On February 17, 2000, the FDA approved a new childhood vaccine called Prevnar. Prevnar is manufactured by Wyeth Lederle Vaccines. Wyeth Lederleis a business unit of Wyeth-Ayerst Laboratories, which is a division ofAmerican Home Products the same company that manufactured RotaShield, thevaccine that was recalled after it caused injury and death to somechildren. Prevnar is marketed to prevent pneumococcal infections that cancause earaches, meningitis, blood poisoning and pneumonia. The AmericanAcademy of Pediatrics Committee on Infectious Diseases has recommendeduniversal vaccination. All children should now receive four doses at 2, 4,6, and 12-15 months of age.1 For an 18-month old child, this brings thetotal number of vaccinations he or she receives to twenty.
PREVNAR A Critical Review of a New Childhood Vaccine
© Michael Horwin, MAmhbiomed@aol.com
September 19, 2000
Summary:
Part I:Potential Conflicts of Interest in Testing, Promotion & Approval
Drs. Black & Shinefield: Wyeth Lederle Paid for Prevnar StudiesDrs. Black and Shinefield of Kaiser Permanente undertook the primarystudies cited regarding Prevnar. Wyeth Lederle, the vaccine'smanufacturer, paid for these studies.
Drs. Black & Shinefield: Wyeth Lederle Paid for ConferencesThese doctors have also presented Prevnar at various conferences throughoutthe world. Wyeth Lederle subsidized these conferences.
Drs. Stephen I. Pelton & Kathryn Edwards: Wyeth Lederle Pays to ReassureParentsWyeth Lederle also pays for an Internet forum (pneumo.com) where thesedoctors answer Prevnar-related questions from concerned parents. Severalof their answers are inconsistent with relevant information reported fromother medical sources.
Dr. Kathyrn Edwards: Wyeth Lederle Pays to Reassure Doctors about PrevnarThe Internet forum subsidized by Wyeth Lederle (pneumo.com) also addressesPrevnar related questions presented by pediatricians and other clinicians.Several of the answers by Dr. Edwards demonstrate inconsistent information.Wyeth Lederle had paid Dr. Edwards $255,023 per year from 1996 to 1998 forthe study of pneumococcal vaccines (i.e. Prevnar). Edwards is also one offifteen full-time members of FDA's Vaccines and Related Biological ProductsAdvisory Committee, the committee that advises the FDA on the licensing ofnew vaccines.
Dr. Margaret B. Rennels: The Wyeth Lederle-Prevnar-RotaShield ConnectionRennels was instrumental in getting RotaShield to market and is nowinvolved in Prevnar. Her university receives a total of over $2.5 millionfrom various drug and vaccine companies including Wyeth Lederle, Prevnar'smanufacturer. She is also one of the twelve members of the Committee onInfectious Diseases, the committee that makes vaccine recommendations aspart of the American Academy of Pediatrics.36
Dr. Jerome Klein: Wyeth Lederle and the National Vaccine Advisory CommitteeThis doctor has been employed by the major vaccine manufacturers to testifyagainst vaccine injured children. He is also chief editor of pneumo.comthe website paid for by Wyeth Lederle to sponsor Prevnar. Furthermore,Klein holds a position on the National Vaccine Advisory Committee, thecommittee that recommends products for universal vaccination.
Part II:Efficacy of Prevnar and other Vaccines Combined with Prevnar
The Efficacy of PrevnarThe efficacy of Prevnar appears to be very limited - 7% fewer new earaches,and 0.1% fewer instances of invasive pneumococcal disease (compared to anexperimental vaccine used as a control).
Prevnar Interferes With Other Childhood VaccinesThe studies done on Prevnar suggest that it may interfere with the efficacyof two other vaccines (pertussis and IPV) and could interfere with two morevaccines (MMR and Varicella).
Statistically Unconvincing StudiesThe studies of efficacy of other vaccines in combination with Prevnar usednumbers of children (n = 214, 47, 156, 0) that are statisticallyquestionable in respect to the seven million children targeted to receivePrevnar.
Part III:Safety of Prevnar
The Safety of PrevnarAccording to the American Academy of Pediatrics, Prevnar may prove to beamong the most reactogenic of vaccines.
Danger of Inappropriate Injection The vaccine insert repeatedly warns the clinician to keep the injectionaway from a child's blood vessels. Doctors and nurses are attentive tothis, but parents should be aware that there is always a danger if thevaccine is wrongly administered.
The Six-Week Threshold is a Very Fine LineThe manufacturer states that injecting a child with Prevnar who is undersix weeks may not be safe, but that it is warranted to inject a six-weekold. This does not provide the practitioner with a reasonable cushion.
ER Visits, Seizures and SIDS Associated with PrevnarReviews the emergency room visits, seizures and SIDS associated withadministration of Prevnar as discussed in the package insert.
Possible Allergic ReactionsPediatricians are warned to be ready for possible allergic or anaphylacticreactions from administration of the vaccine.
Unknown Toxicity and CarcinogenicityPrevnar contains aluminum and according to the manufacturer there have beenno carcinogenic, mutagenic or fertility studies done on the vaccine.
Relationship with Chronic DiseasesNo long-term studies have been completed. One researcher sees a causallink to diabetes.
Prevnar is Administered to Immune-Suppressed ChildrenPrevnar is directed for administration to immune-suppressed children, apractice that apparently has not been studied for either safety or efficacy,
Part IV:The Bottom Line $
The Bottom Line Why Prevnar Will be Injected Into Your Healthy ChildAt $242 per child, Prevnar is expected to deliver sales of between$300-$500 million per year for its manufacturer.
Conclusion
The safety and efficacy evaluations, and federal approval of Prevnar isladen with ethical questions. Many of the doctors directly involved in thetesting and approval process appear to have significant conflicts ofinterest. The efficacy of the vaccine is questionable and safety testinghas been terribly inadequate. There are no long-term studies (i.e. morethan 5 years) of the chronic, debilitating and life threatening diseasesthat this vaccine may cause. The fact that the vaccine is bio-engineeredby combining various types and portions of bacteria should require it toundergo considerable scrutiny. Assuming the vaccine has any efficacy atall, the need for universal vaccination needs to be reexamined in light ofthe small number of children who might be at risk from seriouscomplications from pneumococcal disease.
Introduction
On February 17, 2000, the FDA approved a new childhood vaccine calledPrevnar. Prevnar is manufactured by Wyeth Lederle Vaccines. Wyeth Lederleis a business unit of Wyeth-Ayerst Laboratories, which is a division ofAmerican Home Products the same company that manufactured RotaShield, thevaccine that was recalled after it caused injury and death to somechildren. Prevnar is marketed to prevent pneumococcal infections that cancause earaches, meningitis, blood poisoning and pneumonia. The AmericanAcademy of Pediatrics Committee on Infectious Diseases has recommendeduniversal vaccination. All children should now receive four doses at 2, 4,6, and 12-15 months of age.1 For an 18-month old child, this brings thetotal number of vaccinations he or she receives to twenty.
Does Your Child Need Prevnar?
According to studies quoted by Prevnar's manufacturer if your child is overtwo years old, he or she has about a 1 in 5,000 chance of being diagnosedwith a pneumococcal disease. 47 If your child is under two, the number isreported to increase to 7.5 in 5,000.47 How dangerous is this disease?Apparently it can be life threatening in a very small number of children.For example, according to the manufacturer, Pneumococcal meningitis inchildhood has been "associated with" a mortality rate of approximately 1 in178,571 children.47 Is it reasonable to expect that your child could beone of these victims?
According to the 1994 Red Book Report of the Committee on InfectiousDiseases published by the American Academy of Pediatrics, children who areat risk of pneumococcal infections are those with specific predisposingfactors. The Redbook states:
"(Pneumococcal Infections) are more likely to occur when predisposingconditions exist, including immunoglobulin deficiency, Hodgkin's disease,congenital or acquired immunodeficiency (including HIV), nephroticsyndrome, some viral upper respiratory tract infections, splenicdysfunction, splenectomy and organ transplantation."46
Most healthy children do not have these risk factors.
Part I:Potential Conflicts of Interest in Testing, Promotion & Approval
Six Key Supporters of Prevnar
Six of the most outspoken supporters of the use of Prevnar for universalvaccination are:
1. Dr. Steven Black of Kaiser Permanente2. Dr. Henry Shinefield also of Kaiser Permanente3. Dr. Stephen I. Pelton of Boston Medical Center4. Dr. Jerome Klein also of Boston Medical Center5. Dr. Margaret B. Rennels of the University of Maryland Medical Center6. Dr. Kathryn M. Edwards of Vanderbilt University School of Medicine.
What inspires these doctors to do studies on Prevnar or to get on anairplane and travel thousands of miles to present Prevnar to otherphysicians? What motivates them to spend hours addressing the concerns offearful parents and cautious pediatricians?
Drs. Black & Shinefield: Wyeth-Lederle Paid for Prevnar Studies
Drs. Shinefield and Black of Kaiser Permanente undertook most of thestudies on Prevnar which proved its efficacy and safety.2 According to Dr.Black, "This vaccine is urgently needed...It is great news for parents andphysicians."3 Dr. Shinefield is equally enthusiastic. He states, "It's aremarkable vaccine that will have a dramatic effect."4
How do we know the vaccine is safe and effective? The manufacturer, WyethLederle Vaccines points to the studies of Drs. Black and Shinefield tovouch for the vaccine's safety and efficacy. A Wyeth press release states:
"Results and data released last September and updated this May from a majorclinical trial conducted by Kaiser Permanente.suggested that the vaccine iseffective against invasive pneumococcal disease caused by seven serotypes(strains) of the bacteria most prevalent among children in the U.S."5
Who paid for these studies? According to the Harvard Medical School Officeof Public Affairs, the "study was supported by a grant from Wyeth LederleVaccines & Pediatrics."6 This was confirmed by the Associated Press, whichreported that Wyeth-Lederle Laboratories "paid for the testing."4
In fact, the financial ties between Wyeth Lederle Vaccines and Drs. Blackand Shinefield are so close that the two doctors appeared in a glossy photoin the 1997 Annual Report of American Home Products (Wyeth's parentcompany).8 In the photo you see the two grinning physicians dressed inwhite lab coats while a group of children play in the background.(See http://www.ahp.com/annrpt97/sreport3.htm ).
Drs. Black & Shinefield: Wyeth Lederle Paid for Conferences
Drs. Black and Shinefield also have gone globe trotting to present thewonders of Prevnar to other doctors throughout the world. This list ofconferences where they presented information about Prevnar includes:
Washington DC (Friday October 8, 1999)10Buenos Aires (April 10-13, 2000)11Boston (May 15, 2000)12
The one in Washington DC seemed particularly entertaining because it washeld at the Smithsonian. According to the event's brochure:
"The entire first floor of the Smithsonian National Museum of AmericanHistory will be open to symposium attendees and their guests during theevening. Visitors of all ages can experience the thrill of DNAfingerprinting or measuring the radioactivity of common objects in thehands-on science center." 10
And who paid for the cost of all these conferences so that the doctors inattendance could learn about Prevnar, and their families could measure theradioactivity of common objects?
The conference at the Smithsonian in Washington DC was "supported by anunrestricted educational grant from Wyeth Lederle vaccines."13The one in Buenos Aires was "sponsored by Wyeth Lederle vaccines."14The one in Boston was "supported in part by an educational grant fromWyeth-Lederle Vaccine and Merck Vaccine Division."15
Would Drs. Black & Shinefield be influenced because their studies andefforts were paid for by Wyeth-Lederle? Would their professional judgementbe swayed because the vaccine's manufacturer paid for the conventions theyattended? Do you want the efficacy and safety of products that will beinjected into your children determined by people who are receiving moneyfrom the corporation manufacturing that product?
Drs. Stephen I. Pelton & Kathyrn Edwards:Wyeth Lederle Pays to Reassure Parents
Two other supporters of Prevnar are Dr. Stephen I. Pelton and Dr. KathyrnEdwards. Both spend time answering questions about Prevnar from concernedparents and pediatricians. Below are a few examples:
In this instance, Dr. Pelton assures the concerned mother of a 6-month oldwho experienced adverse reactions to Prevnar. On May 4, 2000 she wrote:
"My 6 month old received the Prevnar vaccine two days ago. Her temperaturewent to 102.6 and she vomited that evening. The fever dropped to 100yesterday. The injection site is very inflammed - it looks like a burnalmost. It has a large knot under it that is not only just beneath theinjection site, but it extends from the site like a finger. Is thisreaction normal?"17
On May 24, 2000, Pelton replied:
"The most common side effect is local reactions. The one that you aredescribing sounds somewhat greater than average but is within the spectrumof what we see."17
On May 7, 2000, another mother advised Dr. Pelton of the unfortunateexperience of her young son after getting Prevnar. She wrote:
My 10-month old son received prevnar four days ago. Since then he has beenvomiting and developed a rash on his body. I will not let him receive thevaccine again."17
This time, it only took three days for Dr. Pelton to write back. On May10, 2000 he replied:
".Rash occurs in about 1% of recipients, vomiting in almost 10% howeverthis was seen to be equal in children who received other vaccines withoutPrevnar."17
On May 15, 2000, another mom wrote about what happened to her 12-month olddaughter after receiving Prevnar and other vaccines in combination. Shewrote:
"My 12-month-old daughter just received HiB, DTP, Chickenpox and Prevnarvaccines on 5/1/00. The morning of 5/13, she vomited for 3 hours and haddiarrhea. After a visit to the Dr., he had her admitted to thehospital.After a chest x-ray, they were able to see that it was pneumoniain her lower right lobe of her lung.I feel 99.9% confident that this wascaused by the combination of vaccines that she received."17
On May 22, 2000, Dr. Pelton responded:
".Most febrile reactions to vaccine occur within 48 hours ofadministration. An event 2 weeks later is unlikely to be due to thevaccine itself."17
But his response fails to mention the admission by vaccine manufacturersthat pneumonia can be a side effect of getting the Hib and DTP vaccinestogether.37
On July 24, 2000, Tmjh wrote:
"I'm concerned about data linking prevnar to the onset of juvenilediabetes. Could you comment?"17
On July 25, 2000 Dr. Pelton responded:
"The best reference that I am aware of denies any linkage between the two."17
This response appears to ignore at least one study completed at theUniversity of Washington which stated, "Aged 65 years or older and havingcardiovascular disease or diabetes mellitus were specific indicationssignificantly correlated with receipt of influenza and pneumococcalvaccine." 38 Prevnar is a pneumococcal vaccine and this study thereforesuggests that late onset of diabetes may possibly be associated with thevaccine. In addition, Dr. J. Bart Classen told the FDA that Prevnar "maybe seven times as toxic as the hemophilus vaccine, possibly causing anestimated 400 to 700 children to develop insulin dependent diabetes per100,000 children immunized. These cases of diabetes may not occur until3.5 to 10 years following immunization."49
A mother named Anne wrote on August 23, 2000:"Parents magazine had a Prevnar ad, which stated 'Prevnar has not beenevaluated for any carcinogenic or mutagenic potential, or impairment offertility.' Can you give me a layman's explanation.should I beworried...?" 17
Dr. Kathyrn Edwards responded on September 5, 2000:
"The vaccine has been studied in animals and found not to be associatedwith cancer or infertility." 17
This is an interesting response because we have been unable to find asingle published report that relates to any carcinogenic or mutagenicstudies on Prevnar. In fact, the manufacturer's insert also fails to citesuch a document. We challenge Dr. Edwards to produce such a peer-reviewedstudy.
A mom named Susan wrote on September 6, 2000:
"(I read) some disturbing comments from parents whose children have alreadyreceived the vaccine. They said it has terrible side effects, such as poorappetite, difficulty breathing, sleeping problems, and can cause juvenilediabetes.of course this has me worried." 17
Dr. Kathryn Edwards responded on September 12, 2000:
"The vaccine was administered to nearly 20,000 children prior to licensureand the side effects seen in these children were carefully evaluated andnot shown to increase the rate of diabetes, respiratory problems, or weightloss." 17
As we have already seen the diabetes question is not resolved. Inaddition, as far as respiratory problems are concerned, it appears thatPrevnar can cause or contribute to such a diagnosis. According to themanufacturer's insert: croup, pneumonia, asthma, bronchiolitis, andwheezing were associated with the administration of Prevnar.32
The forum where all of these questions are asked and answered is titled"Pneumo.com." The entire venue is paid for by Wyeth-Lederle Vaccines, themanufacturer of Prevnar. (The site is "supported by an unrestrictededucational grant from Wyeth-Lederle Vaccines.") In fact, both Edwards andPelton are listed as "National Editors" on the site.18 Could Wyeth'ssponsorship of this forum have anything to do with these doctors' answers?
Dr. Kathyrn Edwards:Wyeth Lederle Pays to Reassure Doctors about Prevnar
Dr. Edwards is not only busy assuring worrisome parents about Prevnar, butfinds the time to reassure concerned pediatricians too. Here are someexamples:
On April 1, 2000, Dr. Hemendra Parikh asked Dr. Edwards about the safety ofinjecting Prevnar and Comvax simultaneously (Comvax = haemophilusinfluenzae type b and hepatitis B together). He wrote:
"Has there been any study to show the impact of the simultaneousvaccination with the pneumococcal vaccine and other recommended childhoodvaccines? Especially the simultaneous vaccination with prevnar andcomvax?"19
On April 5, 2000 Edwards responded that while there are no studies on thisquestion, it should be ok anyway:
".To my knowledge, no studies of the pneumococcal conjugates administeredwith Comvax are ongoing but there is not current information to suggestthat it would be a problem."19
On April 6, 2000, Dr. Mark McGwire asked:
"Any interactions between anabolic steroids, nutritional supplements andprevnar?"19
Edwards considered this to be a funny question. She thought that it wasrather impossible that a parent could give a child a vitamin supplement.On April 10, 2000, she replied:
"I'm glad you have a sense of humor. Fortunately infants and youngchildren receiving the pneumococcal conjugate do not use these supplementsand steroids."19
Is it ethical that this forum is also paid for by Wyeth Lederle, Prevnar'smanufacturer? (The site is "Supported by an unrestricted educational grantfrom Wyeth-Lederle Vaccines.") Was there a conflict of interest whenEdwards accompanied Drs. Black and Shinefield to Boston on May 12-16, 2000,to speak about "the development and performance of conjugate pneumoccocalvaccines (i.e. Prevnar),"20 even though the conference was "supported inpart by an educational grant from Wyeth-Lederle Vaccine and Merck VaccineDivision?"20 Is it ethical that Wyeth Lederle paid Dr. Edwards $255,023per year from 1996 to 1998 for the study of pneumococcal vaccines48 (i.e.Prevnar) and now Edwards is addressing questions from pediatricians andparents about the product? Is it a conflict of interest that Edwards isone of fifteen full-time members of FDA's Vaccines and Related BiologicalProducts Advisory Committee, the committee that advises the FDA on thelicensing of new vaccines?
Dr. Margaret B. Rennels:The Wyeth Lederle-Prevnar-RotaShield Connection
Dr. Margaret B. Rennels has also done a study that proved the safety andefficacy of Prevnar.21 Speaking about the importance of her findings shesaid that there is "an urgent need for pneumococcal vaccines that areeffective in infants."45 Dr. Rennels should know because she has a lot ofexperience with vaccines especially the rotavirus vaccine. According toher bio (which has a nice picture of her - see:http://medschool.umaryland.edu/CVD/FACULTY.HTM):
"Dr. Rennels has been involved in Phase 1 through 4 evaluations of new andimproved vaccines for children over the last 15 years. She participated invirtually all phases of the testing of the recently licensed rotavirusvaccine and was the lead author on the report of the pivotal U.S. efficacystudy. More recently, she has led the U.S. safety and immunogenicity studyof the heptavalent conjugate pneumococcal vaccine (i.e. Prevnar).Currently,she is the principle investigator of a large study of the safety ofrotavirus vaccine in premature infants." 22
She certainly is the rotavirus expert. Her journal letters and articleshave titles like "Rotavirus vaccine comes of age."23 And when there wasthe possibility that RotaShield (the brand name for the rotavirus vaccine)could cause intussusception (collapsing of the intestines that can lead todeath) she wrote an article entitled "Lack of an apparent associationbetween intussusception and wild or vaccine rotavirus infection."24Although Dr. Rennels was part of the US Rhesus Rotavirus Vaccine StudyGroup subsidized by Wyeth-Ayerst research (the manufacturer ofRotaShield)25 her financial ties with the manufacturer would neverinterfere with her judgement. Nor would it interfere with her work as oneof the twelve members of the Committee on Infectious Diseases, thecommittee that makes vaccine recommendations as part of the AmericanAcademy of Pediatrics.36
Because of the increasing numbers of intussusception injuries related withthe vaccine, Wyeth Lederle Vaccines suspended further distribution andadministration of RotaShield on July 16, 1999 and withdrew it from themarket on October 15, 1999.26 This was very remarkable because Rennelshad found a "lack of an apparent association" only one year before.24
Now, Dr. Rennels is busy demonstrating the "safety" of Prevnar. The majorvaccine and drug manufacturers (including Wyeth) have donated a total ofover $2.5 million to the University of Maryland School of Medicine whereDr. Rennels works.27 Is this ethical?
Dr. Jerome Klein:Wyeth Lederle and the National Vaccine Advisory Committee
Our last doctor is named Jerome Klein. He has enthusiastically calledPrevnar "a big win for kids."28 Dr. Klein has done his best to protect thefinancial sanctity of vaccine manufacturers from parents whose childrenhave been injured or killed by a vaccine. He has been hired by the majordrug companies to testify in legal cases on behalf of vaccine manufacturersand against vaccine-injured children. Here's one example as summarizedfrom the legal literature:
On August 22, 1984 a healthy nine-month old baby named Sean Leary wasadministered his third DTP vaccine. Sean immediately began vomiting. Thenext day, he stopped eating. He stayed alert but was no longer active.That night he cried out every 15 to 30 minutes. The pediatricianimmediately noted the "obvious circulation collapse." There at thepediatrician's office, "Sean's eyes rolled back in his head and he stoppedbreathing." He was rushed to an emergency room. Resuscitative effortsfailed and Sean was pronounced dead at 1:44 p.m. Dr. Jerome Kleintestified that the relationship between vaccination and Sean's death was"merely coincidental."29
Dr. Klein is also a member of the National Vaccine Advisory Committee.This committee makes recommendations to the assistant Secretary of Healthconcerning vaccine safety and efficacy. He is also the chief editor of"Pneumo.com" the pro-Prevnar website that is "Supported by an unrestrictededucational grant from Wyeth-Lederle Vaccines."30
Would Dr. Klein's financial ties to Wyeth-Lederle vaccines and other drugcompanies influence his pro-Prevnar stance or his actions as a member ofNational Vaccine Advisory Committee, the committee that recommends vaccinesto our nation's government? Are you comfortable trusting your child'shealth to individuals like Klein who have long-standing relationships withthe multi-national corporations that manufacture the vaccines?
Part II: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 andgenerated by Drs. Black and Shinefield:
"The study showed that children in the vaccine group fared better thanthose in the comparison group in other ways. In the primary analysis ofall acute otitis media episodes (i.e. earaches), children receiving theinvestigational 7-valent pnemococcal vaccine (i.e. Prevnar) had 7 percentfewer new episodes."31
Seven percent few episodes of earaches! Do you find that impressive? Keepin mind that there are at least five other pediatric vaccines that cancause earaches, ear infections or ear-related injury. It appears that wenow have Prevnar, a vaccine designed to prevent adverse effects that can becaused by other vaccines.33
What about preventing invasive pneumococcal disease? According to datafrom the manufacturer's insert, after one dose of the vaccine .016% of therecipients (3 out of 18,906) were diagnosed with invasive pneumococcaldisease.39 But, .14% of controls (27 out of 18,910 children who wereadministered a different experimental vaccine) got invasive pneumococcaldisease. 39 This means that based on this data (relative to the control),Prevnar decreases a child's chance of getting invasive pneumococcal diseaseby about 0.1%!
Prevnar Interferes with Other Childhood Vaccines
When Prevnar is injected along with the other childhood vaccines, does itinterfere with the promised efficacy of the other vaccines? Incredibly,the manufacturer states that in some cases it does and in other cases theyjust do not know. Under "Simultaneous Administration with Other Vaccines,"the package insert states:
"Although some inconsistent differences in response to pertussis antigenswere observed, the clinical relevance is unknown." 32
In other words, Prevnar can interfere with the "effectiveness" of thepertussis vaccines but they really don't know a great deal about theimplications of this. The manufacturer's insert also states:
"MMR and Varicella immunogenicity data from controlled clinical trials withconcurrent administration of Prevnar are not available." 32
This admission is astounding. The manufacturer is stating that they do notknow 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 poliovaccine.
Apparently, Prevnar interferes with at least two other vaccines (Pertussisand IPV) and may interfere with two more (MMR and Varicella). Thisinformation also appears to be contrary to what some parents are being toldregarding how Prevnar acts in combination with other vaccines.
On April 26, 2000, a nurse revealed her concerns about the safety ofPrevnar. 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 beenreleased and advised. I'm not sure the medication is safe.my child is 9weeks old, how safe and effective will this drug be to a newborn, who isborn healthy? Were there any serious side effects? Is it safe toadminister with his routine vaccines? I'm not comfortable with theadministration of 4 vaccines at once."19
Dr. Edwards reassured the nurse that comparable antibody responses aregenerated. A statement that is inconsistent with admissions from themanufacture. On May 1, 2000 she wrote back:
".It is safe to administer with other vaccines.The administration of fourvaccines at once has been shown to generate comparable antibodyresponses."19
Statistically Valid Studies?
How thorough were the studies? According to the Wyeth-Lederle, for thestudy concerning DPT and Hib efficacy with Prevnar, the number of infantsreviewed (who were given Prevnar) was a total of 214. 32 For toddlers thetotal number was 47 children.32 For reviewing the efficacy of Hep B withPrevnar the number of infants studied (who were given Prevnar) was 156. 32For toddlers the total number was zero. 32
Over seven million infants and toddlers are scheduled to receive thisvaccine. The numbers of children tested (214, 47, 156, and 0) do notappear to be statistically valid in comparison to the seven million.Therefore, it is possible that no one really knows what Prevnar will orwon't do in combination with the other childhood vaccines.
Is this Rational?
The vaccine establishment is militant; requiring that every child inAmerica receive every vaccine they decide is necessary. With Prevnar wenow have a vaccine that admittedly interferes with the efficacy of othervaccines. Yet, Prevnar was still approved for universal vaccination. Howis 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.
Part III:Safety of Prevnar
The Safety of Prevnar
Prevnar is a bio-engineered product. It is created by combining theprotein-polysaccharides from seven strains of dangerous Streptococcuspneumoniae bacteria with diphtheria toxin (Corynebacterium diphtheriae)grown in casamino acids and yeast extract and purified with ammoniumsulfate.32 Such a creation has never before existed on this earth and thehuman race has never before in its entire history been exposed to such aproduct.
According to the American Academy of Pediatrics:
"Available data suggest that PCV7 (i.e. Prevnar) may prove to be among themost reactogenic (e.g., local reactions and incidence of fever) vaccine ofthose currently used, including the DTaP and Haemophilus conjugatevaccines."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 (rednessof 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 anaphylacticreaction if a vaccine is accidentally injected directly into a child'sbloodstream. Prevnar appears to be no exception. Under "Precautions," thepackage insert states:
"Prevnar SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED INTRAVENOUSLY. Thesafety 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 bloodvessel or nerve." 32
And again under "Dosage and Administration" the warning is stated a thirdtime:
"For intramuscular injection only. Do not inject intravenously.Afterinsertion of the needle.wait to see if any blood appears in the syringe.Ifblood appears, withdraw the needle and prepare for a new injection atanother site." 32
Most clinicians are very careful and very competent in avoiding thisdanger. But how reasonable is to expect that a pediatrician can alwaysavoid injecting the product "near a blood vessel" when an infant's ortoddler's blood vessels can be very small and the child may be squirmingand 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 deemedmedically irresponsible. For example, according to the insert, "The safetyand effectiveness of Prevnar in children below the age of 6 weeks have notbeen 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 thatone second before a child is 6 weeks old the vaccine is unsafe but onesecond later everything changes and now it is safe. There appears to be noresponsible 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.therewere 162 visits to the emergency room within 3 days of a dose."32Obviously some of these visits have nothing to do with the vaccine (i.e.ingrown toenail) but others may be associated (i.e. pneumonia). Inaddition, "seizures were reported in 8 Prevnar recipients" within threedays of vaccination.32 Furthermore, the insert tells us that, "Twelvedeaths (5 SIDS and 7 with clear alternative cause) occurred among subjectsreceiving 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 andcontrol) received some form of experimental vaccine. Therefore, all weknow is that 33 children are dead and at least 13 died of SIDS. How dothese numbers compare to unvaccinated children? Has there ever been astudy to determine this? What about visits to the ER or seizures after 3days, such as on day 4 or 5 or 6 or 7, etc.? It appears that no study wascompleted.
Possible Allergic Reactions
The insert warns doctors that they should have epinephrine (i.e.adrenaline) "ready and (available)" in case the child has an allergicreaction after vaccination with Prevnar. 32
Unknown Toxicity and Carcinogenicity
Each .5 ml dose of the vaccine includes .125 mg of aluminum.32 Aluminumis considered neurotoxic to humans. Ironically, the American Academy ofPediatrics admits that:
"Aluminum is now being implicated as interfering with a variety of cellularand metabolic processes in the nervous system and in other tissues."41
In addition, as we have already discussed, the manufacturer has admittedthat:
"Prevnar has not been evaluated for any carcinogenic or mutagenicpotential, or impairment of fertility."32
Our children are the guinea pigs and we will see what happens in a fewyears. In fact, cancer is now the leading cause of death by disease forchildren under fifteen years old42 and there is a growing information tosuggest potential vaccine-cancer links with other vaccines alreadyadministered to children.43
Relationship with Chronic Diseases
What do we know about Prevnar's role in causing debilitating andlife-threatening chronic diseases? Not very much. There have been nolong-term studies done (i.e. more than five years). In addition, it isunclear whether the manufacturer has even looked at Prevnar's relationshipwith the growing list of autoimmune diseases diagnosed in children.
Can Prevnar cause diabetes? As discussed above, at least one researcherbelieves it can.49 Will it cause other diseases? Unfortunately theanswer will probably come from the 7 million children targeted to receivethe 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, whichvaccine do you use.?19
Dr. Pelton responded on July 26, 2000,
"The current concept for patients like this is to give the prevnarvaccine."19
Dr. L Eger wrote on August 18, 2000:
"There is a general recommendation to vaccinate immunocompromised childrenwith Prevnar." 19
Dr. Kathryn Edwards responded on August 23, 2000:
"Since the vaccines do not contain live bacterial components they pose nothreat to the patient." 19
Apart from the fact that an immune-suppressed child may not be able toelicit an appropriate immune response to the vaccine, the more importantquestion is - how safe is this practice? The answer appears to be thatnobody knows because according to the manufacturer's insert there have beenno appropriate studies regarding the administration of Prevnar toimmune-suppressed children. Once again, our children are the guinea pigs.
Part IV: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 monthsold) costs $232.44 In this country alone, approximately seven millionchildren under two-years of age are targeted to receive the vaccine.34According to pharmaceutical industry-financial analysts interviewed by thenews agency Reuters, Prevnar is expected to deliver sales of $300 to $500million a year for its manufacturer Wyeth Lederle Vaccines.35 Figureslike these are relatively typical. The following information comes fromtwo annual reports:
We have attempted to obtain additional financial data on specific vaccines,but the manufacturers refuse to release this information to the public.
Conclusion
The evaluation of safety and efficacy and federal approval of Prevnar isladen with ethical questions. Many of the doctors directly involved in thetesting and approval process appear to have significant conflicts ofinterest. The efficacy of the vaccine is questionable and safety testinghas been terribly inadequate. There are no long-term studies (i.e. morethan 5 years) of the chronic, debilitating and life threatening diseasesthat this vaccine may cause. The fact that the vaccine is bio-engineeredby combining various types and portions of bacteria should require it toundergo considerable scrutiny. Assuming the vaccine has any efficacy atall, the need for universal vaccination needs to be reexamined in light ofthe small number of children who might be at risk from seriouscomplications from pneumococcal disease.
Recommendations:All the safety and efficacy data related to Prevnar should be reevaluatedby independent doctors and scientists who have no financial ties to themanufacturer.The need for universal vaccination with Prevnar should also be reevaluatedby independent doctors and scientists who have no financial ties to themanufacturer.
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 informeddecisions regarding what medical interventions (i.e. vaccines) areadministered to your child. There are a number of exemptions available(i.e. religious, medical) if you decide not to vaccinate. For moreinformation about using an exemption or about Prevnar or other childhoodvaccination we encourage you to read, research and ask questions. Forexample, read the manufacturer's inserts for all vaccines before your childis vaccinated. The inserts list adverse reactions, precautions andwarnings. All the inserts are printed in a book called Physician's DeskReference that is available at most large bookstores. In addition, thereare a number of reputable organizations that can provide additionalinformation on childhood vaccination. These organizations include:
the National Vaccine Information Center (NVIC) http://www.909shot.com;
InformedParents Home Page http://www.unc.edu/~aphillip/www/vaccine/informed.htm;
Vaccination Information & Awareness http://www.access1.net/via;
PROVE http://vaccineinfo.net/
Australian Vaccination Network http://www.avn.org.au/
P.A.V.E . http://www.vaccines.bizland.com/;
EagleFoundation http://www.eaglefoundation.org; and many others.
For more information about the conflicts of interest responsible fordetermining what gets injected into your child see the August 21, 2000Staff Report from the U.S. House of Representatives Committee on GovernmentReform entitled "Staff Report on Conflicts of Interest in Vaccine PolicyMaking" at http://www.house.gov/reform/.