http://www.nursingtimes.net/nav?page=nt.news.story&resource=2246191

Meningitis vaccination may increase risk in under-2s
NT Online News
posted on 21 04 2005

Vaccination against meningitis in children under two may make them more susceptible to the disease rather than conferring protection, according to a new study. The authors of research published in Clinical Infectious Diseases say that serogroup C meningococcal polysaccharide vaccine confers a high level of protection among school-age children, but that children under two remain susceptible to infection following vaccination.

They found that, during the first 2 years after immunization, vaccine effectiveness was 95.0% among those age 6 years or older; efficacy was 77.3% during the following 3 years. For those age 2 to 5 years, the vaccine was 62% effective during the first 2 years, but the estimate of effectiveness was negative during the next 3 years. For those younger than 2 years, the estimate of effectiveness was -7.9% during the first period and highly negative (-390.5%) during the second period.

‘The possibility of increased susceptibility to serogroup C meningococcal disease resulting from administration of a polysaccharide vaccine at a young age cannot be excluded,’ say the authors, suggesting that ‘once the protective antibodies have disappeared, the inhibition of the serological response could result in greater susceptibility to invasive disease’.

Reference: De Wals P et al (2005) Effectiveness of Serogroup C Meningococcal Polysaccharide Vaccine: Results from a Case-Control Study in Quebec Clin Infect Dis 40 (8) 1116-1122

FDA Probes Vaccine's Tie to Brain Illness

Menactra protects against rare but devastating cases of bacterial meningitis. The shot is particularly targeted to college students, because close contact is the biggest risk factor for its spread. (Meningitis is a side effect of vaccines)

The five cases reported two to four weeks after Menactra vaccination occurred in 17- or 18-year-olds in New York, Ohio, Pennsylvania and New Jersey, FDA said. All are reported to be recovering. For the full story go here:

FDA News

FOR IMMEDIATE RELEASE
P05-66
September 30, 2005

Media Inquiries:
Julie Zawisza , 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA and CDC Issue Alert on Menactra Meningococcal Vaccine and Guillain Barre Syndrome

The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are alerting consumers and health care providers to five reports of Guillain Barre Syndrome (GBS) following administration of Meningococcal Conjugate Vaccine A, C, Y, and W135 (trade name Menactra), manufactured by Sanofi Pasteur. It is not known yet whether these cases were caused by the vaccine or are coincidental. FDA and CDC are sharing this information with the public now and actively investigating the situation because of its potentially serious nature.

Guillain Barre Syndrome (GBS) is a serious neurological disorder that can occur, often in healthy individuals, either spontaneously or after certain infections. GBS typically causes increasing weakness in the legs and arms that can be severe and require hospitalization.

Meningococcal infection, which Menactra prevents, is a major cause of bacterial meningitis, affecting approximately 1 in 100,000 people annually. The infection can be life threatening: 10-14 percent of cases are fatal and 11-19 percent of survivors may have permanent disability.

According to Jesse Goodman, MD, Director of FDA’s Center for Biologics Evaluation and Research, at the present time there are no changes in recommendations for vaccination; individuals should continue to follow their doctors' recommendations. FDA and CDC are not able to determine if any or all of the cases were due to vaccination. The current information is very preliminary and the two agencies are continuing to evaluate the situation.

Because of the potentially serious nature of this matter, FDA and CDC are asking any persons with knowledge of any possible cases of GBS occurring after Menactra to report them to the Vaccine Adverse Event Reporting System (VAERS) to help the agencies further evaluate the matter. Individuals can report to VAERS on the web at www.vaers.hhs.gov <http://www.vaers.hhs.gov> or by phone at 1-800-822-7967.

The five cases of GBS reported following administration of Menactra occurred in individuals living in NY, OH, PA, and NJ. All five patients were 17 or 18 years of age and developed weakness or abnormal sensations in the arms or legs, two-four weeks after vaccination. All individuals are reported to be recovering or to have recovered. More than 2.5 million doses of Menactra vaccine have been distributed to date. The rate of GBS based on the number of cases reported following administration of Menactra is similar to what might have been expected to occur by coincidence, that is, even without vaccination. However, the timing of the events is of concern. Also, vaccine adverse events are not always reported to FDA so there may be additional cases of which we are unaware at this time.

Prelicensure studies conducted by Sanofi Pasteur of more than 7000 recipients of Menactra showed no GBS cases. CDC conducted a rapid study using available health care organization databases and found that no cases of GBS have been reported to date among 110,000 Menactra recipients.

Croatian toddlers contract meningitis through bad vaccine

Tuesday • October 25, 2005

Ten Croatian toddlers had to be hospitalized after contracting viral meningitis caused by a local vaccine against rubella, measles and mumps, a doctor said.

"We established that ten children (hospitalized for meningitis) were infected by a virus found in vaccine made by the Zagreb Immunological Institute," Ana Bace, a doctor at the Croatian capital's hospital for infectious diseases, told AFP. The children, aged between 12 and 15 months, were infected during the past five months. The combined MoPaRu vaccine has been used in Croatia since 1986. "Pediatricians have constantly demanded in vain that this vaccine ... be replaced," doctor Goran Tesovic told the Jutarnji List daily.

Another, more efficient vaccine of a foreign producer is also registered in Croatia but parents have to pay for it, he added. The Immunological Institute which produces the vaccine slammed a "media campaign of foreign producers." During the past 10 years some 200 children have contracted viral meningitis in Croatia as a result of MoPaRu Vaccine, local media claim.

Meningitis, which often affects small children, is a serious disease in which the tissues enclosing the brain and spinal cord become infected and swollen and can be fatal if not treated properly. It is spread by direct contact with droplets from the nose and mouth of infected people. — AFP

Copyright MediaCorp Press Ltd. All rights reserved.

1: J Neurol. 1978 Feb 14;217(3):219-22.

Meningoencephalitis syndrome following influenza vaccination.

Gross WL, Ravens KG, Hansen HW.

Immunological reactions to non-virus substances of vaccines may be of considerable significance to the pathogenesis of neurological complications after anti-influenza vaccination. A 60 year old female patient with a known allergic diathesis developed a meningoencephalitis syndrome a few hours after vaccination. The case history as well as the clinical course suggested an immunopathogenetic mechanism. We therefore analyzed the immune profile. Intracutaneous testing with chicken meat and chicken egg protein lead to a striking local anaphylactic reaction which is discussed in causal relation to the postvaccination complication.

Publication Types:
Case Reports

Meningitis shot may hold higher GBS risk

By MIKE STOBBE, AP Medical WriterThu Oct 19, 7:40 PM ET

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. 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.

***Emergency Cheese Recall***

Is Listeria growing in your refrigerator? Will you be serving your family a diseased dinner?

In 1985 (vol. 312) the New England Journal of Medicine reported:

"Listeria organisms excreted in cow's milk escaped pasteurization, grew well at refrigerator temperatures, and were ingested by consumers." You might wonder, "Isn't Listeria killed by pasteurization?" In July of 1987, the Journal of Environmental Microbiology reported:

"Milk from cows inoculated with listeria was pooled for 2 to 4 days and then heated at 162 degrees Fahrenheit for 16 seconds in a high-temperature, short-time pasteurization unit. Live listeria bacteria was then successfully isolated from the milk after heat treatment in 11 of 12 pasteurization trials."

Ricotta Salata cheese recalled because of listeria

By JAMES SALZER
The Atlanta Journal-Constitution
Published on: 08/28/07

State Department of Agriculture scientists have found dangerous Listeria monocytogenes bacteria in a Georgia sample of Italian-made Ricotta Salata cheese, officials said this morning. The agriculture department said the contamination was found in a package imported under the brand name of Locatelli and marked to sell by Jan. 21. The cheese was imported by The Ambriola Company, Inc. of Jersey City, New Jersey.

"We have notified the U.S. Food and Drug Administration of today's lab findings, and we are warning the public about the contamination," Agriculture Commissioner Tommy Irvin said. Consumption of food contaminated with the bacteria can cause listeriosis, which can manifest as meningitis. Symptoms of meningitis include high fever, severe headaches, back stiffness and nausea. Listeriosis can also cause miscarriage and stillbirth as well as dangerous infections for infants, the elderly and those with weakened immune systems.

Robert Cohen
http://www.notmilk.com

FDA Probes Vaccine's Tie to Brain Illness

Meningitis shot may hold higher GBS risk

ADVERSE DRUG REACTION

Recurrent aseptic meningitis due to different non-steroidal anti-inflammatory drugs including rofecoxib