Diekema.ppt [Compatibility Mode] - Institute of Medicine

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Febrile Seizure Signal Detection Enhanced monitoring in US • FDA and CDC Announcements on Fluzone ® and febrile seizures •Update on Fluzone ® Influenza Vaccine and VAERS Reports of Febrile Seizures in Children (January 20, 2011) • Update: Vaccine Adverse Events reporting System (VAERS) Data on Febrile Seizures after Vaccination with Fluzone ® , a 2010-2011 Trivalent Inactivated Vaccine, in Children (January 21, 2011) http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm240037.htm http://vaers.hhs.gov/resources/VAERSupdate_FebrileSeizures_Children.pdf DeStefano, ACIP FEB 2011
ACIP General Recommendations Working Group Febrile Seizure Subgroup • Charge (March 2011): –Review data on the risk for febrile seizures after seasonal trivalent inactivated influenza vaccine (TIV) and pneumococcal conjugate vaccine (PCV) in children – Present options to ACIP for any action(s) related to the use of these vaccines for the 2011-12 influenza season –Provide a framework for determining when vaccineassociated febrile seizures should lead to a change in recommendations for administration of one or more vaccines
Page 1 and 2: Febrile Seizures Associated with Tr
Page 3: Febrile Seizure Signal Detection En
Page 7 and 8: Febrile Seizures Background • Sei
Page 9 and 10: ACIP Recommendations for Influenza
Page 11: Febrile Seizures Signal in the Vacc
Page 14 and 15: Lee, ACIP June 2011
Page 16 and 17: Lee, ACIP FEB 2011 16
Page 20 and 21: Joint Signal Evaluation for TIV and
Page 26 and 27: Updated VSD Analysis, August, 2011
Page 28 and 29: VSD Analysis - Comments • Compare
Page 30 and 31: Burden of Influenza Among Children
Page 33 and 34: Febrile Seizures After Influenza In
Page 35 and 36: 13-valent Pneumococcal Conjugate Va
Page 37 and 38: October 2011 ACIP Meeting General R
Page 39 and 40: October 2011 ACIP Meeting General R
Page 41 and 42: www.cdc.gov/vaccines/pubs/vis/
Page 43 and 44: Proposed Framework for Determining

Diekema.ppt [Compatibility Mode] - Institute of Medicine

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