Three additional cases of Guillain-Barré syndrome related to the Menactra MCV4 meningococcal conjugate vaccine have been reported, according to the Centers for Disease Control and Prevention, Atlanta.
Even with these additional cases, the incidence of this adverse effect does not exceed the incidence that might be expected to occur by chance alone, so the CDC has not changed its recommendations regarding the vaccine. However, the timing of the onset of Guillain-Barré syndrome (GBS) within 2–5 weeks of vaccination “is still a concern,” so monitoring continues and controlled clinical trials are planned, the CDC said.
Clinicians are advised to share information about the CDC investigation with adolescents and parents before administering the vaccine. Fact sheets for patients and for health-care workers are available at www.cdc.gov
The CDC alerted physicians to a possible association between the Menactra MCV4 vaccine and GBS in October 2005, based on five cases in teenagers that were reported to the Vaccine Adverse Events Reporting System. The vaccine manufacturer, Sanofi Pasteur Inc., and the Food and Drug Administration updated the package insert, listing previous GBS as a new contraindication to the vaccine and warning clinicians of a possible temporal relation with GBS. At that time the CDC and the FDA also advised clinicians to report any cases of GBS occurring in patients who had received the vaccine. As of February 2006, three additional cases had been reported to VAERS and confirmed.
GBS, a serious neurologic disorder involving demyelination of the peripheral nerves, is characterized by numbness or tingling in the feet or hands which often progresses to the legs and arms and is accompanied by muscle weakness or paralysis and loss of deep tendon reflexes.
The CDC provided details on two of the three newly reported cases that occurred since October 2005. Both involved teenage males who were hospitalized and treated with intravenous immunoglobulin. Both patients recovered fully (MMWR 2006;55:364–6).
The third case is undergoing detailed clinical investigation but meets the provisional case definition for GBS, the CDC said.
The CDC continues to advise that people with a history of GBS should not be vaccinated with the Menactra MCV4 vaccine unless they are at high risk for meningococcal disease. The vaccine is still recommended for others at risk, including first-year college students, military recruits, travelers, scientists who are exposed to meningitis, patients with anatomic or functional asplenia, and patients with terminal complement deficiency. Also, in February 2005, the Advisory Committee on Immunization Practices recommended routine vaccination of adolescents at the preadolescent health-care visit (at ages 11–12 years). For persons not previously vaccinated, the committee recommended vaccination before high-school entry (at approximately 15 years of age).
To report adverse events related to the MCV4 or any vaccine, clinicians should go to www.vaers.hhs.gov