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New meningococcal vaccines in the UK.

Two new vaccines to target invasive meningococcal disease (IMD) were introduced into the UK immunisation schedule in September 2015 (PHE, 2015). IMD has an average incidence of 2/100,000 per year in the UK (Ladhani et al, 2012). Since the introduction of the Meningococcal C (MenC) vaccine in the UK in 1999, IMD due to MenC has significantly decreased in children. Neisseria meningitidis serogroup B--MenB--now accounts for 87 per cent of all cases of IMD (Ladhani et al, 2012) making it the most common cause of meningitis in children aged three months and over (NICE, 2010).

In 2013-14 there were 636 reported cases of IMD in the UK, with MenB being responsible for 85 per cent and 92 per cent respectively in infants (<1 year) and toddlers (1-4 years) (PHE, 2015). The disease carries a significant mortality rate of 6 per cent, attributed to its rapid onset and progression (PHE, 2015), with MenB being responsible for 45 per cent of all deaths from meningitis (PHE, 2015). One-third of sufferers are left with defects in physical, cognitive or psychological functioning (Viner et al, 2012).

Above four years of age, the incidence of IMD due to MenB falls and the incidence of the other strains such as A, C, W and Y begins to increase. After the age of 25 years, the meningococcal strains most responsible for IMD are Y (80 per cent), C (59 per cent) and W (57 per cent) (PHE 2015). A dramatic change has been noticed in the incidence of the MenW strain in recent years with a year-on-year increase since 2009-10 (Campbell et al, 2015)--42 cases in 2012, 76 in 2013, and 117 in 2014 (PHE, 2015). Although initially detected only in adults, MenW cases are now being seen in children of all ages and adolescents, with university students living in crowded conditions such as halls of residence at increased risk (PHE, 2015). Carriage of the strain is highest among young adults who are thought to transmit to other age groups, causing 13 per cent of deaths in recent years from IMD (PHE, 2015).

This article largely discusses the two new meningococcal vaccines and common challenges that community practitioners may face with the introduction of new vaccines. It provides strategies as to how they can enhance uptake of immunisation in the community. Table 1 highlights the revised immunisation schedule to be followed in the UK from September 2015.

MENINGOCOCCAL B VACCINE

The Meningococcal B vaccine, known as 4CMenB, was introduced into the NHS vaccination schedule in September 2015. This inactivated combination vaccine is made up of three N. meningitidis proteins and N. meningitidis capsular group B outer membrane vesicles (PHE, 2015). It is licensed for use from two months of age in the UK and is marketed under the brand name Bexsero[R]. Administration is via intramuscular injection into the upper arm or anterolateral thigh (PHE, 2015). Doses will be given at two, four and 12 months of age (PHE, 2015). Research suggests that 4CMenB may protect against 88 per cent of meningococcal strains in circulation (Frosi et al, 2013) and the vaccine was shown to be 100 per cent immunogenic after the administration of three doses to infants (Vesikari et al, 2013).

MENINGOCOCCAL ACWY VACCINE

The MenACWY vaccine is made from capsular polysaccharides of N. meningitidis serogroups A, C, W and Y. The vaccine is marketed under two brand names: Menveo[R] and Nimenrix[R]. It will be offered to school children around the age of 14 years with the aim that everyone is vaccinated by the time they reach year 13 (PHE, 2015). This has replaced the MenC booster vaccine previously given at this age. There is also a catch-up regimen for first-time university students. Administration is by intramuscular injection in the upper arm. Research suggests MenACWY induced a "robust immune response" against all four serogroups of Meningococcus (Lalwani et al, 2015) and that five years after the vaccine was administered 79 per cent of cases still have immunity to C, W and Y serotypes (Baxter et al, 2015).

SAFETY OF THE NEW VACCINES

The addition of the 4CMenB vaccine to the revised immunisation schedule makes the UK the first country to offer a national, routine and publicly funded MenB vaccination programme in the world. The introduction of two new vaccines into the NHS immunisation schedule is likely to raise questions among parents and the public about their safety profile. Research into the safety of the 4CMenB vaccine has revealed a favourable safety profile (Sarfatti et al 2015), although there was found to be a resultant fever in 77 per cent of infants of more than [greater than or equal to] 38[degrees]C following administration of the vaccine (Vesikari et al, 2013; PHE 2015). The fever generally peaks at six hours post-immunisation and normally resolves by 48 hours. This is compared to an incidence of 45 per cent of febrile events noted after administration of other routine vaccines in childhood (Vesikari et al, 2013). The Joint Committee on Vaccination and Immunisation (JCVI) has therefore recommended that paracetamol be given to infants under the age of one year after administering the 4CMenB vaccine to reduce fever and other symptoms associated with immunisation, such as pain at the injection site (PHE 2015). Parents should be advised to seek medical advice if the child is unwell with a high fever or continues to need multiple doses of antipyretics 48 hours after immunisation (PHE, 2015). The Department of Health guidelines suggest the use of antipyretics on an as-required basis if a fever develops post-immunisation.

The MenACWY vaccine also has a good safety profile. Research performed in Russia in 2014 has shown no serious adverse effects when tested on 197 adolescents (Ilyina et al, 2014). Some common reactions to the vaccine include pain and swelling at the injection site as well as headache, nausea and malaise (PHE, 2015).

CONTRAINDICATIONS

It is important for community healthcare professionals to be aware of contraindications to available vaccines. Neither vaccine should be given to a patient with a confirmed anaphylactic reaction to a previous dose or a constituent of the vaccine. Specialists with an interest in immunisation, such as paediatricians and immunologists, should be contacted if there is any doubt about whether to administer the vaccine or not. Precautions should also be taken in infants born before or at 28 weeks gestation, as apnoea is more common in this group. However, as the 4CMenB vaccine is of particular benefit to premature infants, immunisation should not be delayed but preferably be performed in the hospital setting (PHE, 2015). Patients who are immunocompromised should also be given meningococcal vaccines in line with the normal schedule.

COST-EFFECTIVENESS OF NEW VACCINES

The UK is the first country to introduce the 4CMenB vaccine to their nationwide immunisation programme. Economic models from multiple countries initially indicated that the vaccine was unlikely to be cost-effective (Christensen et al, 2014). However, after further consideration the JCVI in the UK decided that the vaccine is cost-effective and recommended its use in the vaccination schedule (JCVI 2014; Sarfatti et al 2015). It is predicted that this introduction will reduce the cases of MenB by 26.3 per cent in the first five years (Christensen et al, 2014). Over 30 years, the impact of preventing transmission to other groups will result in a 51.8 per cent decrease in cases of Men B (Christensen et al, 2014). One of the vaccine components used in New Zealand during an outbreak of MenB demonstrated an efficacy of 73 per cent (Kelly et al, 2007). Data on the MeNZB vaccine showed it to be effective and provided good insight into further vaccine development (Holst et al, 2013).

The ACWY vaccine was also found to reduce carriage of meningococcal strains in a study of 2,954 university students across England in 2010-11. Serogroup Y carriage in adolescents was decreased by 39 per cent and serogroups CWY by 36.2 per cent (Read et al, 2014). Based on the high prevalence of carriage within the target age group, this is likely to be cost-effective in the long term. As well as reducing carriage, the vaccine given to adolescents is expected to have the greatest impact on IMD incidence, with a 74 per cent reduction over 40 years. (Vickers et al, 2015).

BENEFICIAL EFFECTS EXTEND TO THE COMMUNITY

As well as protecting individuals directly, vaccines have the ability to protect others by interrupting transmission of the organism through a phenomenon known as herd immunity. The same study carried out on 2,954 university students in England in 2010-11 showed that the MenB vaccine reduces carriage of the bacteria after 12 months compared to a control, thus decreasing carriage frequencies across the population (Read et al, 2014). This provides protection to those who haven't been immunised, including those in whom the vaccine is contraindicated. For effective herd immunity a high uptake of the vaccines in the normal population is necessary.

Herd immunity is of particular relevance with the ACWY vaccine. Follow up of 129 cases from the UK from 2010-13 showed that 81 per cent of cases of MenW had been previously healthy and had not travelled before illness (Campbell et al 2015). This highlights that the strain is "endemic and already established in carriage" (Campbell et al, 2015). The vaccines will target adolescents (13-18 years old) as this group shows the highest rate of carriage as well as the greatest increase in incidence of IMD (Campbell et al, 2015). The programme intends to respond to the rapid increase nationally and provide both direct immunity to the patients receiving vaccines, and indirect immunity to the rest of the population.

NO RISK OF VACCINE OVERLOAD

A common concern many parents have is that too many vaccines may result in "antigenic overload" with the immune system unable to respond safely to multiple vaccines at once. Others believe that the immune system of infants is too immature to respond to vaccines and they should be administered when it has had time to mature (Poland and Jacobson 2012). In fact, infants encounter more antigens and microorganisms from the moment they are born than the number presented to them in vaccines. Therefore there is no risk of vaccine overload (Poland and Jacobson 2012). Previous reports have highlighted that even if 11 vaccines were administered at one time to an infant, it would involve less than 0.1 per cent of the immune system (Hilton et al, 2006). Other reasons that parents may cite as to why their children can't receive immunisations include "because Dad is epileptic", or "I hate injections" (Paul et al, 2011). However, providing reassurance and information on the safety of vaccines can reduce anxiety and improve uptake of immunisation.

ROLE OF COMMUNITY PRACTITIONERS

Although vaccines are generally administered by practice nurses in GP surgeries and in schools, health visitors and community nurses have an important role to play in enhancing uptake through providing evidence-based and accurate information, providing reassurance and disspelling myths. From our clinical experience in dealing with families and the available literature, the following strategies are suggested, which may be useful to community practitioners (Sarfatti et al 2015; Paul et al, 2011; PHE 2015; JCVI 2014; Poland and Jacobson 2012).

* Provide relevant, up-to-date, evidence-based and non-biased information to parents regarding the new meningococcal vaccines.

* Explain that the vaccines have been introduced in light of the increasing prevalence and associated morbidity and mortality from other strains of Meningococcus such as MenB, MenW.

* Highlight the favourable safety profiles of both vaccines and the successful use of these vaccines in other countries around the world and in pilot studies in the UK.

* Explain the benefits of the vaccines in reducing the incidence of IMD and the long-lasting effects of vaccination.

* Explain the concept of herd immunity and the impact the new programme will have on reducing the incidence of IMD in other vulnerable groups in the community who have not received the vaccination--in the elderly population or those who are immuonosuppressed or have had a previous anaphylactic reaction to immunisation and therefore cannot receive the vaccine.

* Reassure that the new meningococcal vaccines will not overload the immune system and that vaccination only involves a very small proportion of the immune system following administration.

* Explain that even in cases where a child has had a confirmed case of IMD due to a particular strain of Meningococcus they must still have all the vaccines as per the existing immunisation schedule to protect against the multiple other strains capable of causing further illness in the child.

KATHERINE ELIZABETH LLOYD, fourth year medical student, University of Bristol

DR SIBA PROSAD PAUL, specialty trainee year 8 in Paediatrics, Yeovil District Hospital, Yeovil

DR ANIL KUMAR GARG, paediatrician, Worthing Hospital, Worthing

References

Baxter R, Baine Y, Kolhe D, et al (2015). Five-year antibody persistence and booster response to a single dose of Meningococcal A, C, W, and Y Tetanus Toxoid Conjugate Vaccine in adolescents and young adults: An open, randomized trial. The Paediatric Journal of Infectious Disease [Epub ahead of print]

Campbell H, Saliba V, Borrow R, et al (2015). Targeted vaccination of teenagers following continued rapid endemic expansion of a single meningococcal group w clone (sequence type 11 clonal complex). Eurosurveillance 20 (28): pii=21188.

Christensen H, Trotter CL, Hickman M, et al (2014). Te-evaluating cost effectiveness of universal meningitis vaccination (Bexsero) in England: modelling study. BMJ. 349: g5725.

Frosi G, Biolchi A, Lo Sapio M, et al (2013). Bactericidal antibody against a representative epidemiological meningococcal serogroup B panel confirms that MATS underestimates 4CMenB vaccine strain coverage. Vaccine. 31 (43):4968-74.

Hilton S, Petticrew M, Hunt K (2006). Combined vaccines are like a sudden onslaught to the body's immune system: Parental concerns about vaccine overload and immune-vulnerability. Vaccine. 24 (20): 4321-7.

Holst J, Oster P, Arnold R, et al (2013). Vaccines against meningococcal serogroup B disease containing outer membrane vesicles (OMV). Lessons from past programs and implications for the future. Hum Vaccin Immunother. 9(6): 1241-53.

Ilyina N, Kharit S, Namazova-Baranova L, et al (2014). Safety and immunogenicity of meningococcal ACWY CRM197-conjugate vaccine in children, adolescents and adults in Russia. Human Vaccines & Immunotherapeutics. 10 (8): 2471-81.

Joint Committee of Vaccination and Immunisation (2014). JCVI position statement on use of Bexsero[R] meningococcal B vaccine in the UK [online]. Public Health England. Available at: http://www.gov.uk/govemment/ uploads/system/uploads/attachment_data/file/294245/ JCV\_Statementjon_MenB.pdf (accessed September 2015)

Kelly C, Arnold R, Galloway Y, et al (2007). A prospective study of the effectiveness of the New Zealand meningococcal B vaccine. Americanjournal of Epidemiology .166 (7): 817-23.

Ladhani SN, Flood JS, Ramsay ME, et al (2012). Invasive meningococcal disease in England and Wales: Implications for the introduction of new vaccines. Vaccine. 30 (24): 3710-16.

Lalwani S, Agarkhedkar S, Gogtay N, et al (2015). Safety and immunogenicity of an investigational meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy Indian subjects aged 2 to 75 years. International Journal of infectious Disease. 38: 36-42.

National Institute of Clinical Excellence (2010). Bacterial meningitis and meningococcal septicaemia: Management of bacterial meningitis and meningococcal septicaemia in children and young people younger than 16 years in primary and secondary care [online]. NICE. Available at: http://www.nice.org.uk/ guidance/cgl02/resources (accessed September 2015)

Paul SP, Plaxton F, Wallace A (2011). Safety in numbers. Journal of Family Health Care. 21 (4): 33-5.

Poland GA & Jacobson RM (2012). The clinician's guide to the anti-vaccinationists' galaxy. Human Immunology. 73 (8): 859-66.

Public Health England (PHE) (2015). Invasive meningococcal disease (laboratory reports in England): 2013/2014 annual data by epidemiological year.

Public Health England. Available at: http://www.gov.uk/ government/uploads/system/uploads/attachmentjdata/ file/397913/hpr0315_imd.pdf (accessed September 2015)

Public Health England (2015). Meningococcal ACWY conjugate vaccination (MenAWY) [online]. NHS England and Public Health England. Available at: http:// www.gov.uk/government/uploads/system/uploads/ attachmentjdata/file/437901/150622_ACWY_bipartite_ letter.pdf (accessed September 2015)

Public Health England (PHE) (2015). Meningococcal: the Green Book, chapter 22 [online]. Available at: http:// www.gov.uk/government/uploads/system/ uploads/attachment_data/file/462629/2904512_Green_ Book_Chapter_22_v6_0W.PDF (accessed September 2015)

Vesikari T, Esposito S, Prymula R, et al (2013). Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. The Lancet .381 (9869): 825-35.

Read C, Baxter D, Chadwick DR, et al. (2014). Effect of a quadrivalent meningococcal ACWY glycoconjugate or a serogroup B meningococcal vaccine on meningococcal carriage: an observer-blind, phase 3 randomised clinical trial. The Lancet. 384 (9960): 2123-31.

Sarfatti A, Martinon-Torres F, Nadel S (2015). Vaccine evaluation: lessons from a meningococcal B vaccine. Arch Dis Child. 100(6): 514-6.

Vickers D, Anonychuk A, De Wals R, et al (2015). Evaluation of serogroup C and ACWY meningococcal vaccine programs: Projected impact on disease burden according to a stochastic two-strain dynamic model. Vaccine. 33 (1): 268-75.

Viner RM, Booy R, Johnson H, et al (2012). Outcomes of invasive meningococcal serogroup B disease in children and adolescents (MOSAIC): a case-control study. The Lancet. Neurology. 11 (9) 774-83.

CPD questions (please visit www.communitypractitioner.com/CPD to submit your answers)

1. Invasive meningococcal disease can manifest as

a) Meningitis

b) Septicaemia

c) Pneumonia

d) All of the above

2. Which strain of N. meningitidis is the leading cause of IMD?

a) Men A

b) Men B

c) Men C

d) Men W

e) Men Y

3. How should the 4CMenB vaccine be administered?

a) Subcutaneous injection

b) Intravenous injection

c) Intramuscular injection

d) Orally

4. In addition to school children aged 14, the MenACWY vaccine will also be provided in a catch-up regimen to which of the following groups?

a) Children who have previously suffered from IMD

b) First time university students

c) Health care professionals

d) All university students 5

5. Fever is a known adverse effect from the 4CMenB vaccine. Which of the following statements is true about the associated fever?

a) Peaks at six hours

b) Suggest treatment with paracetamol

c) Resolves by 48 hours

d) All of the above

6. Both meningococcal vaccines have a poor safety profile.

a) True

b) False

7. Herd immunity describes the protection of the non-vaccinated population by preventing infectious disease transmission.

a) True

b) False

8. Which of the following statements about vaccine overload is true?

a) It is better to wait for children's immune systems to develop before administering vaccines

b) Too many vaccines at once can override a child's immune system

c) It can be unsafe to give more than one vaccine at a time

d) None of the above, it is a mythical concept

9. Immunisation should not be given to infants born at or before 28 weeks gestation.

a) True

b) False

10. The role of community health practitioners is to:

a) Provide up-to-date and evidence-based information to parents about meningococcal vaccines

b) Highlight the positive safety profiles of both vaccines

c) Explain the benefits of the vaccine

d) All of the above
Table 1: The routine immunisation schedule from Summer 2015

Age due        Diseases protected     Vaccine given and trade name
               against

Two months     Diphtheria, tetanus,   DTaP/IPV/Hib     Pediacel or
old            pertussis (whooping                     infanrix IPV
               cough), polio                           Hib
               Haemophilus
               influenzae type b
               (Hib)

               Pneumococcal (13       Pneumococcal     Prevenar 13
               serotypes)             conjugate
                                      vaccine (PCV)

               Meningococcal group    MenB             Bexsero
               B (MenB) (2)

               Rotavirus              Rotavirus        Rotarix
               gastroenteritis

Three months   Diphtheria, tetanus,   DTaP/IPV/Hib     Pediacel or
old            pertussis, polio and                    infanrix IPV
               Hib                                     Hib

               Meningococcal group    MenC             NeisVac-C
               C (MenC)

               Rotavirus              Rotavirus        Rotarix

Four months    MenB (2)               MenB             Bexsero
old
               Pneumococcal (13       PCV              Prevenar 13
               serotypes)

12 months      Hib and MenC           Hib/MenC         Menitorix
old                                   booster
               Pneumococcal (13       PCV booster      Prevenar 13
               serotypes)

               Measles, mumps and     MMR              Priorix or MMR
               rubella (German                         VaxPro
               measles)

               MenB (2)               MenB booster     Bexseror

Two to six     Influenza (each year   Live             Fluenz Tetra
years old      from September)        influenza        (3,4)
(including                            vaccine
children in
school years
1 and 2)

Three years,   Diphtheria, tetanus,   DTaP/IPV         Infanrix IPV
four months    pertussis and polio                     or Repevax
old
               Measles, mumps and     MMR (check       MMRVaxPRO4 or
               rubella                first dose       Priorix
                                      given)

Girls aged     Cervical cancer        HPV (two doses   Gardasil
12 to 13       caused by human        6-12 months
years          papillomavirus (HPV)   apart)
               types 16 and 18 (and
               genital warts caused
               by types 6 and 11)

14 years       Tetanus, diphtheria    Td/IPV (check    Revaxis
old (school    and polio              MMR status)
year 9)
               Meningococcal groups   MenACWY          Nimenrix or
               A, C, W and Y                           Menveo
               disease

Age due        Diseases protected     Usual site (1)
               against

Two months     Diphtheria, tetanus,   Thigh
old            pertussis (whooping
               cough), polio
               Haemophilus
               influenzae type b
               (Hib)

               Pneumococcal (13       Thigh
               serotypes)

               Meningococcal group    Left thigh
               B (MenB) (2)

               Rotavirus              By mouth
               gastroenteritis

Three months   Diphtheria, tetanus,   Thigh
old            pertussis, polio and
               Hib

               Meningococcal group    Thigh
               C (MenC)

               Rotavirus              By mouth

Four months    MenB (2)               Left thigh
old
               Pneumococcal (13       Thigh
               serotypes)

12 months      Hib and MenC           Upper arm/thigh
old
               Pneumococcal (13       Upper arm/thigh
               serotypes)

               Measles, mumps and     Upper arm/thigh
               rubella (German
               measles)

               MenB (2)               Left thigh

Two to six     Influenza (each year   Both nostrils
years old      from September)
(including
children in
school years
1 and 2)

Three years,   Diphtheria, tetanus,   Upper arm
four months    pertussis and polio
old
               Measles, mumps and     Upper arm
               rubella

Girls aged     Cervical cancer        Upper arm
12 to 13       caused by human
years          papillomavirus (HPV)
               types 16 and 18 (and
               genital warts caused
               by types 6 and 11)

14 years       Tetanus, diphtheria    Upper arm
old (school    and polio
year 9)
               Meningococcal groups   Upper arm
               A, C, W and Y
               disease

(1.) Where two or more injections are required at once, these should
ideally be given in different limbs. Where this is not possible,
injections in the same limb should be given 2.5cm apart. For more
details see Chapters 4 and 11 in the Green Book. All injected
vaccines are given intramuscularly unless stated otherwise.

(2.) Only for infants born on or after 1 May 2015

(3.) If Fluenz is contraindicated and child is in clinical risk
group, use inactivated flu vaccine

(4.) Contains porcine gelatine
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Author:Lloyd, Katherine Elizabeth; Paul, Siba Prosad; Garg, Anil Kumar
Publication:Community Practitioner
Geographic Code:4EUUK
Date:Nov 1, 2015
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