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PNEUMOCOCCAL
DISEASE AND VACCINE
Pneumococcal
disease is a bacterial infection that can cause serious illness,
including inflammation of the brain, blood infections and pneumonia.
The Prevnar vaccine manufactured by Wyeth Lederle Laboratories (of
American Home Products Corporation, Wyeth-Aherst Lab) is the one
being considered for mandate in some states. It contains only 7
of the more than 90 strains of the pneumococcal organism that causes
disease in humans and cannot prevent meningitis or blood infections
caused by other strains.1
Most
children and adults harbor pneumoccocal organisms in their noses
and throats. It is not clear why some individuals will go on to
develop severe pneumococcal disease and others do not, although
those with weakened immune systems are at very high risk. Over-use
of antibiotics during the past quarter century has caused at least
7 strains of the pneumococcal organism to mutate into antibiotic
resistant forms and these 7 strains are contained in the Prevnar
vaccine. Whether the Prevnar vaccine will place pressure on the
pneumococcal organism to develop vaccine-resistant strains or make
other strains of the bacteria more virulent is unknown.
The
CDC states that pneumococcal infections cause approximately 700
cases of meningitis, 17,000 cases of blood stream infections and
200 deaths in American children under age five every year, with
35 of these deaths being caused by pneumococcal meningitis.2
WHY
OPPOSE A PNEUMOCOCCAL VACCINE MANDATE:
- Flawed Clinical
Trials Did Not Prove Safety: Wyeth Lederle and Kaiser Permanente
compared one experimental vaccine (pneumococcal) against another
(meningococcal)1, which seriously compromised the scientific validity
of the trial. Children in groups who got the pneumococcal vaccine
suffered more seizures, irritability, high fevers and other reactions.
There were 12 deaths in the Prevnar group, including 5 Sudden
Infant Death Syndrome (SIDS) deaths. [Since the vaccine was licensed
in 2000, there have been 3,243 Prevnar-related adverse events
reported to the federal government (VAERS), including 476 serious
events and 79 deaths.]3
- No Long Term
Studies: There were no long term studies to evaluate whether Prevnar
vaccine given alone or in combination with other vaccines is associated
with chronic illness or disability, such as the development of
diabetes, asthma, seizure disorders, learning disabilities, ADHD,
or autism.
- Vaccine Components
Not Thoroughly Evaluated: Each 0.5ml dose of Prevnar contains
0.125 mg. of aluminum, a metal that is neurotoxic. The vaccine
manufacturer states that "Prevnar has not been evaluated
for any carcinogenic or mutagenic potential, or impairment of
fertility." 4,1
- Efficacy
Low For Preventing Ear Infections: Despite the suggestion by the
manufacturer and Kaiser Pemanente officials in pre-licensure press
releases that Prevnar vaccine is an ear infection vaccine, the
vaccine has never been licensed by the FDA to prevent ear infections.
Clinical trials showed that the vaccine decreases a child's chance
of getting an ear infection by only 7 percent.5,
6
- Prevnar May
Interfere With Efficacy of Other Vaccines: The manufacturer product
insert indicates that when Prevnar is given at the same time as
HIB, pertussis and polio vaccines, it may lower the efficacy of
those vaccines for some children. There is no data on what happens
when Prevnar vaccine is given in combination with MMR or chicken
pox vaccines.1
- Voluntary
Use of the Vaccine Is High: Wyeth Lederle, the CDC and AAP have
done an excellent job promoting the mass use of this vaccine by
children. Prevnar topped the sales charts as the number one best
selling new pharmaceutical among all pharmaceuticals brought on
the market in the year 2000, generating $461 million in sales.7
Voluntary uptake of the vaccine is so high that there are Prevnar
vaccine shortages and the CDC recently temporarily revised its
recommendations to urge that only high risk groups of children
should receive all four doses of the vaccine.2 This experience
shows that mandates are not needed.
References:
1. Wyeth-Lederle Product Manufacturer Insert (Pneumococcal 7-Valent
Conjugate Vaccine (PREVNAR). Issued February 2000.
2. Centers for Disease Control. Dec. 10,2001 press release: ACIP
Votes to Temporarily Revise Recommendations for Pneumococcal Conjugate
Vaccine, www.cdc.gov/nip/news/shortages/default.htm
3. Vaccine Adverse Event Reporting System (VAERS) Data
4. Aluminum Toxicity in Infants and Children (RE9607). Pediatrics.
Vol. 97, No. 3 (March 1996).
5. Wyeth-Ayerst Laboratories. Sept. 25, 1998 press release: New
Investigational Vaccine Demonstrates High Efficacy Against Pneumococcal
Disease in Children.
6. Kaiser Permanente. May 4, 1999 press release: Investigational
Vaccine Is First To Show Effectiveness Against Childhood Ear Infections.
7. O'Reiley T. Vaccine Tops Sales Chart. March 4, 2001. Daily Record
(Morris County, NJ).
More
on vaccines:
Aseptic meningitis as a complication
of mumps vaccination
Hepatitis A
Hepatitis
B
Infant Rotovirus
The Meningococcal Vaccine - Public Policy and Individual Choices
Pneumococcal
disease and vaccine
Whooping Cough or Pertussis
Adverse
effects of adjuvants in vaccines
First International Public Conference on Vaccination
Letter
to NEJM from Dr Andrew J Wakefield MB.,BS FRCS
Quotes: Medical Doctors Speak out on Vaccinations
Study Attempts Cover Up of Autism-Mercury
Link
CDC Plans For Mass Vaccination Of All
Children With AIDS Vaccine
Top Ten Vaccine Information Sources Recommended
by the National
Workshop on simian virus-40
Vaccines fueling autism epidemic?
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