Citations:
(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) http://www.kaiserpermanente.org/newsroom/releases/vaccine1.html
(4) Associated Press: New vaccine reduces risk of severe pneumonia in children; October 1, 1999 (last visited 5/20/2000) http://www.idahonews.com/10011999/health_a/386.htm
(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) http://www.ahp.com/releases/wa_072199b.htm
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) http://www.hms.harvard.edu/news/releases/0300lieu.html
Associated Press: New vaccine reduces risk of severe pneumonia in children; October 1, 1999 (last visited 5/20/2000) http://www.idahonews.com/10011999/health_a/386.htm
American Home Products: 1997 Annual Report (last visited 9/2/2000) http://www.ahp.com/annrpt97/sreport3.htm
(deleted from text) http://www.mailbase.ac.uk/lists-p-t/public-health/1999-09/0003.html
MedRegister.Com: Preventing Pediatric Diseases - A Continuing Medical Education Course (last visited on 5/26/2000) http://www.mededregister.com/vaccine.html
9th International Congress on Infectious Diseases, April 10-13, 2000, Buenos Aires, Argentina (last visited on 5/26/2000)
http://isid.organize-it.com/9th_congress/sat_symposia.html
Pediatric Academic Societies & American Academy of Pediatrics Joint Meeting - Haynes Convention Ctr. May 16, 2000 (last visited on 5/27/2000) http://www.aps-spr.org/Meetings/2000/Monday.htm
MedRegister.Com: Preventing Pediatric Diseases - A Continuing Medical Education Course (last visited on 5/26/2000) http://www.mededregister.com/vaccine.html
9th International Congress on Infectious Diseases, April 10-13, 2000, Buenos Aires, Argentina (last visited on 5/26/2000) http://isid.organize-it.com/9th_congress/sat_symposia.html
Pediatric Academic Societies & American Academy of Pediatrics Joint Meeting - Haynes Convention Ctr. May 16, 2000 (last visited 5/27/2000) http://www.aps-spr.org/Meetings/2000/Monday.htm
(16) MedRegister.Com: Preventing Pediatric Diseases - A Continuing Medical Education Course (last visited on 5/26/2000) http://www.mededregister.com/vaccine.html
(17) Pneumo.com Online Forum (last visited 9/13/2000) http://www.pneumo.com/msgboard/messages/parent-messages.html
(18) Pneumo.com "Ask an Expert" (last visited on 9/14/2000) http://pneumo.com/contact/contact2.html
(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) http://www.aps-spr.org/Meetings/2000/Monday.htm
(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")
http://www.umm.edu/annualreport/9798ar/site/main.htm
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) http://www.kaiserpermanente.org/newsroom/releases/vaccine1.html
(32) Pneumoccocal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Package Insert (last visited on 9/13/2000) http://www.pneumo.com/vaccine/PI.html
(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) http://www.aap.org/policy/re9960t.html
(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): http://www.aap.org/policy/01263.html
(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.
(43) http://ouralexander.org/BurtonDan2velec.doc
(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) http://www.pneumo.com/vaccine/PI.html
(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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