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Postmarketing Surveillance Shows Chicken Pox Vaccine Well Tolerated Among Europeans: Presented at ICAAC

By Ed Susman

SAN FRANCISCO -- September 18, 2009 -- Five years after a vaccine to prevent chicken pox was marketed in Europe, adverse events have been rare and most were reported as mild, according to researchers here at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

"This vaccine is very well tolerated, with very few children having vaccine-associated rashes or other adverse events," said Judith Breuer, Barts and The London School of Medicine and Dentistry, London, United Kingdom, on September 13.

The researchers reviewed reports of adverse events received by Sanofi Pasteur MSD, the company that markets the vaccine in Europe.

Between October 2003 and September 2008 the company received 1,005 reports of adverse events after administration of the vaccine, representing 3 reports per 10,000 doses distributed, which is consistent with previous long-term data, Breuer reported.

"About 88% of the events reported were not serious," Breuer said. "That is, they did not require significant medical intervention or therapy."

Furthermore, most of the postvaccine chicken pox-like rashes were associated with the wild-type varicella zoster virus that circulates in the general population and not with the attenuated virus used in the vaccine.

"Rashes found to be associated with the vaccine virus type generally had fewer lesions than those associated with the wild-type virus," Breuer continued.

The vaccine has been shown to be highly effective in reducing the incidence of varicella zoster in the United States since its introduction in 1995. The researchers concluded that the safety data in the European Union revealed results similar to the 10-year US safety data.

[Presentation title: Safety Profile of Varicella Vaccine: 5-Year Results of the European Varicella Zoster Virus Identification Program (VZVIP). Abstract G1-870]

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