Meningococcal vaccine

Meningococcal vaccine refers to any of the vaccines used to prevent infection by Neisseria meningitidis.[1] Different versions are effective against some or all of the following types of meningococcus: A, B, C, W-135, and Y.[1][2] The vaccines are between 85 and 100% effective for at least two years.[1] They result in a decrease in meningitis and sepsis among populations where they are widely used.[3][4] They are given either by injection into a muscle or just under the skin.[1]

Meningococcal vaccine
Vaccine description
Target diseaseNeisseria meningitidis
TypeConjugate or polysaccharide
Clinical data
Trade namesMenactra, Menveo, Menomune, Others
AHFS/Drugs.comMonograph
MedlinePlusa607020
License data
Pregnancy
category
  • AU: B2
  • US: C (Risk not ruled out)
    Routes of
    administration    		Intramuscular (conjugate), Subcutaneous (polysaccharide)
    ATC code
    Legal status
    Legal status
    Identifiers
    ChemSpider
    • none
     NY (what is this?)  (verify)

    The World Health Organization recommends that countries with a moderate or high rate of disease or with frequent outbreaks should routinely vaccinate.[1][5] In countries with a low risk of disease, they recommend that high risk groups should be immunized.[1] In the African meningitis belt efforts to immunize all people between the ages of one and thirty with the meningococcal A conjugate vaccine are ongoing.[5] In Canada and the United States the vaccines effective against all four types of meningococcus are recommended routinely for teenagers and others who are at high risk.[1] Saudi Arabia requires vaccination with the quadrivalent vaccine for international travelers to Mecca for Hajj.[1][6]

    Meningococcal vaccines are generally safe.[1] Some people develop pain and redness at the injection site.[1] Use in pregnancy appears to be safe.[5] Severe allergic reactions occur in less than one in a million doses.[1]

    The first meningococcal vaccine became available in the 1970s.[7] It is on the World Health Organization's List of Essential Medicines.[8]

    Types

    Neisseria meningitidis has 13 clinically significant serogroups, classified according to the antigenic structure of their polysaccharide capsule. Six serogroups, A, B, C, Y, W-135, and X, are responsible for virtually all cases of the disease in humans.

    Quadrivalent (Serogroups A, C, W-135, and Y)

    There are three vaccines available in the United States to prevent meningococcal disease, all quadrivalent in nature, targeting serogroups A, C, W-135, and Y:

    Mencevax (GlaxoSmithKline) and NmVac4-A/C/Y/W-135 (JN-International Medical Corporation) are used worldwide, but have not been licensed in the United States.

    Nimenrix (GlaxoSmithKline), a quadrivalent conjugate vaccine against serogroups A, C, W-135, and Y, is available in the countries of the European Union[9] and some additional countries.

    The first meningococcal conjugate vaccine (MCV-4), Menactra, was licensed in the U.S. in 2005 by Sanofi Pasteur; Menveo was licensed in 2010 by Novartis. Both MCV-4 vaccines have been approved by the Food and Drug Administration (FDA) for people 2 through 55 years of age. Menactra received FDA approval for use in children as young as 9 months in April 2011[10] while Menveo received FDA approval for use in children as young as 2 months in August 2013.[11] The Centers for Disease Control and Prevention (CDC) has not made recommendations for or against its use in children less than 2 years.[12]

    Meningococcal polysaccharide vaccine (MPSV-4), Menomune, has been available since the 1970s. It may be used if MCV-4 is not available, and is the only meningococcal vaccine licensed for people older than 55. Information about who should receive the meningococcal vaccine is available from the CDC.[12]

    Limitations

    The duration of immunity mediated by Menomune (MPSV-4) is three years or less in children aged under five because it does not generate memory T cells.[13][14] Attempting to overcome this problem by repeated immunization results in a diminished, not increased, antibody response, so boosters are not recommended with this vaccine.[15][16] As with all polysaccharide vaccines, Menomune does not produce mucosal immunity, so people can still become colonised with virulent strains of meningococcus, and no herd immunity can develop.[17][18] For this reason, Menomune is suitable for travelers requiring short-term protection, but not for national public health prevention programs.

    Menveo and Menactra contain the same antigens as Menomune, but the antigens are conjugated to a diphtheria toxoid polysaccharide–protein complex, resulting in anticipated enhanced duration of protection, increased immunity with booster vaccinations, and effective herd immunity.[19]

    Endurance

    A study published in March 2006, comparing the two kinds of vaccines found that 76% of subjects still had passive protection three years after receiving MCV-4 (63% protective compared with controls), but only 49% had passive protection after receiving MPSV-4 (31% protective compared with controls).[20] As of 2010, there remains limited evidence that any of the current conjugate vaccines offer continued protection beyond three years; studies are ongoing to determine the actual duration of immunity, and the subsequent requirement of booster vaccinations. The CDC offers recommendations regarding who they feel should get booster vaccinations.[21][22]

    Bivalent (Serogroups C and Y)

    On 14 June 2012, the FDA approved a combination vaccine against two types of meningococcal disease and Hib disease for infants and children 6 weeks to 18 months old. The vaccine, Menhibrix, prevents disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b. This was the first meningococcal vaccine that could be given to infants as young as six weeks old.[23]

    Serogroup A

    A vaccine called MenAfriVac has been developed through a program called the Meningitis Vaccine Project and has the potential to prevent outbreaks of group A meningitis, which is common in sub-Saharan Africa.[24][25]

    Serogroup B

    Vaccines against serotype B meningococcal disease have proved difficult to produce, and require a different approach from vaccines against other serotypes. Whereas effective polysaccharide vaccines have been produced against types A, C, W-135, and Y, the capsular polysaccharide on the type B bacterium is too similar to human neural adhesion molecules to be a useful target.[26]

    A number of "serogroup B" vaccines have been produced. Strictly speaking, these are not "serogroup B" vaccines, as they do not aim to produce antibodies to the group B antigen: it would be more accurate to describe them as serogroup independent vaccines, as they employ different antigenic components of the organism; indeed, some of the antigens are common to different Neisseria species.

    A vaccine for serogroup B was developed in Cuba in response to a large outbreak of meningitis B during the 1980s. This vaccine was based on artificially produced outer membrane vesicles of the bacterium. The VA-MENGOC-BC vaccine proved safe and effective in randomized double-blind studies,[27][28][29] but it was granted a licence only for research purposes in the United States[30] as political differences limited cooperation between the two countries.[31]

    Due to a similarly high prevalence of B-serotype meningitis in Norway between 1975 and 1985, Norwegian health authorities developed a vaccine specifically designed for Norwegian children and young adolescents. Clinical trials were discontinued after the vaccine was shown to cover only slightly more than 50% of all cases. Furthermore, lawsuits for damages were filed against the State of Norway by persons affected by serious adverse reactions. Information that the health authorities obtained during the vaccine development were subsequently passed on to Chiron (now GlaxoSmithKline), who developed a similar vaccine, MeNZB, for New Zealand.

    A MenB vaccine was approved for use in Europe in January 2013. Following a positive recommendation from the European Union's Committee for Medicinal Products for Human Use, Bexsero, produced by Novartis, received a licence from the European Commission.[32] However, deployment in individual EU member countries still depends on decisions by national governments. In July 2013, the United Kingdom's Joint Committee on Vaccination and Immunisation (JCVI) issued an interim position statement recommending against adoption of Bexsero as part of a routine meningococcal B immunisation program, on the grounds of cost-effectiveness.[33] This decision was reverted in favor of Bexsero vaccination in March 2014.[34] In March 2015 the UK government announced that they had reached agreement with GlaxoSmithKline who had taken over Novartis' vaccines business, and that Bexsero would be introduced into the UK routine immunization schedule later in 2015.[35]

    In November 2013, in response to an outbreak of B-serotype meningitis on the campus of Princeton University, the acting head of the Centers for Disease Control and Prevention (CDC) meningitis and vaccine preventable diseases branch told NBC News that they had authorized emergency importation of Bexsero to stop the outbreak.[36] Bexsero was subsequently approved by the FDA in February 2015.[37] In October 2014, Trumenba, a serogroup B vaccine produced by Pfizer, was approved by the FDA.[2]

    Serogroup X

    The occurrence of serogroup X has been reported in North America, Europe, Australia, and West Africa.[38] There is no vaccine to protect against serogroup X N. meningitidis disease.[1]

    Side effects

    Common side effects include pain and redness around the site of injection (up to 50% of recipients). A small percentage of people develop a mild fever. As with any medication, a small proportion of people develop a severe allergic reaction.[39] In 2016 Health Canada warned of an increased risk of anemia or hemolysis in people treated with eculizumab (Soliris). The highest risk was when individuals "received a dose of Soliris within 2 weeks after being vaccinated with Bexsero".[40]

    Despite initial concerns about Guillain-Barré syndrome, subsequent studies in 2012 have shown no increased risk of GBS after meningococcal conjugate vaccination.[41]

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    References
    1. World Health Organization (November 2011). "Meningococcal vaccines : WHO position paper, November 2011". Wkly. Epidemiol. Rec. 86 (47): 521–540. hdl:10665/241846. PMID 22128384. Lay summary (PDF).
    2. "First vaccine approved by FDA to prevent serogroup B Meningococcal disease". U.S. Food and Drug Administration (FDA) (Press release). 29 October 2014. Archived from the original on 15 June 2019. Retrieved 19 October 2019.
    3. Patel, M; Lee, CK (25 January 2005). "Polysaccharide vaccines for preventing serogroup A meningococcal meningitis". The Cochrane Database of Systematic Reviews (1): CD001093. doi:10.1002/14651858.CD001093.pub2. PMID 15674874. CD001093.
    4. Conterno, LO; Silva Filho, CR; Rüggeberg, JU; Heath, PT (19 July 2006). Conterno, Lucieni O (ed.). "Conjugate vaccines for preventing meningococcal C meningitis and septicaemia". The Cochrane Database of Systematic Reviews (3): CD001834. doi:10.1002/14651858.CD001834.pub2. PMID 16855979.
    5. "Meningococcal A conjugate vaccine: updated guidance, February 2015" (PDF). Wkly. Epidemiol. Rec. 90 (8): 57–62. 20 February 2015. hdl:10665/242320. PMID 25702330.
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    8. World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
    9. "Nimenrix". European Medicines Agency. 24 May 2012. Retrieved 23 December 2019.
    10. "22 April 2011 Approval Letter - Menactra". Archived from the original on 28 April 2011. Retrieved 25 April 2011.
    11. "1 August 2013 Approval Letter - Menveo". Archived from the original on 28 September 2013. Retrieved 22 September 2013.
    12. >"Meningococcal Vaccination - What You Should Know". Centers for Disease Control and Prevention (CDC). 26 July 2019. Archived from the original on 20 October 2019. Retrieved 19 October 2019.
    13. Reingold AL, Broome CV, Hightower AW, et al. (1985). "Age-specific differences in duration of clinical protection after vaccination with meningococcal polysaccharide A vaccine". Lancet. 2 (8447): 114–18. doi:10.1016/S0140-6736(85)90224-7. PMID 2862316.
    14. Lepow ML, Goldschneider I, Gold R, Randolph M, Gotschlich EC (1977). "Persistence of antibody following immunization of children with groups A and C meningococcal polysaccharide vaccines". Pediatrics. 60 (5): 673–80. PMID 411104.
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    23. FDA approves new combination vaccine that protects children against two bacterial diseases Archived 2012-06-16 at the Wayback Machine, FDA Press Release, 14 June 2012
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    25. Kristiansen PA, Diomandé F, Wei SC, Ouédraogo R, Sangaré L, Sanou I, Kandolo D, Kaboré P, Clark TA (March 2011). "Baseline Meningococcal Carriage in Burkina Faso before the Introduction of a Meningococcal Serogroup A Conjugate Vaccine". Clin Vaccine Immunol. 18 (3): 435–43. doi:10.1128/CVI.00479-10. PMC 3067389. PMID 21228139.
    26. Finne J et al. An IgG monoclonal antibody to group B meningococci cross-reacts with developmentally regulated polysialic acid units of glycoproteins in neural and extraneural tissues. Journal of Immunology 138(12), 4402–4407 (1987).
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    29. "Finlay Institute VA-MENGOC-BC Most frequent questions and answers". Archived from the original on 8 January 2011. Retrieved 10 March 2009.
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    31. NBC News Digital (12 November 2015). "Cuban scientist barred from receiving U.S. prize". Associated Press. Retrieved 27 May 2019. A Cuban scientist who helped develop a low-cost synthetic vaccine that prevents meningitis and pneumonia in small children says he was offended the U.S. government denied his request to travel to the United States to receive an award.
    32. "First ever MenB vaccine available for use" Archived 2014-10-25 at the Wayback Machine, Oxford Vaccine Group openminds blog article, 24 January 2013
    33. Joint Committee on Vaccination and Immunisation (JCVI) (July 2013). "JCVI interim position statement on use of Bexsero® meningococcal B vaccine in the UK" (PDF). Archived (PDF) from the original on 19 August 2013. Retrieved 16 November 2013.
    34. John Porter (Novartis) (March 2014). "UK review of vaccines flawed, says Novartis' John Porter". Archived from the original on 9 October 2014. Retrieved 6 October 2014.
    35. "Meningitis B vaccine deal agreed - Jeremy Hunt". BBC News. 29 March 2015. Archived from the original on 23 May 2015. Retrieved 7 May 2015.
    36. Aleccia, JoNell (15 November 2013). "Emergency meningitis vaccine will be imported to halt Ivy League outbreak". NBC News. Archived from the original on 16 November 2013. Retrieved 16 November 2013.
    37. "FDA approves a second vaccine to prevent serogroup B meningococcal disease" (Press release). United States Food and Drug Administration. 23 January 2015. Archived from the original on 16 March 2015. Retrieved 15 March 2015.
    38. Clonal Groupings in Serogroup X Neisseria meningitidis. Archived 2009-01-17 at the Wayback Machine
    39. "Vaccines: Vac-Gen/Side Effects". Centers for Disease Control and Prevention. National Center for Immunization and Respiratory Diseases. Archived from the original on 17 March 2017. Retrieved 27 March 2017.
    40. Health Canada "Summary Safety Review - SOLIRIS (eculizumab) and BEXSERO - Assessing the Potential Risk of Hemolysis and Low Hemoglobin in Patients Treated with Soliris and Vaccinated with Bexsero". Archived from the original on 11 August 2017. Retrieved 11 August 2017. 16 September 2016
    41. Yih, Weiling Katherine; Weintraub, Eric; Kulldorff, Martin (1 December 2012). "No risk of Guillain-Barré syndrome found after meningococcal conjugate vaccination in two large cohort studies". Pharmacoepidemiology and Drug Safety. 21 (12): 1359–1360. doi:10.1002/pds.3353. ISSN 1099-1557. PMID 23225672.

    Further reading
    • Conterno LO, Silva Filho CR, Rüggeberg JU, Heath PT (2006). Conterno LO (ed.). "Conjugate vaccines for preventing meningococcal C meningitis and septicaemia". Cochrane Database Syst Rev. 3 (3): CD001834. doi:10.1002/14651858.CD001834.pub2. PMID 16855979.
    • Patel M, Lee CK (2005). Patel M (ed.). "Polysaccharide vaccines for preventing serogroup A meningococcal meningitis". Cochrane Database Syst Rev (1): CD001093. doi:10.1002/14651858.CD001093.pub2. PMID 15674874.
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