcare practitioners and patients are encouraged to report suspected adverse reactions using the yellow card reporting scheme at Fluenz Tetra LAIV is a black triangle medicine, which requires a lower threshold for reporting any suspected adverse effects Public Health Wales 9

10 What if LAIV is clinically contraindicated? As LAIV is a live vaccine not all children are able to receive it. Where LAIV is not suitable due to a clinical contraindication or precaution, children may be offered inactivated flu vaccine, this is an injection. The preferred site for this injection is the deltoid region of the upper arm in children over 1 year. Some inactivated flu vaccines are restricted to use in particular age groups. Practitioners must be familiar with and refer to the SPC for individual brands when administering inactivated flu vaccines. The most common adverse reactions following a flu vaccine injection are injection site reactions, otherwise inactivated flu vaccines have a similar adverse reaction profile to LAIV. Any side effects usually disappear after one or two days. How many doses of inactivated flu vaccine are required? When a child cannot receive LAIV due to a clinical contraindication where the child is aged less than 9 years and has never received any seasonal flu vaccine before, they should receive two doses of inactivated flu vaccine with the second dose at least 4 weeks after the first dose. One dose is sufficient in children aged 9 years or older. Where can I get further information? Immunisation against infectious disease, Influenza: the Green Book, Chapter 19. Available at: [accessed 07 July 2016] Immunisation against infectious disease, Contraindications and special considerations: the Green Book, Chapter 6. Available at: [accessed 21 June 2016] WHC (2016)039 The National Influenza Programme [accessed July Aug 2016] Fluenz Tetra Patient Information Leaflet (PIL) [accessed 7 July 2016] Fluenz Tetra Summary of Product Characteristics (SPC) [accessed 7 July 2016] 2016 Public Health Wales 10

11 References: 1 Joint Committee on Vaccination and Immunisation (2012) Minute of meeting held on 13 June [Online]. Available at: revised.pdf [accessed: 21 June 2016] 2 Welsh Government (2016) WHC (2016)039 The National Influenza Programme Cardiff: Welsh Government. [Online]. Available at: [accessed: 04 Aug 2016] 3 Paget WJ, Balderston C, Casas I, Donker G, Edelman L, Fleming D, et al(2010) Assessing the burden of paediatric influenza in Europe: the European Paediatric Influenza Analysis (EPIA) project. European Journal of paediatrics 169(8): Pebody RG, McLean E, Zhao H, Cleary P, Bracebridge S, Foster K, 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). [Online]. Available at: [accessed: 21 June 2016] 5 Pitman RJ, Nagy LD, Sculpher MJ (2013) Cost-effectiveness of childhood influenza vaccination in England and Wales: Results from a dynamic transmission model. Vaccine 31(6): Joint Committee on Vaccination and Immunisation (2012) JCVI statement on the annual influenza vaccination programme extension of the programme to children 25 July 2012, key point 8. [Online]. Available at: e/224775/jcvi-statement-on-the-annual-influenza-vaccination-programme-25- July-2012.pdf [accessed: 21 June 2016] 7 Public Health England (2015) Immunisation against infectious disease: the Green Book. [Online]. Available at: [accessed: 21 June 2016] 8 AstraZeneca Medical Information UK (2013) Personal communication , 12 September Welsh Government (2016) Vaccines and porcine gelatine. Available at: [accessed: 21 June 2016] 2016 Public Health Wales 11

12 This Question and Answer document was first developed by NHS Education for Scotland and has been amended for use in Wales by the Vaccine Preventable Disease Programme, Public Health Wales. Material contained in this document may be reproduced without prior permission provided it is done so accurately and is not used in a misleading context. Acknowledgement to Public Health Wales to be stated Public Health Wales 2016 Public Health Wales 12