Break the flu cycle: Regional meeting
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London Break the flu cycle: Regional meeting Chaired by Dr George Kassianos 30 October 2017 10:00–12:30 CPD accredited This meeting has been organised and funded by Seqirus UK Ltd. Prescribing Information for surface antigen, inactivated, influenza vaccine adjuvanted with MF59C.1 can 1 be found at the end of this presentation. UK/FLUD/0817/0016ap | October 2017
Meeting objectives Discuss how to raise awareness and address the burden of influenza for adults aged 65 years and over with key decision makers in primary healthcare Share knowledge on the influenza environment: discussing how to implement a best-practice local influenza vaccination programme to improve outcomes Introduction copy Explore the use and effectiveness of current vaccines when considering the guidance and recommendations from appropriate professional bodies Support the professional development of attendees through engaging plenary sessions and interactive workshops 2
Agenda Time Session Speaker 10:00–10:15 Starting the cycle Dr George Kassianos 10:15–10:30 The burden of flu Pauline MacDonald 10:30–10:45 Personalising vaccination care Dr Roger Henderson Dr George Kassianos 10:45–11:15 How do we break the cycle? Dr Roger Henderson Pauline MacDonald 11:15–11:30 copy Introduction Break Workshop sessions 11:30–12:10 1. Best practice: Interactive case study Dr Roger Henderson 2. Practical guidance on adult influenza vaccination Dr George Kassianos Dr George Kassianos 12:10–12:20 Summary of key learnings and faculty questions Dr Roger Henderson Pauline MacDonald 12:20–12:30 Closing remarks Dr George Kassianos 12:30 Lunch 3
Questions During the course of the meeting, questions can be submitted in two ways: • Raise your hand and a microphone Introduction copy will be brought to you • Fill in one of the question cards provided and hand it to one of the meeting organisers 4
Before we start Mobile phones Please make sure your mobile is switched off Fire alarms and location of emergency exits No tests are planned today Introduction Evaluation copy forms Please complete your evaluation forms provided via an email link Certificate of attendance/CPD Will be provided after the meeting via an email link, please use this to obtain 3 CPD credits from the Federation of the Royal Colleges of Physicians Reasonable travel expenses An email link will be provided after the meeting 5
Public Health England: Leading causes of death in England, 2015 Males (% of all male deaths) Females (% of all female deaths) Dementia and Alzheimer’s 1 Heart disease 14% 15% disease 2 Dementia and Alzheimer’s disease 8% Heart disease 9% 3 Lung cancer 7% Stroke 8% 4 Chronic lower respiratory disease 6% Influenza and pneumonia 6% Introduction 5 Stroke copy 6% Chronic lower respiratory disease 6% 6 Influenza and pneumonia 5% Lung cancer 5% 7 Prostate cancer 4% Breast cancer 4% 8 Colorectal cancer 3% Colorectal cancer 2% Kidney disease and other 9 Leukaemia and lymphomas 3% 2% diseases of the urinary system 10 Cirrhosis and other liver disease 2% Leukaemia and lymphomas 2% 6 Public Health England. Chapter 2: major causes of death and how they have changed. Accessed from: https://www.gov.uk/government/publications/health-profile-for-england/chapter-2-major-causes- of-death-and-how-they-have-changed. Accessed October 2017.
Pathogens detected in patients with radiographic community-acquired pneumonia EPIC study, Centers for Disease Control Human rhinovirus Influenza Streptococcus Streptococcus pneumoniae pneumoniae Human metapneumovirus Respiratory syncytial virus Parainfluenza viruses Introduction copy Other Gram negatives Coronaviruses Mycoplasma Mycoplasma pneumoniae pneumoniae Staphylococcus Staphylococcusaureus aureus Adenovirus Legionella Streptococcus spp Other 0 20 40 60 80 100 120 140 160 180 200 7 Wunderink RG, Waterer G. BMJ 2017;358:bmj.j2471.
Seasonal influenza activity summary in different climate areas Travel medicine NORTHERN HEMISPHERE Influenza peak: November–March Introduction copy TROPICS Year-round activity SOUTHERN HEMISPHERE Influenza peak: April–September 8 Cox NJ, Subbarao K. Annu Rev Med. 2000;51:407-421.
Starting the cycle Dr George Kassianos MD (Hons), FRCGP, FESC, FBGTHA, FFTM RCPS (Glasg), FBHS, FHEA, FAcadMEd, DRCOG, LRCP (Edin.), LRCS (Edin.), LRCP&S (Glas.), DMedAcup., DMedHypn., DFP. 9
Disclosures • Dr George Kassianos is BGTHA President and RCGP National Immunisation Lead • He has participated in advisory boards or lectured at meetings organised by Sanofi Pasteur, MSD, Seqirus, Pfizer, AZ and Valneva Introduction copy • Chair of RAISE Pan-European influenza committee 10
All adults and the elderly population get the same vaccine… However, vaccine effectiveness has been observed to differ considerably among ages and is lowest in the elderly! How do we break the current flu cycle? Autumn Practice orders TIV or QIV Introduction copy Autumn/Winter Spring Pharmacists and PHE issues Practices vaccinate the Flu Plan September Spring/Summer Influenza JCVI/PHE reports vaccines arrive vaccine effectiveness 11 CI, confidence interval; PHE, Public Health England; TIV, trivalent influenza vaccine; QLAIV, quadrivalent live attenuated influenza vaccine.
Lower effectiveness of the 2014–2015 influenza vaccine due to A(H3N2) drift Circulating A(H3N2) and B strains genetically and antigenically drifted against the 2014–2015 seasonal flu vaccine for the northern hemisphere Vaccine effectiveness (VE) Adjusted VE 95% CI Any influenza 34% 18–48 Influenza A(H3N2) Introduction copy 29% 9–45 Influenza due to B strain 46% 14–67 VE for
QLAIV overall effectiveness among children 2–17 years in 2015–2016 influenza season Vaccine effectiveness Adjusted QLAIV Against: 95% CI effectiveness Any influenza 58% 25–76 Influenza A (H1N1) pdm09* 42% 9–69 Introduction copy Influenza due to B strains* 81% 40–94 *The 2015–2016 season in the UK was initially dominated by influenza A(H1N1)pdm09 and then influenza of B/Victoria lineage. 13 CI, confidence interval; QLAIV, quadrivalent live attenuated influenza vaccine. Pebody R et al. Euro Surveill. 2016;21:pii=30348.
UK vaccine effectiveness in 65 years and over age group Adjusted influenza vaccine effectiveness (VE) against medically-attended laboratory-confirmed influenza by age group and influenza type in 2016/17, UK1,2 A(H3N2) adjusted* VE Flu B adjusted VE Flu A and B Population (95% CI) (95% CI) adjusted VE (95% CI) 2 – 17 years† 57 (8, 80) 79 (-86, 98) 66 (30, 83) 18 – 64 years 37 (10, 55) 52 (-20, 81) 41 (19, 56) Introduction copy ≥65+ years -68 (-249, 19) 17(-250, 80) -6 (-95, 42) All ages 32 (10, 48) 55 (11, 77) 40 (23, 53) *Adjusted for age-group, sex, month, pilot area and surveillance scheme; † LAIV only. CI, confidence interval, ICU, intensive care unit; JCVI, Joint Committee on Vaccination and Immunisation LAVI, live attenuated influenza vaccine; VE, vaccine effectiveness. 1. JCVI minute of the meeting on 7 June 2017. Draft minute. Available at: https://app.box.com/s/iddfb4ppwkmtjusir2tc/file/198733240440. Accessed September 2017. 14 2. Public Health England. Influenza vaccine effectiveness. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/641162/Influenza_vaccine_effectiveness_in_primary_care_1617_final.pdf Accessed October 2017.
JCVI opinion is that the current influenza vaccine effectiveness for adults ≥65 years is disappointing1 • A downward trend in vaccine efficacy against influenza A(H3N2) has been observed over recent years1–4 - Immunosenescence could be an important factor in the reduced effectiveness being seen •Introduction This contrasted copywith higher A(H3N2) effectiveness in younger adults • Additional benefit for vaccine effectiveness was however, seen from the use of the QIV vaccine for the childhood influenza vaccination programme • The over 65 year old population component of the influenza programme will be considered during the October 2017 JCVI meeting JCVI, Joint Committee on Vaccination and Immunisation; TIV, trivalent influenza vaccine; QIV, inactivated quadrivalent influenza vaccine. 1. JCVI minute of the meeting on 7 June 2017. Draft minute. Available at: https://app.box.com/s/iddfb4ppwkmtjusir2tc/file/198733240440. Accessed October 2017; 2. Belongia EA, et al. Lancet Infect Dis 2016;16:942–51; 3. Kissling E, et al. Euro Surveill. 2017;22:pii=30464; 4. Public Health England. Influenza vaccine effectiveness in adults and children in primary care in the UK: provisional end-of- 15 season results 2016–17. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/641162/Influenza_vaccine_effectiveness_in_primary_care_1617_final.pdf. Accessed October 2017.
National uptake of free influenza vaccine in eligible UK population Flu season ≥ 65s
The burden of flu Pauline MacDonald Independent Nurse Consultant – Infection Matters Ltd 17
Disclosures • Pauline MacDonald has received an honorarium from Seqirus for her time spent preparing this presentation • She has received honoraria in the past from pharmaceutical companies including Sanofi Pasteur and MSD • Thanks to Public Health England for some of the data and figures included in this Introduction copy presentation 18
What this talk will cover: Objectives • Revision of flu the disease and virus • Challenges for flu immunisation and control • Epidemiology and burden of influenza - Particularly in the 65 years and over age-group Introduction copy 19
Influenza – Features • Transmission:1 – Airborne droplets – Articles such as handkerchiefs contaminated by nasopharyngeal secretions • Incubation: ~2 days2 • Virus shed: 5–10 days Introduction copy • Symptoms: Fever, headache, myalgia, fatigue, cough, sore throat, stuffy nose, diarrhoea and vomiting3, no symptoms4 • Complications: Bronchitis, otitis media, pneumonia, meningitis, organ failure, death2,3 1. Centers for Disease Control and Prevention. Clinical signs and symptoms of influenza. Available at: https://www.cdc.gov/flu/professionals/acip/clinical.htm. Accessed October 2017; 2. World Health Organization. Biologicals, Influenza. Available at: 20 http://www.who.int/biologicals/vaccines/influenza/en/. Accessed October 2017; 3. Dasaraju PV, Liu C. Chapter 93 Infections of the Respiratory System. Medical Microbiology 4th edition. 1996; 4. Hayward AC, et al Lancet Respir Med 2014;2:430-431.
Influenza is a single-stranded, helical RNA virus of the orthomyxovirus family What causes influenza? • There are four basic antigen types:1 – A – Multiple strains – B – Two lineages: Victoria and Yamagata – C and D – Not clinically relevant in humans •Introduction Influenza Acopy virus subtypes are determined by their surface antigens in human cells:2–4 – Haemagglutinin (HA): Virus attachment – Neuraminidase (NA): Virus release Hemagglutinin Neuraminidase • 18 “H” subtypes and 11 “N” subtypes 1. World Health Organization. Influenza (Seasonal). Fact sheet. Available at: http://www.who.int/mediacentre/factsheets/fs211/en/. Accessed October 2017; 2. World Health Organization. Biologicals, 21 Influenza. Available at: http://www.who.int/biologicals/vaccines/influenza/en/. Accessed October 2017; 3. Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/flu/avianflu/influenza-a-virus-subtypes.htm. Accessed October 2017; 4. World Health Organization memorandum Bulletin of the World Health Organization 1980;58:585-591.
Influenza is a single-stranded, helical RNA virus of the orthomyxovirus family Type of Hemagglutinin Neuraminidase nuclear material Introduction copy A/Fujian/411/2002 (H3N2) Virus Geographic Strain Year of Virus type location number isolation subtype Standard nomenclature for isolated influenza viruses1 22 1. World Health Organization memorandum Bulletin of the World Health Organization 1980;58:585-591.
Since 1977 influenza A (H1N1 and H3N2), and influenza B have been in circulation Influenza A is the most common circulating virus, however influenza can be unstable and can undergo changes via antigenic drift/shift • Flu A strains are more prone to drift/shift than ‘more stable’ B strains • New influenza virus subtypes due to Human antigenic drift and shift (re-assortment) influenza virus •Introduction New influenza copy subtypes increase potential of epidemics or pandemics – people have little or no protective immunity New virus that • Even minor changes can present Pig infected with both has evolved by genetic re- a challenge for vaccine matching viruses assortment Avian (antigenic shift) influenza virus • So why is all this important?.... 23 World Health Organization. Biologicals, Influenza. Available at: http://www.who.int/biologicals/vaccines/influenza/en/. Accessed October 2017.
Challenges for flu immunisation and control Growing concern of low vaccine efficacy (VE) against influenza A(H3N2)1–3 • Influenza A(H3N2) disproportionately affects the elderly1 • 2016–17 (provisional) end-of-season vaccine effectiveness estimates showed no significant effectiveness in ≥65 year olds3,4 - Thesecopy Introduction results highlight the importance of effective vaccination interventions to protect the elderly population • It is important to consider immunosenescence as a factor when vaccinating ≥65 year olds *Provisional data. 1. Belongia EA, et al. Lancet Infect Dis 2016;16:942–51; 2. Kissling E, et al. Euro Surveill. 2017;22:pii=30464; 3. JCVI minute of the meeting on 7 June 2017. Draft minute. Available at: 24 https://app.box.com/s/iddfb4ppwkmtjusir2tc/file/198733240440. Accessed October 2017; 4. Public Health England. Provisional end-of-season results 2016-17. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/641162/Influenza_vaccine_effectiveness_in_primary_care_1617_final.pdf. Accessed October 2017.
Immune response is lower in elderly due to immunosenescence Immunosenescence: The effects of ageing on the immune system Waning immunity with age (immunosenescence)1 and comorbidities (chronic diseases) Reduced immune Increased susceptibility to response to infection and and severity of infection1 Introduction copy vaccination1 Increased risk of hospitalisation2 Greater risk of disability3 Reduced quality of life3 Increased mortality rate3,4 25 1. Gavazzi G, Krause K-H. Lancet Infect Dis 2002;2:659–66; 2. Thompson WW, et al. JAMA 2004;292:1333–40; 3. McElhaney JE. Vaccine 2005;23:S10–S25; 4. Thompson WW, et al. JAMA 2003;289:179–86.
Influenza epidemiology: 2016–2017 Weekly all age GP influenza-like illness rates for 2016–2017 and past seasons, England (RCGP) 140 • Influenza activity usually between 130 September to March 120 110 • Impact of influenza varies from 100 90 year to year 80 70 • Biggest impact in 2016/17 in older Introduction 60 copy adults: 50 40 • Increased care homes 30 outbreaks, and excess mortality 20 seen in ≥65 year olds 10 0 40 42 44 46 48 50 52 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 • High number of admissions to Week number hospital and ICU/HDU admissions* 2010-11 2014-15 2015-16 2016-17 Baseline threshold Low Medium High Very high *although lower than in past two seasons. HDU, high dependency; IDU, intensive care unit; ILI, influenza-like illness; RCGP, Royal College of General Practitioners. 26 Public Health England (PHE) Surveillance of influenza and other respiratory viruses in the UK: Winter 2016 to 2017 [Online]. PHE, London. Available at: https://www.gov.uk/government/statistics/annual-flu-reports. Accessed October 2017.
Complications associated with influenza in the elderly Influenza-like illness can increase Influenza-like illness can the risk for other diseases exacerbate underlying conditions Stroke1 and Myocardial Heart Disease4 infarction2 Introduction copy COPD5 and Pneumonia3 Asthma6 Image: Tsyhun/Shutterstock.com. COPD, chronic obstructive pulmonary disease. *In patients vaccinated with trivalent influenza virus vaccine with or without intranasal live-attenuated, cold-adapted influenza vaccine. 1. Field TS, et al. Neuroepidemiology 2004;23:228–35; 2. Warren-Gash C, et al. Lancet Infect Dis 2009;9:601–10; 3. Rothberg MB, et al. Am J Med 2008;121:258–64; 4. Madjid M, et al. 27 Tex Heart Inst J 2004;31:4‒13; 5. Neuzil KM, et al. Clin Infect Dis 2003;36:169‒74; 6 Centers for Disease Control and Prevention. Flu and people with asthma. Available at: http://www.cdc.gov/flu/asthma/. Accessed October 2017.
Immunisation recommendations for the elderly In 2000, the JCVI recommended influenza vaccination for over 65 year olds1 • The over 65 population are more vulnerable to morbidity and mortality caused by influenza due to immunosenescence2,3 • In October 2017 JCVI have reviewed the influenza vaccination programme for the over 65 population1 - Review needed due to poor vaccine effectiveness, recent dominance of A(H3N2) Introduction copy with high morbidity and mortality in the elderly, new vaccines entering the market - Minutes of the meeting will be available mid-November 28 1. JCVI minute of the meeting on 7 June 2017. Draft minute. Available at: https://app.box.com/s/iddfb4ppwkmtjusir2tc/file/198733240440. Accessed September 2017. 2. Baguelin M, et al. PLoS Medicine 2013;10:e1001527; 3. Silva DAA, Palmer DB. Immunology 2007;120:435–46.
Summary: Think about your adults aged 65 and over1–5 Many factors contribute to increased risk of flu in adults aged 65 years and over: Sub-optimal Increased Age-related effectiveness incidence of IMMUNO of current co-morbidity SENESCENCE Introduction copy vaccines In adults aged 65 years and over: there are much higher rates of preventable influenza-related complications, including GP consultations, hospitalisations and death. 29 1. Gavazzi G, et al. Lancet Infect Dis 2002;2:659–66; 2. Ansaldi F, et al. Vaccine 2008;26:1525–9; 3. Thompson WW, et al. JAMA 2004;292:1333–40; 4. Thompson WW, et al. JAMA 2003;289:179–86; 5. Rivetti D, et al. Cochrane Database System Rev 2006(2):CD004876.
Questions Refrigerated transport – maintaining the cold chain! 30
Personalising vaccination care Dr Roger Henderson Senior Partner in General Practice, and Media Medic 31
Declarations • Dr Roger Henderson has received an honorarium from Seqirus for his time spent preparing this presentation • He has received honoraria in the past from pharmaceutical companies including Pfizer, GSK, Takeda and Novartis Introduction copy 32
What this talk will cover: Objectives • The downward trend in vaccine efficacy against influenza A(H3N2) • Review of the current the influenza programme • Strategies which could increase protection among the elderly • Introduction to adjuvanted vaccines Introduction copy 33
A downward trend in vaccine efficacy against influenza A(H3N2) has been observed in recent years1–3 In 2016/17 the vaccination rate in adults aged 65 years and over was 70.5%4 2016/17 cumulative influenza confirmed hospital admissions by age group and influenza type Number of admissions by influenza 900 • However, there was only 40% Influenza A(H3N2) 800 Influenza A (H1N1) pdm09 effectiveness in the adjusted 700 Influenza A (unknown subtype) all-age vaccine effectiveness5 600 Influenza B Introduction copy 500 • Vaccine effectiveness against A(H3N2) was lowest in the over 400 65 years age group1 300 200 100 0
Influenza A(H3N2) disproportionately affects the elderly1 A higher rate of ICU/HDU influenza-confirmed admissions were observed in adults aged 65 years and over2 2016/17 cumulative influenza confirmed ICU/HDU admissions by age group and influenza type 500 • ICU lab-confirmed admission Influenza A(H3N2) 450 Influenza A (H1N1) pdm09 rates*, with the largest numbers 400 Influenza A (unknown subtype) of admissions in the over 65 350 Influenza B years age group2 300 250 • Excess mortality reached 200 moderate levels, mostly seen in 150 the over 65 years age group2 100 50 0
What is the solution? What strategies could increase protection among the elderly? 1. Increase uptake among eligible groups to reduce transmission in communities - Children, families, healthcare workers (in practices, hospitals and nursing homes etc.) 2. Achieve a higher vaccination rate among the elderly 3. Alternative route to IM/SC intradermal Introduction copy vaccines… 4. More effective 36 IM, intramuscular; SC, subcutaneous.
There are multiple factors influencing vaccine effectiveness and disease burden in the ≥65 age group Population Influenza strain Vaccine type Coverage Matching of Age-related vaccine strain Vaccine type/ immunosenescence Flu campaigns vs. circulating technology and comorbidities flu strain Antigenic mismatch Less effective resulting in reduced Not all elderly Insufficient immune vaccine resulting Introduction copy response 1 cross-reactive in limited seek healthcare antibodies2 provision4 protection1‒3 Strategies to reduce the disease burden include: Accessing vaccines capable of eliciting better immune response and improving clinical outcomes to protect against influenza infection TIV, trivalent influenza vaccine. 37 1. McElhaney JE. Aging Health 2008;4:603–13; 2. Ansaldi F, et al. Vaccine 2008;26:1525–9; 3. Jefferson T, et al. Cochrane Database System Rev 2010(2):CD004876; 4. Molinari NAM, et al. Vaccine 2007;25:5086–96.
What influenza vaccines are currently available for the UK 2017/2018 influenza season? A trivalent or quadrivalent vaccine composition • Trivalent vaccine comprising of: - an A/Michigan/45/2015 (H1N1)pdm09-like virus - an A/Hong Kong/4801/2014 (H3N2)-like virus - a B/Brisbane/60/2008-like virus • Introduction Quadrivalentcopy vaccine comprising of: - The three viruses present in the TIV vaccination - a B/Phuket/3073/2013-like virus BMI, body mass index; LIAV, live attenuated influenza vaccine; TIV, trivalent influenza vaccine; QIV, quadrivalent influenza vaccine. *At-risk group now includes coeliac patients and morbidly obese patients (BMI >40). 38 Public Health England. National flu immunisation programme 2017/18. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/600880/annual_flu__letter_2017to2018.pdf. Accessed October 2017.
Licensed influenza vaccines available in the UK influenza season 2017/181 Strain Route of Indicated UK Vaccine type Product name coverage administration age group Influenza vaccine, surface antigen, Inactivated; inactivated (Mylan Products); surface antigen; Trivalent Intramuscular ≥ six months old Influenza vaccine surface antigen, non-adjuvanted inactivated (Seqirus UK) Inactivated; ≥ six months old Inactivated influenza vaccine BP split virion; Trivalent Intramuscular (Sanofi Pasteur) non-adjuvanted Influenza vaccine, pre-filled Introduction Inactivated; copy syringe (Pfizer Vaccines); split virion; Trivalent Intramuscular ≥ five years old Influenza vaccine split virion, non-adjuvanted inactivated (Pfizer Vaccines) Live attenuated; 24 months old to Influenza vaccine live attenuated, Quadrivalent Intranasal non-adjuvanted < 18 years old nasal (AstraZeneca) Influenza vaccine split virion, Inactivated; inactivated (GlaxoSmithKline); split virion; Quadrivalent Intramuscular ≥ three years old Quadrivalent influenza vaccine non-adjuvanted (Sanofi Pasteur) 39 1. Public Health England. National flu immunisation programme 2017/18. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/600880/annual_flu__letter_2017to2018.pdf. Accessed October 2017.
Licensed influenza vaccines predicted to be available in the UK influenza season 2018/191,2 Strain Route of Indicated UK Vaccine type Product name coverage administration age group Influenza vaccine, surface antigen, Inactivated; inactivated (Mylan Products); surface antigen; Trivalent Intramuscular ≥ six months old Influenza vaccine surface antigen, non-adjuvanted inactivated (Seqirus UK) Inactivated; Trivalent Inactivated influenza vaccine BP (Sanofi split virion; Intramuscular ≥ six months old Pasteur) non-adjuvanted Influenza vaccine, pre-filled syringe (Pfizer Inactivated; Vaccines); ≥ five years old Introduction copy split virion; non-adjuvanted Trivalent Intramuscular Influenza vaccine split virion, inactivated (Pfizer Vaccines) Inactivated; surface Surface antigen, inactivated, influenza antigen; MF59C.1- Trivalent Intramuscular ≥ 65 years old vaccine adjuvanted with MF59C.1 adjuvanted (Seqirus UK) Live attenuated; 24 months old to Influenza vaccine live attenuated, nasal Quadrivalent Intranasal nonadjuvanted < 18 years old (AstraZeneca) Inactivated; Influenza vaccine split virion, inactivated split virion; Quadrivalent Intramuscular ≥ three years old (GlaxoSmithKline); Quadrivalent influenza non-adjuvanted vaccine (Sanofi Pasteur) 40 1. Public Health England. National flu immunisation programme 2017/18. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/600880/annual_flu__letter_2017to2018.pdf. Accessed October 2017. 2. Seqirus Press Release. New influenza vaccine offers improved protection for older adults. Available at: http://www.seqirus.com/newsroom/New-influenza-vaccine-offers-improved-protection-for-older-adults. Accessed October 2017.
JCVI suggested that an adjuvanted trivalent influenza vaccine may provide vaccine effectiveness in ≥65 years1,2 An adjuvanted trivalent influenza vaccine for those aged over 65 years could potentially be used in the 2018/19 season • Published studies indicated higher vaccine immunogenicity and effectiveness for the adjuvanted vaccine in comparison with non-adjuvanted vaccines • In October 2017, the JCVI is considering the over 65 year Introduction copy olds component of the influenza immunisation programme - These considerations may well generate advice specifically with regard to protecting the elderly against influenza 41 1. JCVI minute of the meeting on 7 June 2017. Draft minute. Available at: https://app.box.com/s/iddfb4ppwkmtjusir2tc/file/198733240440. Accessed October 2017; 2. Seqirus Press Release. New influenza vaccine offers improved protection for older adults. Available at: http://www.seqirus.com/newsroom/New-influenza-vaccine-offers-improved-protection-for-older-adults. Accessed October 2017.
What are adjuvanted vaccines? Adjuvants enhance the magnitude and breadth of the immune response1 Vaccines based on purified Individuals with a naïve or recombinant antigens or weakened immune may induce a suboptimal system respond less immune response in older well to vaccines adults Introduction copy Why enhance the immune response? Vaccine antigen Vaccine-induced immunity may not exactly match may not be long-lasting in the circulating older adults influenza virus strain 42 42 1. O’Hagan DT, et al. Drug Discov Today 2009;14:541–51.
What adjuvanted influenza vaccines are available? • Adjuvanted inactivated, surface antigen or aTIV contains an oil-in-water emulsion of the adjuvant squalene – MF59C.1®1 • The adjuvant can potentially enhance antigen-specific immune response to vaccine antigens resulting in: - Higher antibody levels against all strains within the vaccine, when compared against copy Introduction conventional non-adjuvanted TIV - Production of cross-protective antibodies against unmatched strains when they are similar to those included in the vaccine2,3 - Longer persistence of antibodies, when compared to conventional non-adjuvanted TIV3 43 1. O’Hagan DT, et al. Expert Rev Vaccines 2013;12:13-30; 2. Surface antigen, inactivated, influenza vaccine adjuvanted with MF59C.1 Summary of Product Characteristics October 2017; 3. Frey SE, et al. Vaccine 2014;32:5027–34..
LIVE study Adjuvanted TIV: Real-world data In peak influenza season, influenza-related or pneumonia-related hospitalisation was significantly reduced when adults were vaccinated with aTIV compared with non- adjuvanted TIV1 2 Reduction in risk of hospitalisation due to (95%CI: 0.57, 0.98) 1.6 25% reduction in risk of hospitalisation influenza or pneumonia 1.2 Vaccination with adjuvanted TIV significantly Introduction 0.8 copy reduced risk of influenza-related or pneumonia-related hospitalisations compared with non-adjuvanted TIV 0.4 during peak influenza season*† 0 TIV Adjuvanted TIV Category 1 There was a greater risk in the adjuvanted TIV group of influenza-related hospitalisations occurring before the influenza season. This was due to age, functional limitations and higher rate of comorbidities.† *Residual bias indicates that this value is likely to be an underestimate; †RRs were adjusted to address important confounding factors that contributed to the imbalance between aTIV and TIV groups such as age, sex, influenza season, comorbidities, vaccine provider and functional status, Risk ratio: 1.17 (95% CI: 0.96–1.43). 44 aTIV, adjuvanted trivalent influenza vaccine; CI, confidence interval; RR, risk ratio; TIV, trivalent influenza vaccine. 1. Mannino S, et al. Am J Epidemiol. 2012;176:527–33.
Canadian study Adjuvanted TIV: Real-world data Adjuvanted TIV had an absolute vaccine effectiveness of 58%*, whereas conventional non-adjuvanted TIV was just as effective in the elderly population when compared with unvaccinated subjects†1 2 (95%CI: 4.86, P=0.04) Relative vaccine effectiveness as compared to non-adjuvanted TIV 1.6 Introduction copy 63% higher relative vaccine effectiveness1 1.2 Adjuvanted TIV was 63% more effective than non-adjuvanted TIV 0.8 0.4 0 TIV Adjuvanted TIV Category 1 *(95% CI: 5–82, P
Pivotal Study: Solicited local adverse events Pivotal clinical trial data adjuvanted TIV vs. conventional TIV1 100 aTIV (n=3505) TIV (n=3495) 80 Subjects (%) 1–7 days following vaccination 60 Introduction 40 copy 25 21 20 12 11 1 1 1 1 1
Pivotal Study: Solicited systemic adverse events Pivotal clinical trial data adjuvanted TIV vs. conventional TIV1 100 aTIV (n=3505) TIV (n=3495) 80 Subjects (%) 1–7 days following vaccination 60 Introduction 40 copy 20 15 13 10 13 9 9 8 7 7 5 5 5 4 3 3 3 2 1 0 Systemic adverse events 47 TIV, trivalent influenza vaccine. aTIV, adjuvanted trivalent influenza vaccine 1. Frey SE, et al. Vaccine 2014;32:5027–34.
Summary: Is it time to personalise vaccination care? There is a growing concern of low vaccine efficacy against influenza A(H3N2) in ≥65 year olds1,2 IntroductionThe provisional end-of-season vaccine effectiveness for 2016– copy 17 estimates showed no significant effectiveness in ≥65 year olds3 JCVI suggested that an adjuvanted trivalent influenza vaccine may provide vaccine effectiveness in adults aged ≥65 years4 1. Belongia EA, et al. Lancet Infect Dis 2016;16:942–51; 2. Kissling E, et al. Euro Surveill. 2017;22:pii=30464; 3. Public Health England. Provisional end-of-season results 2016-17. Available at: 48 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/641162/Influenza_vaccine_effectiveness_in_primary_care_1617_final.pdf. Accessed October 2017; 4. JCVI minute of the meeting on 7 June 2017. Draft minute. Available at: https://app.box.com/s/iddfb4ppwkmtjusir2tc/file/198733240440. Accessed October 2017.
How do we break the cycle? Dr George Kassianos, Dr Roger Henderson and Pauline MacDonald 49
Pooled seasonal vaccine effectiveness by influenza strain1 Vaccine improvements are needed to generate greater protection against influenza A(H3N2) than with current vaccines Older adults >60 years Working adults 20–60 years 90 80 Pooled Vaccine Effectiveness (%) 70 60 Introduction 50copy 40 30 20 10 0 -10 A(H3N2) A(H1N1) B 50 1. Belongia EA, et al. Lancet Infect Dis 2016;16:942–51.
Persistence of influenza vaccine protection Single season studies • EU, UK, Australia • Amount of ‘waning’ inconsistent across studies age group and flu-type1 • Decline in vaccine effectiveness within flu season most evident in influenza A(H3N2)1 • For influenza A(H3N2), vaccine effectiveness declined to
Pooled season adjusted vaccine effectiveness (Five seasons) Influenza A(H3N2) • “…while there appears to be waning of vaccine effect over time, we cannot disentangle to what extent this is due to virus change and subsequent non-matching of the vaccine, or loss of vaccine-induced immunity within the individual”1 Overall season (all ages) Early season (all ages) Overall season (60 years and older) Introduction copy 52 Figures from: Kissling E, et al. Euro Surveill. 2016;21:pii=30201. 1. Kissling E, et al. Euro Surveill. 2016;21:pii=30201. 52
So what are the strategies that could increase protection among adults ≥65 years? The current need Higher immune response: 1 Influenza vaccines are less effective in older adults due to immunosenescence Breadth of protection: 2 Influenza Introduction copy vaccines are even less effective in older adults during seasons when drift and strain mismatch occur Persistence: 3 Influenza vaccine effectiveness wanes significantly during the season 53
Break 15 minutes 54
Workshop sessions Dr Roger Henderson: Best Practice – interactive case study Dr George Kassianos: Practical guidance on adult influenza vaccination 55
Workshop session Dr Roger Henderson: Best Practice – interactive case study Senior Partner in General Practice, and Media Medic 56
Best Practice – Interactive case study How do we achieve high influenza vaccination uptake? 57
Why can similar practices vary so much in their influenza vaccination uptake? Practice A Practice B Semi-rural and in same town Average of 15,000 patients each Mainly social classes 1–3, relatively low social deprivation Introduction copy Good literacy population Practice A Practice B 27% 38% Total uptake 62% Total uptake 73% 62% 73% What factors could affect this? ? 58
What are the top five key ways for a practice to optimise influenza vaccination uptake? 59
Top five ways to optimise influenza vaccination update in your practice Have a lead member of staff with tenacity in overall charge of the 1 vaccination campaign 2 Set aspirational uptake targets 3 copy Introduction Develop and use additional flu vaccination prompts in your IT system 4 Have GPs and practice nurses who opportunistically vaccinate 5 Use phone calls and text reminders (mJog) to invite patients 60
What are the simple steps required to change behaviour in your practice in order to optimise uptake? 61
Plan/Invite/Provide/Review principles Plan: By identifying lead member - running campaign and another who will identify all eligible patients. Modify practice IT searches to achieve this if needed Invite: Send a personal invitation to all eligible patients, and collaborate with community midwives too Introduction copy Provide: Allocate appointments as well as walk-in sessions in order to increase attendance. Continue when QOF targets reached Review: Document uptake rates in a written report to all staff, especially those leading the campaign 62
How can we optimise influenza vaccination uptake without patient hesitancy? 63
Improving vaccination uptake without causing patient hesitancy Use a separate Read code for Start vaccinating as soon vaccination bookings to facilitate as vaccine arrives follow-up of non-attenders Send prompt reminders to Ensure all patients receive Introduction copy patients who do not respond accurate information about to invitation vaccination benefits Review vaccine uptake Aim to complete vaccinations fortnightly to allow targeting by end of Oct/early Nov, although of shortfall areas continue vaccinations after this 64
How can we measure the impact of our initiatives to build in a solutions-driven feedback loop? 65
Workshop session Dr George Kassianos: Practical guidance on adult influenza vaccination MD (Hons), FRCGP, FESC, FBGTHA, FFTM RCPS (Glasg), FBHS, FHEA, FAcadMEd, DRCOG, LRCP (Edin.), LRCS (Edin.), LRCP&S (Glas.), DMedAcup., DMedHypn., DFP. 66
Annual flu programme 2017/18 flu season1 Introduction copy 67 1. Public Health England. 2017 to 2018 flu season. Available at: https://www.gov.uk/government/collections/annual-flu-programme#2017-to-2018-flu-season. Accessed October 2017.
Immunisation training resources for healthcare professionals1,2 • Immunology for immunisers animation • e-Learning immunisation resources - Influenza Knowledge Transfer Series Specific on the burden of seasonal influenza in an older adult population - Accredited by the Royal College of General copy Introduction Practitioners (RCGP) • Immunisation knowledge and skills competence assessment tool • Slide sets for core curriculum teaching • Quality framework to support the implementation of national standards and guidelines on immunisation training 1. Public Health England. Immunisation. Immunisation training resources for healthcare professionals. Available at: https://www.gov.uk/government/collections/immunisation#infographics. Accessed October 2017; 2.. mdBriefCase™. Influenza Knowledge Transfer series. Available at: 68 http://www.mdbriefcase.net/uk/influenza?regionID=16&utm_source=RCGP&utm_medium=Referral&utm_campaign=FLU%20KTS&utm_content=UK%20EN%20FLU%20RCGP%20Social%201. Accessed October 2017
Patient Group Directions (PGDs)1 Introduction copy 69 1. Immunisation patient group direction (PGD) templates. Available at: https://www.gov.uk/government/collections/immunisation-patient-group-direction-pgd. Accessed October 2017.
GP vaccination of children aged between two and three years old1,2 Children who are not yet four on 31 August 2017* • All children: One dose of influenza vaccine live attenuated, nasal • If first ever flu vaccination and in ‘at risk groups’: Two doses at least four weeks apart • If influenza vaccine live attenuated, nasal contraindicated AND child in a ‘group at risk’: - TIV children 6 months to
GP vaccination of children 4 to 8 years of age1,2 • Local NHS England teams will commission this service: - Local providers - Predominantly in primary school settings • GPs can immunise children of this age in the ‘at risk groups’* Introduction copy particularly if not vaccinated at school * At risk children include those who have a long-term health condition, such as: asthma and other respiratory diseases, liver, kidney, neurological conditions including learning disabilities (even if well managed) 1. Public Health England. The national flu immunisation programme 2017/18. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/600880/annual_flu__letter_2017to2018.pdf. Accessed October 2017. 71 2. Public Health England. Which flu vaccine should children have?. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/619722/Children_flu_vaccine_graphic.pdf. Accessed October 2017.
PGD for QLAIV1 Introduction copy 72 1. Public Health England. Live attenuated influenza vaccine (Fluenz Tetra®): Patient group direction (PGD) template. Available at: https://www.gov.uk/government/publications/influenza-vaccine- fluenz-tetra-patient-group-direction-pgd-template. Accessed October 2017.
The 2017/18 GP programme1,2 Introduction copy 1. Public Health England. Flu vaccine for children: best practice guide for GPs. Available at: https://www.gov.uk/government/publications/flu-vaccine-best-practice-guide-for-gps. Accessed October 73 2017; 2. Public Health England. Flu vaccination: Who should have it this winter and why. Available at: https://www.gov.uk/government/publications/flu-vaccination-who-should-have-it-this-winter-and- why. Accessed October 2017.
Annual influenza vaccination 2017/18 campaign1 Introduction copy 74 1. Public Health England. The national flu immunisation programme 2017/18. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/600880/annual_flu__letter_2017to2018.pdf.. Accessed October 2017.
Which groups are to be vaccinated?1,2 Influenza vaccination groups • All children aged two and three years old • Children in former primary school ‘pilot areas’ (by GPs) • People in long-stay Residential Homes • Children aged four to eight years old – not prisons, young offenders institutions, (vaccinated at schools) university halls • All patients aged ≥65 years on 31/03/2018 • Carers – those on carer’s allowance, main carer of elderly, child or disabled persons •Introduction All pregnantcopy women – at any stage of pregnancy • Health and Social Care Staff - in direct contact with patients: Employers finance • ‘At risk’ groups – aged between six months vaccination to 64 years old • Locums (via their registered GP) • Other only at GP’s discretion 1. NHS England. Directed Enhanced Service Specification. Available at: https://www.england.nhs.uk/wp-content/uploads/2017/03/sfl-pneumococcal-2017-18-service-specification.pdf . Accessed 75 October 2017. 2. NHS England. Flu Plan Winter 2017/18. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/600532/annual_flu_plan_2017to2018.pdf. Accessed October 2017.
Who are patients in the ‘at risk’ groups?1 Influenza vaccination for at risk groups in those aged six months to 64 years old • Chronic respiratory disease: • Chronic kidney disease: Asthma on inhaled or oral steroids, COPD, Stage 3–5, nephrotic syndrome, transplant interstitial lung disease, cystic fibrosis, • Chronic neurological disease: Pneumoconiosis, bronchopulmonary Stroke, TIA, Polio, MS, cerebral palsy, dysplasia, children with LRT disease learning disorders, Parkinson’s, MND • Chronic heart disease: Introduction copy • Diabetes Congenital, HF, coronary heart disease, hypertension with cardiac complications • Asplenia, splenic dysfunction: Homozygous sickle cell disease, coeliac • Chronic liver disease: disease-may lead to hyposplenism Cirrhosis, biliary atresia, chronic hepatitis • Immunosuppression: • Morbidly obese: Active disease or treatment, oral BMI ≥40 prednisolone ≥20mg for >1 month or child ≥1mg per kg body weight per day COPD, chronic obstructive pulmonary disease; HF, heart failure; LRT, lower respiratory tract infection; MND, motor neurone disease. 76 1. NHS England. Flu Plan Winter 2017/18. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/600532/annual_flu_plan_2017to2018.pdf. Accessed October 2017.
GPs Enhanced Service (ES)1,2 Fee: ES £9.80 per dose • Age ≥65 years on 31 March 2018 • Pregnant women • Children aged 2 and 3 years old • Patients in the ‘at risk’ groups aged 6 months to
Pharmacists influenza vaccination service1 Fee: £9.14 per dose (Fee: £7.64 plus additional fee in recognition of providing the service in the community £1.50) • Age ≥65 years old • Pregnant women • Patients ‘at risk’ aged 18 to
Quality and Outcomes Framework (QOF) for GPs1 Payment Indicator Points stages (%) CHD 004: % of patients with CHD who have a record of flu vaccination in the preceding 1 September – 31 March 7 56–96 STROKE 006: % of patients with TIA or Stroke who have had flu vaccination in the preceding 1 September – 31 March 2 55–95 Introduction copy COPD 006: % of patients with COPD who have a record of flu vaccination in the preceding 1 September – 31 March 6 57–97 Diabetes Mellitus 10: % of patients with DM who have had influenza vaccination in preceding 1 September to 31 March 3 55–95 Total 18 points x £171.20 = £3,082 [For 7,460 patients – England] CHD, coronary heart disease; COPD; chronic obstructive pulmonary disease; DM, diabetes mellitus; TIA, transient ischaemic attack. 79 1. Summary of changes of QOF 2017/18 – England. Available at: http://www.nhsemployers.org/~/media/Employers/Documents/Primary%20care%20contracts/QOF/2017- 18/201718%20Quality%20and%20outcomes%20framework%20summary%20of%20changes.pdf. Accessed October 2017.
PGD for intramuscular inactivated influenza vaccine1 Inactivated influenza vaccine Introduction copy 80 1. Intramuscular inactivated influenza vaccine: patient group direction (PGD) template. Available at: https://www.gov.uk/government/publications/intramuscular-inactivated-influenza-vaccine-patient- group-direction-pgd-template. Accessed October 2017.
I had my flu vaccine Have you? Introduction copy 81
General Medical Council: UK’s regulating body for doctors Good medical practice1 – issued February 2013 Getting an annual influenza vaccination: A professional responsibility Introduction copy 82 1. General Medical Council. Good medical practice 2013. Available at: http://www.gmc-uk.org/guidance/good_medical_practice.asp. Accessed October 2017.
What about other HCPs? Nurses, Midwives and Health Visitors as per the NMC Code1 “Take all reasonable personal precautions necessary to avoid any potential health risks to colleagues, people receiving care and the public” Others such as Physiotherapists, Radiographers, Paramedics registered Introduction copy with the Health and Care Professionals Council:2 “You must take all reasonable steps to reduce the risk of harm to service users, carers and colleagues as far as possible” 83 1. Nursing and Midwifery Council. The code for nurses and midwives. Available at: https://www.nmc.org.uk/standards/code/. Accessed October 2017; 2. Health and Care Professionals Council. Standards of conduct, performance and ethics. Available at: http://www.hcpc-uk.org/assets/documents/10004EDFStandardsofconduct,performanceandethics.pdf. Accessed October 2017.
Summary of key learnings and faculty questions Dr George Kassianos, Dr Roger Henderson and Pauline MacDonald 84
Closing remarks Dr George Kassianos 85
Please complete your evaluation form, which will be provided via an email link 86
A certificate of attendance will be provided via an email link You can apply for 3 continuing professional development (CPD) credits from the Federation of the Royal Colleges of Physicians 87
Please switch your mobile phone back on! 88
Thank you! 89
Fluad® Prescribing information: Fluad® suspension for injection in pre-filled syringe (CTAB), barium sulphate, or in anyone who has had an following have been reported post-marketing: Influenza Vaccine (surface antigen, inactivated, anaphylactic reaction to previous influenza thrombocytopenia, lymphadenopathy, asthenia, adjuvanted with MF59C.1) Presentation: Each 0.5ml vaccination. Immunisation shall be postponed in influenza-like illness, extensive swelling of injected of Fluad® contains 15 micrograms of each of three patients with febrile illness or acute infection. limb, injection-site cellulitis-like reaction, allergic purified influenza virus antigens prepared from the Warnings and Precautions: Appropriate medical reactions including anaphylactic shock (in rare cases), strains of influenza virus that comply with the WHO treatment and supervision should be readily available anaphylaxis, angioedema, vasculitis with transient recommendations (Northern Hemisphere) and EU in case of an anaphylactic event following renal involvement, and neurological disorders such as decision for the 2016/17 season: A/California/7/2009 administration. Do not inject intravascularly or encephalomyelitis, Guillain-Barré syndrome, (H1N1) pdm09-like strain (A/California/7/2009, NYMC subcutaneously. Endogenous or iatrogenic convulsions, neuritis, neuralgia, paraesthesia, X-181) 15 micrograms haemagglutinin, A/Hong immunosuppression may result in insufficient antibody syncope, and presyncope. Overdose: Overdosage is Kong/4801/2014 (H3N2)-like strain (A/Hong response. Latex-sensitive individuals: Although no unlikely to have any untoward effect. Legal Category: Kong/4801/2014, NYMC X-263B) 15 micrograms natural rubber latex is detected in the syringe tip cap, POM. Package Quantities: Packs of 1 or 10 pre-filled haemagglutinin, B/Brisbane/60/2008-like strain the safe use of Fluad® in latex-sensitive individuals syringes. Marketing Authorisation Number: UK: PL Introduction copy (B/Brisbane/60/2008, wild type) 15 micrograms has not been established. Interactions: No clinical 46752/0001. Basic NHS Cost: £9.79 per 0.5ml pre- haemagglutinin, with adjuvant MF59C.1 (9.75mg data on concomitant administration with other vaccines filled syringe, £97.90 per 10 pack. Marketing squalene, 1.175mg polysorbate 80, 1.175mg sorbitan are available. If Fluad® needs to be used at the same Authorisation Holder: Seqirus S.r. l., Via Fiorentina 1, trioleate, 0.66mg sodium citrate, 0.04mg citric acid, time as another vaccine, immunisation should be 53100 Siena, Italy water). Indications: Active immunisation against carried out on separate limbs. It should be noted that For full prescribing information and details of other influenza in the elderly (65 years of age and over), the adverse reactions may be intensified. Pregnancy side effects see the Summary of Product especially for those with an increased risk of and Lactation: Not applicable. Effects on ability to Characteristics at www.gov.uk/pil-spc associated complications. Dosage and drive and use machines: Fluad® has Date of preparation: August 2017 UK/FLUD/0717/0015 Administration: Intramuscular injection into the deltoid no or negligible influence on the ability to drive and use ®Registered trade mark Seqirus S.r.l, Italy muscle using a 1-inch needle. Adults aged 65 years machines. Side Effects: The most common reactions Adverse events should be reported. Reporting forms and over: Single dose 0.5ml. Contra-indications: are headache, myalgia, injection site pain and and information can be found at Hypersensitivity to the active substances, components tenderness, fatigue, nausea, diarrhoea, vomiting, www.mhra.gov.uk/yellowcard. Adverse events relating of the adjuvant, excipients, to chicken or egg proteins sweating, arthralgia, fever, malaise, and shivering; to Seqirus products should also be reported to Seqirus (such as ovalbumin), kanamycin, neomycin sulphate, local reactions include redness, swelling, ecchymosis, Vaccines on 01748 828816 formaldehyde, cetyltrimethylammonium bromide and induration. Uncommon reactions include rash. The 90
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