Meningococcal vaccine

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Meningococcal vaccine
Vaccine description
Target Neisseria meningitidis
Vaccine type Conjugate or polysaccharide
Clinical data
Trade names Menactra, Menveo, Menomune, Others
AHFS/Drugs.com Monograph
MedlinePlus a607020
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  • AU:B1
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Meningococcal vaccine refers to any vaccine used to prevent infection by Neisseria meningitidis . [9] Different versions are effective against some or all of the following types of meningococcus: A, B, C, W-135, and Y. [9] [10] The vaccines are between 85 and 100% effective for at least two years. [9] They result in a decrease in meningitis and sepsis among populations where they are widely used. [11] [12] They are given either by injection into a muscle or just under the skin. [9]

Contents

The World Health Organization recommends that countries with a moderate or high rate of disease or with frequent outbreaks should routinely vaccinate. [9] [13] In countries with a low risk of disease, they recommend that high risk groups should be immunized. [9] 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. [13] In Canada and the United States the vaccines are effective against four types of meningococcus (A, C, W, and Y) are recommended routinely for teenagers and others who are at high risk. [9] Saudi Arabia requires vaccination with the quadrivalent vaccine for international travellers to Mecca for Hajj. [9] [14]

Meningococcal vaccines are generally safe. [9] Some people develop pain and redness at the injection site. [9] Use in pregnancy appears to be safe. [13] Severe allergic reactions occur in less than one in a million doses. [9]

The first meningococcal vaccine became available in the 1970s. [15] It is on the World Health Organization's List of Essential Medicines. [16]

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. [17]

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. 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)

Penbraya was approved for use in the United States in October 2023. [18] It combines the vaccines Trumenba and Nimenrix. [19] Penbraya is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. [18] It is approved for use in individuals 10 through 25 years of age. [18]

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] [21]

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, [22] while Menveo received FDA approval for use in children as young as two months in August 2013. [23] The Centers for Disease Control and Prevention (CDC) has not made recommendations for or against its use in children less than two years. [24] In November 2024, the European Commission (EC) approved Menveo to protect individuals aged two years and older against invasive meningococcal disease . [25]

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. [26]

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. [24]

Nimenrix

Nimenrix (Pfizer). Meningoccal group A, C, W-135 and Y conjugate vaccine Nimenrix (Pfizer).jpg
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. [27] 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. [28] 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. [8] [29] [30] It is not licensed in the United States. [31]

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 memory T cells. [32] [33] Attempting to overcome this problem by repeated immunization results in a diminished, not increased, antibody response, so boosters are not recommended with this vaccine. [34] [35] 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. [36] [37] 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. [38]

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). [39] 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. [40] [41]

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 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. [42] 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. [43]

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. [44] [45]

Serogroup B

Meningococcal B vaccine Meningococcal B vaccine.jpg
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. [46]

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, [47] [48] [49] but it was granted a licence only for research purposes in the United States [50] as political differences limited cooperation between the two countries. [51]

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 adolescents. Clinical trials were discontinued after the vaccine was shown to cover only slightly more than 50% of all cases. [52] 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. [53]

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. [54] 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. [55] This decision was reverted in favor of Bexsero vaccination in March 2014. [56] 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. [57]

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. [58] Bexsero was subsequently approved by the FDA in February 2015 for use in individuals 10 through 25 years of age. [59] [60] 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. [10]

Serogroup X

The occurrence of serogroup X has been reported in North America, Europe, Australia, and West Africa. [61] There is no vaccine to protect against serogroup X N. meningitidis disease. [9]

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. [62] 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". [63]

Despite initial concerns about Guillain-Barré syndrome, subsequent studies in 2012 have shown no increased risk of GBS after meningococcal conjugate vaccination. [64]

Travel requirements

Travellers need to show proof of meningococcal vaccination... .mw-parser-output .legend{page-break-inside:avoid;break-inside:avoid-column}.mw-parser-output .legend-color{display:inline-block;min-width:1.25em;height:1.25em;line-height:1.25;margin:1px 0;text-align:center;border:1px solid black;background-color:transparent;color:black}.mw-parser-output .legend-text{} 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 Meningococcal vaccination travel requirements map.svg
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

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. [65] : 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. [66] For some countries in African meningitis belt, vaccinations prior to entry are not required, but highly recommended. [65] : 21–24 

Meningococcal vaccination requirements for international travel [66]
Country or territoryDetails
Flag of The Gambia.svg  The Gambia All travellers must show proof of vaccination with quadrivalent meningococcal vaccine (ACYW135) upon arrival. [67]
Flag of Indonesia.svg  Indonesia Travellers arriving from or departing to Saudi Arabia must show proof of vaccination with quadrivalent ACYW-135. [68]
Flag of Lebanon.svg  Lebanon Proof of vaccination with quadrivalent ACYW-135 is required for travellers departing Lebanon and going to Hajj, Umrah, and to certain African countries. [69]
Flag of Libya.svg  Libya All travellers must show proof of vaccination with quadrivalent ACYW-135 upon arrival. [70]
Flag of the Philippines.svg  Philippines Proof of vaccination with quadrivalent ACYW-135 is required for travellers going to Hajj and Umrah (in Saudi Arabia). [71]
Flag of Saudi Arabia.svg  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. [72]
  • 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. [72]

Related Research Articles

This is a timeline of the development of prophylactic human vaccines. Early vaccines may be listed by the first year of development or testing, but later entries usually show the year the vaccine finished trials and became available on the market. Although vaccines exist for the diseases listed below, only smallpox has been eliminated worldwide. The other vaccine-preventable illnesses continue to cause millions of deaths each year. Currently, polio and measles are the targets of active worldwide eradication campaigns.

<span class="mw-page-title-main">Influenza vaccine</span> Vaccine against influenza

Influenza vaccines, colloquially known as flu shots or the flu jab, are vaccines that protect against infection by influenza viruses. New versions of the vaccines are developed twice a year, as the influenza virus rapidly changes. While their effectiveness varies from year to year, most provide modest to high protection against influenza. Vaccination against influenza began in the 1930s, with large-scale availability in the United States beginning in 1945.

<span class="mw-page-title-main">Conjugate vaccine</span> Type of vaccine

A conjugate vaccine is a type of subunit vaccine which combines a weak antigen with a strong antigen as a carrier so that the immune system has a stronger response to the weak antigen.

<span class="mw-page-title-main">Pneumococcal polysaccharide vaccine</span> Pneumonia vaccine

Pneumococcal polysaccharide vaccine, sold under the brand name Pneumovax 23, is a pneumococcal vaccine that is used for the prevention of pneumococcal disease caused by the 23 serotypes of Streptococcus pneumoniae contained in the vaccine as capsular polysaccharides. It is given by intramuscular or subcutaneous injection.

<i>Neisseria meningitidis</i> Species of bacterium that can cause meningitis

Neisseria meningitidis, often referred to as the meningococcus, is a Gram-negative bacterium that can cause meningitis and other forms of meningococcal disease such as meningococcemia, a life-threatening sepsis. The bacterium is referred to as a coccus because it is round, and more specifically a diplococcus because of its tendency to form pairs.

<span class="mw-page-title-main">Meningococcal disease</span> Often life-threatening bacterial infection

Meningococcal disease describes infections caused by the bacterium Neisseria meningitidis. It has a high mortality rate if untreated but is vaccine-preventable. While best known as a cause of meningitis, it can also result in sepsis, which is an even more damaging and dangerous condition. Meningitis and meningococcemia are major causes of illness, death, and disability in both developed and under-developed countries.

<span class="mw-page-title-main">Pneumococcal conjugate vaccine</span> Vaccine against Strep pneumoniae

Pneumococcal conjugate vaccine is a pneumococcal vaccine made with the conjugate vaccine method and used to protect infants, young children, and adults against disease caused by the bacterium Streptococcus pneumoniae (pneumococcus). It contains purified capsular polysaccharide of pneumococcal serotypes conjugated to a carrier protein to improve antibody response compared to the pneumococcal polysaccharide vaccine. The World Health Organization (WHO) recommends the use of the conjugate vaccine in routine immunizations given to children.

<span class="mw-page-title-main">Pneumococcal vaccine</span> Vaccine to prevent infection by the bacteria Stretococcus pneumoniae

Pneumococcal vaccines are vaccines against the bacterium Streptococcus pneumoniae. Their use can prevent some cases of pneumonia, meningitis, and sepsis. There are two types of pneumococcal vaccines: conjugate vaccines and polysaccharide vaccines. They are given by injection either into a muscle or just under the skin.

<span class="mw-page-title-main">Hib vaccine</span> Haemophilus influenzae type B vaccine

The Haemophilus influenzae type B vaccine, also known as Hib vaccine, is a vaccine used to prevent Haemophilus influenzae type b (Hib) infection. In countries that include it as a routine vaccine, rates of severe Hib infections have decreased more than 90%. It has therefore resulted in a decrease in the rate of meningitis, pneumonia, and epiglottitis.

<span class="mw-page-title-main">JN-International Medical Corporation</span> Pharmaceutical company in Nebraska, United States

JN-International Medical Corporation (JNIMC) is a U.S.-based biopharmaceutical corporation which since 1998 has been focused on developing vaccines and diagnostics for infectious disease for developing countries. This private corporation was founded in 1998 by Dr. Jeeri R. Reddy with the help of Dr. Kelly F. Lechtenberg in a small rural town, Oakland, Nebraska. From there it grew and expanded until in the year 2000 the corporation moved to Omaha, Nebraska.

NmVac4-A/C/Y/W-135 is the commercial name for a polysaccharide vaccine that protects against meningococcal meningitis caused by Neisseria meningitidis, specifically the serotypes A, C, Y, and W-135. This vaccine is part of a broader group of meningococcal vaccines. It is especially formulated for use in developing countries, aimed at protecting populations during meningitis outbreaks, particularly in high-risk regions like the African meningitis belt.

<span class="mw-page-title-main">Jeeri R. Reddy</span>

Jeeri Reddy an American biologist who became an entrepreneur, developing new generation preventive and therapeutic vaccines. He has been an active leader in the field of the biopharmaceutical industry, commercializing diagnostics and vaccines through JN-International Medical Corporation. He is the scientific director and president of the corporation that created the world's first serological rapid tests for Tuberculosis to facilitate acid-fast bacilli microscopy for the identification of smear-positive and negative cases. Prevention of mother-to-child transmission of HIV was achieved in South East Asia by the use of rapid tests developed by Reddy in 1999. Reddy through his Corporation donated $173,050 worth of Rapid Diagnostic Tests (RDTs) for malaria in Zambia and actively participated in the prevention of child deaths due to Malaria infections. Reddy was personally invited by the president, George W. Bush, and First Lady Laura Bush to the White House for Malaria Awareness Day sponsored by US President Malaria Initiative (PMI) on Wednesday, April 25, 2007.

<span class="mw-page-title-main">Meningitis</span> Inflammation of the membranes around the brain and spinal cord

Meningitis is acute or chronic inflammation of the protective membranes covering the brain and spinal cord, collectively called the meninges. The most common symptoms are fever, intense headache, vomiting and neck stiffness and occasionally photophobia. Other symptoms include confusion or altered consciousness, nausea, and an inability to tolerate light or loud noises. Young children often exhibit only nonspecific symptoms, such as irritability, drowsiness, or poor feeding. A non-blanching rash may also be present.

<span class="mw-page-title-main">African meningitis belt</span> Region of Africa with high rate of incidence of meningitis

The African meningitis belt is a region in sub-Saharan Africa where the rate of incidence of meningitis is very high. It extends from Senegal to Ethiopia, and the primary cause of meningitis in the belt is Neisseria meningitidis.

MenAfriVac is a vaccine developed for use in sub-Saharan Africa for children and adults between 9 months and 29 years of age against meningococcal bacterium Neisseria meningitidis group A. The vaccine costs less than US$0.50 per dose.

CRM197 is a non-toxic mutant of diphtheria toxin, currently used as a carrier protein for polysaccharides and haptens to make them immunogenic. There is some dispute about the toxicity of CRM197, with evidence that it is toxic to yeast cells and some mammalian cell lines.

Sir Andrew John Pollard is the Ashall Professor of Infection & Immunity at the University of Oxford and a Fellow of St Cross College, Oxford. He is an Honorary Consultant Paediatrician at John Radcliffe Hospital and the Director of the Oxford Vaccine Group. He is the Chief Investigator on the University of Oxford COVID-19 Vaccine trials and has led research on vaccines for many life-threatening infectious diseases including typhoid fever, Neisseria meningitidis, Haemophilus influenzae type b, streptococcus pneumoniae, pertussis, influenza, rabies, and Ebola.

Trudy Virginia Noller Murphy is an American pediatric infectious diseases physician, public health epidemiologist and vaccinologist. During the 1980s and 1990s, she conducted research at Southwestern Medical School in Dallas, Texas on three bacterial pathogens: Haemophilus influenzae type b (Hib), Streptococcus pneumoniae (pneumococcus), and methicillin-resistant Staphylococcus aureus (MRSA). Murphy's studies advanced understanding of how these organisms spread within communities, particularly among children attending day care centers. Her seminal work on Hib vaccines elucidated the effects of introduction of new Hib vaccines on both bacterial carriage and control of invasive Hib disease. Murphy subsequently joined the National Immunization Program at the Centers for Disease Control and Prevention (CDC) where she led multi-disciplinary teams in the Divisions of Epidemiology and Surveillance and The Viral Hepatitis Division. Among her most influential work at CDC was on Rotashield™, which was a newly licensed vaccine designed to prevent severe diarrheal disease caused by rotavirus. Murphy and her colleagues uncovered that the vaccine increased the risk of acute bowel obstruction (intussusception). This finding prompted suspension of the national recommendation to vaccinate children with Rotashield, and led the manufacturer to withdraw the vaccine from the market. For this work Murphy received the United States Department of Health and Human Services Secretary's Award for Distinguished Service in 2000, and the publication describing this work was recognized in 2002 by the Charles C. Shepard Science Award from the Centers for Disease Control and Prevention.

<span class="mw-page-title-main">Dan M. Granoff</span> American physician-scientist

Dan M. Granoff is an infectious disease physician-scientist who was named the 2014 Maurice Hilleman/Merck Laureate by the American Society for Microbiology for outstanding contributions to vaccine discovery and development. Beginning in 2011, Granoff held the Clorox Foundation Endowed Chair and was director of the Center of Immunobiology and Vaccine Development at Children's Hospital Oakland Research Institute. His work increased understanding of basic mechanisms of human immunity to encapsulated bacteria, and furthered development of vaccines against Haemophilus influenzae type B (Hib) and Neisseria meningitidis.

Penbraya is a pentavalent conjugate vaccine developed by Pfizer for the prevention of invasive meningococcal disease in people 10 through 25 years of age. Invasive meningococcal disease, caused by the bacterium Neisseria meningitidis, can lead to serious conditions such as meningitis and sepsis. Penbraya is approved for use by the US Food and Drug Administration (FDA). Penbraya is the first pentavalent vaccine that provides coverage against the five most common serogroups causing meningococcal disease.

References

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