Menactra meningococcal vaccine and Guillain-Barré Syndrome

Update on Menactra® and Guillain-Barré syndrome

Extract from report of GACVS meeting of 12-13 June 2007, published in the WHO Weekly Epidemiological Record on 20 July 2007

An update was presented on the reported occurrence of Guillain-Barré syndrome (GBS) after vaccination with a tetravalent conjugated meningococcal vaccine (Menactra®)⁵ in the USA. To date, more than 12 million doses have been delivered in the USA. As of 30 April 2007, a total of 19 cases of GBS, occurring within 6 weeks of vaccination, had been reported to the US Vaccine Adverse Event Reporting System (VAERS). Analysis of the data could not exclude a slightly increased risk of GBS after vaccination, but this finding should be reviewed with caution given the limitation of the reporting system and the uncertainty of the background rate of GBS and its potential for seasonal fluctuation. The manufacturer of the vaccine is planning further studies to evaluate the possible risk of GBS following vaccination with Menactra®.

⁵See No 3, 2007, pp. 18–24.

Full report of GACVS meeting of 12-13 June 2007, published in the WHO Weekly Epidemiological Record on 20 July 2007

Extract from report of GACVS meeting of 29-30 November 2006, published in the WHO Weekly Epidemiological Record on 19 January 2007

An update on the reported occurrence of Guillain-Barré syndrome (GBS) after vaccination with a tetravalent conjugated meningococcal vaccine (Menactra®)⁶ in the United States was presented. As of September 2006, a total of 17 cases had been reported to the US Vaccine Adverse Event Reporting System as occurring within 6 weeks after vaccination. Analysis of the data suggests that there may be a small increased risk (1.25 cases per million doses distributed; 95% confidence interval, 0.058–5.993) of GBS after vaccination with Menactra®, but this finding should be viewed with caution, given the limitations of the reporting system and the uncertainty regarding background incidence rates of GBS.

⁶ See No. 2, 2006, pp. 15-18

Full report of GACVS meeting of 29-30 November 2006, published in the WHO Weekly Epidemiological Record on 19 January 2007

Conjugate meningococcal vaccine and Guillain-Barré Syndrome

Extract from report of GACVS meeting of 1-2 December 2005, published in the WHO Weekly Epidemiological Record on 13 January 2006

Several cases of Guillain-Barré Syndrome (GBS) were recently reported in the United States following the introduction of a tetravalent conjugated meningococcal vaccine. More than 2.5 million doses of this vaccine had been distributed in the United States at the time of these reports. Although a temporal relationship to vaccination prompted an alert by CDC and the Food and Drug Administration, the number of cases reported was similar to what would normally have been expected in this population. Accordingly, no change to vaccination recommendations was proposed. This information has been included in vaccine information sheets and the package insert for the vaccine. Similarly, the GACVS recommended no change in vaccination policies based on these reports.

Full report of GACVS meeting of 1-2 December 2005, published in the WHO Weekly Epidemiological Record on 13 January 2006

References

CDC. Update: Guillain-Barré Syndrome Among Recipients of Menactra® Meningococcal Conjugate Vaccine --- United States, June 2005--September 2006. MMWR 55(41):1120-1124, 2006.

CDC. Guillain-Barré Syndrome Among Recipients of Menactra® Meningococcal Conjugate Vaccine - United States, June-July 2005. MMWR 54(40):1023-1025, 2005.