What You Should Know About Meningococcal Disease & The Vaccine

by Barbara Loe Fisher

Today, pediatricians give American babies as many as 33 doses of 13 different vaccines by 12 months of age.^{1, 2} Now, federal public health officials are considering recommending that doctors give four more doses of a new vaccine – meningococcal vaccine – to babies between two and 12 months old^3,4 in addition to the two doses children already get at 11 and 16 years old.⁵

There are big questions about the necessity, effectiveness, safety and cost of this new proposed change to the child vaccination schedule.

Meningococcal Disease Rare in the U.S.

Invasive Neisseria 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 very rare in the United States. In our population of 308 million, there are between 1400 and 3000 cases every year that fluctuate with natural cycles.⁶ Between 10 and 15% of the cases are fatal with another 10 to 20% ending with brain damage or loss of limbs.

Children Under Age Two Less Likely To Die

It is estimated that, annually, there are between 150 and 300 meningococcal deaths in the U.S.,⁷ with an average of 16 babies under age 12 months dying from the disease⁸ Children under age two are less likely to die from meningococcal infection compared to older age groups.⁹

Incidence in U.S. Has Decreased to Historic Lows

The good news is that the incidence of the disease has decreased more than 60 percent between 1998 and 2007 to less than 1 case in 100,000 people, which is an historic low in the U.S.¹⁰ To put this death rate into context, there are three times as many Americans, who die from heat stroke¹¹ or drown in boating accidents¹² every year than die from invasive meningococcal disease.

Maternal Antibodies, Natural Immunity Protects Majority

That is because 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.¹³ At any given time up 20 to 40 percent of us are asymptomatically colonizing meningococcal organisms in our nasal passages and throats, which throughout life boosts our innate immunity to invasive bacterial infection.^{14, 15} By the time American children enter adolescence, the vast majority have asymptomatically developed immunity that protects them, which is how our population maintains naturally acquired herd immunity and why cases of invasive disease are so rare in all age groups.

Genetically Vulnerable At High Risk for Disease

However, a tiny minority of individuals have genetic variations and other unknown biological factors that prevent them from naturally developing protective circulating antibodies.¹⁶ These are the individuals, tragically, who are up to 7,000 times more likely to get severe invasive meningococcal disease at some point in their lives.¹⁷ Clearly, there must be greater attention paid to developing screening techniques to identify those high-risk individuals and help them avoid a potentially fatal or crippling meningococcal infection.

Environmental High Risk Factors

In addition to genetic factors that place some people at higher risk, there are other biological and environmental factors that make people more susceptible. These 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.^{18, 19}

Constant, Close Personal Contact Required

It is not easy to develop invasive meningococcal disease.²⁰ 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.

Know Symptoms, Get Immediate Medical Care

Symptoms of meningococcal disease 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 that can be caused by a bacterial or viral infection or a vaccine reaction.²¹ These are danger signs and it is very important to seek immediate medical attention and treatment to help prevent permanent injury or death.

Vaccine Has Only 4 Strains

In 2000, the CDC recommended that all college freshmen get a dose of meningococcal vaccine containing four strains (A, C, W-35, Y)²² and, in 2005, that policy was expanded to include all 11 year olds.²³ There is one problem: the vaccine does not contain strain B, which is the strain associated with more than 50 percent of meningococcal cases and deaths,²⁴ especially in children under five years old.²⁵

Vaccine Effectiveness Does Not Last, Need Booster

There is another problem: The vaccine has been found to be, at best, only about 58 percent effective within two to five years after adolescents have gotten the shot.^{26, 27} So, in 2011, when public health officials realized that one dose of meningococcal vaccine did not last, they said that all 16 year olds should get a booster dose.

Vaccine Costs $90 Or More Per Dose

There is another problem: one dose of meningococcal vaccine costs about $90²⁸ or more.

The health care price tag to give four doses of meningococcal vaccine to all four million babies born every year in the U.S. costs a whopping $1.4 billion dollars per year. Plus two more doses for all 11 and 16 year olds adds on another nearly $1 billion dollars.

Vaccine Reactions Add to Vaccine Cost

There is another problem. The health care cost to the American taxpayer does not end with the outlay of cash to pay for 6 doses of the vaccine for every child. What about the unacknowledged health care costs to treat the children, who suffer a vaccine reaction that leads to a trip to the ER or hospitalization or permanent brain and immune system problems?

Vaccine Reaction Injuries & Deaths Reported

The manufacturer product inserts for meningococcal vaccine list the following adverse events reported during clinical trials or post licensure: 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.^{29, 30, 31}

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.,^{32, 33} has recorded more than 2,000 serious health problems, hospitalizations and injuries following meningococcal shots, including 33 deaths with half of the deaths occurring in children under age six.³⁴

Limited or No Data on Giving Vaccine With Other Vaccines

There is very limited or no data on the safety and effectiveness of giving meningococcal vaccines with other vaccines at the same time.³⁵ In 2007, the National Vaccine Information Center reported an increase in serious adverse event reports to VAERS when meningococcal vaccine was given simultaneously with HPV vaccine to young girls.^{36, 37}

States & Colleges Already Mandated Vaccine to Attend School

Ten states have already made meningococcal shots mandatory to attend junior high school and 32 states require the shot for college freshman.^{38, 39} If the CDC recommends all babies and children get an additional four meningococcal shots, drug companies and medical organizations financially connected to the pharmaceutical industry⁴⁰ will certainly lobby state legislatures to legally require the vaccine for all children attending day care centers and schools.

Are Vaccine Companies Pressuring Government?

Question: Why is the government bowing to pressure from drug companies to recommend and mandate that all American babies get four doses of a very expensive meningococcal vaccine that has big problems with effectiveness, especially when naturally acquired herd immunity is already doing such a good job of controlling the disease in the U.S.?

Trading Natural Herd Immunity for Temporary Vaccine Immunity

By mandating that every American use meningococcal vaccine from infancy, we will be trading the natural herd immunity our population has achieved for inferior vaccine acquired immunity that does not last. That will make our population vaccine dependent, which is great news for drug company stockholders, but will it be bad news for our health and the environment?

Creating a Nightmare Scenario?

Like with excessive antibiotic use,^{41, 42} we just might be creating a nightmare scenario for meningococcal organisms to mutate into more lethal vaccine resistant bugs^{43, 44, 45} that will have all of us highly susceptible to invasive meningococcal infection and wishing we had taken the precautionary principle⁴⁶ much more seriously.

Bottom line: Meningococcal vaccine is available and can be used by anyone who wants to use it, but there is no reason for government to recommend and schools to mandate the shots for everyone.

Learn More About Disease & Vaccine

Learn more about meningococcal disease and the vaccine at www.NVIC.org and find out what you can do to protect your right to make informed, voluntary vaccine choices in America.

References:

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[1] Centers for Disease Control. Recommended Immunization Schedule for Persons 0 through 6 Years. United States. 2011.
[2] NVIC. 49 Doses of 14 Vaccines By Age 6?
[3] Lakely J. Health Care Reporters: CDC to Pull Plug on Meningitis Vaccine Over Cost? The Heartland Institute. May 24, 2011.
[4] Ostrom CM. The Seattle Times. Meningitis Vaccine Debated at CDC Forum. July 13, 2011.
[5] Centers for Disease Control. Recommended Immunization Schedule for Persons 7 Through 18 years – United States. 2011.
[6] AAP Committee on Infectious Diseases. Prevention and Control of Meningococcal Disease: Recommendations for Use of Meningococcal Vaccines in Pediatric Patients. Pediatrics August 1, 2005; 116(2): 495-505.
[7] American College Health Association. Press Release: ACHA Issues New Meningococcal Disease Immunization Recommendations for First Year Students Living in Residence Halls. March 17, 2005.
[8] 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.
[9] Cohn A. Epidemiology of Meningococcal Disease in the U.S. Presentation to the FDA Vaccines & Related Biological Products Advisory Committee (VRBPAC). Transcript of April 6, 2011 Meeting. Pages 50-52.
[10] Cohn AC, MacNeil JR, Harrison LH et al. Changes in Neisseria meningitides Disease Epidemiology in the United States, 1998-2007: Implications for Prevention of Meningococcal Disease. Clinical Infectious Diseases January 15, 2010; 50(2): 184-191.
[11] CDC. Heat-Related Deaths – United States, 1999-2003. MMWR July 28, 2006; 55(29): 796-798.
[12] CDC. Stay Safe While Boating: Know the Facts. May 23, 2011.
[13] FDA. Vaccines & Related Biological Products Advisory Committee. FDA Briefing Document: 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. April 6, 2011. Pages 3-4.
[14] Tan L KK, Cadone GM, Borrow R. Advances in the development of vaccines against Neisseria meningitidis. NEJM April 22, 2010; 362(16): 1511-1520.
[15] Manchanda V. Gupta S., Bhalla P. Meningococcal Disease: History, Epidemiology, Pathogenesis, Clinical Manifestations, Diagnosis, Antiomicrobial Susceptibility and Prevention. Indian Journal of Medical Microbiology 2006; 24(1): 7-19.
[16] Bille E, Ure R et al. Association of Bacteriophage with Meningococcal Disease in Young Adults. PLOS One 2008; 3(12): e3885.
[17] See Reference # 13.
[18] CDC. Prevention & Control of Meningococcal Disease - Recommendations of ACIP. MMWR May 27, 2005; 50(RR07): 1-21.
[19] See References #10 & 15.
[20] CDC. Meningitis Questions & Answers.
[21] NIH. Encephalitis. PubMed July 26, 2010.
[22] CDC.Meningococcal Disease and College Students. MMWR June 30, 2000; 48(RR07): 11-20.
[23] See Reference #18.
[24] Granoff DM. Review of Meningococcal Group B Vaccines. Clinical Infectious Diseases

2010; 50(Supplement 2): 554-565.
[25] See Reference #9. Page 50.

[26] CDC. Updated Recommendations for Use of Meningococcal Conjugate Vaccines – ACIP, 2010. JAMA

2011; 305(13): 1291-1293.
[27] See Reference # 9. Pages 55-59.

[28] Tucker M. A Difficult Vaccine Decision. EGMN Notes from the Road. November 2, 2010.

[29] Sanofi-Pasteur. Menactra Product Information Insert. April 22, 2011.

[30] Novartis. Menveo Product Manufacturer Insert. March 2011.

[31] Sanofi Pasteur. Menommune Product Manufacturer Insert. January 2009.

[32] Braun M. Vaccine adverse event reporting system (VAERS): usefulness and limitations.

Johns Hopkins Bloomberg School of Public Health.
[33] 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.

[34] VAERS. MedAlerts database. Reports of health problems, hospitalizations, injuries and deaths following receipt of meningococcal vaccine.

[35] See References #27-29.

[36] NVIC. Press Release: Analysis Shows Greater Risk of GBS Reports When HPV Vaccine Is Given with Meningococcal and Other Vaccines. August 15, 2007.

[37] Debold V, Downey C, Fisher BL. Human Papilloma Virus Vaccine Safety Analysis of Vaccine Adverse Events Reporting System Reports (VAERS): Part III. NVIC August 15, 2007; Adverse Events & Co-Administration of Vaccines: Pages 15-27.

[38] Immunization Action Coalition. Meningococcal Vaccine Mandates for Elementary and High Schools. June 2, 2011.
[39] Immunization Action Coalition. Meningococcal Vaccine Mandates for Colleges & Universities. June 2, 2011.

[40] Fisher BL. Doctors Denying Vaccine Risks: An American Tragedy. NVIC. April 21, 2011.

[41] FDA. Antimicrobial Resistance. June 30, 2011.

[42] Miller T. Spread of Antibiotic-Resistant ‘Superbugs’ Raises Global Concerns. PBS NewsHour. August 12, 2010.

[43] Brueggemann AB, Pai R et al. Vaccine Escape Recombinants Emerge After Pneumococcal Vaccination in the United States. PLOS PathogensNovember 2007; 3(11): e16B.

[44] Millar EV, Pimenta FC et al. Pre-and Post-Conjugate Vaccine Epidemiology of Pneumococcal Serotype 6C Invasive Disease and Carriage Within Navajo and White Mountain Apache Communities. Clinical Infectious Diseases 2010; 51(11): 1258-1265.

[45] van Gils EJM, Hak E et al. Effect of Seven-Valent Pneumococcal Conjugate Vaccine on Staphylococcus aureus Colonization in a Randomized Controlled Trial. PLOS One June 10, 2011; 6(6):e20229.

[46] Science & Environmental Health Network (SEHN). The Wingspread Statement on the Precautionary Principle. January 1998.

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