A groundbreaking study published in 2013 in the journal Vaccine titled, “Comparison of virus shedding after lived attenuated and pentavalent reassortant rotavirus vaccine,” made mention of the fact that rotavirus vaccines contain live viruses capable of causing infection, shedding and transmitting to non-vaccinated subjects:
“In fact, transmission of these two rotavirus vaccines or vaccine-reassortant strains to unvaccinated contacts has been detected [9–13][1], even in the absence of symptoms.”
One of the five studies referenced in the passage above, “Sibling transmission of vaccine-derived rotavirus (RotaTeq) associated with rotavirus gastroenteritis,” published in 2009, is the first report in the literature to identify the transmission of rotavirus vaccine-derived virus to unvaccinated contacts resulting in symptomatic rotavirus gastroenteritis requiring emergency medical attention:
“We document here the occurrence of vaccine-derived rotavirus (RotaTeq [Merck and Co, Whitehouse Station, NJ]) transmission from a vaccinated infant to an older, unvaccinated sibling, resulting in symptomatic rotavirus gastroenteritis that required emergency department care.”
The study also indicated that two of the 5-strains of rotavirus within the Rotateq reassorted to produce a more harmful virus either within the vaccinated infant or within the subsequently infected unvaccinated sibling:
“Results of our investigation suggest that reassortment between vaccine component strains of genotypes P7[5]G1 and P1A[8]G6 occurred during replication either in the vaccinated infant or in the older sibling, raising the possibility that this reassortment may have increased the virulence of the vaccine-derived virus.”
This phenomenon of Rotateq vaccine strain reassortment and subsequent gastoenteritis infection in vaccines recipients was also identified in a 2012 study in 61 infants.[2] Also, A Nicaraguan study published in 2012 found “the widespread use of the RotaTeq vaccine has led to the introduction of vaccine genes into circulating human RVs.,” i.e. the vaccine has altered the genetic makeup of wild-type rotavirus that now infect populations.[3]
It has been estimated that between 80-100% of infants shed rotavirus at some point during 25-28 days after vaccination.[4] [5] This means that the vaccinated pose a clear risk to the non-vaccinated, and may be producing virological conditions ideal for the recombination of the different rotavirus strains into vaccine-resistant ‘super viruses.’
Another case study, reported on in the National Vaccine Information Center’s document on vaccine viral shedding:
In 2010, a case report was published in Pediatrics describing a 30-month old healthy boy who had never received rotavirus vaccine and was infected with vaccine strain rotavirus. 237 He ended up in the emergency room with severe gastroenteritis 10 days after his healthy two-month old brother was given a dose of Merck’s RotaTeq vaccine. A stool sample was taken in the emergency room and came back positive for RotaTeq vaccine derived strains after RT-PCR testing.
The authors of the case report noted that “transmission of RotaTeq strains to
unvaccinated contacts was not evaluated in the pivotal [pre-licensure] clinical trials.” They added that both RotaTeq and Rotarix [GlaxoSmithKline Biologicals] vaccines have “the potential for vaccine-virus transmission to contacts.”
The Rotateq Vaccine: Tip of the Festering Iceberg
The Rotateq rotavirus vaccine was co-created by Dr. Paul Offit, widely recognized as the vaccine industry’s leading promoter and apologist. He is the co-patent holder of one of two live rotavirus vaccines the FDA has approved, and which the CDC recommends should be administered to infants in 3 doses at ages 2 months, 4 months, and 6 months.
Historically incapable of self-recusal despite his glaring conflicts of interest, Offit regularly positions himself as an expert on vaccines, even though he personally gains from presenting his product (and the CDC’s vaccine schedule as a whole) as safe and effective. Case in point, in one notorious interview in Parenting magazine he claimed a child can receive 10,000 vaccines simultaneously without harm.
An article published in Age of Autism summarized Offit’s dubious history:
· Paul Offit, vaccine patent holder for Rotavirus for Merck, was appointed to the Advisory Committee on Immunization Practices, God knows why
· He voted to add the Rotavirus vaccine to the schedule (it wasn’t Merck’s, because his vaccine wasn’t ready for market yet)
· That Rotavirus vaccine damaged a bunch of kids and was pulled from the market, but Offit abstained from recommending its removal
· A couple years later, rotavirus got added back to the schedule, with Offit’s vaccine leading the way
· Offit made tens of millions of dollars from the sale of the Rotavirus patent he held to Merck.
The Rotavirus Vaccine Was Dirty from the Start
The first rotavirus vaccine – Rotashield – comprised of four reassorted rhesus-human rotaviruses was approved in 1999, only to be withdrawn from the market by the FDA nine months later when it was found to increase the risk for a deadly form of bowel obstruction known as intersusseption in a small subset of highly vulnerable children.[6]
Offit’s Rotateq, which consists of 5 reassorted human-bovine retroviruses, was believed to be a safer alternative when it was approved by the FDA in 2006, but newly published research reveals his vaccine suffers from the same problems.
Published this month in Vaccine and titled, “Intussusception risk after RotaTeq vaccination: Evaluation from worldwide spontaneous reporting data using a self-controlled case series approach”, the study evaluated worldwide reports to the manufacturer of Rotateq up to May 2014, adjusting for the phenomenon of under-reporting. The study found that the relative risk of intussception associated with the administration of Rotateq vaccine increases “3-7 days following vaccination, mainly after the first dose and marginally after the second and third doses. “ The increase in relative risk reached 3.45 fold in the period 3-to-7 days after the first dose, relative to the 15-30-day period control period.
Another study linking Rotateq to intussusception was published last year in the New England Journal of Medicine finding approximately 1.5 (95% CI, 0.2 to 3.2) excess cases of intussusception per 100,000 recipients of the first dose.[7]
The Tip of Offit’s Festering Rotateq Iceberg
Death or debilitation by bowel obstruction rapidly following Rotateq vaccination is an acute adverse effect that is unlikely to be overlooked or ignored. This is why the Vaccine Adverse Effects Reporting System (VAERS): a passive, vaccine post-marketing surveillance system, has found it to be a significant side effect. VAERS, however, is believed to capture as little as less than 1% of the actual damage being done by vaccines, indicating that the extent of harm of the Rotateq if several orders of magnitude than presently believed.
Exposure to Rotateq, however, suffers – like many live vaccines – from a darker side, as far as adverse effects go, which may take months, years, or decades to manifest as part of the multifactorial smog cloud of modern day toxicities and exposures that eventually make their way into the bottleneck of a classical diagnosis.
Rotateq, for instance, has been identified to be contaminated with a number of adventitious viruses; that is to say, viruses that contaminated the live cells and/or biological components involved in the vaccine manufacturing process. These surreptitious agents, unknown to the manufacturers and regulatory agencies that approved them, infected the vaccines the children given them. These viruses include:
· Porcine Circovirus 1 (PCV-1): In 2010 the FDA suspended the Rotarix vaccine due to the discovery that it was contaminated with PCV-1 virus, a pig virus considered less harmful than PCV-2. The FDA determined, after review, that PCV-1 does not represent a risk to those exposed to it.
· Porcine Circovirus 2 (PCV-2): A 2014 study conducted by CDC researchers and published in Human Vaccines & Immunotherapeutcs titled, “Detection of PCV-2 DNA in stool samples from infants vaccinated with RotaTeq®,” found for the first time that PCV-2 is shed in the stool of those vaccinated with Rotateq. They found “A total of 235 (28.5%) samples from 59 vaccine recipients were positive for PCV-2 DNA by one or more assays used in this study.” Additionally, “Twenty-two of the 102 vaccine recipients (21.6%) shed RotaTeq® vaccine strain and 10 of these vaccinees (9.8%) were shedding both PCV DNA and rotavirus vaccine RNA.” In pigs, PCV-2 has been linked to serious health problems including, “PCV2-associated pneumonia, PCV2-associated enteritis, PCV2-associated reproductive failure, and Porcine Dermatitis and Nephropathy Syndrome (PDNS).” [source]
· Baboon endogenous retrovirus
Because live vaccines are manufactured through co-culturing cells and biological fluids from various different species, there is plenty of opportunity for viruses to adapt to, and recombine to produce infectious agents capable of far greater virulence. Rotateq is just one of many vaccines in the CDC’s immunization schedule that contain live viruses capable of infecting those given it, including retroviruses, which have been called a modern-day Plague owing to the fact that they are capable of infecting the host as non-HIV acquire immunodeficiency viruses. For more information read Dr. Judy Mikovitz and Kent Heckenlively’s new book Plague.
] Phua KB, Quak SH, Lee BW, Emmanuel SC, Goh P, Han HH, et al. Evaluation of
RIX4414, a live, attenuated rotavirus vaccine, in a randomized, double-blind,
placebo-controlled phase 2 trial involving 2464 Singaporean infants. J Infect
Dis 2005;192(Suppl. 1):S6–16.
“Shedding of vaccine (RIX4414) virus was detected in a large proportion of vaccinated infants (76%–80% of infants, for all 3 dose levels) on the seventh day after administration of the first dose .”
[10] Dennehy PH, Brady RC, Halperin SA, Ward RL, Alvey JC, Fischer Jr FH, et al.
Comparative evaluation of safety and immunogenicity oftwo dosages of an oral
live attenuated human rotavirus vaccine. Pediatr Infect Dis J 2005;24:481–8.
[11] Payne DC, Edwards KM, Bowen MD, Keckley E, Peters J, Esona MD, et al. Sibling
transmission of vaccine-derived rotavirus (RotaTeq) associated with rotavirus
gastroenteritis. Pediatrics 2010;125:e438–41.
“Reassortment between RotaTeq vaccine
strains of genotypes P7[5]G1
and P1A[8]G6 occurred during intestinal
replication, and transmission
occurred to an unvaccinated, older
sibling, which caused symptomatic
rotavirus gastroenteritis that required
ED medical care.”
[12] Boom JA, Sahni LC, Payne DC, Gautam R, Lyde F, Mijatovic-Rustempasic S,
et al. Symptomatic infection and detection of vaccine and vaccine-reassortant
rotavirus strains in 5 children: a case series. J Infect Dis 2012;206:1275–9.
[13] Rivera L, Pena˜ LM, Stainier I, Gillard P, Cheuvart B, Smolenov I, et al. Horizontal
transmission of a human rotavirus vaccine strain—a rand
is a double stranded RNA virus of the family Reoviridae that infects and
causes diarrheal disease in humans and different types of rotavirus strains can also
infect mammals such as cows and monkeys. Rotavirus is highly communicable and
most children have experienced a rotavirus infection by age five years. Rotavirus is
present in the gastrointestinal tract of infected persons and is shed in large quantities in
the stool beginning two days before onset of diarrhea and for up to 10 days after
symptoms begin. Rotavirus has been detected in the stool of immunodeficient persons
for more than 30 days after infection. 231
Rotavirus infection can be asymptomatic or may result in high fever, severe dehydrating
diarrhea, vomiting and very rarely, death, but most infections are uncomplicated and
resolve within 3 to 7 days. Immunodeficient children are at higher risk for complications
from rotavirus infection.he Emerging Risks of Live Virus & Virus Vectored Vaccines:
Vaccine Strain Virus Infection, Shedding & Transmission
NVIC Referenced Report – Nov. 2014, Page 33
There are two live attenuated oral rotavirus vaccines distributed in the U.S. that federal
health officials recommend be given to all infants at two, four and six months old.
Genetically Engineered Rotaviruses Plus Pig Virus DNA
Merck’s RotaTeq vaccine, licensed in 2006, contains five vaccine strain attenuated live
rotaviruses that were genetically engineered using cow and human rotaviruses.
RotaTeq also contains DNA from two pig viruses: porcine circovirus 1 and porcine
circovirus 2. 232
GlaxoSmithKline (GSK) markets Rotarix vaccine, which was licensed in 2008 and
contains vaccine strain live rotaviruses that were genetically engineered using human
rotaviruses. GSK states that “Porcine circovirus type 1 (PCV-1) is present in Rotarix.” 233
Since 2010 when porcine circoviruses were discovered to be contaminating rotavirus
vaccines, 234 both Merck and GSK have insisted that the pig viruses or DNA from pig
viruses present in their live oral rotavirus vaccines “are not known to cause disease in
humans.” However, porcine circovirus 1 is known to cause a lethal wasting disease in
baby piglets. 235
Vaccine Strain Rotavirus Shedding Poses Risks for Immunocompromised
Children
The author of a 2008 article discussing rotavirus vaccine viral shedding and
transmission by vaccinated children stated that “A review of rotavirus vaccine
prelicensure studies shows that viral shedding and transmission were higher with the
old tetravalent rhesus rotavirus vaccine [Rotashield withdrawn in 1999] than with the
current human attenuated monovalent rotavirus vaccine [Rotarix] and the pentavalent
bovine-human reassortment vaccine [RotaTeq].” 236
He warned that “Immunocompromised contacts should be advised to avoid contact with
stool from the immunised child if possible, particularly after the first vaccine dose for at
least 14 days” but added that ”the risk of vaccine transmission and subsequent vaccinederived
disease with the current vaccines is much less than the risk of wild type
rotavirus disease in immunocompromised contacts.”
Healthy Children Can Be Infected with Vaccine Strain Rotavirus Too
In 2010, a case report was published in Pediatrics describing a 30-month old healthy
boy who had never received rotavirus vaccine and was infected with vaccine strain
rotavirus. 237 He ended up in the emergency room with severe gastroenteritis 10 days
after his healthy two- month old brother was given a dose of Merck’s RotaTeq vaccine.
A stool sample was taken in the emergency room and came back positive for RotaTeq
vaccine derived strains after RT-PCR testing.
The authors of the case report noted that “transmission of RotaTeq strains to
unvaccinated contacts was not evaluated in the pivotal clinical trials.” They added that he Emerging Risks of Live Virus & Virus Vectored Vaccines:
Vaccine Strain Virus Infection, Shedding & Transmission
NVIC Referenced Report – Nov. 2014, Page 34
both RotaTeq and Rotarix [GlaxoSmithKline Biologicals] vaccines have “the potential for
vaccine-virus transmission to contacts.”
Majority of Vaccinated Infants Shed Vaccine Strain Rotavirus for A Week or
Longer
In the 2013 RotaTeq product information insert, Merck reported that vaccine-strain
rotavirus shedding was documented in the stool of 32 of 360 (8.9 percent) patients
following one dose of RotaTeq and appeared as early as one day and as late as 15
days after vaccination. The drug company acknowledged that “Transmission of vaccine
virus strains from vaccinees to non-vaccinated contacts has been observed postmarketing.”
238
The CDC reported that “Fecal shedding of rotavirus antigen was evaluated in all or a
subset of infants from seven studies in various countries. After dose 1, rotavirus
antigen shedding was detected by ELISA in 50% to 80% (depending on the study) of
infants at approximately day 7 and 0 to 24% at approximately day 30. After dose 2,
rotavirus antigen shedding was detected in 4% to 18% of infants at approximately day
7, and 0 to 1.2% at approximately day 30. The potential for transmission of vaccine
virus to others was not assessed.” 239
. [1] [9] Phua KB, Quak SH, Lee BW, Emmanuel SC, Goh P, Han HH, et al. Evaluation of RIX4414, a live, attenuated rotavirus vaccine, in a randomized, double-blind, placebo-controlled phase 2 trial involving 2464 Singaporean infants. J Infect Dis 2005;192(Suppl. 1):S6–16.
. [10] Dennehy PH, Brady RC, Halperin SA, Ward RL, Alvey JC, Fischer Jr FH, et al. Comparative evaluation of safety and immunogenicity of two dosages of an oral live attenuated human rotavirus vaccine. Pediatr Infect Dis J 2005;24:481–8.
. [11] Payne DC, Edwards KM, Bowen MD, Keckley E, Peters J, Esona MD, et al. Sibling transmission of vaccine-derived rotavirus (RotaTeq) associated with rotavirus gastroenteritis. Pediatrics 2010;125:e438–41.
. [12] Boom JA, Sahni LC, Payne DC, Gautam R, Lyde F, Mijatovic-Rustempasic S, et al. Symptomatic infection and detection of vaccine and vaccine-reassortant rotavirus strains in 5 children: a case series. J Infect Dis 2012;206:1275–9.
. [13] RiveraL,Pen ̃aLM,StainierI,GillardP,CheuvartB,SmolenovI,etal.Horizontal transmission of a human rotavirus vaccine strain—a randomized, placebo- controlled study in twins. Vaccine 2011;29:9508–13.
[2] J Infect Dis. 2012 Aug 1;206(3):377-83. doi: 10.1093/infdis/jis361. Epub 2012 May 21.
Identification of strains of RotaTeq rotavirus vaccine in infants with gastroenteritis following routine vaccination.
Donato CM1, Ch'ng LS, Boniface KF, Crawford NW, Buttery JP, Lyon M, Bishop RF, Kirkwood CD.
[3] Infect Genet Evol. 2012 Aug;12(6):1282-94. doi: 10.1016/j.meegid.2012.03.007. Epub 2012 Apr 2.
Vaccine-derived NSP2 segment in rotaviruses from vaccinated children with gastroenteritis in Nicaragua.
Bucardo F1, Rippinger CM, Svensson L, Patton JT.
Author information
[4] Phua KB, Quak SH, Lee BW, Emmanuel SC, Goh P, Han HH, et al. Evaluation of
RIX4414, a live, attenuated rotavirus vaccine, in a randomized, double-blind,
placebo-controlled phase 2 trial involving 2464 Singaporean infants. J Infect
Dis 2005;192(Suppl. 1):S6–16.
[5] Comparison of virus shedding after lived attenuated and pentavalent reassortant rotavirus vaccine
[6] Centers for Disease Control and Prevention. Intussusception among recipients of rotavirus vaccine—United States, 1998–1999. JAMA 1999;282:520-1.
[7] N Engl J Med. 2014 Feb 6;370(6):503-12. doi: 10.1056/NEJMoa1303164. Epub 2014 Jan 14.
Intussusception risk after rotavirus vaccination in U.S. infants.
Yih WK1, Lieu TA, Kulldorff M, Martin D, McMahill-Walraven CN, Platt R, Selvam N, Selvan M, Lee GM, Nguyen M.
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