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[1] Date: 1 Oct 2005 From: ProMED-mail Source: USA Food & Drug Administration (FDA) Press Release [edited] _____________________________________________________________ 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 5 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 one 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 whether any or all of the cases were due to vaccination. The current information is very preliminary, and the 2 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 administration 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 or by phone at 1-800-822-7967. _____________________________________________________________ The 5 cases of GBS reported following administration of Menactra occurred in individuals living in New York, Ohio, Pennsylvania, and New Jersey. All 5 patients were 17 or 18 years of age and developed weakness or abnormal sensations in the arms or legs 2-4 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. -- ProMED-mail _____________________________________________________________ ****** [2] Date: 1 Oct 2005 From: ProMED-mail Source: New York Times [edited] _____________________________________________________________ 5 Develop Nerve Disorder After Receiving Meningitis Vaccine ----------------------------------------------- 5 teenagers developed a serious neurological disorder within 2 to 4 weeks after receiving the vaccine Menactra, which prevents a severe and deadly form of meningitis, the Food and Drug Administration reported yesterday [30 Sep 2005]. ------------------------------------- All have recovered or are recovering from the illness, Guillain Barre syndrome, which causes weakness in the arms and legs and can spread to the chest and impair breathing. The drug agency said in a news release, "It is not yet known whether these cases were caused by the vaccine or are coincidental." ------------------------------------ In the meantime, parents should continue to vaccinate their children, said Dr. Karen Midthun, deputy director of the drug agency's Center for Biologics Evaluation. ------------------------------------- The vaccine is needed because meningococcal disease is a horrific illness that comes on suddenly and can be rapidly fatal, with a death rate of about 10 percent. Among survivors, up to 19 percent wind up with permanent disabilities. ------------------------------------- The meningococcal disease affects about one person in 100 000 annually, and college freshmen living in dormitories are among those at greatest risk of contracting it. ------------------------------------- Guillain Barre syndrome has a death rate as high as 5 percent, Dr. Midthun said, adding that a majority "do recover, and recover fully." ------------------------------------- Dr. William Schaffner, chairman of the department of preventive medicine at Vanderbilt University, agreed that vaccination should continue and said that he would insist on vaccination if he had children in the age group generally vaccinated. ------------------------------------ Menactra, made by Sanofi Pasteur, was licensed in the United States in January [2005] and recommended for high school and college freshmen, 11- and 12-year-olds and all travelers to certain countries. So far, more than 2.5 million people have received Menactra shots, and there have been no other reports of Guillain Barre. ------------------------------------- Statistically, the 5 cases could be coincidental. No cases were detected in studies in 7000 patients before the vaccine was licensed. ------------------------------------- Experts from the company, the drug agency and the Centers for Disease Control and Prevention are studying the cases to try to determine whether the vaccine was to blame. One possibility they will consider is whether the syndrome was related to an infection caused by Campylobacter bacteria, a common cause of food poisoning, particularly from chicken. In the United States, the bacterium is linked to up to 40 percent of Guillain Barre cases. ------------------------------------- The 5 cases occurred in New York, Ohio, New Jersey and Pennsylvania. The limited region is puzzling, given the vaccine's wide use. That pattern suggests that it is at least possible that something other than the vaccine could be responsible, Dr. Schaffner said. ------------------------------------- To find out whether there are more cases, the Food and Drug Administration is asking doctors and the public to report any possible cases of the nerve syndrome after vaccination via the Internet at or by calling (800) 822-7967. _____________________________________________________________ [Byline: Denise Grady with contributions by Gina Kolata] _____________________________________________________________ -- ProMED-mail ------------------------------------- [Information on the background incidence of meningococcal meningitis in the USA can be found in the 27 May 2005 Recommendations and Reports (RR) Issue of the Morbidity and Mortality Weekly Report (MMWR) Vol. 54 (RR07): 1-21, Prevention and Control of Meningococcal Disease Recommendations of the Advisory Committee on Immunization Practices (ACIP) . _____________________________________________________________ In 1976, there was an outbreak of GBS in the USA following administration of the Swine Flu vaccine. A good review of this episode and background information on GBS (and other suspected neurologic events associated with receipt of Influenza vaccine) can be found in the Institute of Medicine's publication Immunization Safety Review: Influenza Vaccines and Neurological Complications by Stratton K, Alamario DA, Wizemann T, and McCormick MC, (Editors, Immunization Safety Review Committee) . _____________________________________________________________ "GBS is an acute, immune-mediated paralytic disorder of the peripheral nervous system. Estimates of the annual incidence of GBS range from 0.4 to 4.0 cases per 100 000 population, with most studies pointing to a level of from one to 2 cases per 100 000 (Hughes and Rees, 1997; Magira et al., 2003). GBS occurs throughout the year, and in the United States, the condition is more likely to occur in adults than in children (Asbury, 2000). ------------------------------------ About 2/3rds of GBS cases occur several days or weeks after an infectious event (Hughes and Rees, 1997), commonly a diarrheal illness or a virus-like upper-respiratory infection. From 20 percent to 40 percent of all GBS cases are associated with Campylobacter jejuni infections (Buzby et al., 1997). Exposure to certain vaccines has also been associated with an increased risk for GBS. The potential association between GBS and influenza vaccines, most notably the 1976 swine influenza vaccine, has been widely studied and is the subject of this report. ------------------------------------- The characteristic clinical feature of GBS is an acute, rapidly progressive, symmetrical weakness, with loss of deep tendon reflexes, possible tingling in the feet and hands, and muscle aches (myalgia). Approximately 85 percent of patients will return to normal functioning within 6 to 9 months, but some patients experience relapses or a prolonged disease course with residual neurological deficits (Asbury, 2000; Joseph and Tsao, 2002). The mortality rate is 3-5 percent, with patients succumbing to undetected respiratory failure, malfunction of the autonomic nervous system, or to complications of immobility, such as sepsis or pulmonary embolism (Joseph and Tsao, 2002)." ------------------------------------- At present, the report of 5 cases of Guillain Barre Syndrome (GBS) after more than 2.5 million doses of vaccine have been distributed is not outside of what might be expected by chance alone. Concerns are that the current reporting system for adverse events following vaccination is a passive reporting system, and therefore there may be under-reporting so that these 5 cases may represent the "tip of the iceberg" of a greater problem. Hence, the alert to the health care profession to be aware of the possibility of GBS following receipt of this vaccine and the need to report all suspected cases through the Vaccine Adverse Event Reporting System (VAERS), switching from a passive reporting system to a more active reporting system, raising the awareness of the health sector to this potential problem. ------------------------------------- 1. Schonberger LB, Bregman DJ, Sullivan-Bolyai JZ, Keenlyside RA, Ziegler DW, Retailliau HF, Eddins DL, Bryan JA. 1979. Guillain-Barre syndrome following vaccination in the National Influenza Immunization Program, United States, 1976-1977. Am J Epidemiol 110(2):105-23. ------------------------------------- 2. Langmuir AD, Bregman DJ, Kurland LT, Nathanson N, Victor M. 1984. An epidemiologic and clinical evaluation of Guillain-Barre syndrome reported in association with the administration of swine influenza vaccines. Am J Epidemiol 119(6):841-79. ------------------------------------- 3. Asbury AK. 2000. New concepts of Guillain-Barre syndrome. J Child Neurol 15(3):183-91. ------------------------------------- 4. Buzby JC, Allos BM, Roberts T. 1997. The economic burden of Campylobacter-associated Guillain-Barre syndrome. J Infect Dis 176 Suppl 2:S192-7. --------------------------------------- 5. Hughes RA, Rees JH. 1997. Clinical and epidemiologic features of Guillain-Barre syndrome. J Infect Dis 176 Suppl 2:S92-8. ------------------------------------- 6. Joseph SA, Tsao CY. 2002. Guillain-Barre syndrome. Adolesc Med 13(3):487-94. - Mod.MPP] --------------------------------------------------------------- [see also: 1998 ---- Guillain Barre Syndrome - Venezuela (02) 19981216.2377 Guillain Barre Syndrome - Venezuela 19981212.2364 1995 ---- Campylobacter and Guillain-Barre syndrome 19951127.1130] ................................mpp/msp/dk