Tuesday, February 22, 2011

Safety of H1N1 Vaccine in Postmarketing Surveillance in China

By Laura Huamán

A recent article published in the New England Journal of Medicine found that in a Chinese Surveillance program there was no pattern of adverse events after the administration of influenza A (H1N1) vaccine. Neither did they get evidence of an increased risk of the Guillain-Barre syndrome.  

From September 21, 2009 to March 21, 2010, almost seventy million doses of vaccine were administered. The Chinese Center for Disease control created a surveillance plan for adverse events after immunization with influenza A vaccine. Anyone providing vaccinations had to report the numbers of vaccines and any adverse events to their local CDC, which had then to report to the national Chinese CDC.

Of the almost seventy million vaccinated, 8067 patients reported having an adverse event. Most of the people affected were sixty years of age or older and nine years of age or younger. Eighty one percent of the total adverse events were verified as vaccine reactions. Thirteen percent were rare and more serious, of which most were allergic reactions. Only eleven cases of Guillain-Barre syndrome were reported, thus having a rate of 0.1 per one million doses.

Based on the findings it is safe to assume the safety of the H1N1 vaccine. 

Source: http://www.nejm.org/doi/pdf/10.1056/NEJMoa1008553

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