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RotaVirus IndexNote: RotaTeq® [below] is Merck's Rota Virus vaccine FDA approved February 3, 2006.
RotaTeq® and Rotarix®
Note: Rotarix® is GlaxoSmithKline PLc's Rota Virus Vaccine - February 2008 is under FDA review.
General Information | Additional Information | History | Overview by Mary Tocco | VAERS
General Information |
For the older RotaVirus vaccine that was withdrawn from the market see our History below
General Information: RotaTeq®RotaTeq vaccine adverse events and policy considerations
by David A. Geier, Paul G. King, Lisa K. Sykes, and Mark R. Geier
Online at: ^Full 9 page article -- EXCELLENT! -- PDF file [728KB]
FDA Public Health Notification: (summary)
Rotavirus, Live, Oral, Pentavalent vaccine (RotaTeq)
Audience: Pediatric healthcare professionals, consumersRead full report here http://www.fda.gov/cber/safety/phnrota021307.htm
FDA Public Health Notification (February 13, 2007)
Information on RotaTeq and Intussusception
"Since its licensure on February 3, 2006 until January 31, 2007, 28 cases of intussusception have been reported in the U.S. in infants who received RotaTeq. These cases have been reported to the Vaccine Adverse Event Reporting System (VAERS). The reported 28 cases occurred after dose 1, dose 2 and dose 3. Approximately half of the cases occurred 1 to 21 days after vaccination, with a range of 0 to 73 days. Sixteen of the 28 infants with intussusception required hospitalization and surgery on their intestine. The remaining 12 infants had reduction of the intussusception by contrast or air enema. No deaths due to intussusception were reported."
PACKAGE INSERT - RotaTeq
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FDA/Merck's patient "advice" sheet
[See the history section below for the side effects, conflict of interest, etc regarding the previous RotaVirus vaccine
Rotavirus Vaccine - RotaTeq
Like many other vaccines, this vaccine has not been thoroughly studied before being released. When the first rotavirus vaccine, Rota Shield, was released in 1998, there were also concerns about the inadequate safety studies prior to licensing.
Read entire page on our site (VacLib.org)
Source: http://www.marytocco.com/news.htm now archived at http://www.vaclib.org/news/2007/RotaTeq.htm
History: the previous RotaVirus Vaccine disasterA previous rotavirus vaccine was put on the market in 1998 and withdrawn in 1999 due to a high rate of bowel obstructions.
Congressional Hearing Exposes Conflict of Interest
More conflict of Interest and unscientific decisions
Shoot First and Ask Questions Later: by Michael Belkin
Another Phantom Virus By Gary Krasner
Peter Duesberg’s excellent book, “Inventing The AIDS Virus” (reviewed in WB last year), contains a section entitled, Phantom Viruses And Big Bucks. It described the discovery (actually, “invention”) of a harmless virus that is purportedly the cause of Hepatitis-C. Early last year when I began to read about rotavirus and the proposed new vaccine for it, I immediately thought of that section in Duesberg’s book, but with one exception: Not only is a virus not the cause of diarrhea, but the so called disease itself is just a natural condition in response to an inappropriate diet, and is effectively treatable by parents, without drugs. (Note: Diarrhea may also accompany normal biological changes, such as teething.)
Google Search that yields 30 plus links to vaclib.org pages containing a statement regarding rotavirus vaccine
Collection of internal CDC memos regarding intussusception following the 1999 Rotavirus vaccination campaign.
Note the annual rate of intussusception then was 1,556 in children less than 12 months of age.
Hospital discharge data from 1989 through 1998 were reviewed for children (<1 year old) whose primary or secondary diagnosis was coded as intussusception or rotavirus diarrhea.
Conclusion. Our data suggest that in New York the rate of intussusception has declined, and approximately 1 child in 2600 develops intussusception before 1 year of age.
[Note: 1 child in 2600 is equalivalent to 1538 cases per 4,000,000 infants born per year. Alternately, this is 38.5 per 100,000.]
RotaTeq and VAERSJune 4, 2007 copy of 18 VAERS reports for ROT (RotaTeq) Vaccine.
Notice that not one of the 18 reports identify the manufacturer of the ROT vaccine, except one does list the lot as Merck.
Also notice one from a nurse whose patient sneezed the vaccine into her eyes:
VAERS ID 267380
Symptoms: Cough Dysphonia Malaise Medication error Pain Paraesthesia
At 3:30 pm, I (a registered nurse) was administering the Rototech vaccine to an infant. After delivering half of it slowly, I paused and the baby sneezed, thereby spraying much of it into both of my eyes, with slightly more into the right eye. I immediately rinsed my eyes in the sink, but started having a tingling sensation, which progressed within a minute or two into a ground glass like pain. Then I began to cough uncontrollably, which lasted for hours, until I lost my voice altogether.MY epes became very
18 VAERS reports for RotaTeq
Rotarix Vaccine Contaminates Millions with Pig VirusesNewark, Delaware - March 27, 2010 From the Desk of Kevin A. Muhammad
Rotarix Vaccine Contaminates Millions with Pig Viruses
FDA "Temporarily" Suspends Using Vaccine
On Monday, March 22, 2010, the Food and Drug Administration (FDA) asked pediatricians and other physicians to "temporarily" suspend administering GlaxoSmithKline's vaccine, Rotarix. This vaccine is one of two licensed in the United States (U.S.) that target the rotavirus infections. The other vaccine, RotaTeq, is manufactured by Merck & Co., Inc.
Approximately one million children in the U.S., and about 30 million worldwide have received the Rotarix vaccine since it was FDA-approved in 2008. Nearly 70 million doses have been distributed. How will the remaining dosages be handled? Will they be discarded or will the suspension be lifted for the sake of profits. We must keep our eyes fixed on this issue.
The vaccine was contaminated with a substantial amount of DNA from the porcine circovirus 1, a virus known to infect pigs. An academic research team, using a novel technique to detect viruses in a range of vaccines, discovered the contamination. The research team has not been named, but it immediately alerted GlaxoSmithKline and the FDA.
Read rest of story here: http://r20.rs6.net/tn.jsp ......(PDF File)
FDA ties pneumonia deaths to infant vaccine Agency panel considering approval of oral medicine for diarrhea virus
Reuters: updated 9:20 a.m. MT, Fri., Feb. 15, 2008
WASHINGTON - GlaxoSmithKline Plc's rotavirus vaccine is associated with increased pneumonia-related deaths and other adverse reactions, U.S. regulatory staff said in documents posted on Friday.
The review comes ahead of a Food and Drug Administration advisory meeting next Wednesday to consider approval of the oral vaccine to prevent the most common cause of severe diarrhea and dehydration among infants and young children in the world.
FDA staff said its analysis of 11 studies revealed that in the largest trial, there was a statistically significant increase in deaths related to pneumonia compared with placebo, documents posted on the FDA's Web site said.
That study, which enrolled about 63,000 children, also found an increase in convulsions in children given the drug, named Rotarix. Another study found an increased rate of bronchitis, compared with placebo.
In a conclusion section, the FDA documents noted the pneumonia-related deaths and convulsions, but did not appear to make a recommendation to the advisory panel.
That expert panel will weigh the staff review, but makes its own recommendation, which is typically followed by the FDA.
Additional Information on Rotarix[Denmark] Intussusception in Early Childhood: A Cohort Study of 1.7 Million Children http://pediatrics.aappublications.org/cgi/content/full/114/3/782
Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis (2006)
This study evaluated the safety and efficacy of GSK’s rotavirus vaccine (Rotarix®), with a focus on determining risk of intussusception.
Ruiz-Palacios G, Pérez-Schael I, Velázquez F, et al. New England Journal of Medicine. 354(1):11-22.
Note: Death rate was higher in the vaccinated. "Placebo" contained the same ingredients as the vaccine except for the virus. About 9 percent of the group with drew consent to continue after the first dose.
(2006)pdf English 233 kb
Rotarix® international data sheet (2004)
This informational sheet contains prescription information for administration of Rotarix® in Latin American countries, among others. GSK pdf English 67 kb