Influenza A(H1N1)v virus vaccination programme

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1 Influenza A(H1N1)v virus vaccination programme January 2010 Monica Maguire Health Protection Nurse Specialist

2 Influenza A(H1N1)v Programme Background information about flu virus Emergence of A(H1N1)v virus Epidemiology of Flu A(H1N1)v virus Vaccines against Flu A(H1N1)v virus Indications, contraindications and safety of vaccines

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8 Influenza A viruses 1918 pandemic by H1N pandemic by H2N pandemic by H3N outbreaks by H1N1 (Red Flu) Until 2009, a combination of H3N2 and H1N1 (seasonal) 2009 pandemic by Flu A (H1N1)v, otherwise known as swine flu From 2010 which Flu A?

9 Flu A(H1N1)v virus Mid-February 2009 outbreak of respiratory disease in La Gloria, Mexico Mid-April new virus identified in two specimens in California reported to WHO Contains segments of bird (avian), swine and human viruses new unique combination and has similarities to current pig-type viruses First case in UK 27 th April 2009 June 2009 WHO went to pandemic phase 6

10 Swine Flu Not really a swine flu as swine flu mainly infects pigs Occasionally transmitted to humans in close contact with pigs Last outbreak of swine flu in 1976 in America First analysis of the Flu A(H1N1)v genetic materials showed genetic similarities with existing pig-type viruses WHO name: Influenza A (H1N1)v and also known as Influenza A(H1N1)2009

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12 Age distribution lab confirmed new A/H1N1 cases & deaths: Mexico a disease of children and working age adults

13 Epidemiology/Surveillance Pandemic H1N1 cases rate per 100,000 population by age group as of 16 July 2009 (n=33,112*) in the USA

14 Epidemiology/Surveillance Pandemic H1N1 case fatality ratio by age group 16 July 2009 (n=262) in the USA

15 Epidemiology/Surveillance Distribution by age group of influenza hospitalised cases Emerging Infections Programme Pandemic H1N1-14 July 2009 in the USA

16 UK age distribution: initial cases

17 Confirmed Cases of H1N1 by Age Group (Total number of cases 1092 in GGCNHSB since outbreak began) Number of Cases <= N/K Age Groups

18 Flu A(H1N1)v epidemiology: international situation Spread to every continent CFR ~ around 0.1% Most cases and deaths are in people aged <50 years H1N1 is the dominant Flu A virus in most parts of the world Most viruses still sensitive to oseltamivir

19 (H1N1)v epidemiology - Scotland 1482 patients ever hospitalised by 06 January 2010 About 50% have underlying medical conditions 62 deaths in Scotland, not all with underlying medical conditions

20 Influenza A(H1N1)v: risk factors for severe outcome Underlying chronic conditions Pregnancy (6 deaths in UK by 15 th Oct) Immunocompromised individuals Metabolic abnormality, eg obesity But a significant proportion of severe cases have no underlying risk factors

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23 Flu A (H1N1)v: best guess Number will continue to increase over the next few weeks/months Peak uncertain but experience in Southern Hemisphere encouraging Prepare for the worst case scenario but hope for the best Vaccination will change the epidemiology

24 Those who have been immunised in Phase 1 Clinical Priority Groups (c. (c. 240,000 in in GG&C) Health & Social Care Workers (c. (c. 56,000 in in GG&C) Individuals Individuals aged aged between between six six months months and and up up to to years years in in the the current current seasonal seasonal flu flu vaccine vaccine clinical clinical at-risk at-risk groups. groups. All All pregnant pregnant women. women. Household Household contacts contacts of of immunocompromised individuals. individuals. Healthcare Healthcare workers workers with with direct direct patient patient contact. contact. Social Social care care staff staff who who are are employed employed to to provide provide personal personal care care to to children children and and adults, adults, both both in in care care homes homes and and in in the the community. community. People People aged aged and and over over in in the the current current seasonal seasonal flu flu vaccine vaccine clinical clinical at- atrisk risk groups. groups.

25 Those who have been immunised in Phase 1 Health & Social Care Workers Example Roles Healthcare workers with with Direct Patient Contact. Community Community Pharmacists Pharmacists Doctors Doctors (including (including GPs GPs + Practice Practice staff) staff) Dentists Dentists (hospital (hospital& GDPs) GDPs) Midwives Nurses Nurses Occupational Occupational Therapists Therapists Physiotherapists Physiotherapists other other AHPs AHPs Radiographers Radiographers Students Students and and trainees trainees in in these these disciplines disciplines Local Local risk risk assessment assessment of of non-clinical non-clinical staff staff with with Direct Direct Patient Patient Contact Contact e.g. e.g. ward ward clerks clerks Social Care Staff who who provide Personal Care Care Care home home staff staff in in residential/nursing homes homes who who provide provide personal personal care care to to residents residents Domiciliary Domiciliary care care workers workers employed employed by by agencies agencies who who provide provide personal personal care care to to service service users users in in their their own own homes homes Personal Personal assistants assistants staff staff employed employed to to provide provide personal personal care care to to a single single service service user user Students Students and and trainees trainees

26 Immunosuppressed individuals As detailed in the Green Book Due to disease or treatment Patients undergoing chemotherapy Asplenia or splenic dysfunction HIV patients Individuals on systemic steroids for more than a month at a dose equivalent to Prednisolone at 20mg or more per day, or children under 20kgs at a dose of 1mg or more/kg/day

27 Phase 1 Delivery of the H1N1 vaccination programme should have been completed by 31 st December 2009

28 Phase 2 The cohort group is children aged from 6 months up to 5 years i.e. children born up to 31 st July 2009 Vaccination should be completed by 31 st March 2010 Screening Services Dept will produce a schedule list of all eligible children along with a blank invite letter from the SIRS system Lists and letters for practices that are not participating will be sent to their local CH(C)P so that alternative arrangements can be made. Practices should check that the child has not already been vaccinated as part of Phase 1

29 Phase 2 ordering sundries 21 gauge, 1.5 inch, green needles (100 per box) and/or The 3 ml Braun syringes (100 per box) for mixing the adjuvant with the antigen 25 gauge, 1 inch, integrated/fixed orange needle/syringes for drawing the vaccine dose and administering it to the patient 1 litre and 5 litre sharps/clinical waste bins Orders should be placed via to: scott.hanley@ggc.scot.nhs.uk

30 Phase 2 Ordering Vaccine You can obtain vaccine supplies of Pandermix and Celvapan, by placing an order with your local Vaccine Distribution Centre: Clyde Sector: RAH Pharmacy Tel No: Glasgow Sector: Leverndale Pharmacy Tel No:

31 Flu A(H1N1)v vaccine Which products Schedule Licensing process and time scale Adjuvants Other composition Safety data and side effects

32 Two (H1N1)v specific vaccines in the UK GSK- Pandemrix Baxter- Celvapan Approximately 50:50 split but initially more of GSK than Baxter product Both vaccines licensed by EU countries

33 Flu A(H1N1)v vaccination Both vaccines initially developed and tested as a pandemic vaccine by using antigen from H5N1 influenza (bird flu) Used exactly the same methods and ingredients as above but using Flu A (H1N1)v antigen Very similar process as seasonal flu vaccines

34 GSK vaccine - Pandemrix Inactivated split virion vaccine, so no live viruses Virus grown in hens eggs Contains an adjuvant (ASO3) to boost immune response Contains thiomersal as preservative and has longer shelf life once opened

35 Baxter vaccine - Celvapan Inactivated whole virion vaccine, so no live viruses Virus grown in cell culture, so no egg allergy issue No adjuvant No thiomersal as preservative, so shorter shelf life once opened

36 Adjuvants Added to vaccine to increase immune response Most adjuvants used in vaccines in the UK are aluminium salts. They have been in use over 70 years and are safe GSK vaccine has ASO3 as adjuvant Adjuvant drive immune response

37 Other Composition: Thiomersal Mercury based substance that has been used widely in vaccines for over 60 years Most new vaccines do not use thiomersal as a precaution Added to some multi-dose vaccines to prevent them from being contaminated by bacteria and fungi Added to the GSK products

38 Mercury Heavy metal naturally found in the environment Main source of exposure is the diet mainly organic form methylmercury, found in fish such as tuna Methylmercury can accumulate in the body if individuals eat large quantities of predatory fish or seafood Mercury in thiomersal is ethylmercury in a very small amount and is rapidly broken down in the body.

39 Guillain-Barré Syndrome (GBS) Reversible neurological condition Usually following infections Thought to be due to auto-immune process Recent study showed risk of GBS about 17 times higher following infection with a flu like illness compared to background risk

40 Flu vaccines and GBS A cluster of GBS cases reported following swine flu vaccines used in America in Estimated one case for every 100,000 vaccine used but reason not known. Surveillance since 1976 found no link between seasonal flu vaccine and GBS Flu vaccine found to be protective against GBS

41 Summary so far New flu virus has caused a pandemic Mild self-limiting illness for most people If older people catch the virus they are more likely to become seriously ill 2 vaccines Both safe and licensed

42 Dosage and Schedule: Pandemrix Age Dose Children aged 6 months Single injection of to 10 years 0.25ml Immunocompromised children Two injections of 0.25ml at least 3 weeks apart

43 Dosage and schedule: Celvapan Two doses of 0.5ml at least 3 weeks apart for all individuals aged 6 months and above

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45 Flu A (H1N1)v vaccine: contraindications Pandemrix if severe life threatening allergic reaction to egg and egg products Previous life threatening allergic reaction to flu vaccines Life threatening reaction to any components of the vaccines Confirmed case of (H1N1)v infection Skin rash following flu vaccines not a contraindication

46 Flu A (H1N1)v vaccine Side effects similar to seasonal flu vaccines Headache, fatigue, fever, arthralgia, myalgia and pain and redness at injection site Other rare side effects detailed in the SPC If second dose delayed, do not need to restart course but protection delayed.

47 H1N1 Immunisation Programme Site and Route Route intramuscular Site: -deltoid for children over 1 year and adults -anterolateral aspect of thigh for infants under 1 year old Site and route can affect both the immunogenicity and reactogenicity of the vaccine

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49 H1N1 Immunisation Programme Method To give a vaccine by IM injection: gently stretch the skin flat between your thumb and forefinger Insert the needle at a 90º angle Quickly push the needle straight down into the muscle (it is not necessary to aspirate first) Inject slowly to reduce pain

50 Phase 2 - Recording H1N1 immunisation should be recorded as per the current childhood immunisation method i.e. practices should complete the SIRS-generated schedule lists and return to the Screening Department for input into the SIRS system, as well as recording on their own GP systems. Opt out practices send schedule lists and recording sheets to SIRS

51 H1N1 Immunisation Programme Document the following Product name of the vaccine Batch number this is necessary in case problems associated with a particular batch are identified at a later date Expiry date recording this provides evidence that it was checked prior to administration The date given The site of injection Name and signature of immuniser

52 Flu A (H1N1)v vaccine Vaccines are not interchangeable Co-administration with other vaccines Side effects monitored by Yellow card scheme swine flu ADR Portal at flu

53 Public Flu A (H1N1)v vaccine: communications TV/radio Leaflets/posters Vaccination record card Professional Fact sheets/q&as/dvd Template letter for GPs to invite patients Green Book chapter Websites

54 Resources Green Book chapter available online HPS website NES website Department of Health website PHPU

55 Any questions?