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Meningococcal Overview


meningococcal vaccine
Image source: CDC PHIL

Quick Facts

Meningococcal Disease

  • Meningococcal disease is a serious and potentially life-threatening illness 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.1
  • 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.2
  • Meningococcal rates are low in the U.S. and have steadily declined since the 1990’s. In 2017, there were approximately 350 cases and 45 deaths (13.1 percent fatality rate) attributed to meningococcal disease.3 Individuals most at risk for contracting meningococcal disease are babies under a year old and young adults between the ages of 16 and 23.4
  • Between 10-20 percent of individuals are asymptomatic carriers and colonize the bacteria that causes meningococcal disease in the back of their throats.5
  • Invasive meningococcal disease may cause permanent injury including brain damage, hearing loss, loss of a limb or death.6 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.7

Meningococcal Vaccine:

  • There are four FDA approved meningococcal vaccines currently available for use in the U.S. Two vaccines, Menectra (Sanofi Pasteur) and Menveo (Novartis/GlaxoSmithKline) conjugate vaccines target serogroups A, C, Y and W-135 meningococcal bacteria and two vaccines, BEXSERO (Novartis/GlaxoSmithKline) and TRUMENBA (Wyeth/Pfizer) recombinant vaccines target serogroup B meningococcal bacteria.8
  • 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 16.9 The booster dose recommendation was made in 2010 after studies noted that only 50 percent of adolescents vaccinated at age 11-12 had sufficient vaccine acquired antibodies to protect them against meningococcal disease five years post-vaccination.10
  • The serogroup B recombinant vaccines are available for use and should be considered by adolescents between 16 and 23 years of age, however they are not routinely recommended as part of the vaccination schedule. In 2015, the CDC’s Advisory Committee on Immunization Practices (ACIP) declined to routinely recommend vaccination with the serogroup B vaccines. The committee came to this conclusion after evaluating multiple factors including the high number of people that would require vaccination in order to prevent a single case of meningococcal disease, the low rates of the disease, the vaccine’s cost, lack of efficacy and safety data as well as the potential risk that serious adverse reactions would exceed the number of cases potentially prevented from the vaccine.11
  • As of January 31, 2019, there have been more than 31,330 reports of meningococcal vaccine reactions, hospitalizations, injuries and deaths following meningococcal vaccinations made to the federal Vaccine Adverse Events Reporting System (VAERS), including 174 related deaths, 3,092 hospitalizations, and 437 related disabilities.
  • As of April 1, 2019, there had been 75 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following meningococcal vaccination, including 2 deaths and 73 serious injuries.

Food & Drug Administration (FDA)

  • Menactra (Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine) Product Insert & Licensing Information
  • Menveo (Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) Product Insert & Licensing Information
  • BEXSERO (Meningococcal Group B Vaccine) Product Insert & Licensing Information
  • TRUMENBA (Meningococcal Group B Vaccine) Product 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.

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.

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What is Meningococcal Disease?

Meningococcal disease is a bacterial illness caused by the aerobic, gram-negative bacteria Neisseria meningitidis (N. meningitidis).12 Thirteen types (serogroups) of N. Meningitis or meningococci have been identified13 with six found to be responsible for epidemics resulting in invasive meningococcal disease. These six serogroups include A, B, C, X, W and Y.14 Most frequently, invasive meningococcal disease can cause inflammation of the meninges of the brain and spinal cord (meningitis) and a serious bloodstream infection (septicemia/meningococcemia).15

Symptoms of meningococcal meningitis include headache, stiff neck and fever while symptoms of meningococcemia include rash and fever. Meningitis is the most common presentation of invasive meningococcal disease and accounts for approximately 75 percent of all cases. 20 percent of invasive meningococcal disease cases result in meningococcemia. Both meningitis and meningococcemia can be fatal, with 10 to 15 percent of cases resulting in death.16 Humans are the only species known to carry N. meningitidis and invasive meningococcal disease most frequently occurs in late winter or early spring.17

Symptoms of meningitis begin to appear between 3 and 7 day after exposure to meningococcal bacteria. At first, symptoms 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.18 19

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.20 Less than one percent of individuals who carry meningococci will develop invasive meningococcal disease. Invasive disease occurs when the meningococci bacteria passes through the mucous cells and invades the bloodstream. Often, invasive meningococcal disease has been noted after the development of an upper respiratory infection.21

Meningococcal disease is not easily spread.  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 a toothbrush, with a person who is colonizing the bacteria.22 23 Studies have also found that genetics play a role in both one’s susceptibility to invasive meningococcal disease as well as to disease outcomes.24 Meningococcal disease is treated with antibiotics, and cephalosporins are currently considered to be the antibiotic of choice for treatment at this time.25 Persons who may have been exposed to meningococcal bacteria through close contact with a person diagnosed with the invasive disease can be treated with antibiotics such as rifampin or ciprofloxacin prophylactically to prevent disease development.26

Invasive meningococcal disease is very rare in the United States. In 2017, there were approximately 350 cases of invasive meningococcal disease reported to the CDC.27 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 1 case per 100,000 population.28

Is Meningococcal Disease Contagious?

Meningococcal disease is contagious, however direct personal contact with a carrier is required for disease transmission to occur. Transmission can occur by kissing, sharing items such as silverware, drinking glasses, toothbrushes or lipstick, or by living in the same household as a carrier. Simply touching an object or being in the same room as a carrier will not result in disease transmission. N. meningitidis is a very fragile bacteria and does not survive very long outside of the body.29 30

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.31

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.32

Antibiotics are prescribed to treat meningococcal disease and to halt the transmission of meningococcal bacteria. The bacteria can be transmitted to others for up to 7 days prior to initial symptoms, however an infected individual is no longer considered contagious after 24 hours of antibiotic therapy.33 Antibiotic treatment is also recommended in individuals who may have had close contact to a person diagnosed with meningococcal disease.34

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 16th century,35 however, it was Swiss physician Gaspard Vieusseux who, in 1805, definitely described the disease.36 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 becoming isolated in samples of cerebral spinal fluid collected from six infected individuals.37 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.38

Meningococcal infections presenting as meningococcal meningitis became a nationally reportable disease in the U.S. as early as the first part of the 20th century 39 In the early 1900’s, between 69 and 90 percent of cases were fatal with fatality rates higher among children than adults.40  Between 1913 and 1916, the disease was reported at a rate of 2 cases per 100,000 population. 41

In 1917-1918, meningococcal meningitis disease rates rose significantly, however, in 1919, rates began decreasing steadily over a five year period before returning to the low pre- World War I rates. 42 In the U.S., between 1924 and 1927, the disease rate was again reported at 2 cases per 100,000 population, while in Europe, the rate was noted at 1.4 cases per 100,000 population.43

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. 44 However, by 1928, when both meningococcal meningitis disease and death rates rose significantly, treating physicians frequently reported the antiserum to be completely ineffective.45 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 were, however, concerned in regards to the high number of fatalities resulting from the disease.46

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.47

The last noted 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 with only 3,788 reported cases.48

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 war time 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.49

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. 50 While penicillin can still be used to treat the disease, medical experts currently consider cephalosporins the antibiotic of choice against invasive meningococcal disease.51 In 1960, there were 2,259 reported cases of meningococcal disease 52 and a death rate of 0.4 per 100,000 population.53

Between 1964 and 1968, meningococcal serogroup B was determined 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, however, serogroup C was 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, the strain found to be responsible for the majority of invasive meningococcal disease in the U.S.54 In 1975, there were 1,478 reported meningococcal cases 55 and 308 related deaths.56

In 1985, when the CDC’s Advisory Committee on Immunization Practices (ACIP) made its first recommendations on the recently licensed tetravalent meningococcal polysaccharide 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.57 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. 58

There were 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.59

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 1998.60 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.61

Meningococcal disease from all serogroups declined again from 1,172 reported cases in 2008 62 to 372 cases in 2015.63 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.64

In 2017, there 350 reported cases and 45 deaths attributed to meningococcal disease. Of the reported cases, serogroup B accounted for 134 cases and 16 deaths; Serogroup C accounted for 86 cases and 18 deaths; Serogroup W accounted for 26 cases and 3 deaths; serogroup Y accounted for 31 cases and 2 deaths; nongroupable serogroups accounted for 35 cases and 4 deaths; and unknown serogroups accounted for 38 cases and 2 deaths.65

Globally, the World Health Organization (WHO) states that there is an inadequate surveillance system in place to adequately report on the burden of meningococcal disease resulting in a lack of reliable estimates of 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.66

Can Meningococcal Disease Cause Injury and/or Death?

Meningococcal disease is rare in the U.S. and in 2017, there were 350 reported cases and 45 deaths resulting from the disease.67

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 5 and 20 percent of invasive meningococcal infections result in meningococcemia. 10 and 15 percent of all invasive meningococcal disease cases result in death.68

Meningococcal disease can 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.69

Less common infections resulting from invasive meningococcal disease include epiglottis, otitis media (ear infection), arthritis, and pneumonia.70

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, followed by adolescents and young adults between the ages of 16 and 23 years of age.71

There are certain environmental and biological factors that increase a person’s risk of developing meningococcal disease. Environmental factors include smoking or living with a smoker, alcohol consumption, and living in crowded environment 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 will also increase a person’s risk of developing meningococcal disease. 72 73 Additionally, men who have sex with other men, including HIV infected men, may also be at a greater risk for the disease.74

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.75

Having a low level of serum bactericidal antibody (SBA) has also been associated with a higher risk of meningococcal disease.76  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.77 78

In 2010, the Imperial College London and the Genome Institute of Singapore conducted a large scale study on invasive meningococcal disease and the complications of meningitis and meningococcemia (septicemia) resulting from the disease.  By comparing the genetic make-up of 1,500 meningococcal meningitis sufferers to nearly 5,000 healthy controls, 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, proteins which regulate part of the immune system by recognizing and killing bacteria, were found to play a role in the risk of meningococcal disease. From their findings, researchers concluded that genetic factors likely play a significant role in the development of invasive meningococcal disease.79 80

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. 81

Can Meningococcal Disease be prevented and are there treatment options?

Meningococcal disease can be prevented by avoidance of situations that may encourage the spread of the disease such as refraining from travel to areas where outbreaks are occurring and by avoiding overcrowded areas.82 As smoking and second hand smoke exposure have also been noted to increase the risk of meningococcal disease, smoking cessation and limiting one’s exposure to second hand smoke may reduce meningococcal disease risk.83

Approximately 1 out of every 10 individuals carry meningococcal bacteria in the back of their throat but have no disease symptoms. Even without symptoms, they can still spread the bacteria to others, potentially causing another person to develop invasive meningococcal disease. 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.84

Prophylactic antibiotics such as rifampin or ciprofloxacin can be used to prevent the spread of meningococcal disease among family members or close contacts of a person diagnosed with meningococcal disease.85

Invasive meningococcal disease is treated with antibiotics, and currently cephalosporins such as ceftriaxone and cefotaxime, are considered to be most effective against the disease.86 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.87

What is Meningococcal Vaccine?

There are four FDA approved meningococcal vaccines currently available for use in the United States. Two vaccines, Menectra (Sanofi Pasteur) and Menveo (Novartis/GlaxoSmithKline) conjugate vaccines target serogroups A, C, Y and W-135 meningococcal bacteria and two vaccines, BEXSERO (Novartis/GlaxoSmithKline) and TRUMENBA (Wyeth/Pfizer) recombinant vaccines target serogroup B meningococcal bacteria.88

Menactra is a meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine manufactured by Sanofi Pasteur. Menactra is FDA approved for use in individuals 9 months through 55 years of age. In young children between the ages of 9 and 23 months, the vaccine is recommended as a two dose series, administered 3 months apart. In persons between the age of 2 and 55, a single dose is recommended, however a booster dose can be given four years after the first dose in individuals between the ages of 15 and 55 years.89 Menactra vaccine ingredients include strains of A, C, Y and W-135 meningococcal bacteria, muller Hinton agar (beef extract, acid hydrolysate of casein, starch, agar) Watson Scherp media (casamino acid), formaldehyde, ammonium sulfate, modified culture medium, sodium phosphate buffered isotonic sodium chloride solution.90 91

Menveo is 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 2 months through 55 years of age. Children vaccinated at 2 months of age are recommended to receive 4 doses of the vaccine (2, 4, 6, and 12 months of age). In young children between the ages of 9 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 2 and 55 years of age.92 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. 93 94

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.95  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. 96 97

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 6 months apart. However, if more than 6 months has elapsed between doses, a third dose should not be administered earlier than 4 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 6 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.98  TRUMENBA vaccine ingredients include strains of meningococcal B bacteria, E. coli, defined fermentation growth media, polysorbate 80, and aluminum phosphate. 99 100

The CDC’s Advisory Committee on Immunization Practices (ACIP) recommends that the first dose of meningococcal conjugate vaccine targeting serogroups A, C, Y and W-135 (Menectra or Menveo) 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 as a result be recommended to receive a dose of meningococcal conjugate vaccine.101

The CDC’s Advisory Committee on Immunization Practices (ACIP) 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 to receive 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 25.102 103 104 Additionally, TRUMENBA and BEXSERO vaccines are not interchangeable and the same vaccine brand must be used for all administered doses.105

What is the history of Meningococcal vaccine use in America?

Meningococcal vaccine development in the United States began in the 1960s with the organization of a U.S. military meningococcal research group. 106 Throughout both World Wars, meningococcal disease outbreaks were noted 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 on developing a meningococcal vaccine.107

The first polysaccharide vaccine targeting meningococcal serogroup C was developed by and tested on members of the U.S armed forces by 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 found to be endemic.108

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.109 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.” 110 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.111 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.112

Menomune, the first tetravalent meningococcal polysaccharide vaccine targeting meningococcal serogroups A, C, Y and W-135 received FDA approval for use in 1981113 and by 1982, the military began using this vaccine in place of the bivalent vaccine.114 In 1985, the CDC’s Advisory Committee on Immunization Practices (ACIP) issued their first recommendations on use of the tetravalent vaccine and recommended that 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.115 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.116

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.117 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. 118

Later that year, in May of 2005, the CDC’s Advisory Committee on Immunization Practices (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 freshman living in dormitories, military recruits, microbiologists routinely working with N. meningitidis, and persons traveling to or residing in meningococcal disease endemic countries.119 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 Meningococcal-diphtheria (Td) vaccine.120 121

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).122 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.123

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.124 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.125 In 2010, after a review of safety studies, the CDC’s Advisory Committee on Immunization Practices (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.126 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.127

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 the Advisory Committee on Immunization Practices (ACIP). The newly licensed Meningococcal, diphtheria, and acellular pertussis vaccine (Tdap) was added in March of 2006128 and in June of 2006, Gardasil, Merck’s human papillomavirus vaccine (HPV4) received FDA approval for use in all 11-12 year old females.129 When the 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.130 By August of 2007, the 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.131

In October of 2007, the FDA approved Menactra (MCV4 or MenACWY-D) for use in children over the age of two. 132 One week later, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended that all children between the ages of 2 and 10 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.133  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.134

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.135 By March of 2010, the CDC’s Advisory Committee on Immunization Practices (ACIP) announced that MenACWY-CRM could be used when vaccination with a meningococcal conjugate vaccine was indicated.136 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.137

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 the CDC’s Advisory Committee on Immunization Practices (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,” 138 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 necessary due to the low risk of meningococcal disease in this population.139

In January of 2011, Menveo (MenACWY-CRM) received FDA approval for use in children age 2 through 10 years140 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.141 Following FDA approval, the CDC’s Advisory Committee on Immunization Practices (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 2 years before MenACWY-D vaccination. This recommendation was made as clinical trial data had noted that antibody levels decreased in 3 out of 7 pneumococcal vaccine strains when MenACWY-D was administered at the same time as Prevnar 7 (PCV7) pneumococcal vaccine.142

In June of 2012, the FDA approved the first meningococcal vaccine for use in infants as young as 6 weeks of age. MenHibrix (Hib-MenCY-TT), a meningococcal serogroup C and Y and Haemophilus b (HIB) Meningococcal 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.143 In response to FDA approval of MenHibrix (Hib-MenCY-TT), the CDC’s Advisory Committee on Immunization Practices 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 5 years. Further, with infants under 6 months of age considered most at risk of infection, public health officials believed that one or possibly two doses of the vaccine administered before 6 months of age would likely not impact meningococcal disease rates.144 Citing low demand for the product, GlaxoSmithKline announced the discontinuation of MenHibrix in the United States in October of 2016.145

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.146 Again, while routine vaccination of infants and young children was not recommended, the CDC’s Advisory Committee on Immunization Practices (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 2 months who had received a diagnosis of functional or anatomical asplenia.147

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, 2014.148 Less than 5 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 evaluated safety or immunogenicity of administering TRUMENBA with Tdap, influenza, HPV9 or any licensed meningococcal conjugate vaccines. 149

BEXSERO, a second meningococcal serogroup B vaccine, manufactured by Novartis Vaccines and Diagnostics (GlaxoSmithKline), received FDA approval for use on January 23, 2015.150 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,151 no additional cases of meningococcal serogroup B disease were reported.152 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.153 154 Vaccine researchers therefore 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. 155

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.156

At the CDC’s February 2015 Advisory Committee on Immunization Practices (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.157 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.158

In June 2016, HIV-positive individuals aged 2 months and older were added to the list of persons considered at high risk for meningococcal disease and recommended by the CDC’s Advisory Committee on Immunization Practices (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 2 months to 2 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.159

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 be administered meningococcal conjugate vaccine. This recommendation was made despite acknowledging that neither available meningococcal conjugate vaccine is FDA approved for use in persons older than 55 years of age.160

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 involves the use of TRUMENBA in children 12 months through 9 years of age.161 FDA approval for use of the vaccine in this population is still currently pending.

How effective is Meningococcal vaccine?

Menactra (MCV4 or MenACWY-D), the first meningococcal (serogroups A,C, Y, and W-135) conjugate vaccine received FDA approval in January of 2005 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. Clinical trials on Menactra’s efficacy were not a requirement for FDA licensing and the vaccine’s 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. As well, while the committee recommended that Menactra be administered at the same time as the newly licensed Tdap vaccine, no clinical trials had examined whether administering both vaccines simultaneously would be effective or even safe.162

Menveo (MenACWY-CRM), the second meningococcal (serogroups A, C, Y, and W-135) conjugate vaccine received FDA approval in February of 2010 based on safety and immunogenicity studies reporting the vaccine to be non-inferior to Menactra (MCV4/ MenACWY-D) vaccine. As with Menactra vaccine, no vaccine efficacy studies had ever been completed nor had any studies determined whether or not the vaccine could reduce or eliminate nasopharyngeal carriage. However, the CDC’s Advisory Committee on Immunization Practices (ACIP) also approved the vaccine for use when meningococcal vaccination was indicated.163

When the CDC’s Advisory Committee on Immunization Practices (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.164 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 determined 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. 165

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 determined to be between 49 and 91 percent effective, and between one and three 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.”166

As with 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. 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.167 

While the CDC’s Advisory Committee on Immunization Practices (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.168 169 170 171 Several published studies have reported on the failure of meningococcal vaccines to offer protection in this particular susceptible population.172 173 174 175 176

According to unpublished data submitted by Pfizer to the CDC’s Advisory Committee on Immunization Practices (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 were found to have 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. 177

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 one 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.178

In late 2013 - early 2014, and prior to FDA approval, the FDA and CDC approved 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 of MenB-4C.179 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 MenB-4C 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. 180

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.”181

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.182 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.

According to the CDC, at least 50 percent of individuals receiving meningococcal vaccines targeting meningococcal serogroups A, C, Y, and W-135 (Menactra or Menveo) experience mild side effects such as pain or redness at the injection site and a small number also report joint pain and muscle aches following vaccination. Additionally the CDC warns that persons receiving any vaccine may collapse (faint), experience a severe allergic reaction, severe pain and limited mobility to the vaccinated limb, and even serious injury and death.183

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.184

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.185 186

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.187

In the comprehensive report evaluating scientific evidence, Adverse Effects of Vaccines: Evidence and Causality188, 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.189 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 8 of the 9 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.190 The IOM committee, however, concluded that the scientific evidence “convincingly supports” a causal relationship between anaphylaxis and meningococcal vaccine. 191

According to the CDC, approximately 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, severe pain and limited mobility to the vaccinated arm, and even serious injury and death.192

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.193 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.194

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 3 days of vaccination have increased significantly when the vaccine is administered at 8 and 16 weeks.195

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.196 197 Adverse events reported following FDA approval of TRUMENBA vaccine have included: syncope; hypersensitivity reactions; and anaphylactic reactions.198

As of January 31, 2019, there have been more than 31,330 reports of meningococcal vaccine reactions, hospitalizations, injuries and deaths following meningococcal vaccinations made to the federal Vaccine Adverse Events Reporting System (VAERS), including 174 related deaths, 3,092 hospitalizations, and 437 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. 199 200 201 202 203

As of April 1, 2019, there have been 75 claims filed so far in the federal Vaccine Injury Compensation Program (VICP) for 2 deaths and 73 injuries that occurred after meningococcal vaccination. Of that number, the U.S. Court of Claims administering the VICP has compensated 43 children and adults, who have filed claims for meningococcal vaccine injury.204

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 in regards to 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.205

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.206

Who is at highest risk for complications from 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.207 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. 208 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.”209 Product 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.210 211

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. 212

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.213

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.214

Who should not get meningococcal vaccine?

Contraindications to receiving Menactra meningococcal (Groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine documented in Sanofi Pasteur’s product insert include:215

  • Individuals who experienced a severe allergic reaction after a previous dose of a meningococcal capsular polysaccharide, diphtheria toxoid, or CRM197- containing vaccine, or to any ingredient found in Menactra vaccine.

Menactra vaccine product 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 Menactra 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 Menactra vaccine in pregnant women and no available data on the impact of Menactra vaccine on breastfeeding infants or on human milk excretion and production.

Menactra vaccine is approved for use in adults and children age of 9 months through 55 years of age. Menactra vaccine is not approved for use in infants younger than 9 months of age or in adults older than 55 years of age.

Contraindications to receiving Menveo meningococcal (Groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine documented in Novartis Vaccines and Diagnostics (GlaxoSmithKline) product insert include:216

  • 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.

Menveo vaccine product 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 product insert warns that the decision to vaccinate an infant born prematurely should take into consideration both the potential risks and possible benefits of vaccination.

Menveo vaccine is a Pregnancy Category B product and there are no well controlled or adequate studies on the use of Menveo in pregnant or lactating women. The product insert warns that Menveo should only be used in pregnant women if absolutely necessary.

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 2 months of age or in adults older than 55 years of age.

Contraindications to receiving BEXSERO meningococcal group B vaccine documented in Novartis Vaccines and Diagnostics (GlaxoSmithKline) product insert include:217

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

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.

BEXSERO is a Pregnancy Category B product and there are no well-controlled or adequate studies on the use of BEXSERO in pregnant or lactating women. The product insert warns that BEXSERO should only be used in pregnant women if absolutely necessary and caution is advised when administering the vaccine to nursing mothers.

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) product insert include:218

  • 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.

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 “Quick Facts” at the top of this 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 the Food and Drug Administration’s website.

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 Related to Meningococcal Disease or Meningococcal Vaccines

NVIC Meningococcal Video Playlist

View the collection of video resources within the player below for more information on meningococcal and the meningococcal vaccine.

To view the entire video collection, click the hamburger menu in the upper left corner of the video player above. This will expand a full list of videos. You may also open the video player in full screen mode for optimal display.

NVIC Statements & Commentaries

The Vaccine Reaction

Bibliography & Resource Links

Medical Literature

References

1 CDC Meningococcal Disease Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

2 CDC. Meningococcal Disease - Causes and Spread to Others. Mar. 28, 2017

3 CDC Enhanced Meningococcal Disease Surveillance report, 2017 : confirmed and probable cases reported to the National Notifiable Diseases Surveillance System, 2017 Nov. 21, 2018

4 CDC Meningococcal Disease - Age as a Risk Factor Mar. 28, 2017

5 The College of Physicians of Philadelphia History of Vaccines – Meningococcal Disease Jan. 25, 2018

6 Ibid

7 CDC Meningococcal Disease – Clinical Features Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

8 FDA Vaccines Licensed for Use in the United States Nov. 16, 2018

9 CDC Vaccines and Preventable Disease – Meningococcal Vaccination: What Everyone Should Know May 19, 2017

10 CDC Updated Recommendations for Use of Meningococcal Conjugate Vaccines --- Advisory Committee on Immunization Practices (ACIP), 2010 MMWR Jan. 28, 2011; 60(03);72-76

11 CDC Use of Serogroup B Meningococcal Vaccines in Adolescents and Young Adults: Recommendations of the Advisory Committee on Immunization Practices, 2015 MMWR Oct. 23, 2015;  64(41);1171-6

12 CDC Meningococcal Disease - Neisseria meningitidis Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

13 Aquino Gondim, FDA Meningococcal Meningitis – Background Medscape Jul. 16, 2018

14 WHO Meningococcal Meningitis Feb. 19, 2018

15 CDC Meningococcal Disease Mar. 28, 2017

16 CDC Meningococcal Disease – Clinical Features Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

17 CDC Meningococcal Disease - Epidemiology Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

18 WebMD Meningitis Symptoms Warning Signs Jun. 13, 2017

19 CDC. Meningococcal Disease. April 2017

20 Meningitis Research Foundation of Canada Meningococcal Disease - Meningococcus (Neisseria meningitis) No Date

21 CDC Meningococcal Disease - Neisseria meningitidis Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

22 CDC Meningococcal Disease Causes and Spread to Others Mar. 28, 2017

23 Fisher, BL. What You Should Know About Meningococcal Disease & The Vaccine. July 15, 2011.

24 Brouwer MC, van der Beekn D. Genetics in Meningococcal Disease: One Step Beyond. Clin. Infect. Dis. 2009; 48(5); 595-599.

25 Aquino Gondim, FDA Meningococcal Meningitis Treatment & Management – Pharmacologic Care Medscape Jul 16, 2018

26 Aronin SI, Quagliarello VJ Bacterial Meningitis - Preventive Pearls Infect Med. 2003;20(3) 

27 CDC Enhanced Meningococcal Disease Surveillance report, 2017 : confirmed and probable cases reported to the National Notifiable Diseases Surveillance System, 2017 Nov. 21, 2018

28 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

29 Minnesota Dep. of Health. Meningococcal Disease Facts - How is meningococcal disease spread? Dec. 26, 2017.

30 Meningitis Research Foundation of Canada. Meningococcal Disease - Meningococcus (Neisseria meningitis) No date

31 The College of Physicians of Philadelphia The History of Vaccines – Meningococcal Disease Jan. 25, 2018

32 CDC Meningococcal Disease - Epidemiology Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

33 Meningitis Research Foundation of Canada. Meningococcal Disease - Meningococcus (Neisseria meningitis) No date

34 CDC Meningococcal Disease Causes and Spread to Others Mar. 28, 2017

35 CDC Meningococcal Disease Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

36 Romero J, Houston Merritt H THE SINGULAR AFFECTION OF GASPARD VIEUSSEUX: An Early Description of the Lateral Medullary Syndrome Bull Hist Med. 1941 Jan; 9(1) 72-79

37 Manchanda V, Gupta S, Bhalla P. Meningococcal disease: history, epidemiology, pathogenesis, clinical manifestations, diagnosis, antimicrobial susceptibility and prevention. Indian J Med Microbiol. 2006 Jan;24(1):7-19.

38 CDC Weekly Reports for APRIL 29, 1938 Public Health Rep. 53(17):645-700

39 CDC Weekly Reports for September 28, 1928 Public Health Rep. 43(39):III-2582

40 Flexner S THE RESULTS OF THE SERUM TREATMENT IN THIRTEEN HUNDRED CASES OF EPIDEMIC MENINGITIS. J Exp Med. 1913 May 1;17(5):553-76.

41 CDC Weekly Reports for September 28, 1928 Public Health Rep. 43(39):III-2582

42 Ibid

43 Ibid

44 CDC Weekly Reports for APRIL 29, 1938 Public Health Rep. 53(17):645-700

45 Ibid

46 CDC Weekly Reports for NOVEMBER 13, 1931 Public Health Rep. 46(46):2709-2773

47 CDC Weekly Reports for JANUARY 5, 1940 Public Health Rep. 55(1):1-40

48 CDC Reported incidence of notifiable diseases in the United States, 1951 Weekly mortality report; Feb. 17, 1953 v. 1, no. 54

49 Ibid

50 Manchanda V, Gupta S, Bhalla P. Meningococcal disease: history, epidemiology, pathogenesis, clinical manifestations, diagnosis, antimicrobial susceptibility and prevention. Indian J Med Microbiol. 2006 Jan;24(1):7-19.

51 Aquino Gondim, FDA Meningococcal Meningitis – Background Medscape Jul. 16, 2018

52 CDC Reported incidence of notifiable diseases in the United States 1960 MMWR Oct. 30, 1961; 9 (53)

53 CDC Mortality trends in the United States, 1954-1963 Public Health Service Publication No. 1000-Series 20-No. 2

54 CDC Morbidity and mortality weekly report, Vol. 24, no. 45, November 8, 1975 MMWR 24(45); 381-388

55 CDC Reported morbidity and mortality in the United States 1975 MMWR 24(54); 1-62

56 CDC Reported morbidity and mortality in the United States annual summary 1980 - Page 11 MMWR 29 (54); 1-144

57 CDC Morbidity and mortality weekly report MMWR May 10, 1985; 34 (18); 255-259

58 CDC Summary of notifiable diseases in the United States, 1985 MMWR Jun. 5, 1987; 34 (54); 1-26

59 Rosenstein NE, Perkins BA, Stephens DS et al. The changing epidemiology of meningococcal disease in the United States, 1992-1996. J Infect Dis. 1999 Dec;180(6):1894-901.

60 CDC Summary of notifiable diseases -- United States, 1998 MMWR Dec. 31, 1999; 47 (53); 1-116

61 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

62 CDC Summary of Notifiable Diseases --- United States, 2008 MMWR Jun. 25, 2010; 57(54);1-94

63 CDC Summary of Notifiable Infectious Diseases and Conditions — United States, 2015 MMWR Aug. 11, 2017; 64(53);1–143

64 CDC Meningococcal Disease – Secular Trends in the United States Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

65 CDC Enhanced Meningococcal Disease Surveillance report, 2017 : confirmed and probable cases reported to the National Notifiable Diseases Surveillance System, 2017 Nov. 21, 2018

66 WHO Meningococcal meningitis Feb. 19, 2018

67 CDC Enhanced Meningococcal Disease Surveillance report, 2017 : confirmed and probable cases reported to the National Notifiable Diseases Surveillance System, 2017 Nov. 21, 2018

68 CDC Meningococcal Disease – Clinical Features Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

69 Olbrich KJ, Müller D, Schumacher S et al. Systematic Review of Invasive Meningococcal Disease: Sequelae and Quality of Life Impact on Patients and Their Caregivers Infect Dis Ther. 2018 Dec; 7(4): 421–438.

70 CDC Meningococcal Disease – Clinical Features Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

71 CDC Meningococcal Disease Clinical Information – Burden of Disease Mar. 28, 2017

72 Harrison, LH Epidemiological Profile of Meningococcal Disease in the United States. Clin Infect Dis. 2010 Mar 1; 50(S2): S37.

73CDC. Prevention and Control of Meningococcal Disease: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Mar. 22, 2013; 62(RR02);1-22

74 CDC Meningococcal Disease Surveillance in Men Who Have Sex with Men — United States, 2015–2016 MMWR Sep. 28, 2018 67(38):1060-1063.

75 CDC Meningococcal Disease Clinical Information – Risk Groups Mar. 28, 2017

76 Harrison, LH Epidemiological Profile of Meningococcal Disease in the United States. Clin Infect Dis. 2010 Mar 1; 50(S2): S37.

77 FDA. Use of Serum Bactericidal Antibody as an Immunological Correlate for Demonstration of Effectiveness of Meningococcal Conjugate Vaccines (Serogroup A, C, Y, W-135) Administered to Children Less than 2 years of Age. Vaccines and Related Biological Products Advisory Committee. April 6, 2011.

78Fisher, BL What You Should Know About Meningococcal Disease & The Vaccine. July, 2011.

79 Science Daily. Genetic Differences that Make Some People Susceptible to Meningitis revealed in Major New Study. Imperial College of London, Aug. 9, 2010.

80 Davila S, Wright VJ, Khor CC et al. Genome-wide association study identifies variants in the CFH region associated with host susceptibility to meningococcal disease. Nat Genet. 2010 Sep;42(9):772-6

81 Olbrich KJ, Müller D, Schumacher S et al. Systematic Review of Invasive Meningococcal Disease: Sequelae and Quality of Life Impact on Patients and Their Caregivers Infect Dis Ther. 2018 Dec; 7(4): 421–438.

82 Mayon-White RT, Heath PT.  Preventative Strategies on Meningococcal Disease. Arch Dis Child. 1997 Mar; 76(3): 178–181.

83 Harrison, LH Epidemiological Profile of Meningococcal Disease in the United States. Clin Infect Dis. 2010 Mar 1; 50(S2): S37.

84 Keifer, Dale. How Can I Avoid Getting Meningitis? Healthline. June 13, 2016.

85 Aronin SI, Quagliarello VJ Bacterial Meningitis - Preventive Pearls Infect Med. 2003;20(3) 

86 Aquino Gondim, FDA Meningococcal Meningitis Treatment & Management – Pharmacologic Care Medscape Jul 16, 2018

87 CDC Diagnosis, Treatment, and Complications Mar. 28, 2017

88 FDA Vaccines Licensed for Use in the United States Nov. 16, 2018

89 FDA Menactra Product Insert Apr. 27, 2018

90 CDC Vaccine Excipient & Media Summary Jun. 2018

91 FDA Menactra Product Insert Apr. 27, 2018

92 FDA Menveo Product Insert Oct. 4, 2018

93 CDC Vaccine Excipient & Media Summary Jun. 2018

94 FDA Menveo Product Insert Oct. 4, 2018

95 FDA BEXSERO Product Insert May 31, 2018

96 CDC Vaccine Excipient & Media Summary Jun. 2018

97 FDA BEXSERO Product Insert May 31, 2018

98 FDA TRUMENBA Product Insert Mar. 14, 2018

99 CDC Vaccine Excipient & Media Summary Jun. 2018

100 FDA TRUMENBA Product Insert Mar. 14, 2018

101 CDC Vaccines and Preventable Diseases – Meningococcal Vaccination: What Everyone Should Know May 19, 2017

102 Ibid

103 FDA BEXSERO Product Insert May 31, 2018

104 FDA TRUMENBA Product Insert Mar. 14, 2018

105 CDC Use of Serogroup B Meningococcal Vaccines in Adolescents and Young Adults: Recommendations of the Advisory Committee on Immunization Practices, 2015 MMWR Oct. 23, 2015; 64(41);1171-6

106 Grabenstein JD, Pittman PR, Greenwood JT, Engler RJ. Immunization to protect the US Armed Forces: heritage, current practice, and prospects. Epidemiol Rev. 2006;28:3-26.

107 Artenstein AW, Opal JM, Opal SM et al. History of U.S. military contributions to the study of vaccines against infectious diseases. Mil Med. 2005 Apr;170(4 Suppl):3-11.

108 Artenstein MS Control of Meningococcal Meningitis with Meningococcal Vaccines Yale J Biol Med. 1975 Jul; 48(3): 197–200.

109 Ibid

110 CDC Morbidity and mortality weekly report MMWR Nov. 8, 1975; 24(45); 381-382

111 Ibid

112 Brundage JF, Ryan MA, Feighner BH, Erdtmann FJ. Meningococcal disease among United States military service members in relation to routine uses of vaccines with different serogroup-specific components, 1964-1998. Clin Infect Dis. 2002 Dec 1;35(11):1376-81.

113 CDC Meningococcal Disease - Meningococcal Vaccine Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

114 Brundage JF, Ryan MA, Feighner BH, Erdtmann FJ. Meningococcal disease among United States military service members in relation to routine uses of vaccines with different serogroup-specific components, 1964-1998. Clin Infect Dis. 2002 Dec 1;35(11):1376-81.

115 CDC Morbidity and mortality weekly report MMWR May 10, 1985; 34 (18); 255-259

116 CDC Meningococcal Disease and College Students - Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR Jun. 30, 2000; 49(RR07);11-20

117 FDA January 14, 2005 Approval Letter Jan. 14, 2005

118 CDC Prevention and Control of Meningococcal Disease Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR May 27, 2005; 54(RR07);1-21

119 CDC Prevention and Control of Meningococcal Disease Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR May 27, 2005; 54(RR07);1-21

120 FDA Clinical Review of New Biologics License Application - Menactra, January 14, 2005 Jan. 14, 2005

121 FDA Comparative Safety and Immunogenicity Study in Adults 18-55 year Old Clinical Study - Menactra Jan. 14, 2005

122 CDC FDA and CDC issue alert on Menactra meningococcal vaccine and Guillain Barre Syndrome Health Alert Network Sep. 30, 2005

123 CDC Morbidity and mortality weekly report MMWR Apr. 7, 2006; 55(13); 364-366

124 CDC Notice to Readers: Limited Supply of Meningococcal Conjugate Vaccine, Recommendation to Defer Vaccination of Persons Aged 11--12 Years MMWR May 26, 2006; 55(20);567-568

125 CDC Morbidity and mortality weekly report MMWR Oct. 20, 2006; 55(41); 1120-1124

126 CDC Meningococcal Disease - Contraindications and Precautions to Vaccination Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

127 FDA Menactra Product Insert Apr. 27, 2018

128 CDC Preventing Meningococcal, Diphtheria, and Pertussis Among Adolescents: Use of Meningococcal Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccines - Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR Mar. 24, 2006; 55(RR03);1-34

129 CDC CDC’s Advisory Committee Recommends Human Papillomavirus Virus Vaccination. Press Release. Jun.29, 2006

130 CDC Quadrivalent Human Papillomavirus Vaccine Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR March 12, 2007; 56(Early Release);1-24

131 CDC Notice to Readers: Revised Recommendations of the Advisory Committee on Immunization Practices to Vaccinate All Persons Aged 11--18 Years with Meningococcal Conjugate Vaccine MMWR Aug. 10, 2007; 56(31);794-795

132 FDA October 18, 2007 Approval Letter Oct. 18, 2007

133 CDC Notice to Readers: Recommendation from the Advisory Committee on Immunization Practices (ACIP) for Use of Quadrivalent Meningococcal Conjugate Vaccine (MCV4) in Children Aged 2--10 Years at Increased Risk for Invasive Meningococcal Disease MMWR Dec. 7, 2007; 56(48);1265-1266

134 CDC Report from the Advisory Committee on Immunization Practices (ACIP): Decision Not to Recommend Routine Vaccination of All Children Aged 2--10 Years with Quadrivalent Meningococcal Conjugate Vaccine (MCV4) MMWR May 2, 2008; 57(17);462-465

135 FDA Feburary 19, 2010 Approval Letter – Menveo Feb. 19, 2010

136 CDC Licensure of a Meningococcal Conjugate Vaccine (Menveo) and Guidance for Use --- Advisory Committee on Immunization Practices (ACIP), 2010 MMWR Mar. 12, 2010; 59(09);273

137 FDA Statistical Review and Evaluation (Revised Summary and Conclusions) – Menveo Jan 13, 2010

138 CDC Updated Recommendations for Use of Meningococcal Conjugate Vaccines --- Advisory Committee on Immunization Practices (ACIP), 2010 MMWR Jan. 28, 2011; 60(03);72-76

139 Ibid

140 FDA January 28, 2011 Approval Letter – Menevo Jan. 28, 2011

141 FDA April 22, 2011 Approval Letter – Menactra Apr. 22, 2011

142 CDC Recommendation of the Advisory Committee on Immunization Practices (ACIP) for Use of Quadrivalent Meningococcal Conjugate Vaccine (MenACWY-D) Among Children Aged 9 Through 23 Months at Increased Risk for Invasive Meningococcal Disease MMWR Oct. 14, 2011; 60(40);1391-1392

143 FDA June 14, 2012 Approval Letter – MenHibrix Jun. 14, 2012

144 CDC Infant Meningococcal Vaccination: Advisory Committee on Immunization Practices (ACIP) Recommendations and Rationale MMWR Jan. 25, 2013; 62(03);52-54

145 GSK MenHibrix Discontinuation Notice Oct. 2016

146 FDA August 1, 2013 Approval Letter – Menveo Aug. 1, 2013

147 CDC Use of MenACWY-CRM Vaccine in Children Aged 2 Through 23 Months at Increased Risk for Meningococcal Disease: Recommendations of the Advisory Committee on Immunization Practices, 2013 MMWR June 20, 2014; 63(24);527-530

148 FDA October 29, 2014 Approval Letter – TRUMENBA Oct. 29, 2014

149 FDA Summary Basis for Regulatory Action Oct. 29, 2014

150 FDA January 23, 2015 Approval Letter – BEXSERO Jan. 23, 2015

151 NFID Addressing the Challenges of Serogroup B Meningococcal Disease Outbreaks on Campuses: A Report by the National Foundation for Infectious Diseases May 2014

152 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.

153 McNamara LA, Shumate AM, Johnsen P et al. First Use of a Serogroup B Meningococcal Vaccine in the US in Response to a University Outbreak Pediatrics. 2015 May; 135(5): 798–804.

154 NFID Addressing the Challenges of Serogroup B Meningococcal Disease Outbreaks on Campuses: A Report by the National Foundation for Infectious Diseases May 2014

155 McNamara LA, Shumate AM, Johnsen P et al. First Use of a Serogroup B Meningococcal Vaccine in the US in Response to a University Outbreak Pediatrics. 2015 May; 135(5): 798–804.

156 FDA Summary Basis for Regulatory Action Jan. 23, 2015

157 CDC Use of Serogroup B Meningococcal Vaccines in Persons Aged ≥10 Years at Increased Risk for Serogroup B Meningococcal Disease: Recommendations of the Advisory Committee on Immunization Practices, 2015 MMWR June 12, 2015; 64(22);608-612

158 CDC Use of Serogroup B Meningococcal Vaccines in Adolescents and Young Adults: Recommendations of the Advisory Committee on Immunization Practices, 2015 MMWR Oct. 23, 2015; 64(41);1171-6

159 CDC Recommendations for Use of Meningococcal Conjugate Vaccines in HIV-Infected Persons — Advisory Committee on Immunization Practices, 2016 MMWR Nov. 4, 2016; 65(43);1189–1194

160 CDC Clinical Update - Menomune (meningococcal polysaccharide vaccine) discontinuation Mar. 24, 2017

161 CDC PFIZER GRANTED FDA BREAKTHROUGH THERAPY DESIGNATION FOR TRUMENBA® (MENINGOCOCCAL GROUP B VACCINE) FOR THE PREVENTION OF INVASIVE MENINGOCOCCAL B DISEASE IN CHILDREN AGES 1 TO 9 YEARS Press Release Apr. 23, 2018

162 CDC Prevention and Control of Meningococcal Disease - Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR May 27, 2005; 54(RR07);1-21

163 CDC Licensure of a Meningococcal Conjugate Vaccine (Menveo) and Guidance for Use --- Advisory Committee on Immunization Practices (ACIP), 2010 MMWR Mar. 12, 2010; 59(09);273

164 CDC Prevention and Control of Meningococcal Disease - Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR May 27, 2005; 54(RR07);1-21

165 CDC Updated Recommendations for Use of Meningococcal Conjugate Vaccines --- Advisory Committee on Immunization Practices (ACIP), 2010 MMWR Jan. 28, 2011; 60(03);72-76

166 Cohn AC, MacNeil JR, Harrison LH, et al. Effectiveness and Duration of Protection of One Dose of a Meningococcal Conjugate Vaccine. Pediatrics. 2017 Feb;139(2)

167 CDC Use of Serogroup B Meningococcal Vaccines in Adolescents and Young Adults: Recommendations of the Advisory Committee on Immunization Practices, 2015 MMWR Oct. 23, 2015; 64(41);1171-6

168 FDA TRUMENBA Product Insert Mar. 14, 2018

169 FDA BEXSERO Product Insert May 31, 2018

170 FDA Menveo Product Insert Oct. 4, 2018

171 FDA Menactra Product Insert Apr. 27, 2018

172 Struijk GH, Bouts AH, Rijkers GT et al. Meningococcal sepsis complicating eculizumab treatment despite prior vaccination. Am J Transplant. 2013 Mar;13(3):819-20

173 Parikh SR, Lucidarme J, Bingham C et al. Meningococcal B Vaccine Failure With a Penicillin-Resistant Strain in a Young Adult on Long-Term Eculizumab. Pediatrics. 2017 Sep;140(3). pii: e20162452

174 Gäckler A, Kaulfuß M, Rohn H et al. Failure of first meningococcal vaccination in patients with atypical haemolytic uraemic syndrome treated with eculizumab. Nephrol Dial Transplant. 2018 Jul 9. doi: 10.1093/ndt/gfy225.

175 CDC High Risk for Invasive Meningococcal Disease Among Patients Receiving Eculizumab (Soliris) Despite Receipt of Meningococcal Vaccine MMWR Jul. 14, 2017; 66(27);734-737

176 Lebel E, Trahtemberg U, Block C et al. Post-eculizumab meningococcaemia in vaccinated patients. Clin Microbiol Infect. 2018 Jan;24(1):89-90

177 CDC Use of Serogroup B Meningococcal Vaccines in Adolescents and Young Adults: Recommendations of the Advisory Committee on Immunization Practices, 2015 MMWR Oct. 23, 2015; 64(41);1171-6

178 FDA BEXSERO Product Insert May 31, 2018

179 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

180 McNamara LA, Shumate AM, Johnsen P et al. First Use of a Serogroup B Meningococcal Vaccine in the US in Response to a University Outbreak Pediatrics. 2015 May; 135(5): 798–804.

181 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

182 Institute of Medicine Committee to Review Adverse Effects of Vaccines. Adverse Effects of Vaccines: Evidence and Causality. Evaluating Biological Mechanisms of Adverse Events (p. 57-102), Increased Susceptibility (p. 82). Washington, DC: The National Academies Press 2012.

183 CDC Meningococcal ACWY VIS Aug. 24, 2018

184 FDA Menactra Product Insert Apr. 27, 2018

185 FDA Menveo Product Insert Oct. 4, 2018

186 Tseng HF, Sy LS, Ackerson BK et al. Safety of Quadrivalent Meningococcal Conjugate Vaccine in 11- to 21-Year-Olds. Pediatrics. 2017 Jan;139(1). pii: e20162084.

187 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

188 Institute of Medicine Committee to Review Adverse Effects of Vaccines. Adverse Effects of Vaccines: Evidence and Causality. (Evaluating Biological Mechanisms for Adverse Events: Increased Susceptibility). Washington, DC: The National Academies Press. 2012

189 Institute of Medicine Committee to Review Adverse Effects of Vaccines. Adverse Effects of Vaccines: Evidence and Causality. (Evaluating Biological Mechanisms for Adverse Events: Increased Susceptibility). Washington, DC: The National Academies Press. 2012. Chap. 11, p 599 - 614

190 Ibid

191 Ibid

192 CDC Serogroup B Meningococcal (MenB) VIS Aug. 9, 2018

193 FDA Clinical Review, January 23, 2015 - BEXSERO Jan. 23, 2015

194 FDA BEXSERO Product Insert May 31, 2018

195 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

196 FDA Clinical Review - TRUMENBA Oct. 29, 2014

197 FDA Clinical Review of 125549/17 - TRUMENBA Apr. 14, 2016

198 FDA TRUMENBA Product Insert Mar. 14, 2018

199 Kessler DA, the Working Group, Natanblut S, et al. A New Approach to Reporting Medication and Device Adverse Effects and Product Problems. JAMA. 1993;269(21):2765-2768.

200 FDA.gov. Kessler DA. Introducing MEDWatch: A New Approach to Reporting Medication and Device Adverse Effects and Product Problems. Reprint from JAMA. June 9, 1993.

201 Braun M. Vaccine adverse event reporting system (VAERS): usefulness and limitations. Johns Hopkins Bloomberg School of Public Health

202 Rosenthanl S, Chen R. The reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am J Public Health 1995; 85: pp. 1706-9.

203 AHRQ Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS) Dec 1, 2007-Sep. 30, 2010

204 U.S. Department of Health and Human Services. National Vaccine Injury Compensation Program Data—April 1, 2019. National Vaccine Injury Compensation Program. Apr. 1, 2019

205 CDC Inadvertent Misadministration of Meningococcal Conjugate Vaccine --- United States, June--August 2005 MMWR Sep 22, 2006; 55(37);1016-1017

206 CDC Notes from the Field: Administration Error Involving a Meningococcal Conjugate Vaccine — United States, March 1, 2010–September 22, 2015 MMWR Feb. 19, 2016; 65(6);161–162

207 NVIC Analysis Shows Greater Risk of GBS Reports When HPV Vaccine Is Given with Meningococcal and Other Vaccines. Aug 15, 2007.

208 CDC FDA and CDC issue alert on Menactra meningococcal vaccine and Guillain Barre Syndrome Health Alert Network Sep. 30, 2005

209 CDC Meningococcal Disease - Contraindications and Precautions to Vaccination Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

210 FDA Menactra Product Insert Apr. 27, 2018

211 FDA Menveo Product Insert Oct. 4, 2018

212 Tseng HF, Sy LS, Ackerson BK et al. Safety of Quadrivalent Meningococcal Conjugate Vaccine in 11- to 21-Year-Olds. Pediatrics. 2017 Jan;139(1). pii: e20162084.

213 FDA Menveo Product Insert Oct. 4, 2018

214 FDA BEXSERO Product Insert May 31, 2018

215 FDA Menactra Product Insert Apr. 27, 2018

216 FDA Menveo Product Insert Oct. 4, 2018

217 FDA BEXSERO Product Insert May 31, 2018

218 FDA TRUMENBA Product Insert Mar. 14, 2018


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