- Invasive meningococcal disease is a bacterial infection that involves inflammation of the meninges of the brain and can lead to a serious blood infection. It is not easy to develop invasive meningococcal infection. You have to be susceptible and have regular close personal contact, such as sharing a toothbrush with or kissing person, who is colonizing meningococcal organisms.
- Symptoms of invasive meningococcal infection include fever; severe headache; painful, stiff neck; nausea and vomiting; inability to look at bright lights; mental confusion and irritability; extreme fatigue/sleepiness; convulsions and unconsciousness. In babies, signs of “irritability” can include persistent crying or high pitched screaming with arching of the back, which are symptoms of encephalitis or brain inflammation;
- In the U.S., invasive meningococcal incidence decreased by more than 60% between 1998 and 2007 and, today, there are between 1400 and 3,000 cases reported in the U.S. annually, which is an historic low.
- Between 10% and 15% of meningococcal cases are fatal with another 10% to 20% ending with brain damage or loss of limbs. It is estimated that, annually, there are between 150 and 300 meningococcal deaths in the U.S. with an average of 16 babies under age 12 months dying from the disease;
- At any given time, about 20 to 40 percent of Americans are asymptomatically colonizing meningococcal organisms in their nasal passages and throats, which throughout life boosts innate immunity to invasive meningococcal infection. Mothers, who have innate immunity, transfer maternal antibodies to their newborns to protect them in the first few months of life until babies can make their own antibodies. By the time American children enter adolescence, the vast majority have asymptomatically developed immunity that protects them;
- A small minority of individuals, who have genetic and other unknown biological factors, which prevent them from naturally developing protective circulating antibodies, are up to 7,000 times more likely to get severe invasive meningococcal disease at some point in their lives;
- In addition to genetic factors, high risk factors for developing invasive meningococcal infection include smoking or living in a home where people smoke; a recent respiratory infection; crowded living conditions, such as in military and prisons settings; alcohol use; and an underlying chronic illness, especially immune deficiencies such as lupus or HIV/AIDS;
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.
- There are four meningococcal vaccines licensed and marketed in the U.S.: MenHibrix, Menactra, Menomune, and Menveo;
- In 2000, the CDC recommended that all college freshman get a dose of meningococcal vaccine containing four strains (A, C, W-35, Y) and, in 2005, that policy was expanded to include all 11 year olds.
- The meningococcal vaccine does not contain strain B, which is the strain associated with more than 50 percent of meningococcal cases and deaths, especially in children under five years old;
- The meningococcal vaccine has been found to be about 58 percent effective within two to five years after adolescents have gotten the shot and, in 2011, CDC recommended that all 16 year olds get a booster dose of meningococcal vaccine;
- The manufacturer product inserts for meningococcal vaccine list adverse events reported during clinical trials or post licensure, including irritability, abnormal crying, fever, drowsiness, fatigue, injection site pain and swelling, sudden loss of consciousness (syncope), diarrhea, headache, joint pain, Guillain Barre Syndrome, brain inflammation, convulsions, and facial palsy.
- As of September 1, 2015, there had been 47 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following meningococcal vaccination, including 2 deaths and 45 serious injuries.
- Using the MedAlerts search engine, as of September 30, 2015, the federal Vaccine Adverse Events Reporting System (VAERS), which includes only a small fraction of the health problems that occur after vaccination in the U.S., had recorded more than 1,846 serious health problems, hospitalizations and injuries following meningococcal shots, including 99 deaths with about 34% of the deaths occurring in children under age six.
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Meningococcal Disease in College Students
In 2000, when the CDC recommended the meningococcal vaccine for college freshman (five years before the CDC recommended the meningococcal vaccine for all 11-12 year olds), an important article was published in the Morbidity & Mortality Weekly Report acnknowledging that there is a modestly increased risk for meningococcal disease among college students, particularly those who live in dormitories or resident halls.
to review the 2000 CDC report on meningococcal disease in the U.S..
Following information is a summary from the 2000 CDC report:
1- 1990-1991-A questionnaire designed to evaluate risk factors for meningococcal disease among college students was sent to 1900 universities, resulting in a 38% response rate. Forty-three cases of meningococcal disease were reported during the 2 years from colleges with a total enrollment of 4,393,744 students, for a low overall incidence of 1.0 per 100,000 population per year. However, cases of meningococcal disease occurred 9-23 times more frequently in students residing in dormitories than in those residing in other types of accommodations. The low response rate and the inability of the study to control for other factors make these results difficult to interpret.
2- 1992-1997 - A retrospective, cohort study conducted in Maryland identified 67 cases among persons aged 16-30 and were identified by active laboratory-based surveillance. Fourteen cases were among students attending Maryland colleges, and 11 were among those in 4-year colleges. The overall incidence rate in Maryland college students was similar to the incidence in the US population of persons the same age. Rates were elevated for students living in dormitories compared with students living off-campus.
3- 1998-1999 - US started to keep track of the disease in college students. In this time period 90 cases were reported to the CDC. These cases represent approximately 3% of the total cases that occur each year in the United States. Eighty-seven cases occurred in undergraduate students, and 40% occurred among the 2.27 million freshman students. Eight students died.
[This data suggests that the overall rate of disease among undergraduate college students is lower than the rate among persons aged 18-23 years who are not enrolled in college. Even though the rates were higher in freshmen students (4.6/100,000) living in dormitories, it was still lower than the threshold of 10/100,000 recommended for initiating meningococcal vaccination campaigns.]
Fifty of the students were enrolled in a case-control study and the results showed that freshmen living in dormitories were at a higher risk for disease. In addition white race, radiator heat, and recent upper respiratory infection were associated with disease.
The American College Health Association (ACHA) recommends that college health services take a more proactive role in alerting students and their parents about the dangers of the disease and that college students consider vaccination and that colleges and universities ensure that all students have access to a vaccination program for those that want to be vaccinated.
Cost-effectiveness of Vaccinating College Students
Nationwide vaccination of freshmen, who live in dormitories would result in the administration of 300,000-500,000 doses of vaccine each year, preventing 15-30 cases of disease and one to three deaths per year. The cost per case prevented would be $600,000- $1.8 million at a cost per death prevented of $7 million to $20 million.
Vaccination of all freshmen would result in the administration of 1.4-2.3 million doses of vaccine each year preventing 37-69 cases of disease and 2-4 deaths each year. The cost per case prevented would be $1.4-$2.9 million, at a cost per death prevented of $22 million to $48 million.
[These data suggest that for society as a whole, mandatory vaccination of college students with meningococcal vaccine is unlikely to be cost effective.]
Based on the above information, in 2000 the CDC’s ACIP Committee made the following recommendations regarding the use of meningococcal vaccine in college students:
- Providers to incoming or current college freshmen, particularly those living in dormitories, should inform these students and parents about the disease and the vaccination. ACIP does not recommend that the level of increased risk among freshmen warrants any specific changes in living situations with freshmen.
- College freshmen, who want to reduce their risk for meningococcal disease, should either be administered vaccine (by a doctor's office or student health service) or directed to a site where vaccine is available.
- The risk for disease among non-freshmen college students is similar to that for the general population. However, the vaccine can be administered to non-freshmen undergraduates who want it.
- Colleges should inform incoming and/or current freshmen, particularly those who plan to live or already live in dormitories or residence halls, about meningococcal disease and the availability of the vaccine.
- Public health agencies should provide college and health care providers with information about the disease and the vaccine, as well as information regarding how to obtain the vaccine.
Menactra vaccine licensed in 2005 and marketed by Sanofi Pasteur, was the first meningogoccal vaccine the CDC recommended for universal use by 11 year old children entering sixth grade and 18 year olds entering college. A dose of Menactra vaccine costs between $85 and $100 per shot.
Menactra protects against serotypes A, C, Y and W-135. However, Menactra, like all meningococcal vaccines, not contain serotype B, which causes about one-third of all cases of meningococcal disease in the US. and more than 50 percent of cases in young infants. Therefore, in terms of preventing meningococcal disease in America, Menactra (and other meningococcal vaccines) is ineffective 30 to 50 percent of the time, depending upon age.
Menactra was evaluated by Sanofi in about 7,600 individuals aged 11-55 years in clinical trials comparing Menommune and Menactra vaccines and were followed up for 7 days; 28 days and 6 months. Vaccine adverse reactions among 11-18 year olds in clinical trials cited in the product manufacturer insert include local pain, swelling and redness (10-59%); headache (35%); fatigue (30%); aching joints (17%); diarrhea (12%); loss of appetite (10%); chills and fever (5-7%); vomiting (2%); and rash (1%). There have also been reports of vasovagal syncope (collapse); facial palsy; transverse myelitis; urticaria, and musculoskeletal and connective tissue disorders, including myalgia, and death.
After five cases of Guillain Barre Syndrome were reported to VAERS in 2005, the FDA issued a warning for parents and doctors monitoring of vaccine recipients for signs of GBS. By October 2006, 15 cases of GBS had been reported. While federal health officials suggested the possibility of “a small increased risk of GBS” following receipt of Menactra, the implication was that most of the GBS cases occurring after Menactra were unrelated to the vaccine.
Although both meningococcal and HPV vaccines are recommended by the CDC for all 11-12 year old children in the U.S., Menactra and Gardasil (HPV) vaccines were never studied in pre-licensure clinical trials to evaluate safety when both vaccines were given simultaneously.
On August 15, 2007, the National Vaccine Information Center (NVIC) issued a report analyzing reports of GBS and other serious adverse events to VAERS after individuals received HPV (Gardasil) vaccine alone or administered simultaneously with Menactra. NVIC found a more than 1,000 percent statistically significant increased risk of reports of GBS to VAERS when Gardasil was administered simultaneously with Menactra.
When Menactra was given simultaneously with Gardasil, NVIC also found a statistically significant increased risk of reports of other serious adverse events to VAERS, including:
- Respiratory problem reports increased by 114 percent;
- cardiac problem reports increased by 118 percent;
- neuromuscular and coordination problem reports increased by 234 percent;
- convulsions and central nervous system problem reports increased by 301 percent;
- reports of injuries from falls after unconsciousness (vasovagal syncope) increased by 674 percent;
NVIC Referenced Commentary & Special Reports
Cohn A. Meningococcal Disease in Infants and Considerations for use of Conjugate Vaccines. Presentation at the CDC Public Engagement Stakeholders Meeting, Washington, D.C.. May 25, 2011. Slide: Average Annual Deaths and Case-Fatality Ratios by Serogroup and Age, 2001-2010.
2010; 50(Supplement 2): 554-565.
2011; 305(13): 1291-1293.
VAERS. MedAlerts database
. Reports of health problems, hospitalizations, injuries and deaths following receipt of meningococcal vaccine.