Federal Plans to Monitor Immunization Safety for the Pandemic 2009 H1N1 Influenza Vaccination Program   [open pdf - 140KB]

"Since the 2009 H1N1 influenza first was identified in the spring, the U.S. Department of Health and Human Services has worked in close partnership with virtually every part of the federal government under a national preparedness and response framework. With unprecedented speed, federal health officials collaborated with industry partners to produce, test, and license 2009 H1N1 influenza vaccines that ultimately will be made available to everyone who wants to get vaccinated. As with seasonal influenza, young children, persons with some chronic health disorders, and pregnant women have a higher risk of severe disease. Clinical trials and safety testing of H1N1 flu vaccines are a critical part of the federal government's H1N1 influenza response plans, and careful stewardship of vaccine safety is integral to maintaining public health and trust in the 2009 H1N1 influenza immunization program The 2009 H1N1 influenza outbreak poses unprecedented opportunities for collaboration and coordination of activities to monitor vaccine safety. A robust plan for monitoring adverse events following immunization during mass vaccination for 2009 H1N1 influenza is a critical component to ensure the safety of these vaccines. While the safety of 2009 H1N1 flu vaccines are anticipated to be similar to seasonal influenza vaccines, which have an excellent record, extensive efforts have been made to enhance safety systems for 2009 H1N1 influenza monitoring. The primary intent of these efforts is to accelerate the availability of safety data to inform the immunization program, health care providers, and the public."

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Flu.gov: http://www.flu.gov/
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Listed on November 18, 2009 [Critical Releases]