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The Meningococcal Vaccine - Public Policy and Individual Choices
Paul A. Offit, M.D., and Georges Peter, M.D.
Meningitis And The Meningococcal Vaccine

In the United States, meningococcal quadrivalent polysaccharide vaccine is not recommended for routine use by the CDC or the American Academy of Pediatrics, for the following reasons. There is approximately a 1 in 125,000 chance that their child will contract meningococcal infection or the 1 in 1,250,000 chance that their child will be permanently harmed by or will die from the disease. People must remember that clinicians are unlikely to purchase, store, distribute, and provide information about vaccinations for which health insurance plans do not provide reimbursement. Also, clinicians may assume that a vaccine is not recommended for routine use because of a limited benefit, questions of its safety, or both, and not because of negative economic analyses.

Because the meningococcal vaccine is not recommended for routine use, clinicians and public health agencies are unlikely to educate parents about the disease or about the availability of a vaccine, for several reasons.

  • First, the polysaccharide vaccine is not effective in young children. Although infants and young children have the highest age-related risk of meningococcal disease, they have a poor response, if any, to the vaccine.10
  • Second, the polysaccharide vaccine does not contain serogroup B. Meningococcal serogroup B strains currently account for approximately two thirds of cases in infants less than 1 year old and about one third of cases in persons 5 to 34 years old.4
  • Third, immunity induced by the polysaccharide vaccine is short-lived. In infants and young children who have been immunized with polysaccharide vaccines, there is a rapid decline in the polysaccharide-binding antibodies during the first three years after immunization,13 and the effectiveness of the vaccine may diminish markedly.14

Source Information From the Division of Infectious Diseases, Children's Hospital of Philadelphia, and the Department of Pediatrics, University of Pennsylvania School of Medicine - both in Philadelphia (P.A.O.); and the Division of Pediatric Infectious Diseases, Rhode Island Hospital, and the Department of Pediatrics, Brown Medical School - both in Providence (G.P.).


References
1. Rosenstein NE, Perkins BA, Stephens DS, Popovic T, Hughes JM. Meningococcal disease. N Engl J Med 2001;344:1378-1388.[Full Text]
2. Prevention and control of meningococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2000;49:1-10.[Medline]
3. Kirsch EA, Barton P, Kitchen L, Giroir BP. Pathophysiology, treatment and outcome of meningococcemia: a review and recent experience. Pediatr Infect Dis J 1996;15:967-979.[CrossRef][ISI][Medline]
4. Active bacterial core surveillance (ABCs) report, Emerging Infections Program Network, Neisseria meningitidis, 2001 - provisional. Atlanta: Centers for Disease Control and Prevention, 2002. (Accessed November 18, 2003, at http://www.cdc.gov/ncidod/dbmd/abcs/survreports/mening01_provis.pdf.)
5. Riedo FX, Plikaytis BD, Broome CV. Epidemiology and prevention of meningococcal disease. Pediatr Infect Dis J 1995;14:643-657.[ISI][Medline]
6. Goldschneider I, Gotschlich EC, Artenstein MS. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med 1969;129:1307-1326.[ISI][Medline]
7. Meningococcal vaccines. MMWR Morb Mortal Wkly Rep 1985;34:255-259.[Medline]
8. Meningococcal disease and college students: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2000;49:13-20.[Medline]
9. Meningococcal disease prevention and control strategies for practice-based physicians (addendum: recommendation for college students). Pediatrics 2000;106:1500-1504.[Abstract/Full Text]
10. Lebel MH, Tapiero BF, Saintonge F. Immunogenicity of bivalent AC polysaccharide meningococcal vaccine in children aged 6 months through 24 months. JAMA 2001;285:1578-1579.[Full Text]
11. Finne J, Leinonen M, Mäkelä PH. Antigenic similarities between brain components and bacteria causing meningitis: implications for vaccines development and pathogenesis. Lancet 1983;2:355-357.[Medline]
12. Wyle FA, Artenstein MS, Brandt BL, et al. Immunologic response of man to group B meningococcal polysaccharide vaccines. J Infect Dis 1972;126:514-521.[ISI][Medline]
13. Gold R, Lepow ML, Goldschneider I, Draper TF, Gotschlich EC. Kinetics of antibody production to group A and group C meningococcal polysaccharide vaccines administered during the first six years of life: prospects for routine immunization of infants and children. J Infect Dis 1979;140:690-697.[ISI][Medline]
14. Reingold AL, Broome CV, Hightower AW, et al. Age-specific differences in duration of clinical protection after vaccination with meningococcal polysaccharide A vaccine. Lancet 1985;2:114-118.[ISI][Medline]
15. Zangwill KM, Stout RW, Carlone GM, et al. Duration of antibody response after meningococcal polysaccharide vaccination in US Air Force personnel. J Infect Dis 1994;169:847-852.[ISI][Medline]
16. Kayhty H, Karanko V, Peltola H, Sarna S, Makela PH. Serum antibodies to capsular polysaccharide vaccine of group A Neissera meningitidis followed for three years in infants and children. J Infect Dis 1980;142:861-868.[ISI][Medline]
17. Campbell JD, Edelman R, King JC Jr, Papa T, Ryall R, Rennels MB. Safety, reactogenicity, and immunogenicity of a tetravalent meningococcal polysaccharide-diphtheria toxoid conjugate vaccine given to healthy adults. J Infect Dis 2002;186:1848-1851.[CrossRef][ISI][Medline]
18. MacLennan JM, Shackley F, Heath PT, et al. Safety, immunogenicity, and induction of immunologic memory by a serogroup C meningococcal conjugate vaccine in infants: a randomized controlled trial. JAMA 2000;283:2795-2801.[Abstract/Full Text]
19. Ramsay ME, Andrews N, Kaczmarski EB, Miller E. Efficacy of meningococcal serogroup C conjugate vaccine in teenagers and toddlers in England. Lancet 2001;357:195-196.[CrossRef][ISI][Medline]
20. Balmer P, Borrow R, Miller E. Impact of meningococcal C conjugate vaccine in the UK. J Med Microbiol 2002;51:717-722.[Abstract/Full Text]
21. Scott RD II, Meltzer MI, Erickson LJ, De Wals P, Rosenstein NE. Vaccinating first-year college students living in dormitories for meningococcal disease: an economic analysis. Am J Prev Med 2002;23:98-105.
22. Artenstein MS, Gold R, Zimmerly JG, Wyle FA, Schneider H, Harkins C. Prevention of meningococcal disease by group C polysaccharide vaccine. N Engl J Med 1970;282:417-420.[ISI][Medline]
23. Griffiss JM, Brandt BL, Broud DD. Human immune response to various doses of group Y and W135 meningococcal polysaccharide vaccines. Infect Immun 1982;37:205-208.[ISI][Medline]
24. Borrow R, Goldblatt D, Andrews N, Richmond P, Southern J, Miller E. Influence of prior meningococcal C polysaccharide vaccination on the response and generation of memory after meningococcal C conjugate vaccination in young children. J Infect Dis 2001;184:377-380.[CrossRef][ISI][Medline]
25. Pickering LK, ed. 2003 Red book: report of the Committee on Infectious Diseases. 26th ed. Elk Grove Village, Ill.: American Academy of Pediatrics, 2003:389.

Another Unnecessary Vaccine? Here Comes the Hype for a New Meningitis Vaccine
by Sandy Mintz

The headlines are arresting, the hope almost palpable: Vaccine 'could beat meningitis'; Scientists: Meningitis Vaccine Breakthrough; Meningitis experts pin hopes on new vaccine; Research Raises Hope for New Meningitis Vaccine.

But what is this "meningitis" and can a vaccine really protect us from it? According to the CDC, "Meningitis is an infection of the fluid of a person's spinal cord and the fluid that surrounds the brain. People sometimes refer to it as spinal meningitis. Meningitis is usually caused by a viral or bacterial infection. Knowing whether meningitis is caused by a virus or bacterium is important because the severity of illness and the treatment differ. Viral meningitis is generally less severe and resolves without specific treatment, while bacterial meningitis can be quite severe and may result in brain damage, hearing loss, or learning disability. For bacterial meningitis, it is also important to know which type of bacteria is causing the meningitis because antibiotics can prevent some types from spreading and infecting other people. Before the 1990s, Haemophilus influenzae type b (Hib) was the leading cause of bacterial meningitis, but new vaccines being given to all children as part of their routine immunizations have reduced the occurrence of invasive disease due to H. influenzae. Today, Streptococcus pneumoniae and Neisseria meningitidis are the leading causes of bacterial meningitis."

Sounds pretty scary, and it certainly can be. But as with anything involving for-profit drugs and other biological products, the hype must be separated from the hope.

First, it must be determined what the incidence of the disease has been, both before and after introduction of vaccination, in order to ascertain if there has been a benefit from vaccination, i.e., it has caused a decline in disease incidence. As part of determining whether or not the vaccine is responsible for any declines, incidence of meningococcal disease among the vaccinated must then also be compared to those receiving no meningococcal vaccine, particularly those who have never been vaccinated, period. Finally, the cost (as in negative consequences) of vaccinating must be honestly and fairly compared to the costs of not vaccinating.

Sadly, even the incidence of meningitis is not all that well-established. Currently (as of year-end 2002), only Haemophilus influenzae and certain forms of Streptococcus pneumonia are separately notifiable, with all other meningococcal disease being reported together.

What is known is fairly reassuring, though: bacterial meningitis, although dramatic and frightening, is thought to be quite rare and not highly contagious, only affecting "about 2,400-3,000 people" in the United States each year. (Although the data are a bit confusing. For instance, although in 2000, according to the CDC, there were fewer than 2400 cases reported in the combined category "meningococcal disease", it is unclear whether or not that figure includes both bacterial and viral meningitis. On the other hand, it does not include the over 4500 cases of Streptococcus pneumoniae reported that year as well. Still, the numbers are relatively small.)

Being armed with historical morbidity and mortality data is of little value without additional information, however. Unfortunately that information is also not available. Little to nothing is known about whether or not vaccination is necessarily causally related to either a decline in deaths or a decline in incidence, since no long-term studies comparing the vaccinated to the never vaccinated have ever been conducted. Nor is much known about the possible negative consequences of vaccinating, if there are any. (Although it is true that there have been 644 adverse meningitis vaccine-associated reactions reported to VAERS so far, indefensibly, it is unknown if they represent 644, 6,440 or even 64,400 cases! Nor do we know if and when the vaccine actually caused the reported events.)

Regardless, it is becoming increasing clear that the consequences of vaccinating against meningitis may well be regrettable in the long run. The bacteria targeted by vaccination, rather than remaining content to retreat into the background like a dutiful troop of shrinking violets, seem determined to survive and thrive - and one way they appear to be doing so is by changing serotype and serotype prevalence. Thus vaccination, rather than removing or diminishing the threat of disease, may instead create an endless ostensible need for additional vaccines by causing pathogens to re-emerge in different forms.

At some point might it not be prudent to question "Public Health's" debatable vaccination policy, the strategy it has adopted in what increasingly appears to be a misguided "war against disease"? At some point wouldn't it make sense to take a stab at fashioning some other disease prevention/disease survival plan?

Perhaps now would be a good time to start - by not buying into the hysteria about a rare disease and by questioning the drug company solution to preventing it. For while it is eminently clear that the vaccine manufacturers and those with financial ties to them benefit from the ever-increasing putative need for vaccines, the more important question is, does anyone else?

(To read a related column on this topic, go to Scandals: Changing Disease Epidemiology Via Vaccines - Are We "Robbing Peter To Pay Paul"?.)

Sandy Mintz

"Eternal vigilance is the price of liberty." - Wendell Phillips (1811-1884), paraphrasing John Philpot Curran (1808)

Sandy Mintz is the publisher of the website "Vaccination News", and writer of the columns "Scandals" and "Out of Control." To join her political action egroup or learn more about it, please send an email to sandym@touchngo.com, indicating the purpose of your email in the subject line.

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