Update on Guillain-Barré Syndrome and Menactra® Meningococcal Conjugate Vaccine
Abstract & commentary
By Mary-Louise Scully, MD, Sansum-Santa Barbara Medical Foundation Clinic, Santa Barbara, CA
Dr. Scully reports no financial relationship relevant to this field of study. This article originally appeared in the January 2007 issue of Travel Medicine Advisor. It was edited by Frank Bia, MD, MPH, and peer reviewed by Lin H. Chen, MD. Dr. Bia is Professor of Medicine and Laboratory Medicine; Co-Director, Tropical Medicine and International Travelers' Clinic, Yale University School of Medicine, and Dr. Chen is Assistant Clinical Professor, Harvard Medical School; Director, Travel Resource Center, Mount Auburn Hospital in Cambridge, MA. Dr Bia is a consultant for Pfizer and Sanofi Pasteur, and receives funds from Johnson & Johnson. Dr. Chen reports no financial relationship relevant to this field of study.
Source: CDC. Update: Guillain-Barré Syndrome Among Recipients of Menactra® Meningococcal Conjugate Vaccine- United States, June 2005- September 2006. MMWR. 2006; 55:1120-1124.
Synopsis: This report summarizes the 9 additional reports of Guillain-Barré Syndrome to the Vaccine Adverse Event Reporting System (VAERS) during March through September 2006. There have now been a total of 17 cases. Although the available data suggest a small increased risk for Guillain-Barré Syndrome after Menactra® Meningococcal Conjugate Vaccine (MCV4), the CDC recommends continuing routine vaccination of adolescents, college freshman living in dormitories, and persons increased risk of meningococcal disease.
In October of 2005, the first reports of 5 cases and the possible association of Guillain-Barré Syndrome (GBS) and recipients of Menactra® Meningococcal Conjugate Vaccine (MCV4) were reported. In April 2006, 3 additional confirmed cases of GBS within 6 weeks of MCV4 vaccination were reported. This most recent report summarizes 9 additional cases, resulting in a total of 17 GBS cases reported since June of 2005.
Of the 9 new cases, 5 were male and 4 were females. All but 2 patients (ages 43 and 30) were between the ages of 15 to 18. Each of the 9 cases was reviewed by both a CDC medical officer and a clinical investigator from Boston University. Four of the 9 had received MCV4 as the sole vaccination. The other patients had received concurrent vaccines such as Hepatitis A, Hepatitis B, Tdap, and human papillomavirus (HPV) vaccine. One patient, the 43-year-old male, received 6 other concomitant vaccinations with MCV4, including trivalent inactivated influenza vaccine. The range of onset of the adverse event from vaccination with MCV4 was 2-33 days with a mean of 15.7 days. The timing and onset of neurological symptoms after MCV4 vaccination is of concern.
Using data from the Healthcare Cost and Utilization Project (HCUP) and the Vaccine Safety Datalink (VSD), the background incidence rate for GBS among patients aged 11-19 years was estimated at 0.11 per 100,000 person-months. The rate of GBS was estimated to be 0.20 per 100,000 person-months in 11-19 year olds who had received MCV4. However, in a separate VSD analysis, a total of 126,506 doses of MCV4 were delivered between March 2005 and September 2006, and no cases within 6 weeks of vaccination were observed in recipients aged 11-19 years (0.2 cases would have been expected). Two cases of GBS were reported among an equal number of 11- to 19-year-olds receiving preventive care who had not received MCV4 vaccination.
Campylobacter jejuni, a cause of bacterial gastroenteritis, is a known precipitating factor for GBS. It is unlikely that C. jejuni played a role in these recent reports.
Commentary
Menactra®, a quadrivalent (A, C, Y, and W135) meningococcal conjugate vaccine (MCV4), was licensed in the United States on January 14, 2005. Each 0.5-ml dose of MCV4 contains 4 mg each of capsular polysaccharide from Neisseria meningitidis serogroups A, C, Y, and W135 conjugated to 48 g of diphtheria toxoid. The MCV4 vaccine is approved for ages 11 to 55 years old. In February of 2005, the Advisory Committee on Immunization Practices (ACIP) recommended that in addition to the previous recommendations for first year college students living in dormitories and other high risk groups, MCV4 be given at the preadolescent visit (ages 11-12 years) or prior to high school at 15 years if not previously vaccinated.1
The serogroups responsible for most cases in the United States are serogroups B, C, and Y. No vaccines for serogroup B are readily available except in New Zealand. Serogroup B accounts for a significant amount of disease in Europe and America and often occurs in infants, a group at high risk of invasive disease and little immunologic maturity.2 In the meningitis belt of sub-Saharan Africa, epidemics secondary to serogroup A and more recently W-135 predominate. In the United Kingdom, high rates of serogroup C led to a campaign to immunize all infants and children with a serogroup C conjugate vaccine.
Unfortunately, it may take several years of monitoring to more clearly define the risk association of GBS and MCV4. In May of 2006, in response to a vaccine shortage of MCV4, the CDC and the Advisory Committee on Immunization Practices (ACIP) recommended deferral of vaccination of children aged 11 to 12 years. These vaccine shortages have now been resolved and as of November 3, 2006, the routine vaccination of children 11 to 12 years old should resume.3 Further monitoring will be essential as we resume full-scale vaccination of these adolescents.
An updated fact sheet for health care workers on GBS and Menactra is available at www.cdc.gov. Patients with prior history of GBS should not receive MCV4. Any provider who suspects GBS or any other adverse event after MCV4 is encouraged to report online at www.vaers.hhs.gov or by fax at 877-721-0366.
References
- CDC. Prevention and Control of Meningococcal Disease: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2005;54 (No.RR-7):1-21.
- Harrison L. Vaccine Prevention of Meningococcal Disease: Making Slow Progress. Clin Infect Dis. 2006; 43:1395-1397.
- CDC. Notice to Readers: Improved Supply of Meningococcal Conjugate Vaccine, Recommendation to Resume Vaccination of Children 11-12 Years. MMWR. 2006; 55(43):1177-1178.
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