Issue: March 2011
March 01, 2011
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H1N1 vaccine safe, not associated with Guillain-Barre Syndrome

Liang XF.NEJM.doi:10.1056/NEJMoa1008553.

Issue: March 2011
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Researchers for the National Immunization Program at the CDC in China observed no serious adverse events or increased risk for Guillain-Barre Syndrome after H1N1 vaccination, according to new findings published in the New England Journal of Medicine.

The researchers used a passive surveillance plan to assess adverse events after H1N1 vaccination in China. There were 89.6 million doses of the vaccine administered between September 2009 and March 2010.

Of about 90 million people who were vaccinated, 8,067 experienced an adverse event and 81.2% had an event that was associated with the vaccine. Specifically, 67.8% of adverse events were minor and common whereas 13.4% were more serious, rare events.

Serious and rare adverse events included anaphylactic rash (n=838), anaphylaxis (n=49), Henoch-Schonlein purpura (n=75), angioedema (n=37) and anaphylactic laryngeal edema (n=30). Eight cases of Guillain-Barre Syndrome were associated with vaccination in patients aged between 8 and 67 years. Four cases occurred within 15 days after vaccination and four occurred 15 days after vaccination.

“The rate of the Guillain-Barre syndrome in our study did not exceed the baseline incidence rate of 0.6 to 1.9 cases per 1 million population in European countries or the estimated risk of one case per 1 million doses of seasonal influenza vaccines given in the United States,” the researchers wrote.

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