Cynthia A. Janak
Will the vaccinated infect the unvaccinated? That is the question with Whooping cough
By Cynthia A. Janak
A major media campaign is in force for adults to get the Pertussis vaccination. The commercial just pulls at your heart strings to make you just jump up and want to get vaccinated today. Isn't that what commercials are meant to do? It is like all the commercials for toys around Christmas time. They want mom and dad to go out and buy their toy for little Johnny or Janie.
Look at the advertizing campaign that Merck put out for Gardasil. That was the most successful campaign I have ever seen. You have millions of girls and young women going out and getting the HPV vaccinations. What they do not tell you is that you have a potentially high risk of having a "New Medical Condition" after vaccination. Interesting how they left that fact out of the commercials. I wonder why. NOT
Before I continue I want to tell you about a fact that is known by the CDC, etc. That is called vaccine shedding. (13, 14) This is the transmission of the virus from a vaccinated person to an unvaccinated person. The CDC is referencing "live influenza viruses." Here is the excerpt: Because LAIV (live, attenuated influenza vaccine) contains live influenza viruses, a potential exists for transmission of these viruses from vaccinees to other persons. Vaccinated immunocompetent children can shed vaccine viruses for <3 weeks. (10)
I want you to understand that this is true for vaccines (15, 16, 17, 18) including the Whooping Cough. What you could have happen is that all these parents and child care workers are going to get the vaccine and then take care of children. They will change their dirty diapers and be in close contact with the children that they are trying to protect. When in essence, they are passing the disease to the young children and infants in their care for approximately 3 weeks. (10, 11, 12, 13, 14, 15) This could mean that when a mother kisses, hugs and touches her beautiful baby she could be passing the virus. The same goes for the day care givers of these children. The vaccinated have the potential to infect the unvaccinated child. This could cause the next epidemic of disease like what happened with the small pox epidemic.
What I want to reference first is the article by CNN titled, "Vaccination role unclear in whooping cough outbreak" (1). When I read this title it made me wonder what they were trying to say. To me it implies that vaccination could have a supporting role in why there is a rise in Whooping Cough in California. Because of this title I had to read the whole article. Isn't that what a title is supposed to do? I use that tactic all the time because I want you to read my articles.
What I am going to do now is reference different statements made in this article.
Peaks in cases of the highly contagious disease cycle every two to five years. California saw its last peak in 2005, with 3,182 cases, according to state health officials.
"We're right about at the five-year peak, but we're on track to surpass our 50-year high," said Mike Sicilia of the California Department of Health.
One of the things that everyone knows is that California has a major problem with illegal immigration. One of the impacts of this is that their health care system is in trouble because these people come to California and avail themselves in regards to their children of the free system that is provided. This problem is occurring in many states and the cost impact is severe in some states.
Besides from that, let us look at the stats that they are referencing.
In 2010 there have been 910 cases of pertussis, the technical term for whooping cough, as of June 15, state health officials said, and five infants have died of the disease. Local health departments are investigating 600 more possible cases of illness.
What I find interesting here is that they are upset over 910 cases of Pertussis and as of June 15th five infants have died. Let us make a comparison to what is going on with the HPV vaccines.
Presently we have 18600 reports of adverse events reported to the VAERS (Vaccine Adverse Event Reporting System). Since June of 2006 when the first HPV vaccine was approved we have an annual average of 4650 reports. Now, remember that is only 1–10 % reporting. So, that could give us an annual rate of either 46,500 (10%) or 465,000 (1%). What bothers me is that this is not a problem for the FDA or the CDC.
In the state of California the rate of adverse events due to the HPV vaccine is 1161. If you use the math above you could have 16,110 (10%) or 161,000 (1%) for the state of California. I guess this is not as important as Whooping Cough.
The other fact in the VAERS data base is that 3 people died in California. Once again using the math above that could mean 30 (10%) or 300 (1%). I want to make it clear that I am not stating that these numbers are fact. They are only based on present information from a study that was done on the frequency of VAERS reporting.
Still this is not a problem to the powers that be. Interesting.
Some doctors relate this recent rise in cases to the parents who have shied away from vaccinating children due to fears...
Then in almost the same breath they state this.
Childhood immunization for whooping cough has not decreased substantially, Cherry said. (Dr. James Cherry, professor of pediatric infectious diseases at the University of California, Los Angeles)
Okay so which is it. Is it that there are more people not vaccinating or are the children who are vaccinated having this symptom? We just do not know for sure.
Vaccination for whooping cough begins when a child is two months old, but a series of three shots, to be completed by six months...
For those of you that have been reading my series about the HPV vaccines know that this is called challenge and re-challenge. Briefly, challenge is like priming the pump and getting the immune system to recognize a specific pathogen or antigen. When you receive the second and third dose you now have re-challenge which is like putting the immune system into overdrive attacking the pathogen or antigen. It is at this stage that adverse events can occur. (2, 3, 4, 5, 6)
Vaccination for whooping cough begins when a child is two months old, but a series of three shots, to be completed by six months, is necessary for adequate protection.
Then they state: Reported whooping cough cases nationally have increased since the 1980s, according to the CDC. In 2008, there were more than 13,000 cases reported nationally, including 18 deaths, the CDC said. Cases among teens aged 10 to 19 years, and babies less than six months old, have especially gone up.
In the 1980's we have the implementation of the VAERS database and the National Vaccine Injury Compensation Act. I find it interesting how cases of Whooping Cough increase at this time
Once again, the reports of adverse events reported to VAERS with regards to the HPV vaccines are not an issue. Again I wonder why.
Now, let us get to the best part of this article.
... pass the condition along to infants, in whom the condition is much more serious because their immune and respiratory systems have not yet developed, Shu said. (Dr. Jennifer Shu, a pediatrician at Children's Medical Group in Atlanta, Georgia)
Thank you Dr. Shu for giving us that information about a baby's immune system. Dr. Shu, I have a question for you. If a baby's immune system is not yet developed then why are we challenging and re-challenging that under developed immune system with antigens, pathogens and toxins? I base this question on the facts of the challenge and re-challenge studies that I have found.
I also have a question for Dr. Offit. If the above statement is true then how can an under developed immune system be able to accommodate 10,000 vaccinations?
Let us go on to a little history behind Whooping Cough. I am going to reference an article I wrote back in November of 2007. (7)
What I want to do is give you a little history about disease. I am going to use some charts that I found on Health Sentinel. http://www.healthsentinel.com/graphs.php
What I found interesting about these graphs was that the incidents of disease started to drop off with the advent of better hygiene and diet.
This graph shows a magnified view of the devastation caused by tuberculosis and influenza was far greater than the other infectious diseases of scarlet fever, measles, diphtheria, whooping cough, and typhoid. The graph also reveals the horrible death rate during the 1918 flu pandemic.
As you can see with the last chart the incidence of Pertussis (Whopping Cough) spiked after the vaccine became used. One of the symptoms that I read about the earlier vaccines was a cough that was similar to the whopping cough. What many medical professionals feel is that Whopping Cough was misdiagnosed and that caused the increase in this disease.
The bottom line here is that vaccines did not cause the decrease in disease at all. It was hygiene and diet that led to the decreases. With all the charts I have seen the decreases started way before vaccines were introduced into society. My opinion is that most of the vaccines are no longer needed because of better sanitation practices by the industrial nations and efforts that are being made in the non-industrial nations as to assisting them in better hygiene and sanitation to prevent disease.
We have all the technology and practices in place to prevent disease and/or to diagnose disease early so that mortality from disease will further decline.
The only thing that vaccines are doing is disrupting the natural processes of our intricate immune system. I believe that this is why we have an increase in allergies, asthma and various cancers. We are toying with our bodies in such a way that was never intended. Our children will never have the natural immunity that we had when we were young.
At this point I just do not know what to say about the comments by these professionals and what we have and are being told by them in regards to vaccination.
The only vaccine that I was able to find approved for adults was Adacel® by Sanofi Pasteur. (9)
I wanted to find out what the data was on the clinical trials for Adacel ®. It took me a few hours to find a trial for this vaccine. I wanted to know what the adverse events where for the adult population especially after what I found out about trials. (8) Even impractically large trials will often fail to confirm small increases in events which may be significant when applied to a large population.
The ingredients of this vaccine are Excipients: Aluminum Phosphate (adjuvant) 1.5 mg, 2-phenoxyethanol 0.6% v/v, Manufacturing Process Residuals: Formaldehyde and glutaraldehyde are present in trace amounts. Then you have these active ingredients: Tetanus Toxoid 5 Lf, Diphtheria Toxoid 2 Lf, Acellular Pertussis: Pertussis Toxoid (PT) 2.5 μg, Filamentous Haemagglutinin (FHA) 5 μg, Pertactin (PRN) 3 μg, Fimbriae Types 2 and 3 (FIM) 5 μg
What concerned me was that the Tetanus, Diphtheria and Pertussis are stated as active so in essence it is live. Remember what I stated earlier about shedding. You have the potential to pass TDaP on to your children and your children could get Whooping Cough. The other thing that bothered me was the amount of aluminum in this vaccine so I decided to check out the adverse events in this trial.
On page 32, Table 18: Frequency (%) of Solicited Systemic Reactions Reported in Adolescents and Adults in Study Td506 From Day 0 to 14 After a Single Dose with ADACEL® or Td Vaccine (8) (9)
My only interest is what the numbers where for the adult population but, I am going to give you my findings for the adolescent also. It only seems right. What surprised me was that there was no comprehensive table for unsolicited adverse events or severe adverse events from this vaccine. The other thing is that this table from Study Td506 is only for 14 days. Other information in table format for a longer duration is unavailable. I modified the table to represent the number of participants that were affected.
This is what I found.
Let us look at this as if it is a population of 5,000,000 is vaccinated. That should be interesting. This puts this whole vaccination system in a more realistic perspective.
Well, well, well, look at that. This puts a different outlook of what could happen if all these adults decide to get the TDaP vaccination because of the commercials. That would be quite a few adults home on sick leave and not able to take care of the infant that they were trying to protect. These same adults will be coming into contact with family members and could be passing the disease on to them via shedding for up to 3 weeks. Think about all the doctors' bills that they will be acquiring. I think this is just wrong on so many levels.
These symptoms look to me like that could be inflammation in various parts of the body and if you have a rash that could be an allergic reaction. Interesting, they do not mention this in any real detail.
This is pretty much what you see with all the vaccine trials.
The curious person that I am I wanted to see what the VAERS (Vaccine Adverse Event Reporting System) had with reports from the TDaP vaccines. Interesting numbers and I want you to remember that this could be only 1–10 % reporting so they have the potential to be far greater than what you see here.
Okay, I am done boring you with all these numbers so I am going to ask you some questions like I always do.
With what I have presented today do you think that the advertizing campaign that you see on television is giving you the whole story? My personal opinion is I don't think so. How about you?
Just a final note here for Pregnant and Nursing women. The effect of ADACEL® on the development of the embryo and fetus has not been assessed. Vaccination in pregnancy is not recommended unless there is a definite risk of acquiring pertussis. The effect of administration of ADACEL® during lactation has not been assessed. ... the effect on breast-fed infants of the administration of ADACEL® to their mothers has not been studied.(9)
(1) CNN Health, Vaccination role unclear in whooping cough outbreak, By Elizabeth Landau, CNN, June 28, 2010 9:37 a.m. EDT, http://www.cnn.com/2010/HEALTH/06/28/california.whooping.cough/index.html
(2) Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders (2002), Board on Health Promotion and Disease Prevention (HPDP), Institute of Medicine (IOM), page 39.
(3) Bases for the early immune response after rechallenge or component vaccination in an animal model of acute Mycoplasma pneumoniae pneumonitis, CIMOLAI N. (1) ; MAH D. G. (1) ; TAYLOR G. P. (1) ; MORRISON B. J. (1) ; 1) Division of Medical Microbiology, Department of Pathology, The University of British Columbia, Vancouver, CANADA
(4) Gastrointestinal co-morbidity, autistic regression and Measles-containing vaccines: positive re-challenge and biological gradient, Medical Veritas, Volume 3, Issue 1, April, 2006, By Gary S. Goldman, Ph.D., page 796
(5) Influenza Vaccine and Neurological Adverse Events: VAERS 7/1990–1/2003, Institute of Medicine (IOM), 3/13/03, Penina Haber, Department of Health and Human Services, CDC
(6) Drug Injury, Liability, Analysis and Prevention, Second Edition, James T. O'Donnell, Pharm.D., M.S., FCP, ABCP, FACN, CNS, R.Ph., Chapter 10, Evaluation of Medical Causation, Donald H. Marks, M.D., Ph.D.
(7) The great vaccine cover-up a shocking report, November 10, 2007, http://www.renewamerica.com/columns/janak/071110
(8) "Immunization Before the Next Pandemic? Risks, Benefits and Pathways. The presenter was Jesse L. Goodman, MD, MPH, Director, Center for Biologics Evaluation and Research, IDSA, Washington, DC
(9) PRODUCT MONOGRAPH, ADACEL®, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed, Suspension for injection (For active immunization against Tetanus, Diphtheria and Pertussis, Sanofi Pasteur Limited Date of Approval: Toronto, Ontario, Canada August 2009, Control Number: 130737 https://www.vaccineshoppecanada.com/secure/pdfs/ca/ADACEL_E.pdf
(10) MMWR, Recommendations and Reports, September 26, 2003 / 52(RR13); 1-8, Using Live, Attenuated Influenza Vaccine for Prevention and Control of Influenza, Supplemental Recommendations of the Advisory Committee on Immunization Practices (ACIP) http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5213a1.htm
(11) Clements ML, Stephens I. New and improved vaccines against influenza. In: Levine MM, Woodrow GC, Kasper JB, et al., eds. New generation vaccines. New York: Marcel Dekker, Inc 1997:645–70.
(12) Zangwill KM, Droge J, Mendelman P, et al. Prospective, randomized, placebo-controlled evaluation of the safety and immunogenicity of three lots of intranasal trivalent influenza vaccine among young children. Pediatr Infect Dis J 2001;20:740–6.
(13) King JC, Fast PE, Zangwill KM, et al. Safety, vaccine virus shedding and immunogenicity of trivalent, cold-adapted, live attenuated influenza vaccine administered to human immunodeficiency virus-infected and noninfected children. Pediatr Infect Dis J 2001;20:1124–31.
(14) King JC, Treanor J, Fast PE, et al. Comparison of the safety, vaccine virus shedding and immunogenicity of influenza virus vaccine, trivalent, types A and B, live cold-adapted, administered to human immunodeficiency virus (HIV)-infected and non-HIV-infected adults. J Infect Dis 2000;181:725–8.
(15) MMWR, Recommendations and Reports, April 4, 2003 / 52(RR07);1-16, Recommendations for Using Smallpox Vaccine in a Pre-Event Vaccination Program, "During the interval in which vaccinia virus is shed, inadvertent inoculation can occur from the vaccination site to another area of the body, most commonly the face, eyelid, nose, lips, genitalia, or anus. In addition, transmission could occur to another nonimmune person, leading to self-limited infections or to more serious complications, particularly among persons with medical contraindications to vaccination. The risk for mortality from eczema vaccinatum might be higher among infected contacts than among vaccines." http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5207a1.htm
(16) Rotavirus, "Fecal shedding of vaccine virus was evaluated in a subset of persons enrolled in the phase III trials. Vaccine virus was shed by 9% of 360 infants after dose 1, but none of 249 and 385 infants after doses 2 and 3, respectively. Shedding was observed as early as 1 day and as late as 15 days after a dose. The potential for transmission of vaccine virus was not assessed." http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/rota.pdf
(17) DOI: 10.3201/eid1607.091606, Suggested citation for this article: Shahmahmoodi S, Mamishi S, Aghamohammadi A, Aghazadeh N, Tabatabaie H, Goya MM, et al. Vaccine-associated paralytic poliomyelitis in immunodeficient children, Iran, 1995–2008. Emerg Infect Dis. 2010 Jul; [Epub ahead of print], http://www.cdc.gov/eid/content/16/7/pdfs/09-1606.pdf
(18) Addition of Severe Combined Immunodeficiency as a Contraindication for Administration of Rotavirus Vaccine, MMWR, Weekly / Vol. 59 / No. 22 June 11, 2010, "The eight infants (four males and four females) were diagnosed with SCID between ages 3 months and 9 months and had received 1–3 doses of rotavirus vaccine before the diagnosis. All the infants had diarrhea, and most had additional infections (e.g., Pneumocystis jirovecii, rhinovirus, adenovirus, Salmonella, Escherichia coli, and Giardia) at the time of SCID diagnosis. Rotavirus infection was diagnosed by enzyme immunoassay in seven of the eight patients for whom this information was available. In all eight cases, vaccine-acquired rotavirus infection was confirmed by reverse transcription — polymerase chain reaction (RT-PCR) and nucleotide sequencing. Prolonged shedding of vaccine virus was documented in at least six of these cases, with duration of up to 11 months."
© Cynthia A. Janak
June 30, 2010
A major media campaign is in force for adults to get the Pertussis vaccination. The commercial just pulls at your heart strings to make you just jump up and want to get vaccinated today. Isn't that what commercials are meant to do? It is like all the commercials for toys around Christmas time. They want mom and dad to go out and buy their toy for little Johnny or Janie.
Look at the advertizing campaign that Merck put out for Gardasil. That was the most successful campaign I have ever seen. You have millions of girls and young women going out and getting the HPV vaccinations. What they do not tell you is that you have a potentially high risk of having a "New Medical Condition" after vaccination. Interesting how they left that fact out of the commercials. I wonder why. NOTBefore I continue I want to tell you about a fact that is known by the CDC, etc. That is called vaccine shedding. (13, 14) This is the transmission of the virus from a vaccinated person to an unvaccinated person. The CDC is referencing "live influenza viruses." Here is the excerpt: Because LAIV (live, attenuated influenza vaccine) contains live influenza viruses, a potential exists for transmission of these viruses from vaccinees to other persons. Vaccinated immunocompetent children can shed vaccine viruses for <3 weeks. (10)
I want you to understand that this is true for vaccines (15, 16, 17, 18) including the Whooping Cough. What you could have happen is that all these parents and child care workers are going to get the vaccine and then take care of children. They will change their dirty diapers and be in close contact with the children that they are trying to protect. When in essence, they are passing the disease to the young children and infants in their care for approximately 3 weeks. (10, 11, 12, 13, 14, 15) This could mean that when a mother kisses, hugs and touches her beautiful baby she could be passing the virus. The same goes for the day care givers of these children. The vaccinated have the potential to infect the unvaccinated child. This could cause the next epidemic of disease like what happened with the small pox epidemic.
What I want to reference first is the article by CNN titled, "Vaccination role unclear in whooping cough outbreak" (1). When I read this title it made me wonder what they were trying to say. To me it implies that vaccination could have a supporting role in why there is a rise in Whooping Cough in California. Because of this title I had to read the whole article. Isn't that what a title is supposed to do? I use that tactic all the time because I want you to read my articles.
What I am going to do now is reference different statements made in this article.
Peaks in cases of the highly contagious disease cycle every two to five years. California saw its last peak in 2005, with 3,182 cases, according to state health officials.
"We're right about at the five-year peak, but we're on track to surpass our 50-year high," said Mike Sicilia of the California Department of Health.
One of the things that everyone knows is that California has a major problem with illegal immigration. One of the impacts of this is that their health care system is in trouble because these people come to California and avail themselves in regards to their children of the free system that is provided. This problem is occurring in many states and the cost impact is severe in some states.
Besides from that, let us look at the stats that they are referencing.
In 2010 there have been 910 cases of pertussis, the technical term for whooping cough, as of June 15, state health officials said, and five infants have died of the disease. Local health departments are investigating 600 more possible cases of illness.
What I find interesting here is that they are upset over 910 cases of Pertussis and as of June 15th five infants have died. Let us make a comparison to what is going on with the HPV vaccines.
Presently we have 18600 reports of adverse events reported to the VAERS (Vaccine Adverse Event Reporting System). Since June of 2006 when the first HPV vaccine was approved we have an annual average of 4650 reports. Now, remember that is only 1–10 % reporting. So, that could give us an annual rate of either 46,500 (10%) or 465,000 (1%). What bothers me is that this is not a problem for the FDA or the CDC.
In the state of California the rate of adverse events due to the HPV vaccine is 1161. If you use the math above you could have 16,110 (10%) or 161,000 (1%) for the state of California. I guess this is not as important as Whooping Cough.
The other fact in the VAERS data base is that 3 people died in California. Once again using the math above that could mean 30 (10%) or 300 (1%). I want to make it clear that I am not stating that these numbers are fact. They are only based on present information from a study that was done on the frequency of VAERS reporting.
Still this is not a problem to the powers that be. Interesting.
Some doctors relate this recent rise in cases to the parents who have shied away from vaccinating children due to fears...
Then in almost the same breath they state this.
Childhood immunization for whooping cough has not decreased substantially, Cherry said. (Dr. James Cherry, professor of pediatric infectious diseases at the University of California, Los Angeles)
Okay so which is it. Is it that there are more people not vaccinating or are the children who are vaccinated having this symptom? We just do not know for sure.
Vaccination for whooping cough begins when a child is two months old, but a series of three shots, to be completed by six months...
For those of you that have been reading my series about the HPV vaccines know that this is called challenge and re-challenge. Briefly, challenge is like priming the pump and getting the immune system to recognize a specific pathogen or antigen. When you receive the second and third dose you now have re-challenge which is like putting the immune system into overdrive attacking the pathogen or antigen. It is at this stage that adverse events can occur. (2, 3, 4, 5, 6)
Vaccination for whooping cough begins when a child is two months old, but a series of three shots, to be completed by six months, is necessary for adequate protection.
Then they state: Reported whooping cough cases nationally have increased since the 1980s, according to the CDC. In 2008, there were more than 13,000 cases reported nationally, including 18 deaths, the CDC said. Cases among teens aged 10 to 19 years, and babies less than six months old, have especially gone up.
In the 1980's we have the implementation of the VAERS database and the National Vaccine Injury Compensation Act. I find it interesting how cases of Whooping Cough increase at this time
Once again, the reports of adverse events reported to VAERS with regards to the HPV vaccines are not an issue. Again I wonder why.
Now, let us get to the best part of this article.
... pass the condition along to infants, in whom the condition is much more serious because their immune and respiratory systems have not yet developed, Shu said. (Dr. Jennifer Shu, a pediatrician at Children's Medical Group in Atlanta, Georgia)
Thank you Dr. Shu for giving us that information about a baby's immune system. Dr. Shu, I have a question for you. If a baby's immune system is not yet developed then why are we challenging and re-challenging that under developed immune system with antigens, pathogens and toxins? I base this question on the facts of the challenge and re-challenge studies that I have found.
I also have a question for Dr. Offit. If the above statement is true then how can an under developed immune system be able to accommodate 10,000 vaccinations?
Let us go on to a little history behind Whooping Cough. I am going to reference an article I wrote back in November of 2007. (7)
What I want to do is give you a little history about disease. I am going to use some charts that I found on Health Sentinel. http://www.healthsentinel.com/graphs.php
What I found interesting about these graphs was that the incidents of disease started to drop off with the advent of better hygiene and diet.
This graph shows a magnified view of the devastation caused by tuberculosis and influenza was far greater than the other infectious diseases of scarlet fever, measles, diphtheria, whooping cough, and typhoid. The graph also reveals the horrible death rate during the 1918 flu pandemic.
As you can see with the last chart the incidence of Pertussis (Whopping Cough) spiked after the vaccine became used. One of the symptoms that I read about the earlier vaccines was a cough that was similar to the whopping cough. What many medical professionals feel is that Whopping Cough was misdiagnosed and that caused the increase in this disease.
The bottom line here is that vaccines did not cause the decrease in disease at all. It was hygiene and diet that led to the decreases. With all the charts I have seen the decreases started way before vaccines were introduced into society. My opinion is that most of the vaccines are no longer needed because of better sanitation practices by the industrial nations and efforts that are being made in the non-industrial nations as to assisting them in better hygiene and sanitation to prevent disease.
We have all the technology and practices in place to prevent disease and/or to diagnose disease early so that mortality from disease will further decline.
The only thing that vaccines are doing is disrupting the natural processes of our intricate immune system. I believe that this is why we have an increase in allergies, asthma and various cancers. We are toying with our bodies in such a way that was never intended. Our children will never have the natural immunity that we had when we were young.
At this point I just do not know what to say about the comments by these professionals and what we have and are being told by them in regards to vaccination.
The only vaccine that I was able to find approved for adults was Adacel® by Sanofi Pasteur. (9)
I wanted to find out what the data was on the clinical trials for Adacel ®. It took me a few hours to find a trial for this vaccine. I wanted to know what the adverse events where for the adult population especially after what I found out about trials. (8) Even impractically large trials will often fail to confirm small increases in events which may be significant when applied to a large population.
The ingredients of this vaccine are Excipients: Aluminum Phosphate (adjuvant) 1.5 mg, 2-phenoxyethanol 0.6% v/v, Manufacturing Process Residuals: Formaldehyde and glutaraldehyde are present in trace amounts. Then you have these active ingredients: Tetanus Toxoid 5 Lf, Diphtheria Toxoid 2 Lf, Acellular Pertussis: Pertussis Toxoid (PT) 2.5 μg, Filamentous Haemagglutinin (FHA) 5 μg, Pertactin (PRN) 3 μg, Fimbriae Types 2 and 3 (FIM) 5 μg
What concerned me was that the Tetanus, Diphtheria and Pertussis are stated as active so in essence it is live. Remember what I stated earlier about shedding. You have the potential to pass TDaP on to your children and your children could get Whooping Cough. The other thing that bothered me was the amount of aluminum in this vaccine so I decided to check out the adverse events in this trial.
On page 32, Table 18: Frequency (%) of Solicited Systemic Reactions Reported in Adolescents and Adults in Study Td506 From Day 0 to 14 After a Single Dose with ADACEL® or Td Vaccine (8) (9)
My only interest is what the numbers where for the adult population but, I am going to give you my findings for the adolescent also. It only seems right. What surprised me was that there was no comprehensive table for unsolicited adverse events or severe adverse events from this vaccine. The other thing is that this table from Study Td506 is only for 14 days. Other information in table format for a longer duration is unavailable. I modified the table to represent the number of participants that were affected.
This is what I found.
Let us look at this as if it is a population of 5,000,000 is vaccinated. That should be interesting. This puts this whole vaccination system in a more realistic perspective.
Well, well, well, look at that. This puts a different outlook of what could happen if all these adults decide to get the TDaP vaccination because of the commercials. That would be quite a few adults home on sick leave and not able to take care of the infant that they were trying to protect. These same adults will be coming into contact with family members and could be passing the disease on to them via shedding for up to 3 weeks. Think about all the doctors' bills that they will be acquiring. I think this is just wrong on so many levels.
These symptoms look to me like that could be inflammation in various parts of the body and if you have a rash that could be an allergic reaction. Interesting, they do not mention this in any real detail.
This is pretty much what you see with all the vaccine trials.
The curious person that I am I wanted to see what the VAERS (Vaccine Adverse Event Reporting System) had with reports from the TDaP vaccines. Interesting numbers and I want you to remember that this could be only 1–10 % reporting so they have the potential to be far greater than what you see here.
Okay, I am done boring you with all these numbers so I am going to ask you some questions like I always do.
With what I have presented today do you think that the advertizing campaign that you see on television is giving you the whole story? My personal opinion is I don't think so. How about you?
Just a final note here for Pregnant and Nursing women. The effect of ADACEL® on the development of the embryo and fetus has not been assessed. Vaccination in pregnancy is not recommended unless there is a definite risk of acquiring pertussis. The effect of administration of ADACEL® during lactation has not been assessed. ... the effect on breast-fed infants of the administration of ADACEL® to their mothers has not been studied.(9)
(1) CNN Health, Vaccination role unclear in whooping cough outbreak, By Elizabeth Landau, CNN, June 28, 2010 9:37 a.m. EDT, http://www.cnn.com/2010/HEALTH/06/28/california.whooping.cough/index.html
(2) Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders (2002), Board on Health Promotion and Disease Prevention (HPDP), Institute of Medicine (IOM), page 39.
(3) Bases for the early immune response after rechallenge or component vaccination in an animal model of acute Mycoplasma pneumoniae pneumonitis, CIMOLAI N. (1) ; MAH D. G. (1) ; TAYLOR G. P. (1) ; MORRISON B. J. (1) ; 1) Division of Medical Microbiology, Department of Pathology, The University of British Columbia, Vancouver, CANADA
(4) Gastrointestinal co-morbidity, autistic regression and Measles-containing vaccines: positive re-challenge and biological gradient, Medical Veritas, Volume 3, Issue 1, April, 2006, By Gary S. Goldman, Ph.D., page 796
(5) Influenza Vaccine and Neurological Adverse Events: VAERS 7/1990–1/2003, Institute of Medicine (IOM), 3/13/03, Penina Haber, Department of Health and Human Services, CDC
(6) Drug Injury, Liability, Analysis and Prevention, Second Edition, James T. O'Donnell, Pharm.D., M.S., FCP, ABCP, FACN, CNS, R.Ph., Chapter 10, Evaluation of Medical Causation, Donald H. Marks, M.D., Ph.D.
(7) The great vaccine cover-up a shocking report, November 10, 2007, http://www.renewamerica.com/columns/janak/071110
(8) "Immunization Before the Next Pandemic? Risks, Benefits and Pathways. The presenter was Jesse L. Goodman, MD, MPH, Director, Center for Biologics Evaluation and Research, IDSA, Washington, DC
(9) PRODUCT MONOGRAPH, ADACEL®, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed, Suspension for injection (For active immunization against Tetanus, Diphtheria and Pertussis, Sanofi Pasteur Limited Date of Approval: Toronto, Ontario, Canada August 2009, Control Number: 130737 https://www.vaccineshoppecanada.com/secure/pdfs/ca/ADACEL_E.pdf
(10) MMWR, Recommendations and Reports, September 26, 2003 / 52(RR13); 1-8, Using Live, Attenuated Influenza Vaccine for Prevention and Control of Influenza, Supplemental Recommendations of the Advisory Committee on Immunization Practices (ACIP) http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5213a1.htm
(11) Clements ML, Stephens I. New and improved vaccines against influenza. In: Levine MM, Woodrow GC, Kasper JB, et al., eds. New generation vaccines. New York: Marcel Dekker, Inc 1997:645–70.
(12) Zangwill KM, Droge J, Mendelman P, et al. Prospective, randomized, placebo-controlled evaluation of the safety and immunogenicity of three lots of intranasal trivalent influenza vaccine among young children. Pediatr Infect Dis J 2001;20:740–6.
(13) King JC, Fast PE, Zangwill KM, et al. Safety, vaccine virus shedding and immunogenicity of trivalent, cold-adapted, live attenuated influenza vaccine administered to human immunodeficiency virus-infected and noninfected children. Pediatr Infect Dis J 2001;20:1124–31.
(14) King JC, Treanor J, Fast PE, et al. Comparison of the safety, vaccine virus shedding and immunogenicity of influenza virus vaccine, trivalent, types A and B, live cold-adapted, administered to human immunodeficiency virus (HIV)-infected and non-HIV-infected adults. J Infect Dis 2000;181:725–8.
(15) MMWR, Recommendations and Reports, April 4, 2003 / 52(RR07);1-16, Recommendations for Using Smallpox Vaccine in a Pre-Event Vaccination Program, "During the interval in which vaccinia virus is shed, inadvertent inoculation can occur from the vaccination site to another area of the body, most commonly the face, eyelid, nose, lips, genitalia, or anus. In addition, transmission could occur to another nonimmune person, leading to self-limited infections or to more serious complications, particularly among persons with medical contraindications to vaccination. The risk for mortality from eczema vaccinatum might be higher among infected contacts than among vaccines." http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5207a1.htm
(16) Rotavirus, "Fecal shedding of vaccine virus was evaluated in a subset of persons enrolled in the phase III trials. Vaccine virus was shed by 9% of 360 infants after dose 1, but none of 249 and 385 infants after doses 2 and 3, respectively. Shedding was observed as early as 1 day and as late as 15 days after a dose. The potential for transmission of vaccine virus was not assessed." http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/rota.pdf
(17) DOI: 10.3201/eid1607.091606, Suggested citation for this article: Shahmahmoodi S, Mamishi S, Aghamohammadi A, Aghazadeh N, Tabatabaie H, Goya MM, et al. Vaccine-associated paralytic poliomyelitis in immunodeficient children, Iran, 1995–2008. Emerg Infect Dis. 2010 Jul; [Epub ahead of print], http://www.cdc.gov/eid/content/16/7/pdfs/09-1606.pdf
(18) Addition of Severe Combined Immunodeficiency as a Contraindication for Administration of Rotavirus Vaccine, MMWR, Weekly / Vol. 59 / No. 22 June 11, 2010, "The eight infants (four males and four females) were diagnosed with SCID between ages 3 months and 9 months and had received 1–3 doses of rotavirus vaccine before the diagnosis. All the infants had diarrhea, and most had additional infections (e.g., Pneumocystis jirovecii, rhinovirus, adenovirus, Salmonella, Escherichia coli, and Giardia) at the time of SCID diagnosis. Rotavirus infection was diagnosed by enzyme immunoassay in seven of the eight patients for whom this information was available. In all eight cases, vaccine-acquired rotavirus infection was confirmed by reverse transcription — polymerase chain reaction (RT-PCR) and nucleotide sequencing. Prolonged shedding of vaccine virus was documented in at least six of these cases, with duration of up to 11 months."
© Cynthia A. Janak
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