Continued - Part 2 of 2
Efficacy of Prevnar and other Vaccines Combined with Prevnar
The Efficacy of Prevnar
How good is Prevnar? According to the study paid for by Wyeth Lederle and
generated by Drs. Black and Shinefield:
“The study showed that children in the vaccine group fared better than those in the comparison group in other ways. In the primary analysis of all acute otitis media episodes (i.e. earaches), children receiving the investigational 7-valent pnemococcal vaccine (i.e. Prevnar) had 7 percent fewer new episodes.”31
Seven percent few episodes of earaches! Do you find that impressive? Keep in mind that there are at least five other pediatric vaccines that can cause earaches, ear infections or ear-related injury. It appears that we now have Prevnar, a vaccine designed to prevent adverse effects that can be caused by other vaccines.33
What about preventing invasive pneumococcal disease? According to data from the manufacturer’s insert, after one dose of the vaccine .016% of the recipients (3 out of 18,906) were diagnosed with invasive pneumococcal disease.39 But, .14% of controls (27 out of 18,910 children who were administered a different experimental vaccine) got invasive pneumococcal disease. 39 This means that based on this data (relative to the control), Prevnar decreases a child’s chance of getting invasive pneumococcal disease by about 0.1%!
Prevnar Interferes with Other Childhood Vaccines
When Prevnar is injected along with the other childhood vaccines, does it interfere with the promised efficacy of the other vaccines? Incredibly, the manufacturer states that in some cases it does and in other cases they just do not know. Under “Simultaneous Administration with Other Vaccines,” the package insert states:
“Although some inconsistent differences in response to pertussis antigens were observed, the clinical relevance is unknown.” 32
In other words, Prevnar can interfere with the “effectiveness” of the pertussis vaccines but they really don’t know a great deal about the implications of this. The manufacturer’s insert also states:
“MMR and Varicella immunogenicity data from controlled clinical trials with concurrent administration of Prevnar are not available.” 32
This admission is astounding. The manufacturer is stating that they do not know what Prevnar does to the efficacy of either the MMR or Varicella (chickenpox) vaccines. The insert continues:
“The response to two doses of IPV given concomitantly with Prevnar…(was) lower for (poliovirus) Type 1.” 32
Here they admit that Prevnar actually interferes with the inactivated polio vaccine.
Apparently, Prevnar interferes with at least two other vaccines (Pertussis and IPV) and may interfere with two more (MMR and Varicella). This information also appears to be contrary to what some parents are being told regarding how Prevnar acts in combination with other vaccines.
On April 26, 2000, a nurse revealed her concerns about the safety of Prevnar. She wrote:
“As an RN I have only administered the vaccine to the elderly population, now I was informed that the pediatrician dose for pneumococcal has been released and advised. I’m not sure the medication is safe…my child is 9 weeks old, how safe and effective will this drug be to a newborn, who is born healthy? Were there any serious side effects? Is it safe to administer with his routine vaccines? I’m not comfortable with the administration of 4 vaccines at once.”19
Dr. Edwards reassured the nurse that comparable antibody responses are generated. A statement that is inconsistent with admissions from the manufacture. On May 1, 2000 she wrote back:
“…It is safe to administer with other vaccines…The administration of four vaccines at once has been shown to generate comparable antibody responses…”19
Statistically Valid Studies?
How thorough were the studies? According to the Wyeth-Lederle, for the study concerning DPT and Hib efficacy with Prevnar, the number of infants reviewed (who were given Prevnar) was a total of 214. 32 For toddlers the total number was 47 children.32 For reviewing the efficacy of Hep B with Prevnar the number of infants studied (who were given Prevnar) was 156. 32 For toddlers the total number was zero. 32
Over seven million infants and toddlers are scheduled to receive this vaccine. The numbers of children tested (214, 47, 156, and 0) do not appear to be statistically valid in comparison to the seven million. Therefore, it is possible that no one really knows what Prevnar will or won’t do in combination with the other childhood vaccines.
Is this Rational?
The vaccine establishment is militant; requiring that every child in America receive every vaccine they decide is necessary. With Prevnar we now have a vaccine that admittedly interferes with the efficacy of other vaccines. Yet, Prevnar was still approved for universal vaccination. How is that possible? The message appears to be that it does not matter. Perhaps what matters most is that millions of units of the vaccine are sold.
Safety of Prevnar
The Safety of Prevnar
Prevnar is a bio-engineered product. It is created by combining the protein-polysaccharides from seven strains of dangerous Streptococcus pneumoniae bacteria with diphtheria toxin (Corynebacterium diphtheriae) grown in casamino acids and yeast extract and purified with ammonium sulfate.32 Such a creation has never before existed on this earth and the human race has never before in its entire history been exposed to such a product.
According to the American Academy of Pediatrics:
“Available data suggest that PCV7 (i.e. Prevnar) may prove to be among the most reactogenic (e.g., local reactions and incidence of fever) vaccine of those currently used, including the DTaP and Haemophilus conjugate vaccines.”36
In fact, the manufacturer’s insert describes reactions as the following:
Redness & Tenderness
For one small group of children 20.8 out of 24 (87%) had erythema (redness of skin produced by congestion of capillaries) and 4.2 out of 24 (17.5%) had “tenderness that interfered with limb movement.”40
Danger of Inappropriate Injection
Physicians and nurses know that there is a danger of an anaphylactic reaction if a vaccine is accidentally injected directly into a child’s bloodstream. Prevnar appears to be no exception. Under “Precautions,” the package insert states:
“Prevnar SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED INTRAVENOUSLY. The safety and immunogenicity for other routes of administration (e.g. subcutaneous) have not been evaluated.”32
Under “General,” the insert repeats this warning and states:
“Special care should be taken to prevent injection into or near a blood vessel or nerve.” 32
And again under “Dosage and Administration” the warning is stated a third time:
“For intramuscular injection only. Do not inject intravenously…After insertion of the needle…wait to see if any blood appears in the syringe…If blood appears, withdraw the needle and prepare for a new injection at another site.” 32
Most clinicians are very careful and very competent in avoiding this danger. But how reasonable is to expect that a pediatrician can always avoid injecting the product “near a blood vessel” when an infant’s or toddler’s blood vessels can be very small and the child may be squirming and moving. No vaccination is without risk.
The Six-Week Threshold is a Very Fine Line
The manufacturer’s safety threshold is so narrow that it could be deemed medically irresponsible. For example, according to the insert, “The safety and effectiveness of Prevnar in children below the age of 6 weeks have not been established.” 32 However, the insert goes on to state that “(Prevnar) can be given as young as 6 weeks of age.” 32 This appears to suggest that one second before a child is 6 weeks old the vaccine is unsafe but one second later everything changes and now it is safe. There appears to be no responsible safety cushion built into this language.
ER Visits, Seizures and SIDS Associated with Prevnar
In respect to dangerous reactions, the insert describes the following:
“Of the 17,066 subjects who received at least one dose of Prevnar…there were 162 visits to the emergency room within 3 days of a dose…”32 Obviously some of these visits have nothing to do with the vaccine (i.e. ingrown toenail) but others may be associated (i.e. pneumonia). In addition, “seizures were reported in 8 Prevnar recipients” within three days of vaccination.32 Furthermore, the insert tells us that, “Twelve deaths (5 SIDS and 7 with clear alternative cause) occurred among subjects receiving Prevnar.” 32 This number was less than the “21 deaths (8 SIDS, 12 with clear alternative cause and one SIDS-like death in an older child)” that occurred in the control group. However, both groups (Prevnar and control) received some form of experimental vaccine. Therefore, all we know is that 33 children are dead and at least 13 died of SIDS. How do these numbers compare to unvaccinated children? Has there ever been a study to determine this? What about visits to the ER or seizures after 3 days, such as on day 4 or 5 or 6 or 7, etc.? It appears that no study was completed.
Possible Allergic Reactions
The insert warns doctors that they should have epinephrine (i.e. adrenaline) “ready and (available)” in case the child has an allergic reaction after vaccination with Prevnar. 32
Unknown Toxicity and Carcinogenicity
Each .5 ml dose of the vaccine includes .125 mg of aluminum.32 Aluminum is considered neurotoxic to humans. Ironically, the American Academy of Pediatrics admits that:
“Aluminum is now being implicated as interfering with a variety of cellular and metabolic processes in the nervous system and in other tissues.”41
In addition, as we have already discussed, the manufacturer has admitted that:
“Prevnar has not been evaluated for any carcinogenic or mutagenic potential, or impairment of fertility.”32
Our children are the guinea pigs and we will see what happens in a few years. In fact, cancer is now the leading cause of death by disease for children under fifteen years old42 and there is a growing information to suggest potential vaccine-cancer links with other vaccines already administered to children.43
Relationship with Chronic Diseases
What do we know about Prevnar’s role in causing debilitating and life-threatening chronic diseases? Not very much. There have been no long-term studies done (i.e. more than five years). In addition, it is unclear whether the manufacturer has even looked at Prevnar’s relationship with the growing list of autoimmune diseases diagnosed in children.
Can Prevnar cause diabetes? As discussed above, at least one researcher believes it can.49 Will it cause other diseases? Unfortunately the answer will probably come from the 7 million children targeted to receive the vaccine. Our children are the guinea pigs.
Prevnar is Administered to Immune-Suppressed Children
Prevnar is being administered to immune-suppressed children:
On July 24, 2000, Dr. M. Sadof wrote:
“If you have a patient who is immunocompromised and 24 months old, which vaccine do you use…?19
Dr. Pelton responded on July 26, 2000,
“The current concept for patients like this is to give the prevnar vaccine…”19
Dr. L Eger wrote on August 18, 2000:
“There is a general recommendation to vaccinate immunocompromised children with Prevnar.” 19
Dr. Kathryn Edwards responded on August 23, 2000:
“Since the vaccines do not contain live bacterial components they pose no threat to the patient.” 19
Apart from the fact that an immune-suppressed child may not be able to elicit an appropriate immune response to the vaccine, the more important question is - how safe is this practice? The answer appears to be that nobody knows because according to the manufacturer’s insert there have been no appropriate studies regarding the administration of Prevnar to immune-suppressed children. Once again, our children are the guinea pigs.
The Bottom Line $
The Bottom Line Why Prevnar Will be Injected Into Your Healthy Child
Four doses of Prevnar (the amount for each child starting at two months old) costs $232.44 In this country alone, approximately seven million children under two-years of age are targeted to receive the vaccine.34 According to pharmaceutical industry-financial analysts interviewed by the news agency Reuters, Prevnar is expected to deliver sales of $300 to $500 million a year for its manufacturer Wyeth Lederle Vaccines.35 Figures like these are relatively typical. The following information comes from two annual reports:
We have attempted to obtain additional financial data on specific vaccines, but the manufacturers refuse to release this information to the public.
The evaluation of safety and efficacy and federal approval of Prevnar is laden with ethical questions. Many of the doctors directly involved in the testing and approval process appear to have significant conflicts of interest. The efficacy of the vaccine is questionable and safety testing has been terribly inadequate. There are no long-term studies (i.e. more than 5 years) of the chronic, debilitating and life threatening diseases that this vaccine may cause. The fact that the vaccine is bio-engineered by combining various types and portions of bacteria should require it to undergo considerable scrutiny. Assuming the vaccine has any efficacy at all, the need for universal vaccination needs to be reexamined in light of the small number of children who might be at risk from serious complications from pneumococcal disease.
All the safety and efficacy data related to Prevnar should be reevaluated by independent doctors and scientists who have no financial ties to the manufacturer. The need for universal vaccination with Prevnar should also be reevaluated by independent doctors and scientists who have no financial ties to the manufacturer.
An Important Final Note:
Nothing in this report should be construed as medical advice.
However, as a parent or guardian, you are entitled to make informed
decisions regarding what medical interventions (i.e. vaccines) are
administered to your child. There are a number of exemptions available
(i.e. religious, medical) if you decide not to vaccinate. For more
information about using an exemption or about Prevnar or other childhood
vaccination we encourage you to read, research and ask questions. For
example, read the manufacturer’s inserts for all vaccines before your child
is vaccinated. The inserts list adverse reactions, precautions and
warnings. All the inserts are printed in a book called Physician’s Desk
Reference that is available at most large bookstores. In addition, there
are a number of reputable organizations that can provide additional
information on childhood vaccination. These organizations include:
the National Vaccine Information Center (NVIC) http://www.909shot.com;
Informed Parents Home Page http://www.unc.edu/~aphillip/www/vaccine/informed.htm;
Vaccination Information & Awareness http://www.access1.net/via;
Australian Vaccination Network http://www.avn.org.au/;
P.A.V.E . http://www.vaccines.bizland.com/;
Eagle Foundation http://www.eaglefoundation.org; and many others.
For more information about the conflicts of interest responsible for determining what gets injected into your child see the August 21, 2000 Staff Report from the U.S. House of Representatives Committee on Government Reform entitled “Staff Report on Conflicts of Interest in Vaccine Policy Making” at http://www.house.gov/reform/.
(1) Policy Statement: Recommendations for the Prevention of Pneumococcal
Infections, Including the Use of Pneumococcal Conjugate Vaccine (Prevnar),
Pneumococcal Polysaccharide Vaccine, and Antibiotic Prophylaxis (RE9960);
American Academy of Pediatrics, Volume 106, Number 02, August 2000, pp.
362-366. (last visited on 9/14/2000) http://www.aap.org/policy/re9960.html
(2) See for example: Shinefield HR, Black S, Efficacy of pneumococcal conjugate vaccines in large scale field trials. Pediatr Infect Dis J 2000 Apr;19(4):394-7 Black S, Shinefield H, Fireman B, Lewis E, Ray P, Hansen JR, Elvin L, Ensor KM, Hackell J, Siber G, Malinoski F, Madore D, Chang I, Kohberger R, Watson W, Austrian R, Edwards K, Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Northern California Kaiser Permanente Vaccine Study Center Group. Pediatr Infect Dis J 2000 Mar;19(3):187-95
Lieu TA, Ray GT, Black SB, Butler JC, Klein JO, Breiman RF, Miller MA, Shinefield HR, Projected cost-effectiveness of pneumococcal conjugate vaccination of healthy infants and young children. JAMA 2000 Mar 15;283(11):1460-8
Shinefield HR, Black S, Ray P, Chang I, Lewis N, Fireman B, Hackell J, Paradiso PR, Siber G, Kohberger R, Madore DV, Malinowski FJ, Kimura A, Le C, Landaw I, Aguilar J, Hansen J, Safety and immunogenicity of heptavalent pneumococcal CRM197 conjugate vaccine in infants and toddlers. Pediatr Infect Dis J 1999 Sep;18(9):757-63
(3) Kaiser Permanente News Release: Investigational vaccine is first to show effectiveness against childhood ear infections; May 4, 1999 (last visited 5/20/2000)
(4) Associated Press: New vaccine reduces risk of severe pneumonia in children; October 1, 1999 (last visited 5/20/2000)
(5) American Home Products News & Announcements: American Home Products Corporation’s Pneumococcal Conjugate Vaccine for Children Receives Priority Review status from FDA, July 21, 1999, (last visited 9/14/2000)
(6) Harvard Medical School Office of Public Affairs News release, Researchers Find Use of Pneumococcal Conjugate Vaccine for Children Could Reduce Disease-Related Costs, March 14, 2000 (last visited 5/27/2000)
(7) Associated Press: New vaccine reduces risk of severe pneumonia in children; October 1, 1999 (last visited 5/20/2000)
(8) American Home Products: 1997 Annual Report (last visited 9/2/2000)
(9) (deleted from text)
(10) MedRegister.Com: Preventing Pediatric Diseases - A Continuing Medical Education Course (last visited on 5/26/2000)
(11) 9th International Congress on Infectious Diseases, April 10-13, 2000, Buenos Aires, Argentina (last visited on 5/26/2000)
(12) Pediatric Academic Societies & American Academy of Pediatrics Joint Meeting - Haynes Convention Ctr. May 16, 2000 (last visited on 5/27/2000l
(13) MedRegister.Com: Preventing Pediatric Diseases - A Continuing Medical Education Course (last visited on 5/26/2000)
(14) 9th International Congress on Infectious Diseases, April 10-13, 2000, Buenos Aires, Argentina (last visited on 5/26/2000)
(15) Pediatric Academic Societies & American Academy of Pediatrics Joint Meeting - Haynes Convention Ctr. May 16, 2000 (last visited 5/27/2000)
(16) MedRegister.Com: Preventing Pediatric Diseases - A Continuing Medical Education Course (last visited on 5/26/2000)
(17) Pneumo.com Online Forum (last visited 9/13/2000)
(18) Pneumo.com “Ask an Expert” (last visited on 9/14/2000)
(19) Pneumo.com Online Forum (last visited 9/13/2000)
http://pneumo.com/home.html (click on: “Online Forum for Physicians”)
(20) Pediatric Academic Societies & American Academy of Pediatrics Joint Meeting - Haynes Convention Ctr. May 16, 2000 (last visited 5/27/2000)
(21) Rennels MB, Edwards KM, Keyserling HL, Reisinger KS, Hogerman DA, Madore DV, Chang I, Paradiso PR, Malinoski FJ, Kimura A, Safety and immunogenicity of heptavalent pneumococcal vaccine conjugated to CRM197 in United States infants. Pediatrics 1998 Apr;101(4 Pt 1):604-11
(22) Univesrity of Maryland School of Medicine Faculty (last visited on 9/14/2000) http://medschool.umaryland.edu/CVD/FACULTY.HTM
(23) Rennels MB, Rotavirus vaccine comes of age, J Pediatr 1997 Oct;131(4):512-3
(24) Rennels MB, et al. Lack of an apparent association between intussusception and wild or vaccine rotavirus infection, Pediatr Infect Dis J 1998 Oct;17(10):924-5
(25) Markwick AJ, Rennels MB, Zito ET, Wade MS, Mack ME, Oral tetravalent rotavirus vaccine can be successfully coadministered with oral poliovirus vaccine and a combined diphtheria, tetanus, pertussis and Haemophilus influenzae type b vaccine. US Rhesus Rotavirus Vaccine Study Group. Pediatr Infect Dis J 1998 Oct;17(10):913-8
(26) American Home Products News & Announcements “Wyeth Lederle Vaccines Voluntarily Withdraws from the Market its Rotavirus Vaccine” (last visited on 6/17/2000) Rotashield”http://www.ahp.com/releases/ahp_101599.htm “
(27) See: University of Maryland School of Medicine Donors and Medical System Donors: (last visited 9/14/2000 - Under “Contributions” click on “Medical System” and “School of Medicine”)
Examples include: Warner-Lambert Company - 1,000,000-4,999,999; Parke-Davis - $500,000-$999,999; Hoffman LaRouche, Inc. - $250,000-$499,999; Merck & Company - $250,000-$499,999; Bristol-Myers Squibb - $250,000-$499,999; SmithKline-Beecham $100,00-$249,999; Abbott Laboratories - $10,000-$49,999; Pfizer Inc. - $10,000-$49,999; Wyeth-Ayerst Laboratories $10,000-$49,999 to Medical System and $10,000-$49,999 to Medical School; American Cyanamid - $1,000-$9,999, etc.
(28) Klein JO, The pneumococcal conjugate vaccine arrives: a big win for kids, Pediatr Infect Dis J, 2000 Mar, 19(3) 181-2
(29) Leary v. Secretary of the Department of Health and Human Services, 1994 WL 43395 (Fed.Cl.)
(30) Default Pneumo.com content frame http://pneumo.com/home.html (see top of page)
(31) Kaiser Permanente News Release: Investigational vaccine is first to show effectiveness against childhood ear infections; May 4, 1999 (last visited 5/20/2000)
(32) Pneumoccocal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Package Insert (last visited on 9/13/2000)
(33)See: Parotitis from Biavax: Rubella & Mumps (Merk) 51st Edition of Physicians Desk Reference, Medical Economics Company p.1653-1654, 1997; Tinnitus and earache from Engerix - B: Hep B (Smith Kline) 51st Edition of Physicians Desk Reference, Medical Economics Company p. 2656 - 2658, 1997; Parotitis and otitis media from MMR (Merck) 51st Edition of Physicians Desk Reference, Medical Economics Company p. 1730 -1732, 1997; otitis media from Tetramune (DTP and Hib) (Lederle) 51st Edition of Physicians Desk Reference, Medical Economics Company p. 1449 - 1452, 1997; otitis from Varivax (Merck) 51st Edition of Physicians Desk Reference, Medical Economics Company p. 1807 - 1810, 1997.
(34) Health News Daily, Volume 12, Issue 32, Friday February 18, 2000 (35) ABC News: Pneumococcus Vaccine Approved as reported in Reuters February 17, 2000
(36) Technical Report: Prevention of Pneumococcal Infections, Including the Use of Pneumococcal Conjugate and Polysaccharide Vaccines and Antibiotic Prophylaxis (RE9960)
American Academy of Pediatrics, Gary D. Overturf, MD, and the Committee on Infectious Diseases (last visited on 9/14/2000)
(37) See: Tetramune (DTP and Hib) (Lederle) 51st Edition of Physicians Desk Reference, Medical Economics Company p. 1449 - 1452.
(38) Buchwald D, et al. Influenza and pneumococcal vaccination among Native American elders in a primary care practice. Arch Intern Med 2000 May 22;160(10):1443-8.
(39) Pneumoccocal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Package Insert See: http://www.pneumo.com/vaccine/PI.html Note: The calculation presented results from dividing all invasive pneumococcal serotypes that the children were afflicted with in the “intent to treat” figures (children who received at least one dose of the vaccine) by the number of children and comparing the percentages for Prevnar and the control. This data is derived from the text and figures in Table 1 of the package insert. The studies conducted by Drs. Black and Shinefield claim an efficacy rate of over 90%. But this is computed using relative percentages, not absolute numbers. For example, in the article entitled Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in Children. Northern California Kaiser Permanent Vaccine Study Group (Pediatr Infect Dis J 2000 Mar;19(3); 187-95), Black, Shinefield et al claim an efficacy of Prevnar of over 97%. There were 40 cases of pneumococcal disease (39 in control group and 1 in Prevnar group). Therefore the control group accounted for 97.5% of the children with pneumococcal disease (39/40 = 97.5%). Compared to the control group, Prevnar was 97.5% effective. But these are relative percentages and present a confusing message regarding absolute efficacy and value of the vaccine. For example, imagine your child had a .0000000000000000001 chance of getting a disease (18 zeros). And the vaccine reduced this rate to .000000000000000000001 (20 zeros). Based on Black and Shinefield’s approach (relative percentage) this hypothetical vaccine is actually 99.9% effective. But, as a parent I would be most interested in the absolute value of the vaccine. “Tell me my child’s risk of getting the disease if I don’t vaccinate. Tell me my child’s risk of getting the disease if I do vaccinate.” According to Lederle’s data from the package insert, if you don’t vaccinate with Prevnar the risk is approximately 20 in 100,000 (0.020%) for all persons, and 150 in 100,000 (0.15%) for children under two. If you do vaccinate with Prevnar, the risk decreases to 3 out of 18,906 (.016). If you vaccinate with the control vaccine, the risk is 27 out of 18,910 (0.14%). By looking at this comparison, Prevnar provides an absolute value of 0.13% (0.15 - 0.016 = 0.13%) compared to no vaccination, and 0.12% ( 0.14 - 0.016 = 0.12) compared to the control. (In fact, the data may already be skewed in favor of Prevnar because the Prevnar and control figures were for various ages of children but the comparison without the vaccine is being made to infants. This inflates the comparative efficacy of Prevnar because infants have a higher rate of pneumococcal disease compared with older children.)
(40) Study number 118-12 - Percentage of Subjects Reporting Local Reactions Within 3 Days of Immunization in Infants and Children from 7 Months through 9 Years of Age, Cited in Prevnar’s insert
http://www.pneumo.com/vaccine/PI.html as “Data on File at Lederle Laboratories.”
(41) Aluminum Toxicity in Infants and Children (RE9607), Pediatrics Volume 97, Number 3 March, 1996, pp. 413-416. (last visited on 9/14/2000):
(42) USPHS. 1991. Vital Statistics of the United States, 1988, Volume II: Mortality. National Center for Health Statistics, U.S. Public Health Service, Washington, DC.
(44) Abramowicz, Mark. A pneumococcal conjugate vaccine for infants and children, Medical letter on Drugs & Therapeutics, May 20, 2000
(45) Doctor’s Guide to Medical & Other News, Experimental Vaccine Shows Promise Against Pneumococcal Disease in Kids, April 7, 1998 (last visited on 5/28/2000) http://www.plsgroup.com/dg/6B37A.htm
(46) 1994 red Book Report of the Committee on Infectious Diseases, 23rd Edition published by the American Academy of Pediatrics, 1994, p. 371.
(47) According to the manufacturer’s insert, there are an estimated 10 to 30 cases per 100,000 children less than or equal to two years old. Taking the mean of 20 cases per 100,000 = 1 case in 5,000. If your child is under two, the number is 140 to 160 cases per 100,000. The mean of 150 cases per 100,000 is equivalent to 7.5 cases in 5,000. The manufacturer states that “The annual incidence of pneumococcal meningitis in children between 1 to 23 months of age is approximately 7 cases per 100,000 persons” and that this disease “has been associated with 8% mortality.” Seven cases per 100,000 is equivalent to 70/1,000,000. 8% of 70 = 5.6. 5.6/1,000,000 = 178,571. Source of data: Pneumoccocal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Package Insert (last visited on 9/13/2000)
(48) Conflicts of Interest in Vaccine Policy Making, Majority Staff Report, Committee on Government reform, U.S. House of Representatives, August 21, 2000, p. 17.
(49) New `Tuskegee-Like Experiment' Planned with Pneumococcal Pneumonia Vaccine, Reported by Classen Immunotherapies (last visited on 9/18/2000) http://vaccines.net/pneumoco.htm
(50) SmithKline Beecham 1999 Annual Report, Principal Products p. 38.
(51) Merck 1999 Annual Report, Financial Section, p. 31
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