Rongxia Li1, Brock Stewart2, Michael M McNeil1, Jonathan Duffy1, Jennifer Nelson3, Alison Tse Kawai4, Roger Baxter5, Edward A Belongia6, Eric Weintraub1. 1. Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, USA. 2. Division of Tuberculosis Elimination, Centers for Disease Control and Prevention, Atlanta, GA, USA. 3. Group Health Research Institute, Seattle, WA, USA. 4. Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA. 5. Kaiser Permanente Vaccine Study Center, Oakland, CA, USA. 6. Marshfield Clinic Research Foundation, Marshfield, WI, USA.
Abstract
PURPOSE: The changes in each year in influenza vaccine antigenic components as well as vaccine administration patterns may pose new risks of adverse events following immunization (AEs). To evaluate the safety of influenza vaccines annually administered to people ≥ 6 months, we conducted weekly post licensure surveillance for seven pre-specified adverse events following receipt of influenza vaccines during the 2013-2014 and 2014-2015 seasons in the Vaccine Safety Datalink (VSD). METHODS: We used both a historically-controlled cohort design with the Poisson-based maximized sequential probability ratio test (maxSPRT) and a self-controlled risk interval (SCRI) design with the binomial-based maxSPRT. For each adverse event outcome, we defined the risk interval on the basis of biologic plausibility and prior literature. For the historical cohort design, numbers of expected adverse events were calculated from the prior seven seasons, adjusted for age and site. For the SCRI design, a comparison window was defined either before vaccination or after vaccination, depending on each specific outcome. RESULTS: An elevated risk of febrile seizures 0-1 days following trivalent inactivated influenza vaccine (IIV3) was identified in children aged 6-23 months during the 2014-2015 season using the SCRI design. We found the relative risk (RR) of febrile seizures following concomitant administration of IIV3 and PCV13 was 5.3 with a 95% CI 1.87-14.75. Without concomitant PCV 13 administration, the estimated risk decreased and was no longer statistically significant (RR: 1.4; CI: 0.54 - 3.61). CONCLUSION: No increased risks, other than for febrile seizures, were identified in influenza vaccine safety surveillance during 2013-2014 and 2014-2015 seasons in the VSD.
PURPOSE: The changes in each year in influenza vaccine antigenic components as well as vaccine administration patterns may pose new risks of adverse events following immunization (AEs). To evaluate the safety of influenza vaccines annually administered to people ≥ 6 months, we conducted weekly post licensure surveillance for seven pre-specified adverse events following receipt of influenza vaccines during the 2013-2014 and 2014-2015 seasons in the Vaccine Safety Datalink (VSD). METHODS: We used both a historically-controlled cohort design with the Poisson-based maximized sequential probability ratio test (maxSPRT) and a self-controlled risk interval (SCRI) design with the binomial-based maxSPRT. For each adverse event outcome, we defined the risk interval on the basis of biologic plausibility and prior literature. For the historical cohort design, numbers of expected adverse events were calculated from the prior seven seasons, adjusted for age and site. For the SCRI design, a comparison window was defined either before vaccination or after vaccination, depending on each specific outcome. RESULTS: An elevated risk of febrile seizures 0-1 days following trivalent inactivated influenza vaccine (IIV3) was identified in children aged 6-23 months during the 2014-2015 season using the SCRI design. We found the relative risk (RR) of febrile seizures following concomitant administration of IIV3 and PCV13 was 5.3 with a 95% CI 1.87-14.75. Without concomitant PCV 13 administration, the estimated risk decreased and was no longer statistically significant (RR: 1.4; CI: 0.54 - 3.61). CONCLUSION: No increased risks, other than for febrile seizures, were identified in influenza vaccine safety surveillance during 2013-2014 and 2014-2015 seasons in the VSD.
Authors: Emmanuel B Walter; Nicola P Klein; A Patricia Wodi; Wes Rountree; Christopher A Todd; Amy Wiesner; Jonathan Duffy; Paige L Marquez; Karen R Broder Journal: Pediatrics Date: 2020-02-06 Impact factor: 7.124
Authors: Lisa A Grohskopf; Leslie Z Sokolow; Karen R Broder; Emmanuel B Walter; Joseph S Bresee; Alicia M Fry; Daniel B Jernigan Journal: MMWR Recomm Rep Date: 2017-08-25
Authors: Lisa A Grohskopf; Leslie Z Sokolow; Karen R Broder; Emmanuel B Walter; Alicia M Fry; Daniel B Jernigan Journal: MMWR Recomm Rep Date: 2018-08-24
Authors: V V Oberemok; K V Laikova; K A Yurchenko; N A Marochkin; I I Fomochkina; A V Kubyshkin Journal: Inflamm Res Date: 2020-07-12 Impact factor: 6.986