PREVNAR
A Critical Review of a New Childhood Vaccine
mhbiomed@aol.com
September 19, 2000
Summary:
Part I:
Potential Conflicts of Interest in Testing, Promotion & Approval
Drs. Black & Shinefield: Wyeth Lederle Paid for Prevnar Studies
Drs. Black and Shinefield of Kaiser Permanente undertook the primary studies cited regarding Prevnar. Wyeth Lederle, the vaccine’s manufacturer, paid for these studies.
These doctors have also presented Prevnar at various conferences throughout the world. Wyeth Lederle subsidized these conferences.
Drs. Stephen I. Pelton & Kathryn Edwards: Wyeth Lederle Pays to Reassure Parents
Wyeth Lederle also pays for an Internet forum (pneumo.com) where these doctors answer Prevnar-related questions from concerned parents. Several of their answers are inconsistent with relevant information reported from other medical sources.
Dr. Kathyrn Edwards: Wyeth Lederle Pays to Reassure Doctors about Prevnar
The Internet forum subsidized by Wyeth Lederle (pneumo.com) also addresses Prevnar 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 for the study of pneumococcal vaccines (i.e. Prevnar). Edwards is also one of fifteen full-time members of FDA’s Vaccines and Related Biological Products Advisory Committee, the committee that advises the FDA on the licensing of new vaccines.
Dr. Margaret B. Rennels: The Wyeth Lederle-Prevnar-RotaShield Connection
Rennels was instrumental in getting RotaShield to market and is now involved in Prevnar. Her university receives a total of over $2.5 million from various drug and vaccine companies including Wyeth Lederle, Prevnar’s manufacturer. She is also one of the twelve members of the Committee on Infectious Diseases, the committee that makes vaccine recommendations as part of the American Academy of Pediatrics.36
Dr. Jerome Klein: Wyeth Lederle and the National Vaccine Advisory Committee
This doctor has been employed by the major vaccine manufacturers to testify against vaccine injured children. He is also chief editor of pneumo.com the website paid for by Wyeth Lederle to sponsor Prevnar. Furthermore, Klein holds a position on the National Vaccine Advisory Committee, the committee that recommends products for universal vaccination.
Part II:
Efficacy of Prevnar and other Vaccines Combined with Prevnar
The efficacy of Prevnar appears to be very limited - 7% fewer new earaches, and 0.1% fewer instances of invasive pneumococcal disease (compared to an experimental vaccine used as a control).
The studies done on Prevnar suggest that it may interfere with the efficacy of two other vaccines (pertussis and IPV) and could interfere with two more vaccines (MMR and Varicella).
Part III:
Safety of Prevnar
According to the American Academy of Pediatrics, Prevnar may prove to be among the most reactogenic of vaccines.
Danger of Inappropriate Injection
The vaccine insert repeatedly warns the clinician to keep the injection away from a child’s blood vessels. Doctors and nurses are attentive to this, but parents should be aware that there is always a danger if the vaccine is wrongly administered.
The manufacturer states that injecting a child with Prevnar who is under six weeks may not be safe, but that it is warranted to inject a six-week old. This does not provide the practitioner with a reasonable cushion.
Reviews the emergency room visits, seizures and SIDS associated with administration of Prevnar as discussed in the package insert.
Possible Allergic Reactions
Pediatricians are warned to be ready for possible allergic or anaphylactic reactions from administration of the vaccine.
Prevnar contains aluminum and according to the manufacturer there have been no carcinogenic, mutagenic or fertility studies done on the vaccine.
Relationship with Chronic Diseases
No long-term studies have been completed. One researcher sees a causal link to diabetes.
Prevnar is directed for administration to immune-suppressed children, a practice that apparently has not been studied for either safety or efficacy,
Part IV:
The Bottom Line $
At $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 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.
Introduction
On February 17, 2000, the FDA approved a new childhood vaccine called Prevnar. Prevnar is manufactured by Wyeth Lederle Vaccines. Wyeth Lederle is a business unit of Wyeth-Ayerst Laboratories, which is a division of American Home Products the same company that manufactured RotaShield, the vaccine that was recalled after it caused injury and death to some children. Prevnar is marketed to prevent pneumococcal infections that can cause earaches, meningitis, blood poisoning and pneumonia. The American Academy of Pediatrics Committee on Infectious Diseases has recommended universal 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 the total 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 over two years old, he or she has about a 1 in 5,000 chance of being diagnosed with a pneumococcal disease. 47 If your child is under two, the number is reported 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 in childhood has been "associated with" a mortality rate of approximately 1 in 178,571 children.47 Is it reasonable to expect that your child could be one of these victims?
According to the 1994 Red Book Report of the Committee on Infectious Diseases published by the American Academy of Pediatrics, children who are at risk of pneumococcal infections are those with specific predisposing factors. The Redbook states:
"(Pneumococcal Infections) are more likely to occur when predisposing conditions exist, including immunoglobulin deficiency, Hodgkin’s disease, congenital or acquired immunodeficiency (including HIV), nephrotic syndrome, some viral upper respiratory tract infections, splenic dysfunction, 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 universal vaccination are:
What inspires these doctors to do studies on Prevnar or to get on an airplane and travel thousands of miles to present Prevnar to other physicians? What motivates them to spend hours addressing the concerns of fearful parents and cautious pediatricians?
Drs. Black & Shinefield: Wyeth-Lederle Paid for Prevnar Studies
Drs. Shinefield and Black of Kaiser Permanente undertook most of the studies on Prevnar which proved its efficacy and safety.2 According to Dr. Black, "This vaccine is urgently needed...It is great news for parents and physicians."3 Dr. Shinefield is equally enthusiastic. He states, "It’s a remarkable vaccine that will have a dramatic effect."4
How do we know the vaccine is safe and effective? The manufacturer, Wyeth Lederle Vaccines points to the studies of Drs. Black and Shinefield to vouch for the vaccine’s safety and efficacy. A Wyeth press release states:
"Results and data released last September and updated this May from a major clinical trial conducted by Kaiser Permanente…suggested that the vaccine is effective 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 Office of Public Affairs, the "study was supported by a grant from Wyeth Lederle Vaccines & Pediatrics."6 This was confirmed by the Associated Press, which reported that Wyeth-Lederle Laboratories "paid for the testing."4
In fact, the financial ties between Wyeth Lederle Vaccines and Drs. Black and Shinefield are so close that the two doctors appeared in a glossy photo in the 1997 Annual Report of American Home Products (Wyeth’s parent company).8 In the photo you see the two grinning physicians dressed in white 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 the wonders of Prevnar to other doctors throughout the world. This list of conferences where they presented information about Prevnar includes:
The one in Washington DC seemed particularly entertaining because it was held at the Smithsonian. According to the event’s brochure:
"The entire first floor of the Smithsonian National Museum of American History will be open to symposium attendees and their guests during the evening… Visitors of all ages can experience the thrill of DNA fingerprinting or measuring the radioactivity of common objects in the hands-on science center." 10
And who paid for the cost of all these conferences so that the doctors in attendance could learn about Prevnar, and their families could measure the radioactivity of common objects?
Would Drs. Black & Shinefield be influenced because their studies and efforts were paid for by Wyeth-Lederle? Would their professional judgement be swayed because the vaccine’s manufacturer paid for the conventions they attended? Do you want the efficacy and safety of products that will be injected into your children determined by people who are receiving money from 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. Kathyrn Edwards. Both spend time answering questions about Prevnar from concerned parents and pediatricians. Below are a few examples:
In this instance, Dr. Pelton assures the concerned mother of a 6-month old who experienced adverse reactions to Prevnar. On May 4, 2000 she wrote:
"My 6 month old received the Prevnar vaccine two days ago. Her temperature went to 102.6 and she vomited that evening. The fever dropped to 100 yesterday. The injection site is very inflammed - it looks like a burn almost. It has a large knot under it that is not only just beneath the injection site, but it extends from the site like a finger. Is this reaction normal?"17
On May 24, 2000, Pelton replied:
"The most common side effect is local reactions. The one that you are describing sounds somewhat greater than average but is within the spectrum of what we see."17
On May 7, 2000, another mother advised Dr. Pelton of the unfortunate experience of her young son after getting Prevnar. She wrote:
My 10-month old son received prevnar four days ago. Since then he has been vomiting and developed a rash on his body. I will not let him receive the vaccine again."17
This time, it only took three days for Dr. Pelton to write back. On May 10, 2000 he replied:
"…Rash occurs in about 1% of recipients, vomiting in almost 10% however this was seen to be equal in children who received other vaccines without Prevnar."17
On May 15, 2000, another mom wrote about what happened to her 12-month old daughter after receiving Prevnar and other vaccines in combination. She wrote:
"My 12-month-old daughter just received HiB, DTP, Chickenpox and Prevnar vaccines on 5/1/00. The morning of 5/13, she vomited for 3 hours and had diarrhea. After a visit to the Dr., he had her admitted to the hospital…After a chest x-ray, they were able to see that it was pneumonia in her lower right lobe of her lung…I feel 99.9% confident that this was caused 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 of administration. An event 2 weeks later is unlikely to be due to the vaccine itself."17
But his response fails to mention the admission by vaccine manufacturers that pneumonia can be a side effect of getting the Hib and DTP vaccines together.37
On July 24, 2000, Tmjh wrote:
"I’m concerned about data linking prevnar to the onset of juvenile diabetes. 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 the University of Washington which stated, "Aged 65 years or older and having cardiovascular disease or diabetes mellitus were specific indications significantly correlated with receipt of influenza and pneumococcal vaccine." 38 Prevnar is a pneumococcal vaccine and this study therefore suggests that late onset of diabetes may possibly be associated with the vaccine. In addition, Dr. J. Bart Classen told the FDA that Prevnar "may be seven times as toxic as the hemophilus vaccine, possibly causing an estimated 400 to 700 children to develop insulin dependent diabetes per 100,000 children immunized. These cases of diabetes may not occur until 3.5 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 been evaluated for any carcinogenic or mutagenic potential, or impairment of fertility.’ Can you give me a layman’s explanation…should I be worried...?" 17
Dr. Kathyrn Edwards responded on September 5, 2000:
"The vaccine has been studied in animals and found not to be associated with cancer or infertility." 17
This is an interesting response because we have been unable to find a single published report that relates to any carcinogenic or mutagenic studies on Prevnar. In fact, the manufacturer’s insert also fails to cite such a document. We challenge Dr. Edwards to produce such a peer-reviewed study.
A mom named Susan wrote on September 6, 2000:
"(I read) some disturbing comments from parents whose children have already received the vaccine. They said it has terrible side effects, such as poor appetite, difficulty breathing, sleeping problems, and can cause juvenile diabetes…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 licensure and the side effects seen in these children were carefully evaluated and not shown to increase the rate of diabetes, respiratory problems, or weight loss." 17
As we have already seen the diabetes question is not resolved. In addition, as far as respiratory problems are concerned, it appears that Prevnar can cause or contribute to such a diagnosis. According to the manufacturer’s insert: croup, pneumonia, asthma, bronchiolitis, and wheezing 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, the manufacturer of Prevnar. (The site is "supported by an unrestricted educational grant from Wyeth-Lederle Vaccines.") In fact, both Edwards and Pelton are listed as "National Editors" on the site.18 Could Wyeth’s sponsorship 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, but finds the time to reassure concerned pediatricians too. Here are some examples:
On April 1, 2000, Dr. Hemendra Parikh asked Dr. Edwards about the safety of injecting Prevnar and Comvax simultaneously (Comvax = haemophilus influenzae type b and hepatitis B together). He wrote:
"Has there been any study to show the impact of the simultaneous vaccination with the pneumococcal vaccine and other recommended childhood vaccines? Especially the simultaneous vaccination with prevnar and comvax?"19
On April 5, 2000 Edwards responded that while there are no studies on this question, it should be ok anyway:
"…To my knowledge, no studies of the pneumococcal conjugates administered with Comvax are ongoing but there is not current information to suggest that it would be a problem."19
On April 6, 2000, Dr. Mark McGwire asked:
"Any interactions between anabolic steroids, nutritional supplements and prevnar?"19
Edwards considered this to be a funny question. She thought that it was rather 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 young children receiving the pneumococcal conjugate do not use these supplements and steroids."19
Is it ethical that this forum is also paid for by Wyeth Lederle, Prevnar’s manufacturer? (The site is "Supported by an unrestricted educational grant from Wyeth-Lederle Vaccines.") Was there a conflict of interest when Edwards accompanied Drs. Black and Shinefield to Boston on May 12-16, 2000, to speak about "the development and performance of conjugate pneumoccocal vaccines (i.e. Prevnar),"20 even though the conference was "supported in part by an educational grant from Wyeth-Lederle Vaccine and Merck Vaccine Division?"20 Is it ethical that Wyeth Lederle paid Dr. Edwards $255,023 per year from 1996 to 1998 for the study of pneumococcal vaccines48 (i.e. Prevnar) and now Edwards is addressing questions from pediatricians and parents about the product? Is it a conflict of interest that Edwards is one of fifteen full-time members of FDA’s Vaccines and Related Biological Products Advisory Committee, the committee that advises the FDA on the licensing 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 and efficacy of Prevnar.21 Speaking about the importance of her findings she said that there is "an urgent need for pneumococcal vaccines that are effective in infants."45 Dr. Rennels should know because she has a lot of experience with vaccines especially the rotavirus vaccine. According to her 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 and improved vaccines for children over the last 15 years. She participated in virtually all phases of the testing of the recently licensed rotavirus vaccine and was the lead author on the report of the pivotal U.S. efficacy study. More recently, she has led the U.S. safety and immunogenicity study of the heptavalent conjugate pneumococcal vaccine (i.e. Prevnar)…Currently, she is the principle investigator of a large study of the safety of rotavirus vaccine in premature infants." 22
She certainly is the rotavirus expert. Her journal letters and articles have titles like "Rotavirus vaccine comes of age."23 And when there was the possibility that RotaShield (the brand name for the rotavirus vaccine) could cause intussusception (collapsing of the intestines that can lead to death) she wrote an article entitled "Lack of an apparent association between intussusception and wild or vaccine rotavirus infection."24 Although Dr. Rennels was part of the US Rhesus Rotavirus Vaccine Study Group subsidized by Wyeth-Ayerst research (the manufacturer of RotaShield)25 her financial ties with the manufacturer would never interfere with her judgement. Nor would it interfere with her work as one of the twelve members of the Committee on Infectious Diseases, the committee that makes vaccine recommendations as part of the American Academy of Pediatrics.36
Because of the increasing numbers of intussusception injuries related with the vaccine, Wyeth Lederle Vaccines suspended further distribution and administration of RotaShield on July 16, 1999 and withdrew it from the market on October 15, 1999.26 This was very remarkable because Rennels had found a "lack of an apparent association" only one year before.24
Now, Dr. Rennels is busy demonstrating the "safety" of Prevnar. The major vaccine and drug manufacturers (including Wyeth) have donated a total of over $2.5 million to the University of Maryland School of Medicine where Dr. 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 called Prevnar "a big win for kids."28 Dr. Klein has done his best to protect the financial sanctity of vaccine manufacturers from parents whose children have been injured or killed by a vaccine. He has been hired by the major drug companies to testify in legal cases on behalf of vaccine manufacturers and against vaccine-injured children. Here’s one example as summarized from the legal literature:
On August 22, 1984 a healthy nine-month old baby named Sean Leary was administered his third DTP vaccine. Sean immediately began vomiting. The next day, he stopped eating. He stayed alert but was no longer active. That night he cried out every 15 to 30 minutes. The pediatrician immediately noted the "obvious circulation collapse." There at the pediatrician’s office, "Sean’s eyes rolled back in his head and he stopped breathing." He was rushed to an emergency room. Resuscitative efforts failed and Sean was pronounced dead at 1:44 p.m. Dr. Jerome Klein testified 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 Health concerning vaccine safety and efficacy. He is also the chief editor of "Pneumo.com" the pro-Prevnar website that is "Supported by an unrestricted educational grant from Wyeth-Lederle Vaccines."30
Would Dr. Klein’s financial ties to Wyeth-Lederle vaccines and other drug companies influence his pro-Prevnar stance or his actions as a member of National Vaccine Advisory Committee, the committee that recommends vaccines to our nation’s government? Are you comfortable trusting your child’s health to individuals like Klein who have long-standing relationships with the 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 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:
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:
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:
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.
Part III:
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.
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 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.
Conclusion
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.
Recommendations:
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; PROVE http://vaccineinfo.net/; 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/.
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:
(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
(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")
(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