Vaccine 34 (2016) 2507–2512
Contents lists available at ScienceDirect
Vaccine journal homepage: www.elsevier.com/locate/vaccine
Post-licensure surveillance of quadrivalent inactivated influenza (IIV4) vaccine in the United States, Vaccine Adverse Event Reporting System (VAERS), July 1, 2013−May 31, 2015 Penina Haber a,∗ , Pedro L. Moro a , Paige Lewis a , Emily Jane Woo b , Christopher Jankosky b , Maria Cano a a Immunization Safety Office, Division of Healthcare Quality Promotion, National Center Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC) , 1600 Clifton Rd NE, Atlanta GA 30329, United States b Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, Silver Spring, MD, United States
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Article history: Received 22 January 2016 Received in revised form 14 March 2016 Accepted 15 March 2016 Available online 23 March 2016 Keywords: Vaccine safety Post-licensure surveillance Quadrivalent inactivated influenza vaccines
a b s t r a c t Background: Quadrivalent inactivated influenza vaccines (IIV4) were first available for use during 2013−14 influenza season for individuals aged ≥6 months. IIV4 is designed to protect against four different flu viruses; two influenza A viruses and two influenza B viruses. Methods: We searched the Vaccine Adverse Event Reporting System (VAERS) for US reports after IIV4 and trivalent inactivated influenza vaccine (IIV3) from 7/1/2013–5/31/2015. Medical records were requested for non-manufacturer reports classified as serious (i.e. death, hospitalization, prolonged hospitalization, life-threatening illness, permanent disability). The review included automated data analysis, clinical review of all serious reports, reports of special interest, and empirical Bayesian data mining. Results: VAERS received 1,838 IIV4 reports; 512 (28%) in persons aged 6 months–17 years of which 42 (8.2%) were serious reports; 1,265 (69%) in persons aged >18 years of which 84 (6.6%) were serious reports; two in children 18 years. 2.2. Descriptive statistics We calculated descriptive statistics including the mean and median age of vaccinated individuals, AE onset interval (from vaccination date [day 0] to the reported onset of first symptoms), and the most common MedDRA PTs. We also reviewed reports pertaining to children 18 years, which included 78 non-death serious reports and six death reports; two were children
Contents lists available at ScienceDirect
Vaccine journal homepage: www.elsevier.com/locate/vaccine
Post-licensure surveillance of quadrivalent inactivated influenza (IIV4) vaccine in the United States, Vaccine Adverse Event Reporting System (VAERS), July 1, 2013−May 31, 2015 Penina Haber a,∗ , Pedro L. Moro a , Paige Lewis a , Emily Jane Woo b , Christopher Jankosky b , Maria Cano a a Immunization Safety Office, Division of Healthcare Quality Promotion, National Center Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC) , 1600 Clifton Rd NE, Atlanta GA 30329, United States b Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, Silver Spring, MD, United States
a r t i c l e
i n f o
Article history: Received 22 January 2016 Received in revised form 14 March 2016 Accepted 15 March 2016 Available online 23 March 2016 Keywords: Vaccine safety Post-licensure surveillance Quadrivalent inactivated influenza vaccines
a b s t r a c t Background: Quadrivalent inactivated influenza vaccines (IIV4) were first available for use during 2013−14 influenza season for individuals aged ≥6 months. IIV4 is designed to protect against four different flu viruses; two influenza A viruses and two influenza B viruses. Methods: We searched the Vaccine Adverse Event Reporting System (VAERS) for US reports after IIV4 and trivalent inactivated influenza vaccine (IIV3) from 7/1/2013–5/31/2015. Medical records were requested for non-manufacturer reports classified as serious (i.e. death, hospitalization, prolonged hospitalization, life-threatening illness, permanent disability). The review included automated data analysis, clinical review of all serious reports, reports of special interest, and empirical Bayesian data mining. Results: VAERS received 1,838 IIV4 reports; 512 (28%) in persons aged 6 months–17 years of which 42 (8.2%) were serious reports; 1,265 (69%) in persons aged >18 years of which 84 (6.6%) were serious reports; two in children 18 years. 2.2. Descriptive statistics We calculated descriptive statistics including the mean and median age of vaccinated individuals, AE onset interval (from vaccination date [day 0] to the reported onset of first symptoms), and the most common MedDRA PTs. We also reviewed reports pertaining to children 18 years, which included 78 non-death serious reports and six death reports; two were children
