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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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