Guidance

Meningococcal ACWY programme: information for healthcare professionals

Updated 26 June 2024

Background

In 2015, Public Health England (PHE) reported an increase in endemic Neisseria meningitidis capsular group W sequence Type 11 clonal complex (MenW:cc11) associated with severe invasive disease in England and Wales.

The rise was initially recorded in 2009, with cases in England increasing steadily from 22 in 2009 to 117 cases in 2014. For the first time in a decade, MenW-related deaths were observed in young children and an increase in MenW cases among students attending universities suggested that carriage and transmission of this particular hypervirulent strain had become established across the country.

The JCVI minutes in February 2015 noted that the increase in MenW cases in England and Wales constituted a national outbreak and recommended a national immunisation programme aimed at protecting adolescents against meningococcal capsular groups A, C, W and Y (MenA, MenC, MenW and MenY) strains. This was considered the best option to protect adolescents directly and, at the same time, providing indirect (herd or population) protection across all age groups.

The details of the MenACWY vaccination programme were set out in the bipartite letter which was published on 22 June 2015. This comprised of the introduction of routine adolescent MenACWY vaccination at 13-15 years of age (school years 9 and 10) and a catch up programme for 15-17 year-olds on 31 August 2015. Those entering university or other Higher Education Institutions who had not received MenACWY vaccine were eligible for the vaccine through general practice until their 25th birthday.

Following the MenACWY programme introduction, MenW invasive disease peaked at 255 cases in 2016/17, and then decreased to 194 cases in 2017/2018 and 113 cases in 2018/2019. The programme was also associated with substantial reductions in MenY cases across all age groups, with MenC cases already at very low levels due to the successful MenC vaccination programme; MenA cases are extremely rare in the UK (Campbell and others 2022^{[footnote 1]}).

The COVID pandemic and its associated restrictions from 23 March 2020 was associated with large declines in invasive meningococcal disease nationally. From July 2021, COVID-19 containment measures were withdrawn in England and total IMD increased, but cases of MenW, MenY and MenC remain very low. During the 2021/22 epidemiological year, there were 13 MenW cases compared to 5 cases in 2020/ 2021 and 78 cases during 2019/2020.

IMD cases by capsular group during 2021/2022 (week 27 2021 to week 26 in 2022) are reported in Invasive meningococcal disease in England: annual laboratory confirmed reports for epidemiological year 2021 to 2022 - GOV.UK (www.gov.uk) when MenB disease accounted for 87% (179 out of 205) of all cases, followed by MenW (n=13, 6%), and MenY (n=2). One case each of MenC, MenA and MenE were reported and 8 were ungrouped or ungroupable.

The GOV.UK website has resources including guidance documents and leaflets relating to the Meningococcal ACWY (MenACWY) vaccination programme.

Meningococcal disease

The Green book chapter 22 includes detailed information on meningococcal disease, the history and epidemiology of the disease and the vaccination programme.

Meningococcal disease is caused by invasive infection with the bacterium Neisseria meningitidis, also known as the meningococcus. There are 12 identified capsular groups, of which groups B, C, W and Y were historically the most common in the UK. Since the introduction of the routine MenC vaccination programme, cases of invasive MenC disease have reduced dramatically, with MenB accounting for the majority of cases, both before and after the COVID-19 pandemic.

Meningococci colonise the nasopharynx of humans and are mostly harmless commensals. Between 5% and 11% of adults and up to 25% of adolescents carry the bacteria without any signs or symptoms of the disease. A study looking at Social Behavior and Meningococcal Carriage in British Teenagers found that, in infants and young children, the carriage rate is very low.

Meningococcal disease is transmitted by respiratory aerosols, droplets or by direct contact with the respiratory secretions of someone carrying the bacteria. The incubation period is from 2 to 7 days and the onset of disease varies from insidious with mild prodromal symptoms to fulminant with acute and overwhelming systemic infection.

Meningococcal infection most commonly presents as either meningitis or septicaemia, or a combination of both. Infection with the hypervirulent MenW:cc11 were associated with atypical clinical presentations, including septic arthritis and severe respiratory tract infections (including pneumonia, epiglottitis, and supraglottitis) being over-represented among MenW cases compared with other meningococcal groups. Adolescents and young adults with MenW:cc11 disease also presented primarily with gastrointestinal symptoms without the characteristic rash making clinical diagnosis of the disease difficult.

Meningococcal disease can affect all age groups, but the highest rates of disease are in children under 5 years of age, with the peak incidence in those under 1 year of age. There is a smaller second peak in incidence in young adolescents aged 15 to 19 years.

Meningococcal ACWY vaccination programme

Purpose of the routine programme

In 2015, the JCVI reviewed all the available evidence and advised:

• transmission of MenW:cc11 had been seen across all age groups and across all regions in England indicating that the strain was now endemic
• the highest rates of carriage were observed in the adolescent population with evidence of sustained transmission, particularly among students attending universities
• those at highest risk of complications were young children. For the first time in the past decade, MenW-related deaths had occurred in this age group

To ensure that best protection would be achieved across all age groups, JCVI recommended that the adolescent MenC vaccine, which was routinely administered at around 14 years of age, be directly replaced with the MenACWY conjugate vaccine from 1 September 2015 as an outbreak control measure. The aim was to provide direct protection against MenW disease to those in academic school years 9 or 10 (13 to 15 year olds), and to prevent carriage and transmission within the adolescent population, thus providing indirect (herd) protection across the population.

There was also a time-limited initial catch up for older teenagers and for new university entrants (freshers) in order to curtail the outbreak. Although this is no longer in place, the vaccine is available to adolescents and young adults who missed their school offer until their 25th birthday.

The MenACWY vaccine continues to offer excellent protection against MenC as well as offering additional protection against MenW, and MenY

Eligible cohort

The purpose of the MenACWY programme is to actively offer a single dose of MenACWY conjugate vaccine to:

• all teenagers – this is usually administered in school year 9 or 10 (at around age 14 years)
• anyone, once eligible for the routine programme, until their 25th birthday if they have an unknown or incomplete MenACWY vaccination history
• anyone aged 10 years up to their 25th birthday if they have an incomplete or unknown MenC vaccination history

Further education students

There is an increased risk of invasive meningococcal disease for new university entrants, with exposure to the bacteria often occurring in the first few days to months of starting university, particularly during the ‘freshers’ period at the start of the university year.

University and further education college entrance provides an opportunity to raise awareness of the signs and symptoms of invasive meningococcal disease, to promote vaccination and to check an individual’s vaccination history and offer any missed doses of vaccine. The vaccine should ideally be administered at least 2 weeks before attending university or college to ensure timely protection.

If a prospective student’s immunisation history cannot be confirmed, it is acceptable to offer a dose of MenACWY conjugate vaccine. A toolkit for Higher Education institutions that covers IMD and vaccination messaging and supporting resources is available to download.

Individuals with previously confirmed invasive meningococcal disease

Individuals that have previously had meningococcal disease should be offered the vaccine if they are in one of the eligible groups. This will provide protection against additional meningococcal capsular groups.

Other eligible groups

Individuals with an increased risk of meningococcal disease due to an existing medical condition or treatment, travel, occupational exposure or close contact with a case of meningococcal disease may also be eligible to receive the MenACWY conjugate vaccine.

Pregnant individuals in the eligible cohort

Healthcare professionals should discuss the benefits of vaccination with pregnant and breastfeeding women and can give the vaccine against a patient specific direction (PSD) rather than a PGD.

Many countries, including the UK, routinely recommend inactivated vaccines for pregnant women to offer protection against a number of serious illnesses such as influenza and pertussis (whooping cough). These are offered as part of the established vaccine in pregnancy programme, with no safety concerns being reported for such programmes by the MHRA.

Those who are pregnant should be advised that MenACWY vaccines offer protection against four different meningococcal groups that can cause serious invasive disease. The vaccines do not contain any live bacteria and can be safely administered to pregnant or breast-feeding women, without any evidence of harm to the baby.

While pregnancy itself does not elevate the risk of acquiring meningococcal disease, those in the eligible age cohort have been recommended to receive the vaccine by the JCVI and should be encouraged to be immunised while they remain eligible.

Pregnant women who decline the routine MenACWY vaccination during pregnancy should be offered the vaccine after delivery if they remain eligible for the vaccine according to their age, previous vaccination history and/or underlying medical condition. In the context of potential exposure as a close contact of a confirmed case or an outbreak, the benefits of vaccination alongside minimal risks should be highlighted to the pregnant woman.

Opportunistic provision of MenACWY vaccine

The General Medical Service (GMS) Statement of Financial Entitlement (SFE) makes provision for GP practices to offer MenACWY vaccine opportunistically or if requested by an eligible individual to adolescents and young adults (less than 25 years of age) who miss the routine, school based MenACWY vaccination programme that usually takes place during school years 9 or 10.

Vaccination of those outside of the immunisation programme

Nimenrix, MenQuadfi and Menveo vaccines are licensed for use in children (from 6 weeks, 12 months and 2 years respectively), adolescents and adults at risk of invasive disease from Neisseria meningitidis A, C, W and Y. Those who are not eligible to receive the vaccine as part of the national programme, but who wish to pay privately for the vaccine should discuss their request with a private provider.

GPs are not able to charge their own patients (those registered at their practice) a private fee for the vaccine and should not use centrally procured stock from the national programme to vaccinate private patients. Those seeking the vaccine privately should be made aware that they will be liable for the full costs of the vaccine and any additional administration charges that the private provider may apply.

Individuals that have already received the MenC conjugate vaccine at the age of 10 years or over

Those who have already received a MenC vaccine over the age of 10 years should still be offered MenACWY conjugate vaccine at the recommended age to ensure protection against the additional capsular groups A, W and Y. The MenACWY conjugate vaccine can be administered at any interval after MenC vaccine.

Individuals that have already received MenACWY conjugate vaccine at the age of 10 years or over

Those who have already received a MenACWY conjugate vaccine at the age of 10 years or over for example, for travel purposes, do not require an additional dose as part of the routine MenACWY immunisation programme.

Individuals who are identified as a close contact of a confirmed case of meningococcal disease due to serogroups A, C, W or Y will be offered a dose of MenACWY conjugate vaccine if they have not received a dose in the preceding 12 months.

Individuals that have already received MenACWY conjugate vaccine under the age of 10 years

Those who have received a MenACWY conjugate vaccine under the age of 10 years (for example, for travel purposes or because they were a close contact of a confirmed case of meningococcal infection), will require an additional dose when they are 10 years and over (as part of the MenACWY immunisation programme at around age 14 years unless required earlier).

Individuals that have received previous MenACWY polysaccharide vaccine

Meningococcal polysaccharide vaccines are discontinued and no longer licensed in the UK. Previous vaccination with meningococcal polysaccharide vaccines should not be counted as a valid dose when taking a history from the individual, their parent or carer.

The benefits of immunisation with conjugate vaccine outweigh any potential or theoretical harm associated with re-vaccination after polysaccharide vaccine. Therefore, MenACWY conjugate vaccine should be given irrespective of the time interval since any MenACWY polysaccharide vaccine.

MenACWY vaccine

The recommended vaccines

The recommended vaccines for the programme are the conjugate MenACWY vaccines Menveo, Nimenrix and MenQuadfi. These three vaccines will continue to offer protection against MenC, while offering additional protection against groups A, W and Y. All three vaccines are licensed for use in adolescents and adults and can be safely given with other routine adolescent vaccines. They do not protect against MenB disease – note that a licenced MenB vaccine (Bexsero: 4CMenB) has been part of the routine infant schedule since September 2015.

MenQuadfi is a black triangle medication which means it is subject to additional monitoring. Healthcare professionals are asked to report all suspected adverse reactions to the MHRA’s Yellow Card scheme, (see green book, chapter 9).

Vaccine ordering

MenACWY conjugate vaccines are available to order via ImmForm.

Not all of the 3 MenACWY vaccine brands may be available to order. Healthcare professionals are reminded to only order what they need for a 2 to 4 week period rather than over-ordering or stockpiling vaccines. Vaccines should be ordered, stored and monitored as described in chapter 3 (Storage, distribution and disposal of vaccines) of the green book.

Vaccine dosage

MenACWY vaccine should be administered as a single dose only. The need for, and the timing of a booster dose of MenACWY vaccine, has not yet been determined and therefore is not currently recommended.

Vaccine administration

Menveo and Nimenrix vaccines should be reconstituted according to the manufacturer’s instructions. MenQuadfi does not require reconstitution and comes in a single dose vial.

All 3 vaccines should be administered via intramuscular injection (IM) into the deltoid muscle in the arm (or the anterolateral aspect of the thigh if necessary).

Healthcare professionals should be familiar with the manufacturer’s summary of product characteristics (SPC) and the patient group direction (PGD) to ensure that vaccines are reconstituted, supplied and administered correctly.

• Menveo Summary of Product Characteristics (SPC)
• Nimenrix Summary of Product Characteristics (SPC)
• MenQuadfi Summary of Product Characteristics (SPC)
• MenACWY vaccine: patient group direction (PGD)

Menveo, Nimenrix and MenQuadfi shelf life

Menveo has a shelf life of 2 years, Nimenrix has a shelf life of 3 years and MenQuadfi has a shelf life of 42 months when stored in their original packaging in a refrigerator at the recommended temperatures of +2°C to +8°C.

Contraindications for receiving MenACWY vaccines

There are very few individuals who cannot receive meningococcal vaccines. Where there is doubt, appropriate advice should be sought from a consultant with immunisation expertise, a member of the screening and immunisation team or from the local health protection team rather than withholding immunisation.

MenACWY conjugate vaccines should not be administered to those who have had:

• a confirmed anaphylaxis to a previous dose of the vaccine OR
• a confirmed anaphylaxis to any constituent or excipient of the vaccine

For the composition and full list of excipients of the vaccine, please refer to the manufacturer’s summary of product characteristics.

Inadvertent vaccine administration errors

Failure to reconstitute Menveo or Nimenrix vaccine correctly

If a Menveo or Nimenrix MenACWY vaccine is not reconstituted correctly, the actions below should be taken as the individual may require a repeat dose of vaccine. If a repeat dose is required, it should be given on the same day or as soon as possible.

Health professionals should report the administration error via their local governance system(s) so that appropriate action can be taken, lessons can be learnt and the risk of future errors minimised.

Administration of Menveo vaccine without the MenA component

Health professionals should inform the patient of the administration error and reassure them that no further action is required. The purpose of the routine adolescent programme is to ensure protection against meningococcal capsular groups C and W. In the UK, MenA infections are extremely rare and, therefore, they do not require an additional dose of vaccine. If in the future the patient plans to travel to a country where protection against MenA is required, then they should be advised to be immunised with a further dose of MenACWY conjugate vaccine at that time.

Administration of Nimenrix diluent without reconstituting with the vaccine powder

Nimenrix vaccine must be reconstituted by adding the entire contents of the pre-filled syringe of solvent to the vial containing the ACWY powder. In the event a health professional administers the contents of the prefilled syringe without reconstituting the vaccine powder, the vaccination will need to be repeated as the solvent alone will not offer any protection against meningococcal capsular groups ACWY.

Administration of an incomplete dose

If an incomplete dose of MenACWY vaccine is administered, the dose will need to be repeated as the incomplete dose may not be sufficient to evoke a full immune response. Where possible, the dose of MenACWY vaccine should be repeated on the same day or as soon as possible thereafter.

Further resources

Public Health England/ NHS England. Meningococcal ACWY conjugate vaccination (MenACWY) www.gov.uk/government/publications/menacwy-vaccine-introduction

UK Health Security Agency. Immunisation against infectious diseases: meningococcal chapter 22 www.gov.uk/government/publications/meningococcal-the-green-book-chapter-22

Vaccines communications toolkit for universities and other higher educational settings Immunisation - GOV.UK (www.gov.uk)

UKHSA meningococcal leaflets, consent forms, PGD, information for healthcare practitioners (including a set of teaching slides) and other MenACWY-specific materials Meningococcal ACWY (MenACWY) vaccination programme - GOV.UK (www.gov.uk)

Meningitis Research Foundation www.meningitis.org/

Meningitis Now www.meningitisnow.org/

NHS Choices 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

Reference

1. Campbell H, Andrews N, Parikh S, White J, Edelstein M, Bai X, Lucidarme J, Borrow R, Ramsay M and Ladhani S. Impact of an adolescent meningococcal ACWY immunisation programme to control a national outbreak of group W meningococcal disease in England: a national surveillance and modelling study Lancet Child Adolescent Health 2022 Feb 6;(2): 96-105 ↩