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FDA and CDC Update Information on Menactra Meningococcal Vaccine and Guillain Barre Syndrome

Fri, 20 Oct 2006 00:00:00 -0700

The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are updating a previous alert to consumers and health care providers regarding reports of Guillain Barre Syndrome (GBS) following administration of Meningococcal Conjugate Vaccine A, C, Y, and W135 (trade name Menactra), manufactured by Sanofi Pasteur. In October 2005, FDA and CDC reported 5 cases of GBS following administration of Menactra (http://www.fda.gov/bbs/topics/news/2005/new01238.html).

GBS is a serious, rare neurological disorder that can occur, often in healthy individuals, either spontaneously or after certain infections. GBS typically causes increasing weakness in leg, arm and other muscles that can be severe and require hospitalization. GBS usually resolves on its own, however some people may have residual neurological deficits.

To date a total of 15 confirmed cases of GBS among individuals 11-19 years of age occurring within six weeks of vaccination with Menactra have been reported to the Vaccine Adverse Event Reporting System (VAERS). Two additional cases have been confirmed in persons 20 years of age and older. All individuals are reported to be recovering or have recovered. While the cases reported suggest a small increased risk of GBS following immunization with Menactra, the limitations in VAERS, and the uncertainty regarding background incidence rates for GBS require that these findings be viewed with caution. At this time, CDC and FDA cannot determine with certainty whether Menactra does increase the risk of GBS in persons who receive the vaccine and, if so, to what degree (the current data suggests an estimated possible increase of approximately 1.25 GBS cases for every million vaccinnees, but this estimate has many uncertainties).

Menactra prevents meningococcal disease, which is a major cause of bacterial meningitis (an infection of the lining of the brain and spinal cord) and blood stream infections. Meningococcal disease affects approximately 1 in 100,000 people ages 11-19 annually. The infection can be life threatening: 10-14 percent of cases are fatal and 11-19 percent of survivors may have permanent disability.

At the present time, there are no changes in recommendations for vaccination and individuals should continue to follow their doctors' recommendations. CDC’s Advisory Committee on Immunization Practices will be reviewing this information at its next meeting, October 25-26, 2006.

FDA and CDC are continuing to monitor the situation and are asking any persons with knowledge of any possible cases of GBS occurring after receiving Menactra to report them to VAERS to help the agencies further evaluate the matter. Individuals can report to VAERS on the web at http://www.vaers.hhs.gov or by phone at 1-800-822-7967.

Studies of more than 7,000 recipients performed by sanofi pasteur before the licensure of the vaccine showed no GBS cases. An analysis of Menactra use within the Vaccine Safety Datalink, a database of vaccine information from eight large managed care organizations, revealed that as of September 20, 2006, a total of 126,506 doses had been delivered and, of those, no cases of GBS have been observed among vaccine recipients ages 11-19 within six weeks of vaccination. Additional, larger studies are being planned to provide a more definitive assessment.

Meningitis vaccine may have link to neurological disorder

Mon, 10 Oct 2005 00:00:00 -0700

Public health officials are investigating whether a new vaccine designed to help prevent meningitis, particularly among college students in dorms, could be linked to a rare neurological condition.

The vaccine, called Menactra, helps protect against certain strains of meningococcal bacteria. Produced by Sanofi Pasteur, the vaccine was approved for use in January. While another vaccine was already on the market, doctors had hoped that the new formulation might offer longer immunity.

Since Oct. 4, officials at the U.S. Centers for Disease Control and Prevention have received reports that five teenagers, all ages 17 and 18, developed symptoms of Guillain-Barre syndrome within six weeks of getting the new vaccine. About 2.5 million doses of the vaccine have been sold.

GBS is a disorder in which the body's immune system attacks part of the peripheral nervous system.

While the number of cases is not apparently abnormal, officials are concerned because they occurred so quickly after the teens got the shots, Dr. Nancy Rosenstein of the CDC told experts gathered Friday in San Francisco for the annual meeting of the Infectious Diseases Society of America.

The CDC issued an alert Thursday night in its Morbidity and Mortality Weekly Report that physicians should be acutely aware of any symptoms of GBS in patients newly vaccinated with Menactra. Because no link between the two has been established, officials are recommending continued use of the vaccine.

A similar vaccine has been used in Britain, where 30 million doses have been administered with only five cases of GBS reported.

In a statement, Sinofi Pasteur said, "No causal relationship has been established between Menactra vaccination and GBS, and there remain several possible explanations for the reported cases of GBS."

Menactra Vaccine May Have Tie to Brain Illness

Mon, 03 Oct 2005 00:00:00 -0700

The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are alerting consumers and health care providers that five reports of Guillain Barre Syndrome (GBS) followed administration of Menactra, a new vaccine against meningitis that is manufactured by Sanofi Pasteur.

It is not known yet whether these cases were caused by the vaccine or are coincidental.

Guillain Barre Syndrome (GDS) 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.

Menactra protects against bacterial meningitis, and the vaccine is recommended for college students living in dormitories because close contact is the biggest risk factor for the spread of bacterial meningitis.

Because the FDA and the DCD are not able to determine if any or all of the cases were due to the vaccination, The FDA is recommending that individuals continue to follow their doctors’ recommendations with regard to receiving Menactra.

The five reported cases of GBS followed administration of Menactra in individuals living in New York, Ohio, Pennsylvania and New Jersey. All five patients were 17 or 18 years of age and developed symptoms two to four weeks after being vaccinated. All individuals are in recovery.

More than 2.5 million doses of Menactra vaccine have been distributed to date, and the rate of GBS following administration of the vaccine is what might have been expected to occur by coincidence, that is, even without the vaccination. However the timing of the events is of concern, stated the FDA, and vaccine adverse events are not always reported, so there may be additional cases that have occurred.

Prior to the licensing of Menactra, Sanofi Pasteur studied more then 7000 recipients of Menactra. No GBS cases were found. The CDC also conducted a rapid study using available health care organization databases and found no cases of GBS to have been reported among 110,000 Menactra recipients.

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

Fri, 30 Sep 2005 00:00:00 -0700

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.

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.

FDA Probes Vaccine's Tie to Brain Illness

Fri, 30 Sep 2005 00:00:00 -0700

The government is investigating five reports of teenagers who came down with a serious neurological disorder after receiving a new vaccine against meningitis.

Doctors don't yet know whether the cases of Guillain Barre syndrome are related to the shot, called Menactra, or are coincidence, the Food and Drug Administration emphasized Friday.

The government recommends the vaccine for adolescents and college freshmen living in dormitories, and FDA said there was no reason to change that advice but it alerted the public as a precaution.

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. While there are fewer than 3,000 cases of invasive meningococcal meningitis each year, and 300 deaths, people ages 15 to 24 have the highest mortality rates, and survivors can suffer mental disabilities, hearing loss and paralysis.

Menactra is a new vaccine approved last January; an older meningitis vaccine is available, too, but doesn't provide as much protection.

Guillain Barre syndrome, or GBS, causes increasing weakness in the legs and arms, sometimes severe enough to cause paralysis. It can strike suddenly, either spontaneously or after certain infections.

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.

Studies of more than 7,000 Menactra recipients by manufacturer Sanofi-Pasteur showed no GBS cases, and more than 2.5 million doses have been administered since it hit the market, FDA said. The rate of GBS is similar to what is expected without vaccination, but the timing of the cases is of concern and warrants further investigations, FDA said.

Reported Side Effects Deal Blow to Meningitis Vaccine

Fri, 23 Sep 2005 00:00:00 -0700

News earlier this year that federal health officials were recommending use of a new vaccine against four deadly strains of bacterial meningitis for adolescents brought tears to Jim Garcia's eyes.

"I was sitting in my favorite restaurant in Rocklin having breakfast," said the Loomis man, whose son, John, died in 2000 from meningococcal meningitis. "I broke down. It was this calm, this peace came over me."

Although it was too late for his son, he thought, routine vaccination would mean that millions of other youngsters and their families never would have to confront the devastation of meningococcal disease.

The promise of mass protection, however, suffered a setback recently with news of a potential, but unproven, association between the vaccine, Menactra, and a serious neurological disorder called Guillain-Barr syndrome, or GBS. The information initially caused some local pediatricians to suspend use of the vaccine.

The concerns were prompted by an alert issued Sept. 30 by the federal Centers for Disease Control and Prevention. It noted five youngsters had come down with GBS soon after getting the Menactra vaccine. A sixth case was reported after the alert was sent out.

The initial five cases were in patients 17 or 18 years old, and all developed weakness or abnormal sensations in their arms or legs two to four weeks after the shot. Each of the cases remains under investigation. All of the teens are recovering.

Federal health officials stress that, while the timing of the events is cause for concern, the number of cases so far reported among teens immunized with Menactra is no greater than what would be expected to occur without vaccination. They note, also, that no cases of Guillain Barr cropped up during clinical trials of the vaccine.

"It is something we need to look at very carefully, and that's what's being done," said Dr. Joseph Bocchini, chief of pediatric infectious diseases at Louisiana State University Health Sciences Center and a member of the infectious disease committee of the American Academy of Pediatrics.

"In the interim, we have recommended those individuals at risk for meningococcus infection should continue being given the vaccine because that is a very severe, life-threatening disease."

Menactra, approved by the FDA in January, protects against four types of Neisseria meningitidis, the bacterium that causes a significant percentage of meningococcal infections.

The infection can result in meningitis the inflammation of the lining of the brain and spinal cord and menigococcemia, a related blood infection. Both can be deadly. Meningococcal disease is fatal in 10 percent of cases. Of those who survive, up to one in five will have permanent problems such as hearing loss, neurological damage and limb amputation.

Although meningococcal disease is rare, the Sacramento region had a frightening spate of cases in 2000 and 2001 when five otherwise healthy teenagers, including John Garcia, died after contracting the infection. The deaths spurred state legislation to boost awareness of the disease, and in 2001, several colleges began recommending the vaccine an earlier version called Menomune to all incoming freshmen.

But the coup for parents such as Jim Garcia came with FDA approval of an improved vaccine and the CDC's subsequent recommendation for its use in 11-and 12-year-olds, those entering high school and college freshmen planning to live in a dorm, among other groups.

"We were elated for what part we played in it all of us who came together and put pressure on the CDC," Garcia said.

He said he was shocked to learn of the potential link between Menactra and GBS, ironically the disease that took his father's life. "But until further tests are done, and they can prove (a link), we may have vaccine out there that can prevent a lot of people from contracting meningococcal meningitis."

GBS is a fairly mysterious disease in that its cause is not well understood and there is no real cure, although treatments developed in recent years are effective in reducing the symptoms.

Dr. Robert Miller, a neurologist at California Pacific Medical Center in San Francisco and a member of the International GBS Foundation's advisory board, said GBS is an immune system abnormality.

"The immune system gets stirred up by something an infection, an immunization, a surgical procedure or a traumatic injury," he said. The swine flu vaccine, used during an outbreak in 1976, was shown to trigger GBS.

He said scientists believe the body's immune system overreacts to the foreign invader. In the case of GBS, the immune response inflames the nerves and degrades the surrounding myelin sheath, inhibiting the nerve's ability to transmit impulses.

"And when you can't transmit an impulse, the muscle won't react. It can cause paralysis and it can be permanent," he said.

The majority of people recover, he said, but it can take weeks or months.

In response to the cases of GBS reported to the FDA in youngsters who had received Menactra, the CDC revised its recommendations, but only slightly. The agency now advises that anyone who has had GBS in the past should talk to their doctor before getting the vaccine.

Rose Kwett lost her daughter, MaryJo, a Loretto High School student, to meningococcemia in 2000.

She has been working since to educate students about the disease, and said the greater threat is the vaccine manufacturer's inability to keep up with demand.

Sanofi Pasteur has distributed about 2.5 million doses of Menactra, according to the FDA. About 24 million children are eligible for the immunization.

Even Kwett's son, now 17, was unable to get the vaccine at his last doctor's visit because the stocks were gone, she said.

"(The manufacturer) needs to get to it," she said. "My son is due."

Menactra Meningtis Vaccine Guillain Barre Syndrome Lawyer

Fri, 23 Sep 2005 00:00:00 -0700

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Injured by Menactra?

The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are investigating five reports of Guillain Barre Syndrome (GBS) in teenagers who have taken Menactra, a new vaccine for meningitis. The vaccine's name is Meningococcal Conjugate Vaccine A, C, Y, and W135 (trade name Menactra) and is manufactured by Sanofi Pasteur.

It is not yet known whether these cases were caused by Menactra or are coincidental. The FDA and CDC have been informing the public and are investigating the situation. The FDA and CDC are asking that anyone with information of any possible cases of Guillain Barre Syndrome occurring after Menactra to report them to the Vaccine Adverse Event Reporting System (VAERS) to help the agencies further evaluate the matter.

Guillain Barre Syndrome (GBS) is a severe neurological disorder that may occur frequently in healthy individuals, either spontaneously or after certain infections. Guillain Barre Syndrome generally causes increasing weakness in the legs and arms that can require hospitalization. Meningococcal infection, which Menactra prevents, is a major cause of bacterial meningitis. Bacterial meningitis affects approximately 1 in 100,000 people annually. The infection can be life threatening: 10-14% of cases are fatal, and 11-19% of survivors can have permanent disability.

The five cases of GBS reported following administration of Menactra occurred in individuals living in New York, Ohio, Pennsylvania and New Jersey. All five patients were 17 or 18 years old and developed weakness or abnormal sensations in the arms or legs two to four weeks after vaccination. 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 comparable to what might have been expected to occur by coincidence, even without vaccination. However, the timing of the events is also a major concern. Additionally, vaccine adverse events are not always reported to the FDA, which can potentially skew the data due to unknown cases. The government advises that adolescents and college students living in dormitories receive the vaccine.

If you or a loved one received the Menactra vaccine and suffered side effects, please fill out the form at the right for a free lawsuit case evaluation by a qualified drug side effects attorney.