Here are some articles on the new meningitis vaccine;
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
The government is investigating five reports of teenagers who came down with a serious neurological disorder after receiving a new vaccine against meningitis. 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:
FOR IMMEDIATE RELEASE
September 30, 2005
Julie Zawisza , 301-827-6242
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.
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.
More bad news...
***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.
Postgraduate Medical Journal 2003;79:295-296
© 2003 Fellowship of Postgraduate Medicine
ADVERSE DRUG REACTION Recurrent aseptic meningitis due to different non-steroidal anti-inflammatory drugs including rofecoxib M L Ashwath , H P Katner
Department of Internal Medicine, Mercer University School of Medicine, Macon, Georgia
Aseptic meningitis can be caused by viruses, drugs, and connective tissue disorders. The most common drugs causing it include antibiotics like trimethoprim-sulfamethoxazole, non-steroidal anti-inflammatory drugs (NSAIDs), intravenous immunoglobulins, intrathecal agents, vaccines, and monoclonal antibodies. A patient who had aseptic meningitis from three different NSAIDs including rofecoxib is presented.
Abbreviations: COX, cyclo-oxygenase; DIAM, drug induced aseptic meningitis; NSAIDs, non-steroidal anti-inflammatory drugs
SUNDAY , 29 OCTOBER 2006
By GREG MEYLAN
Public health doctors are worried vaccination rates will fall as a result of speculation about the safety of the meningococcal B vaccine.
Immunisation Advisory Centre director Dr Nikki Turner said negative publicity over the past week had seen an increase in calls from parents concerned about vaccinating their children against the 11 different diseases currently covered by inoculations. Last week, the Sunday Star-Times revealed the Norwegian Institute of Public Health is conducting a study of 160 people who claim they contracted chronic fatigue syndrome after taking part in the vaccine trial in the late 1980s.
On Wednesday, National Party health spokesman Tony Ryall said ACC had paid compensation for an adverse reaction in 33 of the 1.1 million people who received the meningococcal B vaccine. Turner said the average ACC payout was less than $80, not much more than a single doctor's visit, and she was confident the Norwegian study would find no link between the vaccine and chronic fatigue.
She said a Canadian study into a similar claim about a hepatitis B vaccine showed there was no connection, and the meningococcal disease had never been linked to chronic fatigue syndrome. Turner said parents had already started questioning whether to give their children other vaccines, but she hoped the downturn would be short-lived, as occurred after a mistaken link between the measles, mumps and rubella vaccine and autism was reported in the UK.
"There is always a dilemma between the media interests and public health interests," Turner said. As a result of the increased publicity, the Health Ministry had calls from about half a dozen people last week claiming to have suffered an adverse reaction to the vaccine. Meningococcal B vaccine campaign director Dr Jane O'Hallahan said the claims were being dealt with, and each case was being forwarded to the Centre for Adverse Reactions Monitoring for evaluation.
Immunisation Advisory Centre communication director Helen Petousis-Harris said it was significant that the background rate for chronic fatigue syndrome was between 0.18% to 0.5%, but the self reported rate after publicity in Norway was more than 10 times lower at only 0.012%. Petousis-Harris said it was natural that people associated an illness that started at the time of a vaccination with the vaccine, but whether or not this was the case was more complicated to establish.
For example, she said, there were 65 cot deaths a year in New Zealand, more than one a week. "Just by chance a number of these deaths will occur in the same week after immunisation, but research shows that the risk of cot death is slightly lower after immunisation, indicating a protective effect."
http://snipurl.com/codw4 [Daily Mail, UK]
Alert over tainted meningitis vaccine: 60,000-dose recall after tests uncover bug
By Jenny Hope
Last updated at 12:29 AM on 26th February 2009
Alert: A meningitis C vaccine has been withdrawn because it was contaminated with a potentially lethal bacterium. Thousands of doses of meningitis C vaccine were recalled last night after a contamination scare. The alert was sounded after tests found traces of the bug Staphylococcus aureus, which can cause blood poisoning.
About 60,000 doses are being recalled, a third of which had already been delivered to GP surgeries and health clinics in the past month. It is not yet known how many have been given to babies. Government health chiefs said the recall was a 'precautionary measure' and no adverse reactions have been recorded in children in the UK.
A spokesman for the Medicines and Healthcare products Regulatory Agency (MHRA) said the decision to recall the two batches was made just to be on the safe side, even though 'there is no reason for UK children to be at any risk'. She added: 'The batches concerned were tested prior to release and complied with all tests, including the sterility test. 'The tested samples that failed the sterility test were part of a non-routine study undertaken by the company and were not part of the UK market product. This is an entirely precautionary action.
'There is no reason to believe the UK batches are at risk of the problems of the material that was tested. These batches have been withdrawn to ensure that there are no grounds for anyone to be concerned.' A Department of Health spokesman said: 'If people have had this vaccine recently and are concerned contact your GP or NHS Direct. We know which practices have received this vaccine and they will be contacted directly.' The vaccine, sold under the trade name Menjugate, was manufactured and packed in Italy by Novartis.
A spokesman for the pharmaceutical company said it was working with the MHRA and Italian ministry of health to recall two batches of Menjugate Kit distributed in the UK. She said: 'We are investigating a sterility-testing positive result from samples of one lot of aluminium hydroxide solvent which was used for the packaging of two lots of Menjugate. 'The solvent lot passed all release specifications; the subject result was identified during a special study. Novartis is committed to being a safe and reliable provider of vaccines.' Millions of jabs for meningitis C are administered every year in Britain as part of the routine immunisation of babies at two, three and four months. The safety alert affects doses of the vaccine given as boosters at four months. Meningitis, in which the protective membranes around the brain become infected and inflamed, kills at least one in ten sufferers. Some survivors suffer permanent complications such as brain damage, epilepsy and deafness..
A decade ago, Britain became the first country to routinely vaccinate against the meningitis C – a move believed to save 150 lives each winter. The programme was brought in to prevent two out of five cases of the disease – the rest are caused by the B strain for which there is not yet an effective vaccine. The group C bacteria was regarded as a special threat at the time because it formed a growing proportion of overall meningitis infections in Britain.