Meningitis Shot Warning
AnonymousOctober 19, 2006 at 8:17 pm
My daughter, 14 years old, went for her yearly physical. It was suggested that she get the Meningitis shot now as there apparently have been a few more meningits ‘outbreaks’ recently. This is not a shot that is generally given at this age, but apparently doctors offices are now suggesting it to parents who are of high school age. Its not ‘compulsory’ but recommended. Read the materials given to me, pointed out the GBS connection on the back page and declined. Doc wasnt tooo bothered, but i dont think too happy either. In any case, this evening while watching my man ‘Shep”, I happened to see on the ticker (I think thats what its called), the news that moves on the bottom of the screen, this warning … interesting ……….. Went onto the fox news/health page, and had to do some hard looking to find this article.
Meningitis Shot May Hold Higher GBS Risk
Thursday, October 19, 2006
By MIKE STOBBE, AP Medical Writer
[B]ATLANTA — Young people who get a new meningitis shot may be at a slightly higher risk of developing a paralyzing side effect, federal researchers said Thursday.[/B]
Even so, federal health officials said the benefits far outweigh the risk of getting the rare condition, Guillain-Barre syndrome. They are not backing off their recommendation that most students be vaccinated.
The researchers cautioned that they are uncertain about their risk estimate, and a larger study is being planned.
They found the added risk was 1.25 cases of GBS for every 1 million doses of vaccine distributed.
“It’s a very small risk,”said one of the study’s authors, Dr. Robert Davis of the U.S. Centers for Disease Control and Prevention, who noted the risk of getting meningitis without the shot is far greater.
A federal vaccination advisory committee is to discuss the research next week when it takes a new look at the government’s meningitis vaccine recommendations, CDC officials said.
The research was reported Thursday in the CDC’s Morbidity and Mortality Weekly Report.
The vaccine, Menactra, is made by Sanofi Pasteur, which said it tested it in more than 10,000 people. The company reported no cases of Guillain-Barre, or GBS, which is characterized by increasing weakness in the legs and arms, sometimes severe enough to cause paralysis.
The government approved the vaccine for marketing in January 2005, and the CDC recommended it for routine vaccination four months later.
About 6.6 million doses had been distributed through the end of September, according to Sanofi.
The CDC recommends the vaccine for students when they enter high school and college. In particular, college freshmen living in dorms are urged to get the shot because close contact is a major risk in the spread of bacterial meningitis. People ages 15 to 24 have some of the highest mortality rates. Survivors can suffer mental disabilities, hearing loss and paralysis.
Between March 2005 and September 2006, 17 people who developed GBS within six weeks of receiving the vaccine. Fifteen of those were 11 to 19 years old.
Scientists expect a small number of GBS cases to occur naturally, so the researchers calculated an expected rate of cases and compared it to the rate in the vaccinated people.
Death or serious illness from bacterial meningitis occurs at an annual rate of about 1.2 cases per 100,000 youths ages 11 to 19, said Davis, director of the CDC’s immunization safety office.
That means the risk of an unvaccinated youth getting seriously ill from bacterial meningitis is about 10 times greater than the risk of a vaccinated youth developing GBS, according to the study.
The study data is believed to be flawed, however, in part because GBS reports are voluntary, meaning vaccine side effects may be underreported. Also, the natural rate of GBS is based on hospital data that may be flawed, Davis said.
A larger study that would give a more accurate picture of the risk is being discussed with the vaccine maker, Davis said.
As for the new CDC study,”we think the data are inconclusive”and should be interpreted cautiously, said Dr. Gregory Gilmet, Sanofi Pasteur’s medical director of medical affairs.
[I]Copyright 2006 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.[/I]
AnonymousOctober 20, 2006 at 12:22 am
Meningitis vaccine may have paralyzing side-effect: small study
Last Updated: Thursday, October 19, 2006 | 6:39 PM ET
Students who get a new meningitis shot may have a slightly higher risk of developing a rare, paralyzing side-effect, but the benefits of the vaccine outweigh the risks, U.S. health officials say.
The preliminary study suggested there would be 1.25 cases of Guillain-Barre syndrome for every one million doses of the vaccine given out, the U.S. Centers for Disease Control reported in Thursday’s issue of the Morbidity and Mortality Weekly Report.
A larger study is planned to improve the accuracy of the risk estimate.
Guillain-Barre, or GBS, is a rare neurological disorder where the feet, legs, arms and hands become weak. The majority of people recover completely, but sometimes it causes paralysis.
Sanofi Pasteur, the maker of the meningitis vaccine called Menactra, said it has tested the injection in more than 10,000 people with no reported cases of GBS.
A spokesperson for the company called the CDC data “inconclusive” and said it should be interpreted cautiously.
In May, Health Canada approved Menactra for protection against meningococcal disease in people aged 11 to 55.
On routine vaccination list
The U.S. Food and Drug Administration approved it for sale in January and the CDC included it in its list of routine vaccinations four months later.
The CDC recommends the vaccine for students starting high school and university, since people aged 15 to 24 show some of the highest mortality rates from bacterial meningitis.
The CDC report found 17 people developed GBS within six weeks of receiving the vaccine between March 2005 and September 2006. All but two of the people were between 11 and 19 years old.
The risk of falling seriously ill from bacterial meningitis is about 10 times higher than the risk of developing GBS for a vaccinated young person, according to the study.
About 11 per cent to 19 per cent of people who recover from meningitis may show mental disabilities, hearing loss and paralysis.
Since reports of GBS are voluntary, the side-effects of the vaccine may be underreported. But normal rates of the syndrome also made it more difficult for researchers to isolate which cases might be linked to vaccination.
The most common side-effects of the vaccine include pain and redness at the injection site, headache, fatigue and malaise.
With files from the Associated Press Related
Guillain-Barré Syndrome/Menactra report, CDC Morbidity and Mortality Weekly Report
AnonymousOctober 25, 2006 at 11:57 am
CDC Investigating GBS Cases Linked To Meningococcal Vaccine
17 cases of post-vaccination Guillain-Barré Syndrome
The Centers for Disease Control and Prevention is investigating 17 cases of Guillain-Barré Syndrome (GBS) in recipients of meningococcal conjugate vaccine (MCV4) (Menactra®, Sanofi Pasteur Inc., Swiftwater, PA).1
GBS is a serious neurologic disorder involving inflammatory demyelination of the peripheral nerves. During March 2005—February 2006, eight confirmed cases had occurred within six weeks (i.e., the time window of elevated risk noted for GBS after administration of other vaccines) after MCV4 vaccination, according to the Vaccine Adverse Event Reporting System (VAERS). The CDC recently announced that nine additional GBS cases had been reported to VAERS during March—September 2006.
“Although these data suggest a small increased risk for GBS after MCV4 vaccination, the inherent limitations of VAERS and the uncertainty regarding background incidence rates for GBS require that these findings be viewed with caution,” the CDC advised. “Because of the risk for meningococcal disease and the associated morbidity and mortality, CDC continues to recommend routine vaccination with MCV4 for adolescents, college freshmen living in dormitories, and other populations at increased risk.”
Neisseria meningitidis is a major cause of bacterial meningitis and sepsis in the United States. The case-fatality ratio for meningococcal disease is 10%—14%. During 1991—2002, the rate for persons aged 11—19 years was 1.2 per 100,000 per year and was higher than the rate for the general population.
“The completeness of GBS reporting to VAERS, a passive surveillance system, is unknown,” the CDC acknowledged. “If underreporting to VAERS of GBS after MCV4 vaccination has occurred, the risk would be higher than estimated in this report. …The timing of onset of neurologic symptoms within 1—5 weeks of vaccination among reported cases continues to be of concern. …Given the data in this report, [CDC] will review the current recommendations for MCV4.”
CDC encourages all persons to report cases of GBS or any other clinically significant adverse events associated with MCV4 or any other vaccination to VAERS. Reports may be submitted securely online at [url]http://www.vaers.hhs.gov[/url] or by fax at 877-721-0366. Reporting forms and additional information are available at telephone, 800-822-7967.
1. Centers for Disease Control and Prevention. Update: Guillain-Barré Syndrome Among Recipients of Menactra® Meningococcal Conjugate Vaccine — United States, June 2005—September 2006.
AnonymousOctober 30, 2006 at 12:18 pm
It is good to see that more people are getting the information about GBS and the Menactra meningicoccal vaccination. We believe that our daughter got GBS last year, 31 days after receiving the vaccination. Originally, the CDC and FDA announced on Sept. “05 that 5 teens from the northeast came down with GBS after the Menactra vaccination. Very few people got the news. It was a miracle that my husband saw a blurb about it on the Dow Jones scrolling news on a Friday night. We alerted the doctors who had been trying to figure out her illness for 2 1/2 months. They did testing for GBS, all came back “normal”. We now believe that the window of opportunity for testing was long gone. In April of ’06 there were more cases confirmed and this last announcement on Oct. 19th or 20th said that there were 17 cases in all, 15 of them between the ages of 11 and 19. I don’t think that the CDC, FDA or the manufacturer- Sanofi-Aventis are doing enough to get the word out. Such a miniscule percentage of the population have heard about it over this past year. I have a google alert set up on my computer for the past year, so I get news continually, not always about the relationship about the GBS and menactra, but everything in the news about each. Our first encounter with the news last year was a “God” alert. I’m sure that the milder cases just go undetected and there are numbers of patients who are undiagnosed and therefore under-reported to VAERS. My daughter still suffers residual effects, although leads a fairly normal life of a 19 year old. The most damage that she suffers is from the lack of support that she had from her doctors. So, she has no one really to answer her questions or guide her now and gets depressed and angry. I am going to contact some of the doctors in NYC tha Gene suggested. Maybe they won’t blow us off.
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