Meningococcal vaccine

Source: Wikipedia, the free encyclopedia.

Meningococcal vaccine
Vaccine description
TargetNeisseria meningitidis
Vaccine typeConjugate or polysaccharide
Clinical data
Trade namesMenactra, Menveo, Menomune, Others
AHFS/Drugs.comMonograph
MedlinePlusa607020
License data
Pregnancy
category
  • AU: B1
subcutaneous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
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Meningococcal vaccine refers to any

just under the skin.[8]

The World Health Organization recommends that countries with a moderate or high rate of disease or with frequent outbreaks should routinely vaccinate.[8][12] In countries with a low risk of disease, they recommend that high risk groups should be immunized.[8] 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.[12] 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.[8] Saudi Arabia requires vaccination with the quadrivalent vaccine for international travellers to Mecca for Hajj.[8][13]

Meningococcal vaccines are generally safe.[8] Some people develop pain and redness at the injection site.[8] Use in pregnancy appears to be safe.[12] Severe allergic reactions occur in less than one in a million doses.[8]

The first meningococcal vaccine became available in the 1970s.[14] It is on the World Health Organization's List of Essential Medicines.[15]

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.[16]

Types

Neisseria meningitidis has 13 clinically significant serogroups, classified according to the antigenic structure of their polysaccharide capsule.[medical citation needed] Six serogroups, A, B, C, Y, W-135, and X, are responsible for virtually all cases of the disease in humans. Neisseria meningitidis Serogroup B is a major cause of meningococcal disease in younger children and adolescents.[medical citation needed]

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

Main article: Penbraya

Penbraya was approved for use in the United States in October 2023.

indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y.[17] It is approved for use in individuals 10 through 25 years of age.[17]

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:

Menveo and MenQuadfi are approved for medical use in the European Union.[6][7][19]

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,[20] while Menveo received FDA approval for use in children as young as two months in August 2013.[21] The Centers for Disease Control and Prevention (CDC) has not made recommendations for or against its use in children less than two years.[22]

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.[23]

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.[22]

Nimenrix

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.[24] 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.[25] 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.[26][27] It is not licensed in the United States.[28]

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.

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

mucosal immunity, so people can still become colonised with virulent strains of meningococcus, and no herd immunity can develop.[33][34]
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 toxoid polysaccharide–protein complex, resulting in anticipated enhanced duration of protection, increased immunity with booster vaccinations, and effective herd immunity.[35]

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).[36] 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.[37][38]

Bivalent (serogroups C and Y)

In June 2012, the FDA approved a combination vaccine against two types of meningococcal disease and

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.[40]

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.[41][42]

Serogroup B

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 human neural adhesion molecules to be a useful target.[43]

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.[medical citation needed]

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,[44][45][46] but it was granted a licence only for research purposes in the United States[47] as political differences limited cooperation between the two countries.[48]

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.[49] 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.[50]

A MenB vaccine was approved for use in Europe in January 2013. Following a positive recommendation from the European Union's

GlaxoSmithKline who had taken over Novartis's vaccines business, and that Bexsero would be introduced into the UK routine immunization schedule later in 2015.[54]

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.[55] Bexsero was subsequently approved by the FDA in February 2015 for use in individuals 10 through 25 years of age.[56][57] 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.[9]

Serogroup X

The occurrence of serogroup X has been reported in North America, Europe, Australia, and West Africa.[58] There is no vaccine to protect against serogroup X N. meningitidis disease.[8]

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.[59] 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".[60]

Despite initial concerns about

Guillain-Barré syndrome, subsequent studies in 2012 have shown no increased risk of GBS after meningococcal conjugate vaccination.[61]

Travel requirements

Travellers need to show proof of meningococcal vaccination...
  Upon arrival in the Hajj and Umrah zones (foreign and domestic pilgrims, workers, and residents of Mecca and Medina)
  Before departure to Hajj and Umrah in Saudi Arabia, and to certain African countries
  Before departure to and upon arrival from Saudi Arabia
  Before departure to Hajj and Umrah in Saudi Arabia
  Upon arrival
  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.[62]: 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.[63] For some countries in African meningitis belt, vaccinations prior to entry are not required, but highly recommended.[62]: 21–24 

Meningococcal vaccination requirements for international travel[63]
Country or territory Details
 The Gambia All travellers must show proof of vaccination with quadrivalent meningococcal vaccine (ACYW135) upon arrival.[64]
 Indonesia Travellers arriving from or departing to Saudi Arabia must show proof of vaccination with quadrivalent ACYW-135.[65]
 Lebanon Proof of vaccination with quadrivalent ACYW-135 is required for travellers departing Lebanon and going to Hajj, Umrah, and to certain African countries.[66]
 Libya All travellers must show proof of vaccination with quadrivalent ACYW-135 upon arrival.[67]
 Philippines Proof of vaccination with quadrivalent ACYW-135 is required for travellers going to Hajj and Umrah (in Saudi Arabia).[68]
 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.[69]
  • 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.[69]

References

  1. ^ "TGA eBS - Product and Consumer Medicine Information Licence". Archived from the original on 13 June 2021. Retrieved 13 June 2021.
  2. ^ "Prescription medicines: registration of new chemical entities in Australia, 2017". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 10 April 2023. Retrieved 9 April 2023.
  3. ^ "Prescription medicines and biologicals: TGA annual summary 2017". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 31 March 2024.
  4. ^ "Regulatory Decision Summary - MenQuadfi". Health Canada. 23 October 2014. Archived from the original on 5 June 2022. Retrieved 4 June 2022.
  5. ^ "Vaccines". Health Canada. 9 May 2018. Retrieved 13 April 2024.
  6. ^ a b "Menveo EPAR". European Medicines Agency (EMA). Archived from the original on 2 December 2020. Retrieved 29 November 2020.
  7. ^ a b "MenQuadfi EPAR". European Medicines Agency (EMA). 15 September 2020. Archived from the original on 28 January 2022. Retrieved 29 November 2020.
  8. ^
    PMID 22128384. Archived from the original
    (PDF) on 29 August 2021. Retrieved 20 December 2019.
  9. ^ a b "First vaccine approved by FDA to prevent serogroup B Meningococcal disease" (Press release). U.S. Food and Drug Administration (FDA). 29 October 2014. Archived from the original on 15 June 2019. Retrieved 19 October 2019.
  10. PMID 15674874
    . CD001093.
  11. PMID 16855979
    .
  12. ^
    PMID 25702330. Archived
    (PDF) from the original on 19 October 2015. Retrieved 5 October 2020.
  13. ^ "Saudi Arabia: Hajj/Umrah Pilgrimage". Centers for Disease Control and Prevention (CDC). Archived from the original on 12 August 2017. Retrieved 15 August 2017.
  14. ISBN 9780470656167
    .
  15. hdl:10665/371090
    . WHO/MHP/HPS/EML/2023.02.
  16. ^ "International Coordinating Group (ICG) on Vaccine Provision". Archived from the original on 30 November 2021. Retrieved 30 November 2021.
  17. ^ a b c "Penbraya". U.S. Food and Drug Administration. 20 October 2023. Retrieved 15 November 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  18. ^ "FDA Approves Penbraya, the First and Only Vaccine for the Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents". Pfizer (Press release). 20 October 2023. Retrieved 15 November 2023.
  19. ^ "MenQuadfi Product information". Union Register of medicinal products. Archived from the original on 5 March 2023. Retrieved 3 March 2023.
  20. ^ "22 April 2011 Approval Letter – Menactra". U.S. Food and Drug Administration (FDA). Archived from the original on 28 April 2011. Retrieved 25 April 2011.
  21. ^ "1 August 2013 Approval Letter – Menveo". U.S. Food and Drug Administration (FDA). Archived from the original on 28 September 2013. Retrieved 22 September 2013.
  22. ^ a b "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.
  23. ^ "MenQuadfi". U.S. Food and Drug Administration (FDA). Archived from the original on 4 May 2022. Retrieved 4 May 2022.
  24. ISBN 978-0-323-54696-6
    .
  25. PMID 26900984
    .
  26. ^ "Nimenrix". European Medicines Agency. 24 May 2012. Archived from the original on 23 December 2019. Retrieved 23 December 2019.
  27. ^ "Nimenrix – Summary of Product Characteristics (SmPC) – (emc)". www.medicines.org.uk. Archived from the original on 29 November 2020. Retrieved 27 November 2020.
  28. ^ "Advisory Committee on Immunization Practices (ACIP)" Archived 28 November 2020 at the Wayback Machine. CDC (June 2020).
  29. S2CID 36704156
    .
  30. S2CID 24021572
    .
  31. PMID 11137248
    .
  32. PMID 10462244
    .
  33. PMID 3130424
    .
  34. PMID 3184335
    .
  35. PMID 21270745
    .
  36. PMID 16479517
    .
  37. PMID 21270745
    .
  38. PMID 19779400
    .
  39. ^ FDA approves new combination vaccine that protects children against two bacterial diseases Archived 16 June 2012 at the Wayback Machine, FDA Press Release, 14 June 2012
  40. ^ "MenHibrix". U.S. Food and Drug Administration (FDA). 28 February 2023. Archived from the original on 17 February 2023. Retrieved 8 May 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  41. PMID 21653956
    .
  42. PMID 21228139
    .
  43. S2CID 24162009
    .
  44. PMID 11401992
    .
  45. S2CID 10828810
    .
  46. ^ "Finlay Institute VA-MENGOC-BC Most frequent questions and answers". Archived from the original on 8 January 2011. Retrieved 10 March 2009.
  47. ^ "World: Americas Cuba vaccine deal breaks embargo". BBC News Online. 29 July 1999. Archived from the original on 3 February 2009. Retrieved 25 October 2009.
  48. ^ NBC News Digital (12 November 2015). "Cuban scientist barred from receiving U.S. prize". Associated Press. Archived from the original on 7 June 2019. 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.
  49. doi:10.1093/eurpub/7.3.261. Archived
    from the original on 28 October 2021. Retrieved 28 October 2021.
  50. ^ Burstyn BS (7 February 2005). "Investigation: The Meningococcal Gold Rush". Scoop. Archived from the original on 28 October 2021. Retrieved 28 October 2021.
  51. ^ "First ever MenB vaccine available for use". Oxford Vaccine Group. 24 January 2013. Archived from the original on 25 October 2014.
  52. ^ 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.
  53. ^ Porter J (March 2014). "UK review of vaccines flawed, says Novartis' John Porter". Archived from the original on 9 October 2014. Retrieved 6 October 2014.
  54. ^ "Meningitis B vaccine deal agreed – Jeremy Hunt". BBC News. 29 March 2015. Archived from the original on 23 May 2015. Retrieved 7 May 2015.
  55. ^ Aleccia JN (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.
  56. ^ "Bexsero". U.S. Food and Drug Administration (FDA). 7 January 2022. Archived from the original on 4 May 2022. Retrieved 4 May 2022.
  57. ^ "FDA approves a second vaccine to prevent serogroup B meningococcal disease" (Press release). U.S. Food and Drug Administration (FDA). 23 January 2015. Archived from the original on 16 March 2015. Retrieved 15 March 2015.
  58. ^ Clonal Groupings in Serogroup X Neisseria meningitidis. Archived 17 January 2009 at the Wayback Machine
  59. ^ "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.
  60. ^ 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". 23 October 2014. Archived from the original on 11 August 2017. Retrieved 11 August 2017. 16 September 2016
  61. S2CID 43096082
    .
  62. ^ a b "International Travel and Health. Chapter 6 - Vaccine-preventable diseases and vaccines (2019 update)" (PDF). World Health Organization. United Nations. 2020. Archived (PDF) from the original on 11 April 2020. Retrieved 2 December 2020.
  63. ^ a b "Countries with risk of yellow fever transmission and countries requiring yellow fever vaccination (July 2019)". World Health Organization. United Nations. 4 July 2019. Archived from the original on 8 March 2021. Retrieved 2 December 2020.
  64. ^ "Gambia Required Vaccinations: Meningococcal Meningitis". iamat.org. International Association for Medical Assistance to Travellers (IAMAT). 20 August 2020. Archived from the original on 31 October 2020. Retrieved 2 December 2020.
  65. ^ "Indonesia Required Vaccinations: Meningococcal Meningitis". iamat.org. International Association for Medical Assistance to Travellers (IAMAT). 20 August 2020. Archived from the original on 27 February 2021. Retrieved 2 December 2020.
  66. ^ "Lebanon Required Vaccinations: Meningococcal Meningitis". iamat.org. International Association for Medical Assistance to Travellers (IAMAT). 20 August 2020. Archived from the original on 26 October 2020. Retrieved 2 December 2020.
  67. ^ "Libya Required Vaccinations: Meningococcal Meningitis". iamat.org. International Association for Medical Assistance to Travellers (IAMAT). 20 August 2020. Archived from the original on 16 January 2021. Retrieved 2 December 2020.
  68. ^ "Philippines Required Vaccinations: Meningococcal Meningitis". iamat.org. International Association for Medical Assistance to Travellers (IAMAT). 20 August 2020. Archived from the original on 26 October 2020. Retrieved 2 December 2020.
  69. ^ a b "Saudi Arabia Required Vaccinations: Meningococcal Meningitis". iamat.org. International Association for Medical Assistance to Travellers (IAMAT). 20 August 2020. Archived from the original on 27 February 2021. Retrieved 2 December 2020.

Further reading

External links

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