USA. Five cases of Guillain- Barré syndrome (GBS) have been reported in the United States following the administration of the meningococcal conjugate vaccine A, C, Y and W-135 (trade name Menactra), manufactured by Sanofi Pasteur. It is not known yet whether the adverse events were caused by the vaccine.

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 the vaccine (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 and 11-19 percent of survivors may have permanent disability.

Dr Jesse Goodman, the Director of the FDA's Center for Biologics Evaluation and Research, advises that at the present time there are no changes in recommendations for vaccination; individuals should continue to follow their doctor's recommendations. The FDA is 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. The Global Advisory Committee on Vaccine Safety (GACVS), an expert clinical and scientific advisory body reporting to WHO, reviewed this issue at its thirteenth meeting in Geneva, 1-2 December 2005. The committee's findings will be published in the next issue of the Weekly Epidemiological Record.

Reference:

FDA News. United States Food and Drug Administration, 30 September 2005 (http://www.fda.gov).