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Meningococcal Overview

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Meningococcal: The Disease

Meningococcal disease is a bacterial infection caused by the bacteria Neisseria meningitidis (N. meningitidis). There are thirteen identified types (serogroups) of N. meningitidis or meningococci, with six causing epidemics resulting in invasive meningococcal disease. Meningitis is the most common form of invasive meningococcal disease, accounting for about 75 percent of all cases.

Symptoms of meningitis usually appear between three and seven days after exposure to the meningococcal bacteria. At first, symptoms may appear mild and similar to cold or flu symptoms, such as headache, fever, aches, and pains. As the illness progresses, additional symptoms may arise, including skin rash, severe headache, stiff neck, nausea, vomiting, inability to look at bright lights, mental confusion and irritability, extreme fatigue/sleepiness, convulsions, and unconsciousness. In babies, symptoms may include a high-pitched moaning cry, difficulty or refusal to feed, and bulging of the fontanel (the soft area on the top of the head). Learn more about Meningococcal…

Meningococcal Vaccine

There are currently seven FDA licensed meningococcal vaccines in the U.S. However, two vaccines, Menactra and Menomune, are no longer produced. In total, these vaccines target five of the 13 meningococcal serotypes. Menveo, MenQuadfi, and PENBRAYA are conjugate vaccines that target serogroups A, C, Y and W-135. BEXSERO and TRUMENBA are recombinant vaccines that target serogroup B.

The CDC recommends that children 11 to 12 years of age receive the first dose of ACWY meningococcal vaccine conjugate, and a booster dose at age 16. For individuals at age 16 or older, vaccines for all currently available serogroups (A, C, W, Y and B) are recommended by the CDC. The CDC also recommends that high risk children between 2 months and 10 years and high-risk adults be vaccinated with meningococcal conjugate vaccine.Learn more about Meningococcal vaccine…

Meningococcal Quick Facts

Meningococcal

Meningococcal disease is a serious and potentially life-threatening infection caused by the bacteria Neisseria meningitides. Most frequently, the illness can result in inflammation of the meninges of the brain (meningitis) and a serious bloodstream infection (septicemia/meningococcemia). Invasive meningococcal disease can also present as arthritis and pneumonia.
Meningococcal disease is not easily spread and requires one to be susceptible to the infection and to have regular close contact with a person who is colonizing the bacteria. Between 10-20 percent of individuals are asymptomatic carriers and colonize the bacteria that causes meningococcal disease in the back of their throats. Natural community immunity contributes significantly to low disease incidence. Research shows that about 20 to 40 percent of Americans are asymptomatically colonizing meningococcal organisms in their nasal passages and throats. This colonization boosts an individual’s innate immunity to invasive meningococcal infection throughout life. The CDC has recognized high levels of innate community immunity and noted that the majority of Americans will experience asymptomatic infection as children or young adults without complications and develop protective bactericidal antibodies against meningococcal disease.
Meningococcal rates are low in the U.S. and have steadily declined since the 1990’s. In 2020, there were approximately 235 cases in the U.S. Of these cases 26 percent were unknown and ungroupable serotypes with 20 percent occurring in children too young to be vaccinated. For 2020, 23 death were reported, or less than ten percent of cases. Individuals most at risk for contracting meningococcal disease are infants, adolescents, young adults and seniors. Continue reading quick facts…

Meningococcal Vaccine

The CDC states that individuals receiving meningococcal vaccines may experience mild side effects such as pain or redness at the injection site, headache, fatigue, muscle and joint pain, fever, chills, nausea, and diarrhea. Additionally, the CDC warns that persons receiving any vaccine may collapse (faint), experience a severe allergic reaction, and even serious injury and death. Serious adverse events associated with meningococcal vaccines include anaphylaxis, wheezing, upper airway swelling, difficulty breathing, hypotension, itching, hives, lymph node swelling, Guillain-Barre syndrome, convulsions, facial palsy, vasovagal syncope, paresthesia, transverse myelitis, acute disseminated encephalomyelitis, extensive swelling of the injected limb and injection site.
Meningococcal B vaccines have not been given a routine recommendation by the CDC due to several factors. These factors included the high number of vaccinations that would be required to prevent a single case of the disease, low rates of disease, cost of the vaccine, lack of efficacy and safety data, and the possibility of serious adverse vaccine reactions exceeding the number of cases prevented.
In 2020, 85.7 percent of college students (18-24 years) and 69.2 percent of persons not attending college (18-24 years) had received at least one dose of MenACWY vaccine. For this same age group and college status, 14.3 percent of college students and 18.2 percent of persons not attending college had received at least one dose of MenB vaccine. Continue reading quick facts…

NVIC encourages you to become fully informed about Meningococcal and the Meningococcal vaccine by reading all sections in the table of contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

What is Meningococcal Disease?

Meningococcal disease is a bacterial illness caused by the aerobic, gram-negative bacteria Neisseria meningitidis (N. meningitidis). Thirteen types (serogroups) of N. Meningitis or meningococci have been identified with six found to be responsible for epidemics resulting in invasive meningococcal disease. These six serogroups include A, B, C, X, W and Y. Most frequently, invasive meningococcal disease can cause inflammation of the protective membranes (meninges) covering the brain and spinal cord (meningitis) and a serious bloodstream infection (septicemia/meningococcemia).

Symptoms of meningitis begin to appear between three and seven days after exposure to meningococcal bacteria and may appear mild and similar to cold or flu symptoms and may include headache, fever, aches and pains.

As the illness progresses, additional symptoms can include skin rash, severe headache, stiff neck, nausea, vomiting, inability to look at bright lights, mental confusions and irritability, extreme fatigue/sleepiness, convulsions and unconsciousness. In babies, symptoms can include a high-pitched moaning cry, difficulty or refusal to feed, and the fontanel, the soft area on the top of the head, may also be bulging.

Meningitis is the most common presentation of invasive meningococcal disease and accounts for approximately 75 percent of all cases. Humans are the only species known to carry N. meningitidis and invasive meningococcal disease most frequently occurs in late winter or early spring.

Approximately 10-20 percent of adolescents and adults are asymptomatic carriers of meningococci. Although they have no symptoms of the disease, they carry the bacteria in the back of their throat and can transmit the disease to others. Less than one percent of individuals who carry meningococci will develop invasive meningococcal disease. Invasive disease occurs when the meningococci bacteria pass through the mucous cells and invades the bloodstream. Often, invasive meningococcal disease has occurred after the development of an upper respiratory infection.

Mothers who have innate immunity transfer maternal antibodies to their infants to protect them for the first few months of life until they can make their own antibodies.

Meningococcal disease is not easily spread.

NVIC “Quick Facts” is not a substitute for becoming fully informed about Meningococcal disease, meningitis and the Meningococcal vaccine. NVIC recommends consumers read the more complete information following the "Quick Facts", as well as the vaccine manufacturer product information inserts, and speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child.

Is Meningococcal Disease Contagious?

Meningococcal disease is contagious, but is not easily spread. N. meningitidis is a very fragile bacteria and does not survive very long outside of the body and causes invasive meningococcal disease.

Invasive meningococcal disease is very rare in the United States. In 2020, there were approximately 235 cases of invasive meningococcal disease reported to the CDC. Between 1998 and 2007 and prior to the introduction of vaccines targeting meningococcal serogroups A, C, Y, and W-135, meningococcal disease rates had already decreased substantially to less than one case per 100,000 population.

Transmission of the disease requires one to be susceptible to the disease and to have direct close and lengthy contact, such as kissing or sharing items such as silverware, drinking glasses, toothbrushes, or lipstick, or by living in the same household as a carrier.

However, living in the same household as a carrier or someone suffering from meningococcal disease does not necessarily place a person at high risk for developing meningococcal disease. Studies have shown that only 3-4 percent of household members contract a secondary case of meningococcal disease when a family member has been diagnosed with meningococcal disease. Secondary risk transmission generally occurs in only 2-4 cases per 1,000 household members.

Between 10-20 percent of the population are asymptomatic carriers of N. meningitidis, the bacteria responsible for invasive meningococcal disease. Although asymptomatic carriers have no symptoms, they can potentially transmit the bacteria to others.

Studies have also found that genetics play a role in both one’s susceptibility to invasive meningococcal disease as well as to disease outcomes.

Learn about treatment and prevention and injury and death related to meningococcal disease.

What is the history of Meningococcal Disease in America and other countries?

The first reports of invasive meningococcal disease were noted as far back as the 16^th century, however, it was Swiss physician Gaspard Vieusseux who, in 1805, definitively described the disease. In 1884, two Italian pathologists became the first researchers to describe the meningococcal bacteria, and in 1887, it was determined to be the cause of bacterial meningitis after being isolated in samples of cerebral spinal fluid collected from six infected individuals. During the First World War, at a time when meningococcal disease rates were noted to be significantly higher, the classification of strains (currently referred to as serogroups) began with the discovery of at least two distinct strains of the bacteria.

Meningococcal infections presenting as meningococcal meningitis became a nationally reportable disease in the U.S. as early as the first part of the 20^th century. In the early 1900’s, between 69 and 90 percent of cases were fatal, with fatality rates higher among children than adults. Between 1913 and 1916, the disease was reported at a rate of two cases per 100,000 population.

In 1917-1918, meningococcal meningitis disease rates rose significantly, however, in 1919, rates began decreasing steadily and continued to do so over a five-year period before returning to the low pre- World War I rates. In the U.S., between 1924 and 1927, the disease rate was again reported at two cases per 100,000 population, while in Europe, the rate was noted to be at 1.4 cases per 100,000 population.

First Attempts to Prevent Disease

Between 1918 and 1928, horse antiserum was primarily used to treat meningococcal meningitis and public health officials reported that the antiserum was relatively successful in decreasing mortality rates from the disease. However, by 1928, when both meningococcal meningitis disease and death rates rose significantly, treating physicians frequently reported the antiserum to be completely ineffective. In 1929, during an epidemic of meningococcal meningitis, approximately 11,000 cases and 5,208 deaths were reported. While public health officials acknowledged that disease rates had increased significantly during this epidemic, they also reported that meningococcal disease was still very rare. They did, however, express concerns about the high number of fatalities associated with the disease.

In the latter part of the 1930s, researchers began experimenting with sulfonamides as a potential treatment for meningococcal disease. Certain experiments involved the use of a sulfonamide, such as sulfanilamide, or sulfapyridine alone or administered along with horse antiserum. Public health officials reported that the use of horse antiserum in combination with a sulfonamide appeared to be most effective.

The last reported epidemic of meningococcal disease occurred in 1943-1944. In 1943, there were 18,223 reported cases of meningococcal disease, however, by 1950, the disease rate had significantly decreased and only 3,788 cases were reported that year.

At Risk Populations Identified

In 1952, public health officials reported infants to be four times more likely than school children and adults to develop meningococcal disease and that the disease was more likely to spread in overcrowded populations. Further, upon evaluation of the four meningococcal disease epidemics occurring between 1915 and 1951, health officials noted that two took place during wartime and two during a time when industrial activities had significantly increased. As a result, they concluded that meningococcal disease outbreaks were more likely to occur during periods of high travel and at times when individuals relocated from a rural setting to more populated urban setting.

In the 1950s and 1960s, meningococcal disease strains resistant to sulfonamides began to emerge, prompting a change in treatment protocols to include the use of antibiotics such as penicillin and chloramphenicol. While penicillin can still be used to treat the disease, medical experts currently consider cephalosporins the antibiotic of choice against invasive meningococcal disease. In 1960, there were 2,259 reported cases of meningococcal disease and the death rate was report to be 0.4 per 100,000 population.

Between 1964 and 1968, meningococcal serogroup B was found to be responsible for the majority of disease cases, however, in 1969, meningococcal serogroup C disease emerged in both military and civilian populations. By 1972, meningococcal serogroup B re-emerged and accounted for the majority of cases. Serogroup C was still found to be responsible for at least one-third of meningococcal cases. When the first meningococcal serogroup A and C polysaccharide vaccines were licensed for use in the United States in 1975, they were ineffective against meningococcal serogroup B, which was the strain responsible for most cases of invasive meningococcal disease. In 1975, there were 1,478 reported meningococcal cases and 308 related deaths.

Vaccine Recommendations in U.S.

In 1985, when the CDC’s Advisory Committee on Immunization Practices (ACIP) made its first recommendations on the recently licensed tetravalent meningococcal polysaccharide vaccine targeting serogroups A, C, Y, and W-135 for use in persons with functional or anatomic asplenia or terminal complement component deficiencies, serogroup B accounted for between 50 to 55 percent of all meningococcal disease. Meningococcal serogroup C accounted for 20-25 percent, followed by serogroup W-135 at 15 percent, serogroup Y at 10 percent and serogroup A at 1-2 percent. At this time, there were 2,479 reported cases of meningococcal disease, and the disease rate was reported to be at 1.04 cases per 100,000 population.

There was an average of 2,400 cases of meningococcal disease reported yearly between 1992 and 1996, with disease rates higher among infants and adults 30 years of age and older. Serogroup C accounted for 35 percent of cases, followed by serogroup B at 32 percent, and serogroup Y at 26 percent. Meningococcal polysaccharide vaccines were administered primarily during an outbreak of the disease as the vaccine offered only short-term protection and was ineffective in children under the age of two.

From 1998 to 2007, and prior to the introduction of meningococcal conjugate vaccines targeting serogroups A, C, Y, and W-135, meningococcal disease rates continued to decrease. By 2007, there were 1,077 reported cases of meningococcal disease, down significantly from the 2,725 cases reported in 1998. Disease rates dropped from 0.92 cases per 100,000 population in 1998 to only 0.33 cases per 100,000 population by 2007. Researchers reported that while they could not offer any explanation for the significant decrease in the number of cases of meningococcal disease, they acknowledged that the newly licensed meningococcal conjugate vaccine was not responsible for the reduction in disease rates.

Meningococcal disease from all serogroups declined again from 1,172 reported cases in 2008 to 372 cases in 2015. Serogroup B invasive disease also declined significantly during the same time period even without the availability of a meningococcal serogroup B vaccine. Again, meningococcal disease researchers could not offer any explanation to account for the decrease in the number of reported meningococcal serogroup B disease cases during this time period.

In 2020, there were 235 reported cases and 23 deaths attributed to meningococcal disease. Of the reported cases, serogroup B accounted for 55 cases and 6 deaths; Serogroup C accounted for 54 cases and 2 deaths; Serogroup W accounted for 15 cases and 3 deaths; serogroup Y accounted for 50 cases and 6 deaths; nongroupable serogroups accounted for 26 cases and 3 deaths; and unknown serogroups accounted for 35 cases and 3 deaths.

In January 2022, an outbreak of serogroup C meningococcal disease began, with most cases reported among men who have sex with other men. As of January 2023, there have been 43 cases and nine deaths associated with this outbreak, with thirty-five percent of cases occurring in persons with HIV illness. All cases have occurred in adults between the ages of 20 and 77.

Globally, the World Health Organization (WHO) states that there is an inadequate surveillance system in place to reliably report on the burden of meningococcal disease. This results in a lack of accurate estimates in the number of cases that occur annually. The sub-Saharan desert, an area stretching from Ethiopia in the east to Senegal in the west, has historically accounted for the highest number of meningococcal meningitis cases worldwide. Often referred to as the meningitis belt, WHO reports that approximately 30,000 cases occur annually. Untreated cases of meningococcal disease are reported to have a fatality rate of approximately 50 percent and over 10 percent of individuals who develop the disease suffer severe long-term residual health problems as a result.

Can Meningococcal Disease cause injury and/or death?

Yes, however, meningococcal disease is rare in the U.S. and in 2020, there were 235 reported cases and 23 deaths resulting from the disease. Of these cases, 26 percent were unknown and ungroupable serotypes, with 20 percent occurring in children too young to be vaccinated.

The most serious complications of invasive meningococcal disease are meningitis and septicemia (meningococcemia). Meningitis involves the inflammation of the protective layers of the brain and spinal cord and accounts for 75 percent of severe meningococcal infections. Meningococcal disease can also cause meningococcemia, sometimes referred to as blood poisoning. Between five and twenty percent of invasive meningococcal infections result in meningococcemia. Ten to fifteen percent of all invasive meningococcal disease cases result in death.

Meningococcal disease can also cause long-term residual health problems in cases where it does not prove fatal. Between 10 and 20 percent of survivors suffer serious complications that can include arthritis, infections of the heart or eye, hearing loss, brain damage, loss of limbs or seizure. Children are more likely to suffer complications and long-term serious residual health problems as a result of the disease.

Less common infections resulting from invasive meningococcal disease include epiglottis, otitis media (ear infection), arthritis, and pneumonia.

Learn about treatment and prevention and who is at most risk for meningococcal disease.

Who is Most at Risk for Contracting Meningococcal Disease?

Babies and young children under the age of one are at highest risk for developing invasive meningococcal disease, along with adolescents and young adults between the ages of 16 and 23 years of age, and older adults.

Environmental, Biological and Genetic Factors

Environmental and biological factors can also increase a person’s risk of developing meningococcal disease. Environmental factors include smoking or living with a smoker, alcohol consumption, and living in crowded environments that may include prisons or military settings. Low socioeconomic status and minority ethnicity have also been linked to higher rates of meningococcal disease.

Biological factors such as functional or anatomic asplenia, genetic polymorphism, and innate immune system deficiencies, as well as chronic immune system disorders such as lupus or HIV/AIDS or even a recent respiratory illness, may also increase a person’s risk of developing meningococcal disease.

Additionally, men who have sex with other men, including HIV-infected men, may also be at a greater risk for the disease. In 2020, nearly 5 percent of meningococcal cases occurred in person living with HIV disease.

A 2010 large-scale study on invasive meningococcal disease and the complications of meningitis and meningococcemia (septicemia) resulting from the disease found that individuals who developed meningitis from meningococcal disease had genetic markers in a number of genes that prevented them from fighting the meningococcal bacteria and play a significant role in the development of invasive meningococcal disease.

Prescription Drugs Can Increase Risk

Individuals who take eculizumab (Soliris®), a medication often prescribed for paroxysmal nocturnal hemoglobinuria (PNH) or atypical hemolytic uremic syndrome, are also at a higher risk for the disease.

Having a low level of serum bactericidal antibody (SBA) has also been associated with a higher risk of meningococcal disease. Due to genetic and biological factors, a small minority of the population are unable to develop protective antibodies against meningococcal bacteria and have up to a 7,000 times greater risk of developing invasive meningococcal disease in their lifetime.

Learn about meningococcal disease complications.

Who is at highest risk for suffering complications from Meningococcal Disease?

Children who develop invasive meningococcal disease are more likely to suffer complications, often resulting in long-term severe health problems. Serious and often permanent health problems can include hearing loss, seizures, visual impairments, skin necrosis and scarring resulting in the need for skin grafting or amputations, learning difficulties, anxiety, behavioral and emotional problems. When meningococcal disease is not fatal, between 10 and 20 percent of all survivors will have severe and often permanent health problems resulting from the disease.

In a 2010 large-scale study on invasive meningococcal disease and the complications of meningitis and meningococcemia (septicemia) resulting from the disease, researchers found that individuals who developed meningitis from meningococcal disease had genetic markers in a number of genes that prevented them from fighting the meningococcal bacteria. Genetic variations in Factor H and Factor H-related proteins regulating immune system response to kill bacteria were found to play a role in the risk of meningococcal disease.

Can Meningococcal Disease be prevented and are there treatment options?

Meningococcal disease can be prevented by refraining from travel to areas where outbreaks are occurring and by avoiding overcrowded areas. Because smoking and second-hand smoke exposure have also been found to increase the risk of meningococcal disease, smoking cessation and limiting exposure to secondhand smoke may reduce meningococcal disease risk.

Good hygiene practices can help prevent the spread of the disease. Not sharing utensils, drinking glasses, food, towels, toothbrushes, and lipstick are effective ways to prevent transmission of the disease.

Prophylactic antibiotics such as rifampin, ciprofloxacin, ceftriaxone, or penicillin can be used to prevent the spread of meningococcal disease among family members or close contacts of a person diagnosed with meningococcal disease.

Invasive meningococcal disease is treated with antibiotics, and currently cephalosporins such as ceftriaxone and cefotaxime, are considered to be most effective against the disease. Blood and/or cerebral spinal fluid (CSF) is collected and tested to determine the presence of infection. These samples are also cultured to determine what specific bacteria are present so the most appropriate antibiotic can be selected to treat the disease.

Antibiotic-resistant serogroup Y meningococcal strains have emerged and in 2020, of the 41 isolates of meningococcal serogroup Y available to the CDC for analysis, 8 were found to be resistant to ciprofloxacin and penicillin, and 13 were found to be resistant to penicillin only. Additionally, two cases of penicillin-resistant were found in non-US residents who sought care in the US.

What is Meningococcal Vaccine?

There are five FDA approved meningococcal vaccines available for use in the United States targeting a total of five serotypes of the 13 for meningococcal disease.

Two vaccines, Menveo (Novartis/GlaxoSmithKline) and MenQuadfi (Sanofi Pasteur) are conjugate vaccines that target serogroups A, C, Y and W-135 meningococcal bacteria, two vaccines, BEXSERO (Novartis/GlaxoSmithKline) and TRUMENBA (Wyeth/Pfizer) are recombinant vaccines that target serogroup B meningococcal bacteria, and one vaccine PENBRAYA (Pfizer Ireland) is a meningococcal conjugate vaccine targeting serogroups A, B, C, Y, and W-135. Two additional meningococcal vaccines, Menactra (Sanofi Pasteur) and Menomune (Sanofi Pasteur) remain licensed in the US, however, production of both vaccines has been discontinued by the manufacturer.

Below is brief information on meningococcal vaccines in use in the U.S. Click the hyperlinked vaccine name to access vaccine product inserts on the FDA’s website. These inserts contain additional information on ingredients, safety, and clinical trials for each vaccine. NVIC encourages readers to review product inserts as part of their information gathering and decision-making process.

Menveo is a meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine manufactured by Novartis Vaccines and Diagnostics (GlaxoSmithKline). Menveo is FDA approved for use in persons two months through 55 years of age. Children vaccinated at two months of age are recommended to receive four doses of the vaccine (2, 4, 6, and 12 months of age). In young children between the ages of nine and 23 months, the vaccine is recommended as a two-dose series, with the second dose administered in the second year of life and at least 3 months following the first dose. One dose of the vaccine is recommended for individuals between the ages of two and 55 years of age. Menveo vaccine ingredients include strains of serogroup A, C, Y and W-135 meningococcal bacteria, Franz Complete medium, formaldehyde, CY medium, yeast extracts, purified polysaccharides and CRM 197 protein.

MenQuadfi is a meningococcal (groups A, C, Y, and W-135) polysaccharide tetanus toxoid conjugate vaccine manufactured by Sanofi Pasteur. MenQuadfi is FDA approved for use in individuals two years of age and older to be administered as a single dose. For persons 15 years of age and older, it can be given as booster dose if at least four years have passed since the first dose was given, or as a single dose for persons who are considered at risk for meningococcal disease. MenQuadfi vaccine ingredients include strains of A, C, Y and W-135 meningococcal bacteria, muller Hinton agar, Watson Scherp media, carbonyldiimidazole, adipic acid dihydrazide, periodate, ammonium sulfate, tetanus toxoid protein carrier, sodium chloride, sodium acetate, and formaldehyde.

BEXSERO is a meningococcal group B recombinant vaccine manufactured by Novartis Vaccines and Diagnostics (GlaxoSmithKline). BEXSERO is FDA approved for use in individuals aged 10 through 25 years. It is given in a series of two shots at least one month apart. BEXSERO has shown an immune response against three serogroup B strains as measured by serum bactericidal activity. The effectiveness of the vaccine against diverse serogroup B meningococcal disease has not been confirmed. BEXSERO vaccine ingredients include strains of the meningococcal B bacteria, factor H binding protein, outer membrane vesicles, aluminum hydroxide, sodium chloride, histidine, sucrose, E. coli, deoxycholate and kanamycin.

TRUMENBA is a meningococcal group B recombinant vaccine manufactured by Wyeth (Pfizer) Pharmaceuticals. TRUMENBA is FDA approved for use in individuals aged 10 through 25 years and can be administered in both a two or three dose schedule. As a two-dose schedule, the two doses are given six months apart. However, if more than six months has elapsed between doses, a third dose should not be administered earlier than four months after the second dose. As a three-dose schedule, the second dose is given 1-2 months after the first dose and the third dose is given six months following the first dose. Both the effectiveness of a 2-dose schedule as well as the vaccine’s ability to offer any protection against the diverse serogroup B meningococcal strains have not been confirmed. TRUMENBA vaccine ingredients include strains of meningococcal B bacteria, E. coli, defined fermentation growth media, polysorbate 80, and aluminum phosphate.

PENBRAYA is a meningococcal conjugate vaccine manufactured by Pfizer Ireland Pharmaceuticals. PENBRAYA is FDA approved for use in individuals aged 10 through 25 years, to be given intramuscularly (IM) as a 2-dose series administered at least six months apart. PENBRAYA vaccine ingredients include strains of A, B, C, Y and W-135 meningococcal bacteria, E. Coli, polysorbate 80, aluminum phosphate, trometamol, L-histidine, sodium chloride, and sucrose.

CDC Vaccine Recommendations

The CDC recommends that the first dose of meningococcal conjugate vaccine targeting serogroups A, C, Y and W-135 (Menveo or MenQuadfi) be administered at age 11-12 with a second booster dose given at the age of 16. ACIP also recommends that high risk children between 2 months and 10 years and high-risk adults be vaccinated with meningococcal conjugate vaccine. Conditions considered to increase a person’s risk for meningococcal disease include HIV- infection, complement component deficiencies, functional or anatomical asplenia, travel to meningococcal disease endemic areas, the use of eculizumab (Soliris®) medication and exposure to Neisseria meningitides due to employment as a microbiologist. At times, populations may also be identified as high risk for the disease related to an outbreak of meningococcal serogroup A, C, Y or W-135 disease and may be recommended to receive a dose of meningococcal conjugate vaccine.

The CDC also states that adolescents may be vaccinated with meningococcal group B vaccine (BEXSERO or TRUMENBA) and that persons considering the vaccine are recommended to receive it between 16 and 18 years of age. Routine vaccination with meningococcal group B vaccine is recommended only for high-risk individuals aged 10 and older with conditions that include functional or anatomical asplenia, complement component deficiencies, or for individuals taking eculizumab (Soliris®) medication. In the event of a meningococcal group B outbreak, populations may also be identified as high risk and recommended meningococcal group B vaccines. While the CDC recommends meningococcal serogroup B vaccines for high-risk adults, meningococcal group B vaccines have not received FDA approved for use in persons over the age of 25. Additionally, TRUMENBA and BEXSERO vaccines are not interchangeable and the same vaccine brand must be used for all administered doses.

Healthy individuals aged 16 to 23 years and high-risk individuals aged 10 and older who are recommended to receive meningococcal A, C, Y and W-135 vaccine (MenACWY) and meningococcal B vaccine (MenB) at the same visit may receive PENBRAYA (MenABCWY) in lieu of separate doses of MenACWY and MenB vaccines.

NVIC “Quick Facts” is not a substitute for becoming fully informed about Meningococcal disease, meningitis and the Meningococcal vaccine. NVIC recommends consumers read the more complete information following the "Quick Facts", as well as the vaccine manufacturer product information inserts, and speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child.

What is the history of Meningococcal vaccine use in America?

Early Polysaccharide Meningococcal Vaccines

Meningococcal vaccine development in the United States began in the 1960s with the organization of a U.S. military meningococcal research group. Throughout both World Wars, meningococcal disease outbreaks occurred and often impacted new recruits within their first three months of service. While meningococcal disease death rates had decreased as result of the discovery and use of sulfonamides by the late 1930’s, sulfa-resistant meningococcal strains had begun to emerge in the 1940s, leading military scientists to begin research and develop a meningococcal vaccine.

The first polysaccharide vaccine targeting meningococcal serogroup C was developed by and tested on members of the U.S armed forces in early 1968. Military scientists also developed a meningococcal serogroup A polysaccharide vaccine; however, clinical trials of this vaccine took place in African communities where serogroup A meningococcal disease was endemic.

By October of 1971, all new U.S. Armed Forces recruits were required to receive the military’s meningococcal serogroup C vaccine, a vaccine not yet licensed for use by the FDA. It wasn’t until 1974 that the FDA licensed three meningococcal polysaccharide vaccines, but only for limited use. The first licensed vaccines included a monovalent meningococcal serogroup A vaccine, a monovalent meningococcal serogroup C vaccine, and a bivalent serogroup A and C vaccine. In 1975, the CDC’s Advisory Committee on Immunization Practices (ACIP) declined to routinely recommend the vaccines and stated that there was “insufficient data on their benefits.” The vaccines were, however, recommended for use in the event of a meningococcal serogroup A or C outbreak but permission for use was required by both the FDA and CDC. Additionally, the CDC stated that while travelers visiting countries where meningococcal disease was considered endemic might benefit from vaccination, they also noted that no cases of meningococcal disease had ever been reported among Americans visiting these high risk areas. The military continued to routinely administer meningococcal polysaccharide serogroup C vaccine to all new recruits until 1978 at which time it switched to the bivalent meningococcal serogroup A and C polysaccharide vaccine.

Menomune, the first tetravalent meningococcal polysaccharide vaccine targeting meningococcal serogroups A, C, Y and W-135 received FDA approval for use in 1981 and by 1982, the military began using this vaccine in place of the bivalent vaccine. In 1985, ACIP issued their first recommendations on use of the tetravalent vaccine and recommended the vaccine for individuals with terminal complement component deficiencies, functional or anatomical asplenia, or in the event of an outbreak of serogroup A, C, Y and W-135 meningococcal disease. In the spring of 2000, ACIP recommended college students, particularly college freshman living in dormitories, consider tetravalent meningococcal polysaccharide vaccination but chose not to recommend routine vaccination, stating that meningococcal disease rates were low and routine vaccination would not be cost effective.

Meningococcal Conjugate Vaccines

The first meningococcal conjugate vaccine, Menactra, manufactured by Sanofi Pasteur, received FDA approval in January 2005 for use in persons ages 11 through 55 years. Menactra (MCV4 or MenACWY-D), a vaccine conjugating meningococcal serogroups A, C, Y and W-135 to a diphtheria toxoid, received FDA approval on the basis that it was not inferior in both safety and immunogenicity to the available tetravalent meningococcal polysaccharide vaccine, Menomune.

Later that year, in May of 2005, the CDC’s ACIP recommended that all 11-12-year olds receive the newly approved vaccine. In its recommendation, ACIP reported that a single vaccine dose would likely be effective for at least 22 years, and by vaccinating all 11-12-year olds, 21 cases and 3 deaths would be averted in the first year, and 270 cases and 36 deaths would be prevented over a period of 22 years. The committee also recommended the vaccine for use in persons between the ages of 11 and 55 with functional or anatomical asplenia and complement component deficiencies as well as for college freshmen living in dormitories, military recruits, microbiologists routinely working with N. meningitidis, and persons traveling to or residing in meningococcal disease endemic countries. When the recommendation was made, the vaccine had only been studied in approximately 5,000 health adolescents, and only one study of just over 1,000 teenagers had evaluated the safety and immunogenicity of the vaccine when administered concomitantly with the tetanus-diphtheria (Td) vaccine.

By September of 2005, the FDA and CDC issued a joint advisory warning of a potential association between Menactra vaccine and Guillain-Barre Syndrome (GBS). The vaccine product insert was updated to warn of the possible association of the vaccine to GBS and a previous history of GBS was listed as a contraindication to vaccination. The CDC, however, continued to recommend vaccination even as additional cases of GBS following Menactra vaccine administration were reported.

In May of 2006, the CDC issued a recommendation to defer vaccination of all 11-12 year olds in anticipation of a vaccine shortage, however, vaccination of all adolescents entering high school and all college freshman residing in dormitories continued to be recommended. Despite a meningococcal vaccine shortage, reports of GBS following Menactra vaccine administration continued to be submitted to the Vaccine Adverse Events Reporting System (VAERS). The CDC issued another update on the additional cases of GBS following Menactra vaccine in October 2006 but continued to recommend vaccination, reporting that GBS rarely occurred and data evaluation of a link would take years to determine.

In 2010, after a review of safety studies, ACIP voted to remove a personal history of GBS as a contraindication to meningococcal vaccination, and stated that the vaccine’s benefits outweighed the possible risk of developing a recurrent case of GBS. The Menactra product insert, however, continues to caution that a previous diagnosis of GBS may increase a person’s chance for recurrent illness and the decision to administer Menactra should carefully consider both the possible risks and potential benefits to vaccination.

By November 2006, the supply of Menactra vaccine had improved and routine vaccination of all 11-12-year olds was resumed along with continued vaccination of all high school freshman and college freshmen residing in dormitories. However, by November of 2006, additional vaccines targeting all 11-12-year olds had been both FDA approved and added to the CDC’s vaccine schedule by ACIP. The newly licensed tetanus, diphtheria, and acellular pertussis vaccine (Tdap) was added in March of 2006 and in June of 2006, Gardasil, Merck’s human papillomavirus vaccine (HPV4) received FDA approval for use in all 11-12 year old females. When ACIP published its recommendation on the HPV vaccine in March of 2007, it acknowledged that no evidence existed on the safety or effectiveness of administering the vaccine with Menactra or other newly recommended vaccines, however physicians were encouraged to simultaneously administer all recommended vaccines based on an assumption of safety. By August of 2007, ACIP recommended that all adolescents between the ages of 11 and 18 be vaccinated with the meningococcal conjugate vaccine at the earliest opportunity as the vaccine supply was believed to be sufficient enough to handle the increased demand for the product anticipated by this updated recommendation.

In October of 2007, the FDA approved Menactra (MCV4 or MenACWY-D) for use in children over the age of two. One week later, ACIP recommended that all children between the ages of two and ten years with functional or anatomical asplenia, complement component deficiencies, as well as children traveling to meningococcal disease endemic areas be vaccinated with MCV4. The vaccine was also recommended over the previously approved meningococcal polysaccharide vaccine despite any evidence that it was more effective than the previously recommended meningococcal polysaccharide vaccine. In February 2008, the committee, however, declined to decrease the recommended age of routine MCV4 vaccination to include children as young as two years of age, reporting that the current strategy of vaccinating all 11-12 year olds was likely to be most cost effective.

Menveo (MenACWY-CRM), a second meningococcal serogroup A, C, Y, and W-135 conjugate vaccine manufactured by Novartis Vaccine and Diagnostics (GlaxoSmithKline) received FDA approval in February of 2010 for use in persons aged 11 through 55 years. By March of 2010, ACIP announced that MenACWY-CRM could be used when vaccination with a meningococcal conjugate vaccine was indicated. Only one pre-licensing clinical trial of Menveo examined the safety and effectiveness of administering the vaccine concomitantly with both Tdap and HPV vaccine. The clinical trial involved 540 females between the ages of 11 and 18, however, trial results were not required by the FDA prior to the vaccine’s approval.

By October of 2010, public health officials had discovered that meningococcal conjugate vaccines were not as effective as previously thought. Meningococcal conjugate vaccines did not offer long-term vaccine acquired immunity and health officials reported that over 50 percent of teenagers vaccinated at age 11-12 years would likely not be protected against meningococcal disease when the risk of disease development was significantly higher, by age 16 through 21. As ACIP had previously determined age 11-12 to be a time when adolescents were noted to have a greater number of preventative care visits and that recommending the vaccine at this age would “strengthen the pre-adolescent vaccination platform,” a booster dose of meningococcal conjugate vaccine was recommended at age 16 in lieu of increasing the age recommendation to 16 years. The committee, however, stated that if the first dose of meningococcal conjugate vaccine was administered at age 16 or older, no additional booster dose would be required and that meningococcal vaccination of healthy individuals 21 years of age and older was not needed due to the low risk of meningococcal disease in this population.

In January of 2011, Menveo (MenACWY-CRM) received FDA approval for use in children age two through ten years and in April of 2011, Menactra (MenACWY-D) was approved for use in infants and young children between the ages of 9 and 23 months. Following FDA approval, ACIP voted to recommend Menactra (MenACWY-D) for use in infants and young children with complement component deficiencies, those traveling to areas where meningococcal disease was considered endemic, as well as those residing in an institution or community setting in the midst of a meningococcal outbreak. However, children with functional or anatomical asplenia, a population noted to be at greater risk for pneumococcal disease, were advised to wait until the age of two years before MenACWY-D vaccination. This recommendation was made as clinical trial data had noted that antibody levels decreased in three out of seven pneumococcal vaccine strains when MenACWY-D was administered at the same time as Prevnar 7 (PCV7) pneumococcal vaccine.

In June of 2012, the FDA approved the first meningococcal vaccine for use in infants as young as six weeks of age. MenHibrix (Hib-MenCY-TT), a meningococcal serogroup C and Y and Haemophilus b (HIB) tetanus toxoid conjugate vaccine manufactured by GlaxoSmithKline, received approval to be administered on a four dose schedule at 2, 4, 6, and 12 to 15 months of age. In response to FDA approval of MenHibrix (Hib-MenCY-TT), ACIP approved the vaccine for use in infants with complement component deficiencies or anatomical or functional asplenia and for use in the event of an outbreak of meningococcal serogroup C or Y. It was not, however, recommended for use in infants or young children traveling to sub-Saharian Africa as the vaccine would offer no protection against meningococcal serogroups A and W-135 disease, the two most common serogroups found within this region. Routine vaccination of infants and young children was not recommended as MenHibrix (Hib-MenCY-TT) offered no protection against meningococcal serogroup B, the serogroup responsible for approximately 60 percent of all invasive meningococcal disease in infants and children under the age of five years. Further, with infants under six months of age considered most at risk of infection, public health officials believed that one or possibly two doses of the vaccine administered before six months of age would likely not impact meningococcal disease rates. Citing low demand for the product, GlaxoSmithKline announced the discontinuation of MenHibrix in the United States in October of 2016.

In August of 2013, the FDA approved the use of Menveo (MenACWY-CRM) to be administered as a 4-dose series in infants at 2, 4, 6, and 12 to 15 months of age. Again, while routine vaccination of infants and young children was not recommended, the ACIP did, however, recommend the vaccine for use in infants and young children traveling to or residing in countries where meningococcal disease was considered endemic, during an outbreak of meningococcal disease for which the vaccine was indicated, in young children with complement component deficiencies, as well as for those with functional or anatomical asplenia. While simultaneous administration of Menactra (MenACWY-D) vaccine with Prevnar 7 (PCV7) vaccine was found to decrease pneumococcal antibody levels, this was not noted when Menveo (MenACWY-CRM) was administered concomitantly with PCV7 vaccine and therefore the vaccine was recommended for use in infants beginning at age two months who had received a diagnosis of functional or anatomical asplenia.

In April 2020, the FDA approved a third meningococcal conjugate vaccine, MenQuadfi (Sanofi Pasteur), targeting meningococcal serogroups A, C, Y, and W-135 for use in persons two years of age and older. Menactra was discontinued by Sanofi Pasteur in 2022.

Meningococcal Serogroup B Vaccines

The first meningococcal serogroup B vaccine, TRUMENBA, manufactured by Wyeth (Pfizer) pharmaceuticals, received FDA approval for use in persons aged 10 through 25 years of age on October 29, 2014. Less than five months earlier, TRUMENBA was given Breakthrough Therapy designation by the FDA and as meningococcal serogroup was considered a significant health threat, the FDA’s Center for Biologics Evaluation and Research (CBER) to agree to review TRUMENBA under the accelerated approval regulation. Pre-licensing clinical trials of TRUMENBA involved less than 4,600 healthy individuals predominantly between the ages of 11 and 18 years and the vaccine was only studied for safety and immunogenicity when administered with HPV4 vaccine. Pre-licensing clinical studies did not evaluate safety or immunogenicity of administering TRUMENBA with Tdap, influenza, HPV9 or any licensed meningococcal conjugate vaccines.

BEXSERO, a second meningococcal serogroup B vaccine, manufactured by Novartis Vaccines and Diagnostics (GlaxoSmithKline), received FDA approval for use on January 23, 2015. However, in late 2013 - early 2014, prior to FDA approval, the unlicensed vaccine was permitted by the CDC and FDA for use at both Princeton University and the University of California Santa Barbara (UCSB) where outbreaks of meningococcal serogroup B disease had been reported. At UCSB, where 51 percent of students received one vaccine dose and only 37 percent completed the recommended two dose series, no additional cases of meningococcal serogroup B disease were reported. At Princeton University, where 90 percent of students opted to receive 2 doses of the unlicensed vaccine, no further cases of meningococcal serogroup B disease were reported among vaccinated Princeton students but one additional case was reported in a student from another local university who had been in close contact with several Princeton University students. Vaccine researchers concluded that while the vaccine appeared effective at protecting vaccinated individuals, it likely had no impact on nasopharyngeal carriage and vaccinated individuals could still potentially spread the disease to others.

BEXSERO also received Breakthrough Therapy designation by the FDA, and through the accelerated approval designation, it was licensed within 10 months. At the time of FDA approval, no clinical studies had examined the safety or immunogenicity of BEXSERO when administered concomitantly with any other vaccine.

At the CDC’s February 2015 ACIP meeting, the two newly licensed meningococcal group B (MenB) vaccines were recommended for use in persons 10 years and older with functional or anatomical asplenia, complement component deficiencies, as well as individuals taking eculizumab (Soliris®) medication, microbiologists routinely exposed to Neisseria meningitidis, and in the event of a meningococcal serogroup B disease outbreak. At the June 2015 ACIP meeting, the committee declined to routinely recommend MenB vaccines but stated that they could be administered to adolescents and young adults between the ages of 16 and 23 years of age, with the preferred age considered between 16 and 18 years. Routine MenB vaccination was not considered cost effective as data suggested that overall, it would only prevent between 15 and 29 cases, and 2 to 5 deaths, and among college students, approximately 9 cases and 1 death.

In June 2016, HIV-positive individuals aged two months and older were added to the list of persons considered at high risk for meningococcal disease and recommended by ACIP to receive meningococcal conjugate vaccines (serogroup A, C, Y and W-135). At the time of this recommendation, committee members admitted that there had never been any safety or immunogenicity studies of the vaccine for use in HIV-positive children aged two months to two years or among HIV-positive adults 25 years of age and older. Further, this decision was made despite conflicting data on meningococcal disease case-fatality rates. Studies from South Africa had noted a high meningococcal disease death rate among HIV-positive persons whereas studies from New York City and the United Kingdom had found lower death rates among HIV-positive individuals in comparison to persons without HIV disease.

In February of 2017, Sanofi Pasteur announced the discontinuation of the Menomune tetravalent meningococcal polysaccharide vaccine. In response, the CDC announced that persons 56 years of age and older recommended to receive meningococcal vaccination could be administered a meningococcal conjugate vaccine. This recommendation was made despite acknowledging that neither available meningococcal conjugate vaccine was FDA approved for use in persons older than 55 years of age.

On April 23, 2018, Pfizer (Wyeth) announced that its TRUMENBA meningococcal group B vaccine had once again received Breakthrough Therapy designation by the FDA. The designation involved the use of TRUMENBA in children 12 months through 9 years of age. FDA approval for use of the vaccine in this population is still currently pending.

Pentavalent Meningococcal Vaccines (MenABCW-Y)

On October 20, 2023, the FDA approved PENBRAYA, a meningococcal conjugate vaccine targeting meningococcal serogroups A, B, C, Y, and W-135. This vaccine was approved in individuals between the ages of 10 and 25 years, to be given intramuscularly at a two-dose series administered at least six months apart.

The CDC’s ACIP voted on October 25, 2023 to recommend the use of PENBRAYA in healthy individuals aged 16 to 23 years and high-risk individuals aged 10 and older who are recommended to receive meningococcal A, C, Y and W-135 vaccine (MenACWY) and meningococcal B vaccine (MenB) at the same visit.

Meningococcal Vaccine Recommendations Under Review By the CDC

Meningococcal vaccine recommendations are scheduled to be reviewed in the next 15 months. Potential changes to the meningococcal recommendations may potentially include the elimination of the age 11–12-year-old meningococcal vaccine (MenACWY), or a switch to a “shared clinical decision-making” recommendation at this age. Additional changes potentially under consideration include an adjustment to the age of recommendation for MenB vaccines to be given closer to age 18-19, and a review of the current “shared clinical decision-making” recommendation.

^{NVIC “Quick Facts” is not a substitute for becoming fully informed about Meningococcal disease, meningitis and the Meningococcal vaccine. NVIC recommends consumers read the more complete information following the "Quick Facts", as well as the vaccine manufacturer product information inserts, and speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child.}

How effective is Meningococcal vaccine?

Below is effectiveness information for meningococcal vaccines licensed in the U.S. Click on each vaccine below to learn more.

In general, it is important to understand that the FDA approval of the below vaccines was based on non-inferior safety and immunogenicity profiles. In layman’s terms this means that the vaccine under licensure consideration is no worse than another already licensed. FDA approval of Menactra, the first conjugate vaccine, was made on the basis of non-inferiority against an existing polysaccharide vaccine no longer in use (Menomune). Subsequent FDA approvals of later vaccines have continued to be scaffolded on non-inferior standards largely due to “ethical concerns” of a placebo group not having access to vaccines.

Similar to meningococcal conjugate vaccines, meningococcal serogroup B (MenB) vaccines received FDA approval based on blood tests indicating immune response (immunogenicity) to the particular strains found within the vaccine. Meningococcal serogroup B strains, however, are quite diverse, and as a result, vaccine effectiveness is difficult to assess. Additionally, serogroup B disease rates were at historical lows and disease outbreaks sporadic prior to the licensing of MenB vaccines may limit the ability to determine effectiveness. See additional information below for MenB vaccines.

First Licensed ACYW-135 Conjugate Vaccine - Menactra

Clinical trials on Menactra’s (MCV4 or MenACWY-D) efficacy were not a requirement when FDA licensed its use in 2005. Menactra was the first meningococcal (serogroups A, C, Y, and W-135) conjugate vaccine and received FDA approval on the basis that the vaccine was not inferior in safety or immunogenicity when compared with Menomune meningococcal polysaccharide vaccine, the only FDA approved meningococcal vaccine available at the time. Immunogenicity was based on blood antibody testing completed 28 days following vaccine administration.

In the spring of 2005, when the CDC’s Advisory Committee on Immunization Practices (ACIP) voted that all 11-12-year olds be administered the vaccine, it acknowledged that immunogenicity data was not sufficient enough to determine the vaccine’s effectiveness. Further, data was not available to determine whether the vaccine could reduce or eliminate vaccine type meningococcal bacteria from the nasopharyngeal region and prevent persons who carried the bacteria from spreading it to others.

The ACIP also recommended that Menactra be administered at the same time as the newly licensed Tdap vaccine, though no clinical trials had examined whether administering both vaccines during the same visit would be effective or safe.

When ACIP initially recommended routine vaccination of all 11-12 year olds with Menactra meningococcal conjugate vaccine in 2005, committee members estimated that a single dose of the vaccine would be effective for an average of 22 years. However, by October of 2010, five years after the initial approval vote, ACIP voted to add a booster dose of meningococcal vaccine at age 16. By this time, data on vaccine effectiveness had determined that by age 16 to 21 years, at a time when the risk of meningococcal disease was noted to be higher, more than 50 percent of 11-12-year olds would lack any protection from the vaccine and be at risk for developing meningococcal disease.

A 2017 published study on Menactra (MenACWY-D) vaccine effectiveness found that overall, a single vaccine dose was between 51 and 80 percent effective. Within one year after vaccination, the vaccine was found to be between 49 and 91 percent effective, and after 1 to 3 years, this number decreased to between 44 and 83 percent. MenACWY-D vaccine was found to be only 25 to 79 percent effective by 3 to 8 years following vaccination. Study authors concluded that a booster dose of meningococcal conjugate vaccine would likely provide more long-term vaccine acquired immunity, but also stated that the additional impact gained from the booster dose in terms of cases prevented is likely to be limited

Menveo Men ACWY- CRM Conjugate Vaccine

Approved by the FDA in 2010, Menveo (serogroups A, C, Y, and W-135) conjugate vaccine approval was based on safety and immunogenicity studies reporting the vaccine to be non-inferior to the Menactra (MCV4/ MenACWY-D) conjugate vaccine. As with the Menactra vaccine, no vaccine efficacy studies were completed at the time of licensure, nor had any studies determined whether or not the vaccine could reduce or eliminate nasopharyngeal carriage.

Shortly after FDA licensure, the ACIP recommended Menveo for use when meningococcal vaccination was indicated.⁹

MenQuadfi ACWY Conjugate Vaccine

MenQuadfi received FDA approval 2020 based on clinical trials that reported the vaccine was not inferior in safety or immunogenicity when compared with Menomune, Menactra, and Menveo conjugate vaccines.

BEXSERO and TRUMEMBA MenB Vaccines

Meningococcal serogroup B (MenB) vaccines received FDA approval based on blood tests indicating immune response (immunogenicity) to the particular strains found within the vaccine. Meningococcal serogroup B strains, however, are quite diverse, and as a result, vaccine effectiveness is difficult to assess.

Moreover, with meningococcal serogroup B disease rates at historical lows and disease outbreaks sporadic even prior to the licensing of TRUMENBA (MenB-FHbp) and BEXSERO (MenB-4C) vaccines, data on the effectiveness of meningococcal group B vaccines was considered almost impossible to attain. Immunogenicity, however, is not necessarily indicative that either available Men B vaccine is, in fact, effective against any of the various meningococcal group B strains that may be circulating in the environment.

While ACIP recommends that all persons with complement component deficiencies as well as those taking the medication eculizumab (Soliris®) be vaccinated with a meningococcal conjugate vaccine as well as a Men B vaccine, all meningococcal vaccine package inserts state that these individuals will continue to remain at high risk of meningococcal disease even if they develop antibodies following vaccination. Several published studies have reported on the failure of meningococcal vaccines to offer protection in this particular susceptible population.

According to unpublished data submitted by Pfizer to ACIP in 2015, blood antibody levels believed to be indicative of a protective immune response decrease quickly after three doses of TRUMENBA (MenB-FHbp) vaccine. This data reported that within four years, only about 50 percent of vaccine recipients had blood antibody levels above or at the lowest acceptable level indicative of an immune response but only to three out of four of the meningococcal serogroup B vaccine strains tested.

In BEXSERO (MenB-4C) pre-licensing immunogenicity trials, the three antigen strains found within the vaccine were measured in college students in the United Kingdom at 1 and 11 months following the administration of two doses of the vaccine. At one month, 88 percent of vaccine recipients had an immune response considered to be protective, however by 11 months, this number decreased to only 66 percent. The long-term effectiveness of BEXSERO vaccine is unknown at this time.

In late 2013 - early 2014, and prior to FDA approval, the FDA and CDC approved BEXSERO (MenB-4C) for use during an outbreak of meningococcal serogroup B invasive disease at Princeton University. In 2016, a published study reported that nearly 34 percent of vaccine recipients had no evidence of a protective immune response against the particular meningococcal serogroup B strain responsible for the outbreak at Princeton University eight weeks following the second dose. While no additional cases of meningococcal serogroup B invasive disease occurred among vaccine recipients at Princeton University, one additional fatal case was reported during the same time period in a student attending another university who had a history of close contact with several Princeton University students. This additional case provided evidence that the vaccine did not eliminate N. meningitidis serogroup B carriage and that vaccinated individuals who carry serogroup B meningococci in their nasopharyngeal area could still transmit the bacteria and potentially cause invasive disease in others.

A 2017 published study examining meningococcal carriage during an outbreak of meningococcal serogroup B at a large university in Oregon found that neither BEXSERO (MenB-4C) nor TRUMENBA (MenB-FHbp) had any impact on meningococcal nasopharyngeal carriage reduction and that implementing vaccine programs to target meningococcal serogroup B did not result in herd protection. High vaccination rates coupled with the use of preventative antibiotics in persons with a history of close contact to a person diagnosed with invasive meningococcal disease was recommended during an outbreak, with study authors encouraging that further research be completed to determine the effectiveness, coverage, and duration of protection afforded by both MenB vaccines.

PENBRAYA ABCWY Pentavalent Vaccine

In October 2023, the FDA approved use of PENBRAYA, a pentavalent meningococcal vaccine targeting the A, B, C, W, and Y meningococcal serogroups. According to the vaccine’s package insert, the effectiveness of PENBRAYA was determined by one clinical study that compared the antibody responses of meningococcal A, B, C, Y and W-135 in individuals who received PENBRAYA to the same antibody responses in individuals who received TRUMEMBA MenB and meningococcal (serogroups A, C, W and Y) oligosaccharide diphtheria CRM197 conjugate vaccine simultaneously. The manufacturer reported that antibody responses to PENBRAYA were non-inferior to those of TRUMEMBA MenB and meningococcal (serogroups A, C, W and Y) oligosaccharide diphtheria CRM197 conjugate vaccine. There is no information available on the long-term effectiveness of PENBRAYA or how effective this vaccine will be outside of clinical trials. Data is also lacking on the effectiveness of giving PENBRAYA at the same time as other vaccines.²⁸

Can meningococcal vaccine cause injury & death?

The Institute of Medicine (IOM) has acknowledged that there is individual susceptibility to vaccine reactions for genetic, biological and environmental reasons, but that vaccine providers cannot accurately predict prior to a vaccine’s administration who will suffer complications, injury or death from vaccination. However, a person who has previously had a serious reaction to a vaccination or is acutely or chronically ill should become informed about all potential risks associated with vaccination and discuss any concerns with a trusted health care professional before receiving a meningococcal vaccine or any other vaccine.

Meningococcal Conjugate Vaccines

According to the CDC, individuals receiving meningococcal vaccines targeting meningococcal serogroups A, C, Y, and W-135 (Menactra or Menveo) may experience mild side effects such as pain or redness at the injection site, headache, fatigue, and muscle pain. Additionally, the CDC warns that persons receiving any vaccine may collapse (faint), experience a severe allergic reaction, and even serious injury and death.

Adverse events reported by Sanofi Pasteur in the Menactra vaccine product insert include: injection site redness, pain, and swelling; irritability; diarrhea; drowsiness; anorexia; headache; fatigue; vomiting; abnormal crying; loss of appetite; rash; joint pain; chills; anaphylaxis; wheezing; upper airway swelling; difficulty breathing; hypotension; itching; hives; lymph node swelling; Guillain-Barre syndrome; convulsions; dizziness; facial palsy; vasovagal syncope; paresthesia; transverse myelitis; acute disseminated encephalomyelitis; muscle pain; and extensive swelling of the injected limb and injection site.

Adverse events reported by Novartis Vaccines and Diagnostics (GlaxoSmithKline) in the pre-licensing clinical trials of Menveo vaccine include: injection site tenderness, swelling, and redness; sleepiness; irritability; persistent crying; changes in eating habits; diarrhea; vomiting; fever; rash; headache; joint and muscle pain; malaise; nausea; chills; dehydration; gastroenteritis; Kawasaki’s Disease; acute disseminated

encephalomyelitis; appendicitis; pneumonia; staphylococcal infection; dehydration; tonic and febrile convulsion; limb injury; varicella; road traffic accidents; vitello-intestinal duct remnant; Cushing’s syndrome; viral hepatitis; pelvic inflammatory disease; intentional multiple drug overdose; simple partial seizure; suicidal depression and suicide attempts. Among infants and young children under 2 years of age, two deaths were reported within 28 days of vaccination. Deaths were listed as sepsis and sudden death. Adverse events reported following the licensing of Menveo vaccine have included: anaphylaxis; falls; head injury; vaccination site cellulitis, pain, redness, persistent itching, swelling, and inflammation; extensive swelling of the vaccinated limb; fatigue; malaise; fever; ear pain; hearing impairment; vestibular disorder; vertigo; eyelid ptosis; increased body temperature; increased Alanine aminotransferase; bone and joint pain; skin exfoliation; oropharyngeal pain; balance disorder; facial paresis; dizziness; syncope; tonic convulsions; headache; and Bell’s palsy. In a post marketing safety study, the administration of Menveo vaccine concomitantly with Tdap and HPV vaccine was noted to significantly increase the risk of Bell’s palsy within 84 days of vaccine administration.

A 2017 published study of Menveo vaccine by researchers who examined adverse reaction reports submitted to the Vaccine Adverse Events Reporting System (VAERS) between 2010 and 2015 noted additional medical conditions following vaccination to include Guillain-Barre syndrome, facial nerve palsy, seizures, intracranial hypertension, acute disseminated encephalomyelitis, chronic inflammatory demyelinating polyradiculopathy, migraine, headache, hypotonia/motor delay, polyneuritis, neuromyopathy, anaphylaxis, allergic reactions, drug eruption, vasovagal syncope, myocarditis and pericarditis, appendicitis, viral meningitis, streptococcal pneumonia, Steven Johnson Syndrome, erythema multiforme, fibromyalgia, pyomyositis, muscular weakness, juvenile idiopathic arthritis, psychiatric disorders, gastrointestinal disorders, glioma, osteosarcoma, Kawasaki’s disease, idiopathic thrombocytopenic purpura (ITP), and hyperthyroidism.

Adverse events reported by Sanofi Pasteur in the pre-licensing clinical trials of MenQuadfi vaccine include: injection site pain, swelling, and redness, fever, muscle pain, malaise, headache, dizziness, syncope, nausea, vomiting, nasal congestion, dizziness, dysgeusia (distorted sense of taste), hypoaesthesia (decreased sense of taste), rash, injection site infection, viral pharyngitis, upper respiratory tract infection, sinusitis, urinary tract infection, otitis externa, pharyngitis streptococcal, arthralgia and back pain.

In the comprehensive report evaluating scientific evidence, Adverse Effects of Vaccines: Evidence and Causality , published in 2012 by the Institute of Medicine (IOM), nine reported vaccine adverse events following meningococcal serogroup A, C, Y, and W-135 vaccination were evaluated by a physician committee. These adverse events included encephalitis, encephalopathy, multiple sclerosis, chronic headache, Guillain-Barre Syndrome, acute disseminated encephalomyelitis, chronic inflammatory disseminated polyneuropathy, anaphylaxis, and transverse myelitis.

In eight of the nine meningococcal vaccine-related adverse events evaluated, the IOM committee concluded that there was inadequate evidence to support or reject a causal relationship between meningococcal vaccine and the reported adverse event, primarily because there was either an absence of methodologically sound published studies or too few quality studies to make a determination. The IOM committee, however, concluded that the scientific evidence “convincingly supports” a causal relationship between anaphylaxis and meningococcal vaccine.

Meningococcal Group B Vaccines

According to the CDC, more than 50 percent of meningococcal serogroup B (BEXSERO or TRUMENBA) vaccine recipients experience mild side effects that may include pain, redness, and swelling to the injection site, headache, joint or muscle pain, fever or chills, diarrhea or nausea, and fatigue. The CDC also warns that persons receiving any vaccine may collapse (faint), experience a severe allergic reaction, and even serious injury and death.

Adverse events reported by Novartis Vaccines and Diagnostics (GlaxoSmithKline) in the pre-licensing clinical trials of BEXSERO vaccine included: redness, pain, and swelling at the injection site; muscle and joint pain; fatigue; nausea; headache; fever; nasopharyngitis; upper respiratory infection; anaphylaxis; juvenile arthritis; acute thyroiditis; bacterial meningitis; appendicitis, muscular weakness, generalized and submandibular lymphadenopathy, rhabdomyolysis; septic shock; pneumonia; and generalized Tonic-Clonic seizure. Four deaths were reported during pre-licensing clinical trials, however, study investigators declared them to be unrelated to vaccination. These deaths included suicide, drowning, motor vehicle accident, and the death of a 7-week-old infant from post-natal respiratory complications. The infant’s mother had received her last dose of the vaccine approximately 9-10 months prior to the infant’s birth. Adverse events reported following FDA approval of BEXSERO have included: vasovagal responses to injection; syncope; allergic reaction; rash; eye swelling; extensive swelling of the vaccinated limb; blisters around or at the injection site; and persistent injection site nodule.

In the United Kingdom, where BEXSERO (4CMenB) has been routinely administered in a three-dose series to infants at 8 weeks, 16 weeks, and between 12-13 months since September 2015, researchers have found that fever related hospitalizations within three days of vaccination have increased significantly when the vaccine is administered at 8 and 16 weeks.

Adverse events reported by Wyeth Pharmaceuticals (Pfizer) in the pre-licensing clinical trials of TRUMENBA vaccine included: pain, swelling, and redness at the injection site; headache; fever; vomiting and diarrhea; fatigue; chills; muscle and joint pain; nervous system disorders; ligament strain; oropharyngeal pain; eye disorders; severe vertigo, chills, and headache; severe vomiting with fever; anaphylaxis; hydrocephalus; post-infectious arthritis; deep vein thrombosis; Type 2 diabetes mellitus; contact dermatitis; decreased appetite; migraine; asthma; hypothyroidism; scoliosis; Crohn's disease; exacerbation of psoriasis; celiac disease; exacerbation of celiac disease; autoimmune thyroiditis; acute idiopathic thrombocytopenia purpura (ITP); Sydenham’s chorea; IgA nephropathy; hyperthyroidism; rheumatoid arthritis; Bell’s Palsy; lymphoid tissue hyperplasia; psychiatric disorders; appendicitis; cellulitis; depression; thymic disorder; extremity weakness; appendicitis; nodular fasciitis; epiphysiolysis; bipolar disorder; leg and wrist fracture; abdominal pain; hemorrhoids; and biliary dyskinesia. One death resulting from a motor vehicle accident was reported during pre-licensing clinical trials. Adverse events reported following FDA approval of TRUMENBA vaccine have included: syncope; hypersensitivity reactions; and anaphylactic reactions.

Pentavalent Meningococcal Vaccines (MenABCWY)

In clinical trials of Pfizer’s PENBRAYA pentavalent meningococcal vaccine, trial participants received either a dose of PENBRAYA meningococcal vaccine (MenABCWY) or meningococcal (serogroups A, C, W and Y) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY) and TRUMEMBA meningococcal Group B (MenB) vaccine (MenB+MenACWY-CRM) at the first vaccination visit. At the second vaccination visit, trial participants received either PENBRAYA or a dose of MenB (TRUMEMBA).

The safety evaluation of PENBRAYA in clinical trials involved three studies of individuals between the ages of 10 and 25 years of age. 2,744 individuals received PENBRAYA and 1,802 received MenACWY-CRM and MenB at the first vaccination visit. and MenB only at the second vaccination visit. A total of 1,792 participants in both groups had previously received a dose of a MenACWY vaccine. None of the trial participants had previously received a dose of MenB. Clinical trials on the use of PENBRAYA given at the same time as other vaccines were not conducted.

Adverse events reported by Pfizer in the pre-licensing clinical trials of PENBRAYA meningococcal vaccine included: injection site pain, redness, and swelling, fatigue, headache, muscle and joint pain, vomiting, diarrhea, fever, and chills. Females (87.2 percent) who received PENBRAYA reported higher rates than males (75.6 percent) of systemic reactions. Headache and fatigue were the most frequently reported systemic adverse reactions reported.

Within 30 days of vaccination, a total of 9.8 percent of participants in the PENBRAYA and 8.8 percent of participants in the MenB+MenACWY-CRM group reported at least one adverse event following any dose of vaccination. The most commonly reported adverse events were categorized as being related to an infection or infestation or to an injury, poisoning or procedural complication. Falls among both groups were the most commonly reported adverse reaction.

After the first dose of vaccination, 3.6 percent of MenABCWY recipients and 4.2 percent of MenB+MenACWY-CRM recipients sought medical attention within 30 days of vaccination. After the second vaccine dose, 3.6 percent of MenABCWY recipients and 2.8 percent of the MenB recipients sought a medical evaluation. Most of the medical evaluations were reported to be related to a diagnosis of COVID-19.

Among clinical trial participants, one participant in the MenB+MenACWY-CRM group reported new diagnosis of a neuroinflammatory disorder (restless leg syndrome) and two participants reported a new autoimmune disorder (alopecia areata, Hashimoto thyroiditis). There were no reports of newly diagnosed chronic medical conditions among individuals who received PENBRAYA.

Three clinical trial participants reported a total of five serious adverse events (SAE) following PENBRAYA vaccination within 30 days of vaccination. These included spinal injury resulting from a motor vehicle accident, an attempted suicide with a subsequent diagnosis of anxiety and depression six days after the first vaccine dose in an individual with a history of auditory hallucinations and ongoing friendship stressors, and a hospitalization for disruptive mood disorder 14 days after the second vaccine dose in a male with a past history of multiple psychiatric disorders (psychosis, ADHD, oppositional defiant disorder, depression, anxiety). There were no SAEs in the MenB+MenACWY-CRM group. No SAEs were considered by Pfizer’s clinical trial investigators or the FDA to be related to vaccination.

From one month after the second vaccination visit to the six-month follow-up visit, four individuals in the PENBRAYA group and four in the MenB group reported an SAE. Two individuals in the PENBRAYA group reported a diagnosis of depression, and there was one tibial fracture and one post-tonsillectomy bleed. Among the MenB group, the reported SAEs included E Coli Urinary Tract infection, appendicitis, migraine, and a drug overdose. Pfizer’s clinical trial investigators and the FDA determined that none of the SAEs reported at the six-month follow-up visit were related to vaccination.

There were no deaths reported during the clinical trial.

Reported Adverse Events Following Meningococcal Vaccine Administration

As of March 29, 2024, there have been 47,077 reports of meningococcal vaccine reactions, hospitalizations, injuries and deaths following meningococcal vaccinations made to the federal Vaccine Adverse Events Reporting System (VAERS), including 268 related deaths, 5,030 hospitalizations, and 610 related disabilities.

However, the numbers of vaccine-related injuries and deaths reported to VAERS may not reflect the true number of serious health problems that occur develop after meningococcal vaccination.

Even though the National Childhood Vaccine Injury Act of 1986 legally required pediatricians and other vaccine providers to report serious health problems following vaccination to federal health agencies (VAERS), many doctors and other medical workers giving vaccines to children and adults fail to report vaccine-related health problem to VAERS. There is evidence that only between one and 10 percent of serious health problems that occur after use of prescription drugs or vaccines in the U.S. are ever reported to federal health officials, who are responsible for regulating the safety of drugs and vaccines and issue national vaccine policy recommendations.

As of April 1, 2024, there have been 140 claims filed in the federal Vaccine Injury Compensation Program (VICP) for 3 deaths and 137 injuries that occurred after meningococcal vaccination. Of that number, the U.S. Court of Claims administering the VICP has compensated 71 children and adults, who have filed claims for meningococcal vaccine injury.

Meningococcal Vaccine Adverse Events Related to Administration Errors

In addition to reactions and injuries following meningococcal vaccination, administration errors resulting in adverse events have also been reported. Menactra (MCV4/MenACWY-D) meningococcal conjugate vaccine is approved to be administered intramuscularly (IM) while Menomune meningococcal polysaccharide vaccine is approved to given subcutaneously (SC). Following FDA approval of Menactra vaccine, multiple reports surfaced regarding the incorrect administration of Menactra vaccine by subcutaneous injection. In September of 2006, the CDC issued a report regarding the over 100 reported vaccine errors involving Menactra vaccine misadministration. Twelve reports resulted in adverse events; however, all were considered to be non-serious. The CDC conducted a study examining immune responses from individuals who received the incorrectly administered vaccine and determined vaccine acquired antibodies to be acceptable and did not recommend revaccination. In this report, the CDC reminded vaccine providers to review all vaccine product inserts prior to administering any vaccine.

In February of 2016, the CDC issued a second report detailing meningococcal vaccine administration errors, this time involving the Menveo (MenACWY-CRM) meningococcal conjugate vaccine. Menveo vaccine is supplied in two separate vials and must be combined prior to vaccine administration. However, between March 1, 2010 and September 22, 2015, 407 reports of Menveo vaccine misadministration were submitted to the Vaccine Adverse Events Reporting System (VAERS). Reported errors included vaccine providers administering only the liquid MenCYW-135 component of the vaccine or otherwise administering only the lyophilized MenA component by reconstituting it in liquids such as saline, sterile water, or even with another vaccine. Fifteen percent of vaccine administration errors involving Menveo resulted in adverse events that included redness to the injection, fever and pain. The CDC also admitted that as a passive surveillance system, VAERS likely only captured a fraction of meningococcal vaccine misadministration error and many more additional cases were likely to have occurred. Again, vaccine providers were advised to review and follow the instructions provided in the vaccine product insert and on the vial labels prior to administration.

NVIC “Quick Facts” is not a substitute for becoming fully informed about Meningococcal disease, meningitis and the Meningococcal vaccine. NVIC recommends consumers read the more complete information following the "Quick Facts", as well as the vaccine manufacturer product information inserts, and speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child.

Who should not get meningococcal vaccine?

Persons receiving meningococcal vaccine in conjunction with other recommended vaccines such as HPV and Tdap vaccines may be at higher risk for complications following vaccine administration.

In August of 2007, NVIC issued a safety report detailing concerns with Gardasil (HPV4) vaccine, specifically when the vaccine was administered concomitantly with Menactra (MenACWY-D) meningococcal conjugate vaccine. After reviewing reports submitted to the Vaccine Adverse Events Reporting System (VAERS) NVIC found a significantly greater risk of severe adverse events including Guillain-Barre Syndrome (GBS), respiratory and cardiac problems, central nervous system problems, convulsions, coordination and neuromuscular problems when HPV4 was co-administered with Menactra.

While the CDC and FDA had alerted the public to a possible association between Menactra vaccine and GBS in September of 2005, the CDC continued to recommend vaccination despite the potential safety signal. A previous history of GBS was considered a contraindication to meningococcal vaccine administration until 2010, when the CDC’s Advisory Committee on Immunization Practices (ACIP) voted to remove it, stating that “the benefits of meningococcal vaccination outweigh the risk for recurrent GBS in these persons.” Package inserts for both Menactra and Menveo meningococcal vaccines warn that individuals with a previous history of GBS may be at a greater risk for redeveloping GBS following the administration of meningococcal vaccines, and that the decision to vaccinate should take into consideration both the potential risks and possible benefits of vaccination.

Persons receiving Menveo (MenACWY- CRM) concomitantly with HPV, Tdap and influenza vaccines are also at greater risk for developing Bell’s palsy within 84 days of vaccination.

Infants born prematurely are considered to be at high risk for apnea following intramuscular vaccination. The Menveo meningococcal vaccine product insert warns that the decision to vaccinate an infant born prematurely should take into consideration both the possible risks and potential benefits of vaccination.

Persons with a latex sensitivity may be at greater risk for an allergic reaction if they receive a dose of BEXSERO from prefilled syringes as the tip caps of prefilled syringes contain natural rubber latex.

Who is at highest risk for complications from Meningococcal Vaccine?

Meningococcal Conjugate Vaccine Contraindications (MenACWY)

Contraindications to receiving Menveo meningococcal (Groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine documented in Novartis Vaccines and Diagnostics (GlaxoSmithKline) package insert include:

Individuals who experienced a severe allergic reaction after a previous dose of Menveo, any component of the vaccine, or any other CRM197, diphtheria toxoid, or meningococcal-containing vaccine.

The Menveo vaccine package insert also warns that persons with a previous medical history of Guillain-Barre Syndrome (GBS) may be at an increased risk of the disease following administration with the vaccine. The decision to vaccinate should be made only after careful consideration of the potential risks and possible benefits to vaccination.

Infants born prematurely are considered to be at a greater risk for apnea following intramuscular vaccination. The Menveo meningococcal vaccine package insert warns that the decision to vaccinate an infant born prematurely should take into consideration both the potential risks and possible benefits of vaccination.

There are no well-controlled or adequate studies on the use of Menveo vaccine in pregnant women and no available data on the impact of Menveo vaccine on breastfeeding infants or on human milk excretion and production.

Menveo vaccine is approved for use in persons 2 months through 55 years of age. Menveo vaccine is not approved for use in infants younger than two months of age or in adults older than 55 years of age.

Contraindications to receiving MedQuadfi meningococcal (Groups A, C, Y, and W-135) conjugate vaccine documented in Sanofi Pasteur package insert include:

Individuals who experienced a severe allergic reaction after a previous dose of MenQuadfi, any component of the vaccine, or tetanus toxoid.

The MenQuadfi vaccine package insert also warns that persons with a previous medical history of Guillain-Barre Syndrome (GBS) may be at an increased risk of the disease following administration with the vaccine. The decision to vaccinate should be made only after careful consideration of the potential risks and possible benefits to vaccination.

There are no well-controlled or adequate studies on the use of MenQuadfi vaccine in pregnant women and no available data on the impact of MenQuadfi vaccine on breastfeeding infants or on human milk excretion and production.

MenQuadfi vaccine is approved for use in persons two years of age and older. MenQuadfi vaccine is not approved for use in children younger than two years of age.

Meningococcal Group B Vaccine Contraindications (MenB)

Contraindications to receiving BEXSERO meningococcal group B vaccine documented in Novartis Vaccines and Diagnostics (GlaxoSmithKline) package insert include:

Individuals who experienced hypersensitivity or a severe allergic reaction after a previous dose of BEXSERO or to any ingredient found in the vaccine.

There are no well-controlled or adequate studies on the use of BEXSERO vaccine in pregnant women and no available data on the impact of BEXSERO vaccine on breastfeeding infants or on human milk excretion and production.

BEXSERO vaccine is approved for use in persons 10 through 25 years of age. BEXSERO vaccine is not approved for use in children younger than aged 10 or in adults older than 25 years.

Contraindications to receiving TRUMENBA meningococcal group B vaccine documented in Wyeth Pharmaceutical (Pfizer) package insert include a severe allergic reaction after a previous dose of TRUMENBA.

There are no well-controlled or adequate studies on the use of TRUMENBA in pregnant women and no available data on the impact of TRUMENBA vaccine on breastfeeding infants or on human milk excretion and production.

TRUMENBA vaccine is approved for use in persons 10 through 25 years of age. TRUMENBA vaccine is not approved for use in children younger than 10 years or in adults older than 25 years. The safety and effectiveness of TRUMENBA has not been evaluated in children under the age of 10 or in adults over the age of 65.

Pentavalent Meningococcal Vaccine Contraindications (MenABCWY)

Contraindications to receiving PENBRAYA meningococcal vaccine include a history of severe allergic reaction to any of the ingredients found within the vaccine.

The PENBRAYA vaccine package insert also warns that persons with a previous medical history of Guillain-Barre Syndrome (GBS) may be at an increased risk of the disease following administration with the vaccine. The decision to vaccinate should be made only after careful consideration of the potential risks and possible benefits to vaccination.

There are no well-controlled or adequate studies on the use of PENBRAYA vaccine in pregnant women and no available data on the impact of PENBRAYA vaccine on breastfeeding infants or on human milk excretion and production.

PENBRAYA vaccine is FDA approved for use in individuals 10 through 25 years of age. PENBRAYA vaccine is not approved for use in children younger than 10 years of age or adults older than 25 years.

What questions should I ask my doctor about the meningococcal vaccine?

NVIC’s If You Vaccinate, Ask 8! Webpage downloadable brochure suggests asking eight questions before you make a vaccination decision for yourself, or for your child. If you review these questions before your appointment, you will be better prepared to ask your doctor questions. Also make sure that the nurse or doctor gives you the relevant Vaccine Information Statement (VIS) for the vaccine or vaccines you are considering well ahead of time to allow you to review it before you or your child gets vaccinated.

Copies of VIS for each vaccine are also available on the CDC's website and there is a link to the VIS for vaccines on NVIC's meningococcal Quick Facts page.

It is also a good idea to read the vaccine manufacturer product insert that can be obtained from your doctor or public health clinic because federal law requires drug companies marketing vaccines to include certain kinds of vaccine benefit, risk and use information in product information inserts that may not be available in other published information. Meningococcal vaccine product inserts are located on NVIC’s meningococcal Quick Facts page.

Other questions that may be useful to discuss with your doctor before getting the meningococcal vaccine are:

If other vaccines in addition to meningococcal vaccine are scheduled for my child at this office visit, am I allowed to modify the schedule so fewer vaccines are given at once?
What should I do if my child has a high fever or appears very ill after vaccination?
What other kinds of reaction symptoms should I call to report after meningococcal vaccination?
If the meningococcal vaccine doesn’t protect my child, do I have any other options for preventing meningococcal infection?

Under the National Childhood Vaccine Injury Act of 1986, doctors and all vaccine providers are legally required to give you vaccine benefit and risk information before vaccination; record serious health problems following vaccination in the permanent medical record; keep a permanent record of all vaccines given, including the manufacturer’s name and lot number; and report serious health problems, injuries and deaths that follow vaccination to VAERS.

Remember, if you choose to vaccinate, always keep a written record of exactly which shots/vaccines you or your child have received, including the manufacturer’s name and vaccine lot number. Write down and describe in detail any serious health problems that develop after vaccination and keep vaccination records in a file you can access easily.

It also is important to be able to recognize a vaccine reaction and seek immediate medical attention if the reaction appears serious, as well as know how to make a vaccine reaction report to federal health officials at the Vaccine Adverse Reporting System (VAERS). NVIC’s Report Vaccine Reactions—It’s the Law webpage can help you file a vaccine reaction report yourself to VAERS if your doctor fails or refuses to make a report.

NVIC Press Releases, Statements & Commentaries

NVIC Statements & Commentaries

NVIC ACIP Votes Against Universal Use of Meningococcal B Vaccines. July 12, 2015.
NVIC Advisory Committee for Immunization Practices – June 24, 2015 National Vaccine Information Center Public Comment June 24, 2015
NVIC What You Should Know About Meningococcal Disease and The Vaccine. July 5, 2011.
NVIC NEW Gardasil vs. Menactra Risk Report (February 2009) Feb. 2009
NVIC Gardasil and HPV Infection - Analysis Shows Greater Risk of GBS Reports When HPV Vaccine Is Given with Meningococcal and Other Vaccines Aug. 15, 2007

The Vaccine Reaction

Cáceres M. CDC Pushes Pfizer’s Pentavalent Meningococcal Vaccine. Apr. 7, 2024.
Mercola, J Meningococcal Vaccine May Be Ineffective on College Campuses Sep. 27, 2016.
TVR Staff A Dozen Boys in England Collapse After Receiving Meningococcal ACWY Vaccine Mar. 16, 2016.
Wrangham, T CDC Advisory Committee Votes Against Universal Use of MenB Vaccines July 16, 2015.

Bibliography & Resource Links

Medical Literature

CDC Inadvertent Misadministration of Meningococcal Conjugate Vaccine --- United States, June--August 2005 MMWR Sep 22, 2006; 55(37);1016-1017.
Cohn AC, MacNeil JR, Harrison LH et al. Changes in Neisseria meningitidis disease epidemiology in the United States, 1998-2007: implications for prevention of meningococcal disease. Clin Infect Dis. 2010 Jan 15;50(2):184-91.
Basta NE, Mahmoud AAF, Wolfson J et al. Immunogenicity of a Meningococcal B Vaccine during a University Outbreak N Engl J Med 2016; 375:220-228.
Su JR, Miller ER, Duffy J, et al. Notes from the Field: Administration Error Involving a Meningococcal Conjugate Vaccine--United States, March 1, 2010-September 22, 2015. MMWR. 2016 Feb 19;65(6):161-2.
Myers TR, McNeil MM, Ng CS et al. Adverse events following quadrivalent meningococcal CRM-conjugate vaccine (Menveo®) reported to the Vaccine Adverse Event Reporting system (VAERS), 2010-2015. Vaccine. 2017 Mar 27;35(14):1758-1763.
Murdoch H, Wallace L, Bishop J et al. Risk of hospitalisation with fever following MenB vaccination: self-controlled case series analysis. Arch Dis Child. 2017 Oct;102(10):894-898.
McNamara LA, Thomas JD, MacNeil J et al. Meningococcal Carriage Following a Vaccination Campaign With MenB-4C and MenB-FHbp in Response to a University Serogroup B Meningococcal Disease Outbreak-Oregon, 2015-2016. J Infect Dis. 2017 Nov 27;216(9):1130-1140.
Soeters HM, McNamara LA, Blain AE et al. University-Based Outbreaks of Meningococcal Disease Caused by Serogroup B, United States, 2013–2018 Emerg Infect Dis. 2019 Mar; 25(3): 434–440.

Meningococcal disease & vaccine quick facts

laboratory vials — *Image source: CDC PHIL*

Meningococcal Disease

Meningococcal disease is a serious and potentially life-threatening illness caused by the bacteria Neisseria meningitides. The illness can often result in inflammation of protective membranes (meninges) covering the brain and spinal cord of the brain (meningitis) and a serious bloodstream infection (septicemia/meningococcemia). Invasive meningococcal disease can also present as arthritis and pneumonia.
Meningococcal disease is not easily spread and requires one to be susceptible to the infection and to have regular close contact with a person who is colonizing the bacteria.
Meningococcal rates are low in the U.S. and have steadily declined since the 1990’s. In 2020, there were approximately 235 cases in the U.S. Of these cases 26 percent were unknown and ungroupable serotypes with 20 percent occurring in children too young to be vaccinated. For 2020, 23 deaths were reported, or less than one percent of cases. Individuals most at risk for contracting meningococcal disease are infants, adolescents, young adults and seniors.
Between 10-20 percent of individuals are asymptomatic carriers and colonize the bacteria that causes meningococcal disease in the back of their throats. Natural community immunity contributes significantly to low disease incidence. Research shows that about 20 to 40 percent of Americans are asymptomatically colonizing meningococcal organisms in their nasal passages and throats. This colonization boosts an individual’s innate immunity to invasive meningococcal infection throughout life. Infants are protected for the first few months of life by the transfer of maternal antibodies from immune mothers until they can make their own antibodies. The CDC has recognized high levels of innate community immunity and noted that the majority of Americans will experience asymptomatic infection as children or young adults without complications and develop protective bactericidal antibodies against meningococcal disease.
Invasive meningococcal disease may cause permanent injury including brain damage, hearing loss, loss of a limb or death. Persons noted to be at highest risk of developing complication from meningococcal disease are those with certain genetic factors, HIV, smokers as well as those who have a family member with the disease.

Meningococcal Vaccine:

There are five FDA approved meningococcal vaccines available for use in the U.S. that target a total of 5 of the 13 serotypes of meningococcal disease. Menveo (Novartis/GlaxoSmithKline) and MenQuadfi (Sanofi Pasteur) conjugate vaccines target serogroups A, C, Y and W-135 meningococcal bacteria. BEXSERO (Novartis/GlaxoSmithKline) and TRUMENBA (Wyeth/Pfizer) recombinant vaccines target serogroup B meningococcal bacteria. PENBRAYA (Pfizer Ireland) conjugate vaccines targets serogroups A, B, C, Y and W-135. Two additional meningococcal vaccines, Menactra (Sanofi Pasteur) and Menomune (Sanofi Pasteur) remain licensed in the US, however, production of both vaccines has been discontinued by the manufacturer.
The CDC recommends all children receive their first dose of meningococcal serogroup A, C, Y and W-135 conjugate vaccine at age 11-12 and an additional booster dose at age 16.
The serogroup B recombinant vaccines are available for use and should be considered by adolescents between 16 and 23 years of age; however, in 2015, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted not to routinely recommend this vaccine due cost, low rates of serogroup B infections, and lack of efficacy and safety data.
According to the CDC, mild vaccine side effects include pain or redness at the injection site, headache, fatigue, muscle and joint pain, fever, chills, nausea and diarrhea. Additionally, the CDC warns that persons receiving any vaccine may collapse (faint), experience a severe allergic reaction, and even serious injury and death. Serious adverse events associated with meningococcal vaccines include anaphylaxis, wheezing, upper airway swelling, difficulty breathing, hypotension, itching, hives, lymph node swelling, Guillain-Barre syndrome, convulsions, facial palsy, vasovagal syncope, paresthesia, transverse myelitis, acute disseminated encephalomyelitis, extensive swelling of the injected limb and injection site.

As of March 29, 2024, there have been 47,077 reports of meningococcal vaccine reactions, hospitalizations, injuries and deaths following meningococcal vaccinations made to the federal Vaccine Adverse Events Reporting System (VAERS), including 268 related deaths, 5,030 hospitalizations, and 610 related disabilities. As of April 1, 2024 there had been 140 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following meningococcal vaccination, including 3 deaths and 137 serious injuries.

Food & Drug Administration (FDA)

Menveo (Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) Package Insert & Licensing Information
MenQuadfi (Meningococcal (Groups A, C, Y, W) Conjugate Vaccine) Package Insert & Licensing Information
BEXSERO (Meningococcal Group B Vaccine) Package Insert & Licensing Information
TRUMENBA (Meningococcal Group B Vaccine) Package Insert & Licensing Information
PENBRAYA (Meningococcal Groups A, B, C, Y, and W-135) Package Insert & Licensing Information

Centers for Disease Control (CDC)

Vaccine Reaction Symptoms & Ingredients

Our Ask 8, If You Vaccinate webpage contains vaccine reaction symptoms and more.

Search for Vaccine Reactions

NVIC hosts MedAlerts, a powerful VAERS database search engine. MedAlerts examines symptoms, reactions, vaccines, dates, places, and more.

Reporting a Vaccine Reaction

Since 1982, the NVIC has operated a Vaccine Reaction Registry, which has served as a watchdog on VAERS. Reporting vaccine reactions to VAERS is the law. If your doctor will not report a reaction, you have the right to report a suspected vaccine reaction to VAERS.

Meningitis and Vaccines

Inflammation of the meninges (covering) of the brain or spinal cord.

(The Merck Manual, 16th edition)

Etiology and Incidence

Inflammation can be due to infection or irritation. Following is a list of various organisms/conditions that cause meningitis:

Infectious Meningitis

Acute -Bacteria
Subacute - TB/Syphilis

Aseptic Meningitis

Acute - Virus
Subacute - Malignancies/Diseases

Bacterial Meningitis & Vaccines

3 pathogens(organisms) account for 80% of cases of bacterial meningitis: Neisseria meningitidis (meningococcus), Hemophilus influenza type b, and Streptococcus pneumoniae (pneumococcus).

Hemophilus influenzae was the most common cause of bacterial meningitis in the United States. Nearly all cases occur in children under 6 years of age.

Vaccine: Hib - against H.influenzae type b. Recommended for children 2 months to 5 years of age. On the Recommended Childhood Immunization Schedule. Mandated.
Pneumococcal meningitis (S. pneumoniae*)is the most frequently observed agent in adults over the age of 30 years.

Vaccine: Pnu-Imune 23 (PPV23) - against S. Pneumoniae (primarily for pneumococcal pneumonia). Recommended for all persons over 65 years of age and younger persons with certain chronic medical problems. Not effective in children under 2 years of age.
Not on Recommended Childhood Immunization Schedule. Not mandated in children.

Vaccine: Prevnar (PCV) - against S. pneumoniae (primarily for pneumococcal meningitis). Recommended for all infants and toddlers.
On current Recommended Childhood Immunization Schedule. Mandated in many states.

* {84 different serotypes of Streptococcus pneumoniae have been identified (Harrison's Principles of Internal Medicine, 13th edition). Primarily s. pneumoniae causes pneumococcal pneumonia and pneumococcal meningitis but it may also cause endocarditis, otitis media (middle ear infection), mastoiditis, paranasal sinusitis or conjunctivitis.}
Meningitis due to N. meningitidis is most often encountered in children and young adults and may occur in epidemics.
Vaccine: Menactra - against N. meningitidis (meningococcal). It is currently highly recommended for freshmen college students, especially those living on campus.

Normally recommended for
1. High-risk individuals (immune deficient, asplenic[spleen removed or non-functioning]
2. Travelers where endemic/epidemic (Sub-Saharan Africa)
3. Persons 2 years of age and above in epidemic or endemic areas.
Not on Recommended Childhood Immunization Schedule. Not mandated.

Meningococcal Disease in College Students

The following information is from the Centers for Disease Control regarding the modestly increased risk for meningococcal disease among college students, particularly those who live in dormitories or resident halls. The full CDC report can be viewed at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4907a2.htm

The full report presents recommendations developed by the Advisory Committee on Immunization Practices (ACIP), regarding the education of students and parents about meningococcal disease and the polysaccharide meningococcal vaccine so that they can make informed decisions regarding vaccination.

The following information is a summary from the CDC report:

Recent studies provide data concerning the risk of sporadic meningococcal disease among college students:

1- 1990-1991-A questionnaire designed to evaluate risk factors for meningococcal disease among college students was sent to 1900 universities, resulting in a 38% response rate. Forty-three cases of meningococcal disease were reported during the 2 years from colleges with a total enrollment of 4,393,744 students, for a low overall incidence of 1.0 per 100,00 population per year. However, cases of meningococcal disease occurred 9-23 times more frequently in students residing in dormitories than in those residing in other types of accommodations. The low response rate and the inability of the study to control for other factors make these results difficult to interpret.

2- 1992-1997 - A retrospective, cohort study conducted in Maryland identified 67 cases among persons aged 16-30 and were identified by active laboratory-based surveillance. Fourteen cases were among students attending Maryland colleges, and 11 were among those in 4-year colleges. The overall incidence rate in Maryland college students was similar to the incidence in the US population of persons the same age. Rates were elevated for students living in dormitories compared with students living off-campus.

3- 1998-1999 - US started to keep track of the disease in college students. In this time period 90 cases were reported to the CDC. These cases represent approximately 3% of the total cases that occur each year in the United States. Eighty-seven cases occurred in undergraduate students, and 40% occurred among the 2.27 million freshman students. Eight students died.

This data suggests that the overall rate of disease among undergraduate college students is lower than the rate among persons aged 18-23 years who are not enrolled in college. Even though the rates were higher in freshmen students (4.6/100,000) living in dormitories, it was still lower than the threshold of 10/100,000 recommended for initiating meningococcal vaccination campaigns.

Fifty of the students were enrolled in a case-control study and the results showed that freshmen living in dormitories were at a higher risk for disease. In addition white race, radiator heat, and recent upper respiratory infection were associated with disease.

The American College Health Association (ACHA) recommends that college health services take a more proactive role in alerting students and their parents about the dangers of the disease and that college students consider vaccination and that colleges and universities ensure that all students have access to a vaccination program for those that want to be vaccinated.

Cost-effectiveness

Nationwide vaccination of freshmen who live in dormitories would result in the administration of 300,000-500,000 doses of vaccine each year, preventing 15-30 cases of disease and one to three deaths per year. The cost per case prevented would be $600,000- $1.8 million at a cost per death prevented of $7 million to $20 million.

Vaccination of all freshmen would result in the administration of 1.4-2.3 million doses of vaccine each year preventing 37-69 cases of disease and 2-4 deaths each year. The cost per case prevented would be $1.4-$2.9 million, at a cost per death prevented of $22 million to $48 million.

These data suggest that for society as a whole, vaccination of college students is unlikely to be cost effective.

Based on the above information the Advisory Committee on Immunization Practices of the Centers for Disease Control made the following recommendations regarding the use of meningococcal vaccine in college students:

Providers to incoming or current college freshmen, particularly those living in dormitories should inform these students and parents about the disease and the vaccination. ACIP does not recommend that the level of increased risk among freshmen warrants any specific changes in living situations with freshmen.
College freshmen who want to reduce their risk for meningococcal disease should either be administered vaccine (by a doctor's office or student health service) or directed to a site where vaccine is available.
The risk for disease among non-freshmen college students is similar to that for the general population. However, the vaccine can be administered to non-freshmen undergraduates who want it.
Colleges should inform incoming and/or current freshmen, particularly those who plan to live or already live in dormitories or residence halls about meningococcal disease and the availability of the vaccine.
Public health agencies should provide college and health care providers with information about the disease and the vaccine as well as information regarding how to obtain the vaccine.

NVIC Note: At the present time the CDC has not suggested universal use of this vaccine for college students. The vaccine does not protect against all strains of the disease. There are reported cases of students who have been vaccinated, contract meningitis and die. From a cost/benefit perspective, requiring this vaccine in every state would be very expensive.

Morbidity and Mortality Weekly Report, Recommendations and Reports, Prevention and Control of Meningococcal Disease and Meningococcal Disease and College Students, June 30, 2000.
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4907a2.htm

The government has created a Vaccine Information Sheet or VIS for this disease. You can view this sheet at: http://www.cdc.gov/nip/publications/VIS/vis-mening.pdf