1. Introduction of a meningococcal ACWY immunisation programme for adolescents An update for healthcare professionals July 2015 PHE publications gateway number: 2015172

2. Key Message Meningococcal disease is caused by invasive infection with the bacterium Neisseria meningitides also known as meningococcus There are 12 capsular groups of meningococcus of which group B, C, W and Y were historically more common in the UK Invasive meningococcal disease most commonly presents as meningitis or septicaemia and can affect all age groups, particularly children under 2 years The meningococcal bacteria colonises the nasopharynx of humans. Between 5-11% of adults and up to 25% of adolescents carry the bacteria without any signs or symptoms Replacing the Men C vaccine in adolescents with MenACWY conjugate offers wider direct protection against capsular groups A, C, W and Y whilst preventing carriage of the disease in this age group 2Immunisation against meningococcal ACWY disease for adolescents

3. Meningococcal ACWY programme 1. Urgent Catch-up programme commencing August 2015 Adolescents in the 2014/15 academic school year 13 (DOB 01/09/1996- 31/08/1997) ie those aged 17-18 years should be offered MenACWY conjugate vaccine from 1 August 2015 as part of a GP led call and recall immunisation programme in England. Those eligible to receive the vaccine should be called and recalled on the basis of age It is strongly recommended that adolescents in this cohort are immunised as soon as practically possible once the vaccine is available and prior to the start of the 2015/16 academic year The catch up programme will run from 1 August 2015 until 31 March 2016 The vaccine should offered to all adolescents in the eligible cohort regardless of their intention to continue into further education. 3Immunisation against meningococcal ACWY disease for adolescents

4. Meningococcal ACWY programme 2. First time university entrants up to 25 years commencing August 2015 From the 1 August 2015, GP practices should opportunistically offer the MenACWY conjugate vaccine to older first-time university entrants up to the age of 25 years Vaccine directly replaces the MenC vaccine as part of the “freshers” programme. This includes those who may have previously received the MenC vaccine at 10 years or over First time university entrants aged less than 25 years who have previously received a dose of MenACWY conjugate vaccine 10 years or over do not require an additional dose of vaccine 4Immunisation against meningococcal ACWY disease for adolescents

5. Meningococcal ACWY programme 3. Routine cohort commencing September 2015 Commencing on 1 September 2015 adolescents in academic years years 9 or 10 or both* ie those aged between 13-15 years, will be offered the MenACWY conjugate vaccine as part of the routine adolescent school based immunisation programme in England. The vaccine will directly replace the MenC vaccine offered as part of the adolescent programme- “around 14 years” 5Immunisation against meningococcal ACWY disease for adolescents

6. Meningococcal ACWY programme 4. Second Catch-up cohort commencing January 2016 Additionally, a further catch up programme is also scheduled to commence from January 2016 for adolescents aged 15-16 years (DOB 01/09/1999 - 31/08/2000) in the 2015/16 academic school year 11 delivered as part of a school based catch-up immunisation programme in England. 5. Third catch-up campaign A further element of the catch-up campaign is being planned in to cover current school years 11 and 12 when these students reach year 13. The delivery route of vaccination for this age group will be confirmed before the end of 2015 6Immunisation against meningococcal ACWY disease for adolescents

7. CohortsAcademic YearAge/ Dates of Birth Urgent catch-up programme Commencing 1 August 2015 to 31 March 2016 Year 13 (2014/15 academic year) GP led call and recall model Aged 17-18 years Those born on or after 1 September 1996 to 31 August 1997 “Freshers” programme Commencing 1 August 2015 First time university entrants up to 25 years GP opportunistic delivery model Routine adolescent programme Commencing 1 September 2015 Years 9 or 10 or both* School based delivery model Aged 13-15 years Direct replacement of MenC adolescent vaccine 2 nd Catch- up programme Commencing January 2016 Year 11 (2015/16 academic year) School based delivery model Aged 15-16 years Those born on or after 1 September 1999 to 31 August 2000

8. Vaccine supply Vaccine will become available at different times for the different cohorts covered: From July 2015 :for current school year 13s and older university entrants through GPs From August 2015: for routine adolescent programme through schools From January 2016 : for current school year 10 (then school year 11) From April 2016: for the current school year 12s (then school year 13) From April 2017: for the current school year 11s (then school year 13) PHE will have less buffer stock than is usually be the case for a national programme Increased risk of temporary ordering restrictions/or vaccines may become temporarily unavailable. We will aim to ensure that any periods of supply disruption are minimised 8Immunisation against meningococcal ACWY disease for adolescents

9. Aim of resource To raise awareness of invasive meningococcal disease (IMD) epidemiology and the impact of IMD on infants and adolescents To support and educate healthcare professionals involved in discussing immunisation against meningococcal ACWY disease with patients, parents or carers To promote the uptake of meningococcal ACWY vaccine through increasing awareness in healthcare professionals involved in immunisation 9Immunisation against meningococcal ACWY disease for adolescents

10. Learning outcomes After completing this training, healthcare professionals will be able to: Describe the aetiology and epidemiology of meningococcal disease Be aware of the most common types of meningococci in the UK and their relationship in causing invasive meningococcal disease Advise and inform patients or parents/carers of those who are eligible around the importance of replacing the Men C vaccine with MenACWY vaccine in England, providing evidence based information Understand the healthcare professionals role in supporting the implementation of the meningococcal B immunisation programme Identify sources of additional information and resources 10Immunisation against meningococcal ACWY disease for adolescents

11. Contents 1.What is meningococcal disease 2.Why replace the Men C vaccine in adolescents with MenACWY 3.Immunisation against meningococcal ACWY disease and the use of Menveo® or Nimenrix® 4.The role of health care professionals 5.Resources 11Immunisation against meningococcal ACWY disease for adolescents

12. What is meningococcal disease 12Immunisation against meningococcal ACWY disease for adolescents

13. What is meningococcal disease? Meningococcal disease occurs as a result of an invasive bacterial infection caused by Neisseria meningitidis also known as meningococci There are 12 identified capsular groups of meningococcus, groups B, C, W and Y are the most common in the UK Meningococcal infection most commonly presents as either meningitis or septicaemia, or a combination of both Highest rates of disease are in children under 2 years, particularly infants aged 5 months although invasive disease can occur at any age 13Immunisation against meningococcal ACWY disease for adolescents

14. Cont’d… Since the introduction of the routine meningococcal C conjugate immunisation programme, cases of invasive meningococcal disease (IMD) in the UK from group C have reduced dramatically capsular group B now accounts for approximately 80% of all laboratory confirmed cases reported to Public Health England Although cases of meningococcal disease overall has been in decline since 2000, cases of capsular group W were first observed in previously healthy adults in 2009 In 2011, cases of meningococcal W had extended across all age groups and across all regions in England, indicating the strain is now endemic 14Immunisation against meningococcal ACWY disease for adolescents

15. Neck stiffness & muscle pain Babies and toddlersChildren and young adults Fever with poor peripheral perfusion Poor feeding, refusing food or vomitingVomiting Tense, bulging fontanelle and photophobia Severe headache and photophobia Fretful, unusual cry, moaning or rapid breathing Confusion and irritability Neck stiffnessNeck stiffness and muscle pain Pale blotchy complexion &/or non blanching rash that does not fade when a glass is rolled over it Drowsy & loss of consciousness Symptoms can appear in any order, some may not appear at all. 15Immunisation against meningococcal ACWY disease for adolescents Clinical presentation of meningococcal disease

16. The meningococcal rash A distinctive red rash can appear anywhere on the body The rash is formed of tiny “pinpricks” also known as petechiae and appears red in colour. The rash may later develop into purple bruising of the skin The meningococcal rash can be distinguished from other rashes by pressing a glass tumbler against it A meningococcal rash will not fade when a glass tumbler is rolled over it A febrile illness and rash that does not fade is a sign of meningococcal septicaemia 16 The ‘tumbler’ test picture courtesy of Meningitis Research Foundation http://www.meningitis.org/symptoms Immunisation against meningococcal ACWY disease for adolescents

17. Transmission, infectivity, incubation and carriage Transmission is through person to person spread from respiratory aerosols, droplets or by direct close contact with respiratory secretions of someone who is carrying the bacteria Infectivity of meningococcal is relatively low and requires prolonged close contact, for example those living in the same household or through direct contact with nose and respiratory secretions such as intimate “wet” kissing Incubation period ranges from 2 to 7 days with the onset of disease ranging from severe with overwhelming features to insidious mild prodromal symptoms Meningococcus colonises the nose and throat of humans. Between 5-11% of adults and up to 25% of adolescents carrying the bacteria 17Immunisation against meningococcal ACWY disease for adolescents

18. Potential complications of meningococcal disease It is estimated that approximately one quarter of those diagnosed with meningococcal disease caused by Neisseria meningitides will suffer complications as a result Complications can vary in severity and can either be temporary or permanent. The more severe the disease, the greater the risk of complications Complications can include Loss of hearing, loss of vision, loss of memory and/or concentration, difficulties in coordination and balance, epilepsy, cerebral palsy, limb amputations and may result in death 18Immunisation against meningococcal ACWY disease for adolescents

19. Why replace the Men C vaccine in adolescents with MenACWY 19Immunisation against meningococcal ACWY disease for adolescents

20. Why replace the Men C vaccine in adolescents with MenACWY Although cases of meningococcal disease overall have been in decline since 2000, cases of meningococcal W were first observed in previously healthy adults in 2009 In 2011, cases had extended across all age groups and across all regions in England, indicating the strain had become endemic For the first time in a decade, meningococcal W related deaths have been observed in young infants, particularly those under 2 years of age Additionally, an increase in MenW cases among university students across the country suggests that carriage and transmission of bacteria has become established 20Immunisation against meningococcal ACWY disease for adolescents

21. Cont’d… In February 2015, the JCVI agreed that the current increase in meningococcal W cases in England and Wales constitutes an outbreak As control measure, an immunisation programme has been recommended for all adolescents aged 14-18 years and includes replacing the adolescent dose of MenC with MenACWY Operationally, adolescents aged between 13-18 years will be offered the vaccine as part of routine and catch up programmes, including “freshers” up to the age of 25 years This continues to ensure direct protection against meningococcal C as previously recommended and additionally against capsular groups W, A and Y JCVI agreed this was the best option as it generates population level herd immunity, providing protection across all other age groups, including infants who are most at risk 21Immunisation against meningococcal ACWY disease for adolescents

22. 22Immunisation against meningococcal ACWY disease for adolescents

23. Changes to MenC conjugate vaccine schedule 23Immunisation against meningococcal ACWY disease for adolescents

24. Immunisation against meningococcal ACWY disease -The use of Menveo® AND Nimenrix® vaccines 24Immunisation against meningococcal ACWY disease for adolescents

25. The recommended vaccine (s) Brand name: Menveo® Generic Name: meningococcal group A oligosaccharide; meningococcal group C; meningococcal group W135 oligosaccharide; meningococcal group Y oligosaccharide Multi-component group A, C, W135 and Y conjugate vaccine marketed by GlaxoSmithKline Licensed for use in children from 2 years, adolescents and adults at risk of invasive disease from Neisseria meningitidis A, C, W and Y and be safely given with other routine adolescent vaccines Recommended for adolescents and adults as part of a routine and catch- up immunisation programme 25Immunisation against meningococcal ACWY disease for adolescents

26. The recommended vaccine (s) Menveo® is one of two vaccines recommended for the routine MenACWY immunisation programme for adolescents Menveo® will be centrally supplied through Immform It is important immunisers familiarise themselves with the vaccine and its product information to avoid administration errors 26 Image courtesy of GSK Immunisation against meningococcal ACWY disease for adolescents

27. Administration of Menveo® Menveo® should be administered via intramuscular injection (IM) into the arm (deltoid muscle) The vaccine is supplied containing two separate vials- one vial containing Men A (powder) and the second vial containing MenCWY (solution) The MenCWY solution should be injected into the MenA powder to reconstitute Invert and shake the solution and powder vigorously and withdraw 0.5 ml of reconstituted product. It is normal for a small amount of liquid to remain in the vial following withdrawal of the dose One dose equals 0.5mls 27Immunisation against meningococcal ACWY disease for adolescents

28. Cont’d… After reconstitution, the solution should be clear, colourless to light yellow and free from visible foreign particles Prior to administration, healthcare professionals should change the needle for a suitable needle for IM administration into the deltoid muscle The vaccine should not be administered where there are variations in physical appearance or signs of foreign particulate are observed after shaking 28Immunisation against meningococcal ACWY disease for adolescents

29. The recommended vaccine (s) Brand name: Nimenrix® Generic Name: Neisseria meningitidis group A polysaccharide, Neisseria meningitidis group C polysaccharide, Neisseria meningitidis group W-135 polysaccharide, Neisseria meningitidis group Y polysaccharide Multi-component group A, C, W135 and Y conjugate vaccine marketed by GlaxoSmithKline Licensed for use in children from 12 months, adolescents and adults at risk of invasive disease from Neisseria meningitidis A, C, W and Y and be safely given with other routine adolescent vaccines Recommended for adolescents and adults as part of a routine and catch- up immunisation programme 29Immunisation against meningococcal ACWY disease for adolescents

30. The recommended vaccine (s) Nimenrix® is one of two vaccines recommended for the routine MenACWY immunisation programme for adolescents Nimenrix® will be centrally supplied through Immform It is important immunisers familiarise themselves with the vaccine and its product information to avoid administration errors 30 Image courtesy of GSK Immunisation against meningococcal ACWY disease for adolescents

31. Administration of Nimenrix® Nimenrix® should be administered via intramuscular injection (IM) into the arm (deltoid muscle) The vaccine is supplied containing one vial of powder and one pre-filled syringe The contents of the pre-filled syringe should be vigorously mixed with the contents of the vial prior to administration providing one dose- 0.5mls After reconstitution, the solution should be clear, colourless to light yellow and free from visible foreign particles The vaccine should not be administered where there are variations in physical appearance or signs of foreign particulate are observed after shaking 31Immunisation against meningococcal ACWY disease for adolescents

32. Administration of Menveo® OR Nimenrix ® Menveo® or Nimenrix® should 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 32Immunisation against meningococcal ACWY disease for adolescents aged

33. Contraindications Menveo® OR Nimenrix® should not be administered to those who have had: 1. A confirmed anaphylaxis to a previous dose of the vaccine OR 2.A confirmed anaphylaxis to any constituent or excipient of the vaccine There are very few individuals who cannot receive meningococcal vaccines Where there is doubt, appropriate advice should be sought rather than withholding immunisation 33Immunisation against meningococcal ACWY disease for adolescents

34. Precautions Minor illnesses without fever or systemic upset are not valid reasons to postpone immunisation Pregnancy and breast-feeding Meningococcal vaccines may be given to pregnant women when clinically indicated. There is no evidence of risk from vaccinating pregnant women or those who are breast-feeding with inactivated virus or bacterial vaccines or toxoids Immunosuppression and HIV infection Individuals with immunosuppression and human immunodeficiency virus (HIV) infection (regardless of CD4 count) should be given meningococcal vaccines in accordance with the routine schedule 34Immunisation against meningococcal ACWY disease for adolescents

35. Possible adverse reactions (adolescents) Pain, tenderness, swelling or redness at the injection site and mild fever Older children and adults: headaches, nausea, rash and malaise Neurological reactions such as dizziness, febrile/afebrile seizures, faints, numbness and hypotonia are very rare 35Immunisation against meningococcal ACWY disease for adolescents

36. Reporting suspected adverse reactions Yellow card scheme All suspected adverse reactions should be reported to the MHRA using the yellow card scheme Success depends on early, complete and accurate reporting Report even if uncertain about whether vaccine caused condition http://mhra.gov.uk/yellowcard See chapter 8 of Green Book for details 36Immunisation against meningococcal ACWY disease for adolescents

37. The role of healthcare professionals To provide clear, concise and accurate information to patients, parents or carers of those receiving the MenACWY vaccine as part of the routine adolescent immunisation programme Every effort should be made by healthcare professionals to maximise the uptake of the meningococcal ACWY vaccine in adolescents and to ensure that patients, parents or carers are fully informed about the importance of ensuring protection against meningococcal ACWY disease 37Immunisation against meningococcal ACWY disease for adolescents

38. Key Message Meningococcal disease is caused by invasive infection with the bacterium Neisseria meningitides also known as meningococcus There are 12 capsular groups of meningococcus of which group B, C, W and Y were historically more common in the UK Invasive meningococcal disease most commonly presents as meningitis or septicaemia and can affect all age groups, particularly children under 2 years The meningococcal bacteria colonises the nasopharynx of humans. Between 5-11% of adults and up to 25% of adolescents carry the bacteria without any signs or symptoms Replacing the Men C vaccine in adolescents with MenACWY offers wider direct protection against capsular groups A, C, W and Y whilst preventing carriage of the disease in this age group 38Immunisation against meningococcal ACWY disease for adolescents

39. Useful links Public Health England/ NHS England. Meningococcal ACWY conjugate vaccination (MenACWY). https://www.gov.uk/government/publications/menacwy-vaccine-introduction https://www.gov.uk/government/publications/menacwy-vaccine-introduction Public Health England. Immunisation against infectious diseases: meningococcal chapter 22. https://www.gov.uk/government/publications/meningococcal-the-green- book-chapter-22 https://www.gov.uk/government/publications/meningococcal-the-green- book-chapter-22 Public Health England. Meningococcal group W (MenW) immunisation advised for 14 to 18 year-olds. [internet] https://www.gov.uk/government/news/meningococcal-group-w-menw- immunisation-advised-for-14-to-18-year-olds https://www.gov.uk/government/news/meningococcal-group-w-menw- immunisation-advised-for-14-to-18-year-olds Public Health England. meningococcal leaflets https://www.gov.uk/government/collections/meningococcal-acwy-menacwy- vaccination-programme https://www.gov.uk/government/collections/meningococcal-acwy-menacwy- vaccination-programme 39Immunisation against meningococcal ACWY disease for adolescents

40. Cont’d… Meningitis Research Foundation: http://www.meningitis.org/http://www.meningitis.org/ Meningitis Now. https://www.meningitisnow.org/https://www.meningitisnow.org/ NHS Choices. http://www.nhs.uk/conditions/Meningitis/Pages/Introduction.aspxhttp://www.nhs.uk/conditions/Meningitis/Pages/Introduction.aspx Joint Committee on Vaccination and Immunisation. www.gov.uk/government/groups/joint-committee-on-vaccination-and- immunisation www.gov.uk/government/groups/joint-committee-on-vaccination-and- immunisation 40Immunisation against meningococcal ACWY disease for adolescents

41. References 1. Ladhani, S. Beebeejaun, K. Lucidarme, J. Campbell, H. Gray, S. Kaczmarkski, E. Ramsay, M.E, Borrow, R. (2015). Increase in Endemic Neisseria meningitidis Capsular Group W Sequence Type 11 Complex Associated With Severe Invasive Disease in England and Wales. Clin Infect Dis. (2015) 60 (4): 578-585. [internet] accessed 15 June 2015. http://cid.oxfordjournals.org/content/60/4/578.long http://cid.oxfordjournals.org/content/60/4/578.long 2. Public Health England (2015) Health Protection Report: Continuing increase in meningococcal group W (MenW) disease in England. Weekly report. Vol 9. No.7. Published 27 February 2015. [internet]. Accessed 15 June 2015. https://www.gov.uk/government/uploads/system/uploads/attachment_data/fil e/407865/hpr0715_men-w.pdf https://www.gov.uk/government/uploads/system/uploads/attachment_data/fil e/407865/hpr0715_men-w.pdf 3. Joint Committee on Vaccination and Immunisation (2015). Minutes of the meeting 4 February 2015. [internet] accessed 15 June 2015. https://www.gov.uk/government/groups/joint-committee-on-vaccination-and- immunisation https://www.gov.uk/government/groups/joint-committee-on-vaccination-and- immunisation 41Immunisation against meningococcal ACWY disease for adolescents