Near real-time surveillance for Guillain-Barré syndrome after influenza vaccination among the Medicare population, 2010/11 to 2013/14 |
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| Institution: | 1. Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA;2. Stanford University, Stanford, CA, USA;3. Acumen LLC, Burlingame, CA, USA;4. Centers for Medicare and Medicaid Services, Washington, DC, USA;1. Adult Vaccines, Merck USA, West Point, PA, United States;2. Department of Health Policy, Vanderbilt University School of Medicine, Nashville, TN, United States;3. Division of Infectious Diseases, Vanderbilt University School of Medicine, Nashville, TN, United States;1. Vaccine Research, The Foundation for the Promotion of Health and Biomedical Research of the Valencian Community (FISABIO)-Public Health, Valencia, Spain;2. Spanish Reference Laboratory for Meningococci, National Centre for Microbiology, Instituto de Salud Carlos III, Madrid, Spain;3. Health Inequalities, The Foundation for the Promotion of Health and Biomedical Research of the Valencian Community (FISABIO)-Public Health, Valencia, Spain;1. Immunisation, Hepatitis & Blood Safety Department, National Infection Service, Public Health England, 61 Colindale Avenue, London NW9 5EQ, United Kingdom;2. Immunisation, Hepatitis & Blood Safety Dept., National Infection Service, Public Health England, Wellington House, 133-155 Waterloo Road, London SE1 8UG, United Kingdom;3. UCL Institute of Child Health, 30 Guilford Street, London WC1N 1EH, United Kingdom;1. Shantha Biotechnics Private Limited – A Sanofi Company, Hyderabad, India;2. Sanofi Pasteur, Marcy-l''Étoile, France;3. Sanofi Pasteur, Swiftwater, USA;4. Dept. of Pediatrics, JSS Medical College, Mysore, India;5. Dept. of Pediatrics, SBKS MI & RC, Sumandeep Vidyapeeth, Vadodara, India;6. Dept. of Pediatrics, KLE University’s, Jawaharlal Nehru Medical College, Belagavi, India;7. Dept. of Pediatrics, Maulana Azad Medical College, Delhi, India;8. Dept. of Pediatrics, Institute of Child Health, Kolkata, India;9. Dept. of Pediatrics, Bharati Vidyapeeth Deemed University Medical College, Pune, India;10. Dept. of Pediatrics, Christian Medical College, Ludhiana, India;11. Dept. of Pediatrics, Christian Medical College, Vellore, India;12. Dept. of Community Medicine, School of Public Health, Post Graduate Institute of Medical Education & Research, Chandigarh, India;13. Dept. of Pediatrics, Sawai Man Singh Medical College, Jaipur, India;14. Dept. of Pediatrics, Topiwala National Medical College and BYL Nair Ch. Hospital, Mumbai, India;1. National Vaccine Program Office, Office of the Assistant Secretary for Health, US Department of Health and Human Services, Washington DC, United States;2. Acumen LLC, Burlingame, CA, United States;3. Center for Medicare, Centers for Medicare & Medicaid Services, Baltimore, MD, United States |
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| Abstract: | BackgroundGuillain-Barré syndrome (GBS) is a serious acute demyelinating disease that causes weakness and paralysis. The Food and Drug Administration (FDA) began collaborating with the Centers for Medicare and Medicaid Services (CMS) to develop near real-time vaccine safety surveillance capabilities in 2006 and has been monitoring for the risk of GBS after influenza vaccination for every influenza season since 2008.MethodsWe present results from the 2010/11 to 2013/14 influenza seasons using the Updating Sequential Probability Ratio Test (USPRT), with an overall 1-sided α of 0.05 apportioned equally using a constant alpha-spending plan among 20 consecutive weekly tests, 5 ad hoc tests, and a 26th final end of season test. Observed signals were investigated using the self-controlled risk interval (SCRI) design.ResultsOver 15 million people were vaccinated in each influenza season. In the 2010/11 influenza season, we observed an elevated GBS risk during the season, with an end of season SCRI analysis finding a nonsignificant increased risk (RR = 1.25, 95% CI: 0.96–1.63). A sensitivity analysis applying the positive predictive value of the ICD-9 code for GBS from the 2009/10 season estimated a RR = 1.98 (95% CI: 1.42–2.76). Although the 2010/11 influenza vaccine suggested an increased GBS risk, surveillance of the identical vaccine in the 2011/12 influenza season did not find an increased GBS risk after vaccination. No signal was observed in the subsequent three influenza seasons.ConclusionsConducting near real-time surveillance using USPRT has proven to be an excellent method for near real-time GBS surveillance after influenza vaccination, as demonstrated by our surveillance efforts during the 2010/11–2013/14 influenza seasons. In the 2010/2011 influenza season, in addition to the 2009 H1N1 influenza pandemic, using near real-time surveillance we were able to observe a signal early in the influenza season and the method has now become routine. |
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| Keywords: | Influenza Flu Vaccine Immunization Guillain-Barré syndrome |
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