Meningococcal vaccine: Difference between revisions

{{Short description|Vaccines used to prevent infection by Neisseria meningitidis}}

{{Use dmy dates|date=November 2022}}

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<!-- Vaccine data -->

| target = ''[[Neisseria meningitidis]]''

| vaccine_type = Conjugate or polysaccharide

<!-- Clinical data -->

| tradename = Menactra, Menveo, Menomune, Others

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| INN_EMA = Meningococcal group B

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Conjugate: [[intramuscular]]|

Polysaccharide: [[subcutaneous injection|subcutaneous]]

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<!-- Definition and medical uses -->

'''Meningococcal vaccine''' refers to any [[vaccine]] used to prevent infection by ''[[Neisseria meningitidis]]''.<ref name=WHO2011>{{cite journal|vauthors=((World Health Organization))|title=Meningococcal vaccines : WHO position paper, November 2011|journal=Wkly. Epidemiol. Rec.|date=November 2011|volume=86|issue=47|pages=521–540|pmid=22128384|hdl=10665/241846|url=https://www.who.int/immunization/position_papers/MC_summary_14_Nov_2011.pdf?ua=1|access-date=20 December 2019|archive-date=29 August 2021|archive-url=https://web.archive.org/web/20210829150513/https://www.who.int/immunization/position_papers/MC_summary_14_Nov_2011.pdf?ua=1|url-status=dead}}</ref> Different versions are effective against some or all of the following types of meningococcus: A, B, C, W-135, and Y.<ref name=WHO2011/><ref name=FDA2014>{{cite press release | title=First vaccine approved by FDA to prevent serogroup B Meningococcal disease | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=29 October 2014 | url=https://www.fda.gov/news-events/press-announcements/first-vaccine-approved-fda-prevent-serogroup-b-meningococcal-disease | archive-url=https://web.archive.org/web/20190615024209/https://www.fda.gov/news-events/press-announcements/first-vaccine-approved-fda-prevent-serogroup-b-meningococcal-disease | archive-date=15 June 2019 | url-status=live | access-date=19 October 2019}}</ref> The vaccines are between 85 and 100% effective for at least two years.<ref name=WHO2011/> They result in a decrease in [[meningitis]] and [[sepsis]] among populations where they are widely used.<ref>{{cite journal | vauthors = Patel M, Lee CK | title = Polysaccharide vaccines for preventing serogroup A meningococcal meningitis | journal = The Cochrane Database of Systematic Reviews | issue = 1 | pages = CD001093 | date = January 2005 | pmid = 15674874 | doi = 10.1002/14651858.CD001093.pub2 | id = CD001093 }}</ref><ref>{{cite journal | vauthors = Conterno LO, Silva Filho CR, Rüggeberg JU, Heath PT | title = Conjugate vaccines for preventing meningococcal C meningitis and septicaemia | journal = The Cochrane Database of Systematic Reviews | issue = 3 | pages = CD001834 | date = July 2006 | pmid = 16855979 | doi = 10.1002/14651858.CD001834.pub2 | veditors = Conterno LO }}</ref> They are given either by [[intramuscular|injection into a muscle]] or [[subcutaneous injection|just under the skin]].<ref name=WHO2011/>

<!-- Recommendations -->

The [[World Health Organization]] recommends that countries with a moderate or high rate of disease or with frequent outbreaks should [[Vaccination schedule|routinely vaccinate]].<ref name=WHO2011/><ref name=WHO2015A/> In countries with a low risk of disease, they recommend that high risk groups should be immunized.<ref name=WHO2011/> 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.<ref name=WHO2015A>{{cite journal|title=Meningococcal A conjugate vaccine: updated guidance, February 2015.|journal=Wkly. Epidemiol. Rec.|date=20 February 2015|volume=90|issue=8|pages=57–62|pmid=25702330|url=https://www.who.int/wer/2015/wer9008.pdf|hdl=10665/242320|access-date=5 October 2020|archive-date=19 October 2015|archive-url=https://web.archive.org/web/20151019090948/http://www.who.int/wer/2015/wer9008.pdf|url-status=live}}</ref> In Canada and the United States the vaccines effective against four types of meningococcus (A, C, W, and Y) are recommended routinely for teenagers and others who are at high risk.<ref name=WHO2011/> Saudi Arabia requires vaccination with the quadrivalent vaccine for international travellers to [[Mecca]] for [[Hajj]].<ref name=WHO2011/><ref>{{cite web|title=Saudi Arabia: Hajj/Umrah Pilgrimage|url=https://wwwnc.cdc.gov/travel/yellowbook/2018/select-destinations/saudi-arabia-hajj-umrah-pilgrimage|website=[[Centers for Disease Control and Prevention]] (CDC)|access-date=15 August 2017|url-status=live|archive-url=https://web.archive.org/web/20170812021532/https://wwwnc.cdc.gov/travel/yellowbook/2018/select-destinations/saudi-arabia-hajj-umrah-pilgrimage|archive-date=12 August 2017}}</ref>

<!-- Safety and formulations -->

Meningococcal vaccines are generally safe.<ref name=WHO2011/> Some people develop pain and redness at the injection site.<ref name=WHO2011/> Use in pregnancy appears to be safe.<ref name=WHO2015A/> [[Anaphylaxis|Severe allergic reactions]] occur in less than one in a million doses.<ref name=WHO2011/>

<!-- Society and culture -->

The first meningococcal vaccine became available in the 1970s.<ref>{{cite book| vauthors = Barrett AD |title=Vaccinology : an essential guide|date=2015|isbn=9780470656167|page=168|publisher=John Wiley & Sons |url=https://books.google.com/books?id=NvKyBwAAQBAJ&pg=PA168}}</ref> It is on the [[WHO Model List of Essential Medicines|World Health Organization's List of Essential Medicines]].<ref name="WHO23rd">{{cite book | vauthors = ((World Health Organization)) | title = The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023) | year = 2023 | hdl = 10665/371090 | author-link = World Health Organization | publisher = World Health Organization | location = Geneva | id = WHO/MHP/HPS/EML/2023.02 | hdl-access=free }}</ref>

Inspired by the response to the 1997 outbreak in Nigeria, the WHO, [[Médecins Sans Frontières]], and other groups created the International Coordinating Group on Vaccine Provision for Epidemic Meningitis Control, which manages global response strategy. ICGs have since been created for other epidemic diseases.<ref>{{Cite web |url=https://www.who.int/groups/icg |title=International Coordinating Group (ICG) on Vaccine Provision |access-date=30 November 2021 |archive-date=30 November 2021 |archive-url=https://web.archive.org/web/20211130223130/https://www.who.int/groups/icg |url-status=live }}</ref>

''[[Neisseria meningitidis]]'' has 13 clinically significant [[serotype|serogroups]], classified according to the antigenic structure of their polysaccharide capsule.{{medcn|date=November 2023}} Six serogroups, A, B, C, Y, W-135, and X, are responsible for virtually all cases of the disease in humans. [https://pocketsinfo.com/meningococcal-vaccine/ Neisseria meningitidis] Serogroup B is a major cause of meningococcal disease in younger children and adolescents.{{medcn|date=November 2023}}

=== Pentavalent (serogroups A, B, C, W, and Y) ===

{{main|Penbraya}}

Penbraya was approved for use in the United States in October 2023.<ref name="FDA Penbraya">{{cite web | title=Penbraya | website=U.S. Food and Drug Administration | date=20 October 2023 | url=https://www.fda.gov/vaccines-blood-biologics/vaccines/penbraya | access-date=15 November 2023}} {{PD-notice}}</ref> It combines the vaccines Trumenba and Nimenrix.<ref>{{cite press release | title=FDA Approves Penbraya, the First and Only Vaccine for the Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents | website=Pfizer | date=20 October 2023 | url=https://www.pfizer.com/news/press-release/press-release-detail/fda-approves-penbrayatm-first-and-only-vaccine-prevention | access-date=15 November 2023}}</ref> Penbraya is [[indicated]] for active immunization to prevent invasive disease caused by ''Neisseria meningitidis'' serogroups A, B, C, W, and Y.<ref name="FDA Penbraya" /> It is approved for use in individuals 10 through 25 years of age.<ref name="FDA Penbraya" />

===Quadrivalent (serogroups A, C, W-135, and Y)===

There are three quadrivalent vaccines available in the United States targeting serogroups A, C, W-135, and Y:

* three [[conjugate vaccine]]s (MCV-4), Menactra, Menveo, and MenQuadfi.{{cn|date=November 2023}} The pure polysaccharide vaccine Menomune, MPSV4, was discontinued in the United States in 2017.{{cn|date=November 2023}}

Menveo and MenQuadfi are approved for medical use in the European Union.<ref name="Menveo EPAR">{{cite web | title=Menveo EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/menveo | access-date=29 November 2020 | archive-date=2 December 2020 | archive-url=https://web.archive.org/web/20201202015358/https://www.ema.europa.eu/en/medicines/human/EPAR/menveo | url-status=live }}</ref><ref name="MenQuadfi EPAR">{{cite web | title=MenQuadfi EPAR | website=[[European Medicines Agency]] (EMA) | date=15 September 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/menquadfi | access-date=29 November 2020 | archive-date=28 January 2022 | archive-url=https://web.archive.org/web/20220128102509/https://www.ema.europa.eu/en/medicines/human/EPAR/menquadfi | url-status=live }}</ref><ref>{{cite web | title=MenQuadfi Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1483.htm | access-date=3 March 2023 | archive-date=5 March 2023 | archive-url=https://web.archive.org/web/20230305052310/https://ec.europa.eu/health/documents/community-register/html/h1483.htm | url-status=live }}</ref>

====Menactra and Menveo====

The first meningococcal conjugate vaccine (MCV-4), Menactra, was licensed in the US in 2005, by [[Sanofi Pasteur]]; Menveo was licensed in 2010, by [[Novartis]]. Both MCV-4 vaccines are 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,<ref>{{cite web |url=https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm252511.htm |title=22 April 2011 Approval Letter – Menactra|publisher=U.S. [[Food and Drug Administration]] (FDA)|access-date=25 April 2011 |url-status=dead |archive-url=https://web.archive.org/web/20110428014053/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm252511.htm |archive-date=28 April 2011 }}</ref> while Menveo received FDA approval for use in children as young as two months in August 2013.<ref>{{cite web |url=https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm363785.htm |title=1 August 2013 Approval Letter – Menveo |publisher=U.S. [[Food and Drug Administration]] (FDA) |access-date=22 September 2013 |url-status=dead |archive-url=https://web.archive.org/web/20130928072445/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm363785.htm |archive-date=28 September 2013 }}</ref> The [[Centers for Disease Control and Prevention]] (CDC) has not made recommendations for or against its use in children less than two years.<ref name="cdc1"/>

====Menquadfi====

Menquadfi, manufactured by [[Sanofi Pasteur]], was approved by the US [[Food and Drug Administration]] (FDA) in April 2020, for use in individuals two years of age and older.<ref>{{cite web |url=https://www.fda.gov/vaccines-blood-biologics/menquadfi |access-date=4 May 2022 |title=MenQuadfi |publisher=U.S. [[Food and Drug Administration]] (FDA) |archive-date=4 May 2022 |archive-url=https://web.archive.org/web/20220504223021/https://www.fda.gov/vaccines-blood-biologics/menquadfi |url-status=live }}</ref>

====Menomune====

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.<ref name="cdc1">{{cite web | title=Meningococcal Vaccination – What You Should Know | website=[[Centers for Disease Control and Prevention]] (CDC) | date= 26 July 2019 | url=https://www.cdc.gov/vaccines/vpd/mening/public/index.html | archive-url=https://web.archive.org/web/20191020052155/https://www.cdc.gov/vaccines/vpd/mening/public/index.html | archive-date=20 October 2019 | url-status=live | access-date=19 October 2019}}</ref>

====Nimenrix====

[[File:Nimenrix (Pfizer).jpg|thumb|Nimenrix (Pfizer). Meningoccal group A, C, W-135 and Y conjugate vaccine]]

Nimenrix (developed by GlaxoSmithKline and later acquired by [[Pfizer]]), is a quadrivalent conjugate vaccine against serogroups A, C, W-135, and Y.<ref name=Torresi2019>{{Cite book | vauthors = Torresi J, Kollaritsch H | chapter = Recommend/Required Travel Vaccines |chapter-url= https://books.google.com/books?id=M4d7DwAAQBAJ&q=nimenrix&pg=PA115 |title=Travel Medicine |date=2019|publisher=Elsevier|isbn=978-0-323-54696-6| veditors = Keystone JS, Kozarsky PE, Connor BA, Nothdurft HD, Mendelson M, Leder K }}</ref> In April 2012 Nimenrix was approved as the first quadrivalent vaccine against invasive meningococcal disease to be administered as a single dose in those over the age of one year, by the European Medicines Agency.<ref name=Assaf2016>{{cite journal | vauthors = Assaf-Casals A, Dbaibo G | title = Meningococcal quadrivalent tetanus toxoid conjugate vaccine (MenACWY-TT, Nimenrix™): A review of its immunogenicity, safety, co-administration, and antibody persistence | journal = Human Vaccines & Immunotherapeutics | volume = 12 | issue = 7 | pages = 1825–1837 | date = July 2016 | pmid = 26900984 | pmc = 4964831 | doi = 10.1080/21645515.2016.1143157 }}</ref> In 2016, they approved the vaccine in infants six weeks of age and older, and it has been approved in other countries including Canada and Australia, among others.<ref>{{cite web|url=https://www.ema.europa.eu/en/medicines/human/EPAR/nimenrix|title=Nimenrix|publisher=European Medicines Agency|date=24 May 2012|access-date=23 December 2019|archive-date=23 December 2019|archive-url=https://web.archive.org/web/20191223072211/https://www.ema.europa.eu/en/medicines/human/EPAR/nimenrix|url-status=live}}</ref><ref>{{Cite web|title=Nimenrix – Summary of Product Characteristics (SmPC) – (emc)|url=https://www.medicines.org.uk/emc/medicine/26514#gref|access-date=27 November 2020|website=www.medicines.org.uk|archive-date=29 November 2020|archive-url=https://web.archive.org/web/20201129022506/https://www.medicines.org.uk/emc/medicine/26514#gref|url-status=live}}</ref> It is not licensed in the United States.<ref>[https://www.cdc.gov/vaccines/acip/meetings/downloads/min-archive/min-2020-06-508.pdf "Advisory Committee on Immunization Practices (ACIP)"] {{Webarchive|url=https://web.archive.org/web/20201128185052/https://www.cdc.gov/vaccines/acip/meetings/downloads/min-archive/min-2020-06-508.pdf |date=28 November 2020 }}. CDC (June 2020).</ref>

====Mencevax====

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.

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 cell]]s.<ref>{{cite journal |vauthors=Reingold AL, Broome CV, Hightower AW, etal | title=Age-specific differences in duration of clinical protection after vaccination with meningococcal polysaccharide A vaccine | journal=Lancet | year=1985 | volume=2 | issue=8447 | pages=114–18 | pmid=2862316 | doi=10.1016/S0140-6736(85)90224-7 | s2cid=36704156 }}</ref><ref>{{cite journal |vauthors=Lepow ML, Goldschneider I, Gold R, Randolph M, Gotschlich EC | title=Persistence of antibody following immunization of children with groups A and C meningococcal polysaccharide vaccines | journal=Pediatrics | year=1977 | volume=60 | pages=673–80 | pmid=411104 | issue=5 | doi=10.1542/peds.60.5.673 | s2cid=24021572 }}</ref> Attempting to overcome this problem by repeated immunization results in a diminished, not increased, [[antibody]] response, so boosters are not recommended with this vaccine.<ref>{{cite journal |vauthors=Borrow R, Joseh H, Andrews N, etal | title=Reduced antibody response to revaccination with meningococcal serogroup A polysaccharide vaccine in adults | journal=Vaccine | year=2000 | volume=19 | issue=9&ndash;10 | pages=1129–32 | pmid=11137248 | doi= 10.1016/s0264-410x(00)00317-0}}</ref><ref>{{cite journal |vauthors=MacLennan J, Obaro S, Deeks J, etal | title=Immune response to revaccination with meningococcal A and C polysaccharides in Gambian children following repeated immunization during early childhood | journal=Vaccine | year=1999 | volume=17 | issue=23&ndash;24 | pages=3086–93 | pmid=10462244 | doi=10.1016/S0264-410X(99)00139-5 }}</ref> 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.<ref>{{cite journal |vauthors=Hassan-King MK, Wall RA, Greenwood BM | title=Meningococcal carriage, meningococcal disease and vaccination | journal=J Infect | year=1988 | volume=16 | issue=1 | pages=55–9 | pmid=3130424 | doi=10.1016/S0163-4453(88)96117-8 }}</ref><ref>{{cite journal |vauthors=Moore PS, Harrison LH, Telzak EE, Ajello GW, Broome CV | title=Group A meningococcal carriage in travelers returning from Saudi Arabia | journal=J Am Med Assoc | year=1988 | volume=260 | pages=2686–89 | pmid=3184335 | doi=10.1001/jama.260.18.2686 | issue=18 }}</ref> For this reason, Menomune is suitable for travellers 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 toxin|diphtheria toxoid]] polysaccharide–protein complex, resulting in anticipated enhanced duration of protection, increased immunity with booster vaccinations, and effective herd immunity.<ref>{{cite journal | title = Updated recommendations for use of meningococcal conjugate vaccines --- Advisory Committee on Immunization Practices (ACIP), 2010 | journal = MMWR. Morbidity and Mortality Weekly Report | volume = 60 | issue = 3 | pages = 72–76 | date = January 2011 | pmid = 21270745 | author1 = Centers for Disease Control and Prevention (CDC) }}</ref>

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).<ref name=Vu_2006>{{cite journal | vauthors = Vu DM, Welsch JA, Zuno-Mitchell P, Dela Cruz JV, Granoff DM | title = Antibody persistence 3 years after immunization of adolescents with quadrivalent meningococcal conjugate vaccine | journal = The Journal of Infectious Diseases | volume = 193 | issue = 6 | pages = 821–828 | date = March 2006 | pmid = 16479517 | doi = 10.1086/500512 | doi-access = free }}</ref> 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.<ref>{{cite journal | title = Updated recommendations for use of meningococcal conjugate vaccines --- Advisory Committee on Immunization Practices (ACIP), 2010 | journal = MMWR. Morbidity and Mortality Weekly Report | volume = 60 | issue = 3 | pages = 72–76 | date = January 2011 | pmid = 21270745 | author1 = Centers for Disease Control and Prevention (CDC) }}</ref><ref>{{cite journal | author = Centers for Disease Control and Prevention (CDC) | title = Updated recommendation from the Advisory Committee on Immunization Practices (ACIP) for revaccination of persons at prolonged increased risk for meningococcal disease | journal = MMWR. Morbidity and Mortality Weekly Report | volume = 58 | issue = 37 | pages = 1042–1043 | date = September 2009 | pmid = 19779400 }}</ref>

===Bivalent (serogroups C and Y)===

In 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]]'' [[serotypes|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.<ref>[https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm308350.htm ''FDA approves new combination vaccine that protects children against two bacterial diseases''] {{webarchive|url=https://web.archive.org/web/20120616161343/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm308350.htm |date=16 June 2012 }}, ''FDA Press Release'', 14 June 2012</ref> Menhibrix is [[indicated]] for active immunization to prevent invasive disease caused by ''Neisseria meningitidis'' serogroups C and Y and ''Haemophilus influenzae'' type b for children 6 weeks of age through 18 months of age.<ref>{{cite web | title=MenHibrix | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=28 February 2023 | url=https://www.fda.gov/vaccines-blood-biologics/vaccines/menhibrix | access-date=8 May 2023 | archive-date=17 February 2023 | archive-url=https://web.archive.org/web/20230217114523/https://www.fda.gov/vaccines-blood-biologics/vaccines/menhibrix | url-status=live }} {{PD-notice}}</ref>

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.<ref>{{cite journal |vauthors=LaForce FM, Okwo-Bele JM |title=Eliminating epidemic Group A meningococcal meningitis in Africa through a new vaccine |journal=Health Aff (Millwood) |volume=30 |issue=6 |pages=1049–57 |date=June 2011 |doi=10.1377/hlthaff.2011.0328 |pmid=21653956|doi-access=free }}</ref><ref>{{cite journal |vauthors=Kristiansen PA, Diomandé F, Wei SC, Ouédraogo R, Sangaré L, Sanou I, Kandolo D, Kaboré P, Clark TA |title=Baseline Meningococcal Carriage in Burkina Faso before the Introduction of a Meningococcal Serogroup A Conjugate Vaccine |journal=Clin Vaccine Immunol |volume=18 |issue=3 |pages=435–43 |date=March 2011 |doi=10.1128/CVI.00479-10 |pmc=3067389 |pmid=21228139}}</ref>

[[File:Meningococcal B vaccine.jpg|thumb|Meningococcal B vaccine]]

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 [[Neural cell adhesion molecule|human neural adhesion molecules]] to be a useful target.<ref>{{cite journal | vauthors = Finne J, Bitter-Suermann D, Goridis C, Finne U | title = An IgG monoclonal antibody to group B meningococci cross-reacts with developmentally regulated polysialic acid units of glycoproteins in neural and extraneural tissues | journal = Journal of Immunology | volume = 138 | issue = 12 | pages = 4402–4407 | date = June 1987 | pmid = 3108388 | doi = 10.4049/jimmunol.138.12.4402 | s2cid = 24162009 | doi-access = free }}</ref>

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.{{medcn|date=October 2019}}

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 [[Bacterial outer membrane vesicles|outer membrane vesicles]] of the bacterium. The VA-MENGOC-BC vaccine proved safe and effective in randomized double-blind studies,<ref>{{cite journal |vauthors=Pérez O, Lastre M, Lapinet J, Bracho G, Díaz M, Zayas C, Taboada C, Sierra G |title=Immune Response Induction and New Effector Mechanisms Possibly Involved in Protection Conferred by the Cuban Anti-Meningococcal BC Vaccine |journal=Infect Immun |volume=69 |issue=7 |pages=4502–8 |date=July 2001 |doi=10.1128/IAI.69.7.4502-4508.2001 |pmid=11401992 |pmc=98525}}</ref><ref>{{cite journal |vauthors=Uli L, Castellanos-Serra L, Betancourt L, Domínguez F, Barberá R, Sotolongo F, Guillén G, Pajón Feyt R |title=Outer membrane vesicles of the VA-MENGOC-BC vaccine against serogroup B of Neisseria meningitidis: Analysis of protein components by two-dimensional gel electrophoresis and mass spectrometry |journal=Proteomics |volume=6 |issue=11 |pages=3389–99 |date=June 2006 |doi=10.1002/pmic.200500502 |pmid=16673438|s2cid=10828810 }}</ref><ref>{{cite web |url=http://www.finlay.sld.cu/english/products/pregunvamengocbcenglish.htm |title=Finlay Institute VA-MENGOC-BC Most frequent questions and answers|access-date=10 March 2009 |url-status=dead |archive-url=https://web.archive.org/web/20110108221151/http://www.finlay.sld.cu/english/products/pregunvamengocbcenglish.htm |archive-date=8 January 2011 }}</ref> but it was granted a licence only for research purposes in the United States<ref>{{cite web |title= World: Americas Cuba vaccine deal breaks embargo |url= http://news.bbc.co.uk/2/hi/americas/406780.stm |publisher= BBC News Online |date= 29 July 1999 |access-date= 25 October 2009 |url-status= live |archive-url= https://web.archive.org/web/20090203062429/http://news.bbc.co.uk/2/hi/americas/406780.stm |archive-date= 3 February 2009 }}</ref> as political differences limited cooperation between the two countries.<ref>{{cite web |url=http://www.nbcnews.com/id/10010619/ns/world_news-americas/t/cuban-scientist-barred-receiving-us-prize/ |title=Cuban scientist barred from receiving U.S. prize |author=NBC News Digital |date=12 November 2015 |publisher=Associated Press |access-date=27 May 2019 |quote=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. |archive-date=7 June 2019 |archive-url=https://web.archive.org/web/20190607004818/http://www.nbcnews.com/id/10010619/ns/world_news-americas/t/cuban-scientist-barred-receiving-us-prize/ |url-status=live }}</ref>

Due to a similarly high prevalence of B-serotype meningitis in Norway between 1974 and 1988, 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.<ref>{{cite journal | vauthors = Djupesland PG, Bjune G, HØ E, Grønnesby JK, Mundal R |title=Serogroup B meningococcal disease in the Norwegian armed forces: What can we learn from an inconclusive vaccine protection trial?|journal=European Journal of Public Health |volume=7 |issue=3 |date=September 1997 |pages=261–266 |doi=10.1093/eurpub/7.3.261 |url=https://academic.oup.com/eurpub/article/7/3/261/503242|doi-access=free|access-date=28 October 2021|archive-date=28 October 2021|archive-url=https://web.archive.org/web/20211028020230/https://academic.oup.com/eurpub/article/7/3/261/503242|url-status=live}}</ref> 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.<ref>{{cite web|url=https://www.scoop.co.nz/stories/HL0502/S00064.htm|title=Investigation: The Meningococcal Gold Rush|work=Scoop|date=7 February 2005| vauthors = Burstyn BS |access-date=28 October 2021|archive-date=28 October 2021|archive-url=https://web.archive.org/web/20211028020230/https://www.scoop.co.nz/stories/HL0502/S00064.htm|url-status=live}}</ref>

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]].<ref>{{cite web |url=http://www.ovg.ox.ac.uk/OVG/blogs/ojohn/first-ever-menb-vaccine-available-use |title=First ever MenB vaccine available for use |date=24 January 2013 |website=[[Oxford Vaccine Group]] |url-status=dead |archive-url=https://web.archive.org/web/20141025140252/http://www.ovg.ox.ac.uk/OVG/blogs/ojohn/first-ever-menb-vaccine-available-use |archive-date=25 October 2014}}</ref> 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.<ref name=JVCI2013>{{cite web|author=Joint Committee on Vaccination and Immunisation (JCVI)|title=JCVI interim position statement on use of Bexsero® meningococcal B vaccine in the UK|url=https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/224896/JCVI_interim_statement_on_meningococcal_B_vaccination_for_web.pdf|access-date=16 November 2013|date=July 2013|url-status=live|archive-url=https://web.archive.org/web/20130819233254/https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/224896/JCVI_interim_statement_on_meningococcal_B_vaccination_for_web.pdf|archive-date=19 August 2013}}</ref> This decision was reverted in favor of Bexsero vaccination in March 2014.<ref name=JVCI2014>{{cite web| vauthors = Porter J |title=UK review of vaccines flawed, says Novartis' John Porter|url=http://www.pharmatimes.com/Article/14-08-28/UK_review_of_vaccines_flawed_says_Novartis_John_Porter.aspx|access-date=6 October 2014|date=March 2014|url-status=live|archive-url=https://web.archive.org/web/20141009002527/http://www.pharmatimes.com/Article/14-08-28/UK_review_of_vaccines_flawed_says_Novartis_John_Porter.aspx|archive-date=9 October 2014}}</ref> In March 2015 the UK government announced that they had reached agreement with [[GlaxoSmithKline]] who had taken over Novartis's vaccines business, and that Bexsero would be introduced into the UK routine immunization schedule later in 2015.<ref name=BBCBexsero>{{cite news|title=Meningitis B vaccine deal agreed – Jeremy Hunt|url=https://www.bbc.co.uk/news/health-32101921|access-date=7 May 2015|newspaper=BBC News|date=29 March 2015|url-status=live|archive-url=https://web.archive.org/web/20150523204724/http://www.bbc.co.uk/news/health-32101921|archive-date=23 May 2015}}</ref>

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.<ref name=Aleccia2013>{{cite news| vauthors = Aleccia JN |title=Emergency meningitis vaccine will be imported to halt Ivy League outbreak|url=https://www.nbcnews.com/health/emergency-meningitis-vaccine-will-be-imported-halt-ivy-league-outbreak-2D11603651|access-date=16 November 2013|newspaper=NBC News|date=15 November 2013|url-status=live|archive-url=https://web.archive.org/web/20131116001446/https://www.nbcnews.com/health/emergency-meningitis-vaccine-will-be-imported-halt-ivy-league-outbreak-2D11603651|archive-date=16 November 2013}}</ref> Bexsero was subsequently approved by the FDA in February 2015 for use in individuals 10 through 25 years of age.<ref>{{cite web |url=https://www.fda.gov/vaccines-blood-biologics/vaccines/bexsero |access-date=4 May 2022 |title=Bexsero |publisher=U.S. [[Food and Drug Administration]] (FDA) |date=7 January 2022 |archive-date=4 May 2022 |archive-url=https://web.archive.org/web/20220504221620/https://www.fda.gov/vaccines-blood-biologics/vaccines/bexsero |url-status=live }}</ref><ref name=FDABexsero>{{cite press release |title=FDA approves a second vaccine to prevent serogroup B meningococcal disease |url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm431370.htm |publisher=U.S. [[Food and Drug Administration]] (FDA) |date=23 January 2015 |access-date=15 March 2015 |url-status=dead |archive-url=https://web.archive.org/web/20150316080719/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm431370.htm |archive-date=16 March 2015 }}</ref> In October 2014, Trumenba, a serogroup B vaccine produced by [[Pfizer]], was approved by the FDA for use in individuals 10 through 25 years of age.<ref name=FDA2014/>

The occurrence of serogroup X has been reported in North America, Europe, Australia, and West Africa.<ref>[https://www.cdc.gov/Ncidod/EID/vol8no5/01-0227.htm Clonal Groupings in Serogroup X Neisseria meningitidis.] {{webarchive|url=https://web.archive.org/web/20090117112753/http://www.cdc.gov/ncidod/eid/vol8no5/01-0227.htm |date=17 January 2009 }}</ref> There is no vaccine to protect against serogroup X ''N. meningitidis'' disease.<ref name=WHO2011/>

==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. A small proportion of people develop a severe allergic reaction.<ref>{{cite web|title=Vaccines: Vac-Gen/Side Effects|url=https://www.cdc.gov/vaccines/vac-gen/side-effects.htm#mening|website=Centers for Disease Control and Prevention|publisher=National Center for Immunization and Respiratory Diseases|access-date=27 March 2017|url-status=live|archive-url=https://web.archive.org/web/20170317050028/https://www.cdc.gov/vaccines/vac-gen/side-effects.htm#mening|archive-date=17 March 2017}}</ref> 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".<ref>Health Canada {{cite web |url=https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/summary-safety-review-soliris-eculizumab-bexsero-multicomponent-meningococcal-vaccine.html |title=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|date=23 October 2014|access-date=11 August 2017 |url-status=live |archive-url=https://web.archive.org/web/20170811222931/https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/summary-safety-review-soliris-eculizumab-bexsero-multicomponent-meningococcal-vaccine.html |archive-date=11 August 2017 }} 16 September 2016</ref>

Despite initial concerns about [[Guillain-Barré syndrome]], subsequent studies in 2012 have shown no increased risk of GBS after meningococcal conjugate vaccination.<ref>{{cite journal | vauthors = Yih WK, Weintraub E, Kulldorff M | title = No risk of Guillain-Barré syndrome found after meningococcal conjugate vaccination in two large cohort studies | journal = Pharmacoepidemiology and Drug Safety | volume = 21 | issue = 12 | pages = 1359–1360 | date = December 2012 | pmid = 23225672 | doi = 10.1002/pds.3353 | s2cid = 43096082 }}</ref>

==Travel requirements==

[[File:Meningococcal vaccination travel requirements map.svg|thumb|upright=1.9|Travellers need to show proof of meningococcal vaccination...

{{Legend|#008000|Upon arrival in the Hajj and Umrah zones (foreign and domestic pilgrims, workers, and residents of Mecca and Medina)}}

{{Legend|#0000ff|Before departure to Hajj and Umrah in Saudi Arabia, and to certain African countries}}

{{Legend|#008080|Before departure to and upon arrival from Saudi Arabia}}

{{Legend|#00D4AA|Before departure to Hajj and Umrah in Saudi Arabia}}

{{Legend|#FFCC00|Upon arrival}}

{{Legend|#FF9955|[[African meningitis belt]]: vaccination recommended for visitors}}]]

{{See also|Vaccination requirements for international travel}}

Travellers who wish to enter or leave certain countries or territories must be vaccinated against meningococcal meningitis, preferably 10–14 days before crossing the border, and be able to present a vaccination record/certificate at the border checks.<ref name="WHO Travel and Health">{{Cite web |url=https://www.who.int/ith/CHAPTER_6_For_Publication.pdf |title=International Travel and Health. Chapter 6 - Vaccine-preventable diseases and vaccines (2019 update) |work=World Health Organization |publisher=United Nations |date=2020 |access-date=2 December 2020 |archive-date=11 April 2020 |archive-url=https://web.archive.org/web/20200411151558/https://www.who.int/ith/CHAPTER_6_For_Publication.pdf |url-status=live }}</ref>{{rp|21–24}} Countries with required meningococcal vaccination for travellers include [[The Gambia]], Indonesia, Lebanon, Libya, the Philippines and, most importantly and extensively, Saudi Arabia for Muslims visiting or working in [[Mecca]] during the [[Hajj]] or [[Umrah]] pilgrimages.<ref name="WHO country list">{{Cite web |url=https://www.who.int/publications/m/item/countries-with-risk-of-yellow-fever-transmission-and-countries-requiring-yellow-fever-vaccination-(july-2019) |title=Countries with risk of yellow fever transmission and countries requiring yellow fever vaccination (July 2019) |work=World Health Organization |publisher=United Nations |date=4 July 2019 |access-date=2 December 2020 |archive-date=8 March 2021 |archive-url=https://web.archive.org/web/20210308153504/https://www.who.int/publications/m/item/countries-with-risk-of-yellow-fever-transmission-and-countries-requiring-yellow-fever-vaccination-(july-2019) |url-status=live }}</ref> For some countries in [[African meningitis belt]], vaccinations prior to entry are not required, but highly recommended.<ref name="WHO Travel and Health"/>{{rp|21–24}}

{| class="wikitable sortable" style="text-align:left;" align="left" width=1100

! colspan="2" align="left" | Meningococcal vaccination requirements for international travel<ref name="WHO country list"/>

|-

! align="left" width=100 | Country or territory

! Details

|-

| {{flag|The Gambia}}

| All travellers must show proof of vaccination with quadrivalent meningococcal vaccine (ACYW135) upon arrival.<ref>{{Cite web |url=https://www.iamat.org/country/gambia/risk/meningococcal-meningitis |title=Gambia Required Vaccinations: Meningococcal Meningitis |work=iamat.org |publisher=International Association for Medical Assistance to Travellers (IAMAT) |date=20 August 2020 |access-date=2 December 2020 |archive-date=31 October 2020 |archive-url=https://web.archive.org/web/20201031162816/https://www.iamat.org/country/gambia/risk/meningococcal-meningitis |url-status=live }}</ref>

|-

| {{flag|Indonesia}}

| Travellers arriving from or departing to Saudi Arabia must show proof of vaccination with quadrivalent ACYW-135.<ref>{{Cite web |url=https://www.iamat.org/country/indonesia/risk/meningococcal-meningitis |title=Indonesia Required Vaccinations: Meningococcal Meningitis |work=iamat.org |publisher=International Association for Medical Assistance to Travellers (IAMAT) |date=20 August 2020 |access-date=2 December 2020 |archive-date=27 February 2021 |archive-url=https://web.archive.org/web/20210227182113/https://www.iamat.org/country/indonesia/risk/meningococcal-meningitis |url-status=live }}</ref>

|-

| {{flag|Lebanon}}

| Proof of vaccination with quadrivalent ACYW-135 is required for travellers departing Lebanon and going to Hajj, Umrah, and to certain African countries.<ref>{{Cite web |url=https://www.iamat.org/country/lebanon/risk/meningococcal-meningitis |title=Lebanon Required Vaccinations: Meningococcal Meningitis |work=iamat.org |publisher=International Association for Medical Assistance to Travellers (IAMAT) |date=20 August 2020 |access-date=2 December 2020 |archive-date=26 October 2020 |archive-url=https://web.archive.org/web/20201026011804/https://www.iamat.org/country/lebanon/risk/meningococcal-meningitis |url-status=live }}</ref>

|-

| {{flag|Libya}}

| All travellers must show proof of vaccination with quadrivalent ACYW-135 upon arrival.<ref>{{Cite web |url=https://www.iamat.org/country/libya/risk/meningococcal-meningitis |title=Libya Required Vaccinations: Meningococcal Meningitis |work=iamat.org |publisher=International Association for Medical Assistance to Travellers (IAMAT) |date=20 August 2020 |access-date=2 December 2020 |archive-date=16 January 2021 |archive-url=https://web.archive.org/web/20210116184136/https://www.iamat.org/country/libya/risk/meningococcal-meningitis |url-status=live }}</ref>

|-

| {{flag|Philippines}}

| Proof of vaccination with quadrivalent ACYW-135 is required for travellers going to Hajj and Umrah (in Saudi Arabia).<ref>{{Cite web |url=https://www.iamat.org/country/philippines/risk/meningococcal-meningitis |title=Philippines Required Vaccinations: Meningococcal Meningitis |work=iamat.org |publisher=International Association for Medical Assistance to Travellers (IAMAT) |date=20 August 2020 |access-date=2 December 2020 |archive-date=26 October 2020 |archive-url=https://web.archive.org/web/20201026002443/https://www.iamat.org/country/philippines/risk/meningococcal-meningitis |url-status=live }}</ref>

|-

| {{flag|Saudi Arabia}}

|

* Proof of vaccination is required for travellers 2 years of age and older who are Hajj or Umrah pilgrims and seasonal or pilgrim workers in Hajj and Umrah areas. Vaccination with quadrivalent ACYW135 (either polysaccharide or conjugate) must be issued not less than 10 days before arrival and not more than 3 years (polysaccharide vaccine) or 5 years (conjugate vaccine) before arrival. The immunisation certificate should clearly state if the traveller was vaccinated with the conjugate vaccine for the 5-year validity to apply.<ref name="KSA">{{Cite web |url=https://www.iamat.org/country/saudi-arabia/risk/meningococcal-meningitis |title=Saudi Arabia Required Vaccinations: Meningococcal Meningitis |work=iamat.org |publisher=International Association for Medical Assistance to Travellers (IAMAT) |date=20 August 2020 |access-date=2 December 2020 |archive-date=27 February 2021 |archive-url=https://web.archive.org/web/20210227193923/https://www.iamat.org/country/saudi-arabia/risk/meningococcal-meningitis |url-status=live }}</ref>

* Vaccination is also required for domestic pilgrims, residents of Mecca and Medina, and any persons participating in Hajj or Umrah or seasonal or pilgrimage work in Hajj and Umrah zones. At the discretion of the Ministry of Health, travellers may be administered prophylactic antibiotics upon arrival.<ref name="KSA"/>

|-

|}

{{Clear}}

{{reflist}}

==Further reading==

{{refbegin}}

* {{cite journal |vauthors=Conterno LO, Silva Filho CR, Rüggeberg JU, Heath PT |title=Conjugate vaccines for preventing meningococcal C meningitis and septicaemia |journal=Cochrane Database Syst Rev |volume=3 |pages=CD001834 |year=2006 |doi=10.1002/14651858.CD001834.pub2 |pmid=16855979 | veditors = Conterno LO |issue=3}}

* {{cite journal |vauthors=Patel M, Lee CK |title=Polysaccharide vaccines for preventing serogroup A meningococcal meningitis |journal=Cochrane Database Syst Rev |issue=1 |pages=CD001093 |year=2005 |doi=10.1002/14651858.CD001093.pub2 |pmid=15674874 | veditors = Patel M }}

* {{cite book | publisher = U.S. [[Centers for Disease Control and Prevention]] (CDC) | title = Epidemiology and Prevention of Vaccine-Preventable Diseases | veditors = Hall E, Wodi AP, Hamborsky J, Morelli V, Schillie S | edition = 14th | location = Washington D.C. | year = 2021 | chapter = Chapter 14: Meningococcal Disease | chapter-url = https://www.cdc.gov/vaccines/pubs/pinkbook/mening.html | url=https://www.cdc.gov/vaccines/pubs/pinkbook/index.html }}

{{refend}}

* {{cite web | title=Meningococcal ACWY Vaccine Information Statement | date=27 April 2023 | publisher=U.S. [[Centers for Disease Control and Prevention]] (CDC) | url=https://www.cdc.gov/vaccines/hcp/vis/vis-statements/mening.html }}

* {{cite web | title=Meningococcal B Vaccine Information Statement | date=27 April 2023 | publisher=U.S. [[Centers for Disease Control and Prevention]] (CDC) | url=https://www.cdc.gov/vaccines/hcp/vis/vis-statements/mening-serogroup.html }}

* {{cite web | title=Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine | date=28 February 2023 | publisher=U.S. [[Food and Drug Administration]] (FDA) | url=https://www.fda.gov/vaccines-blood-biologics/vaccines/menactra }}

* {{cite web | title=Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined | date=28 February 2023 | publisher=U.S. [[Food and Drug Administration]] (FDA) | url=https://www.fda.gov/vaccines-blood-biologics/vaccines/menomune-acyw-135 }}

* {{cite web | title=Menveo | date=28 February 2023 | publisher=U.S. [[Food and Drug Administration]] (FDA) | url=https://www.fda.gov/vaccines-blood-biologics/vaccines/menveo }}

* {{cite web | title=Trumenba | date=9 March 2023 | publisher=U.S. [[Food and Drug Administration]] (FDA) | url=https://www.fda.gov/vaccines-blood-biologics/vaccines/trumenba }}

* {{MeshName|Meningococcal Vaccines}}

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