PMID- 30739795
OWN - NLM
STAT- MEDLINE
DCOM- 20200804
LR  - 20200804
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 37
IP  - 11
DP  - 2019 Mar 7
TI  - Post-licensure surveillance of trivalent adjuvanted influenza vaccine (aIIV3; 
      Fluad), Vaccine Adverse Event Reporting System (VAERS), United States, July 
      2016-June 2018.
PG  - 1516-1520
LID - S0264-410X(19)30128-8 [pii]
LID - 10.1016/j.vaccine.2019.01.052 [doi]
AB  - BACKGROUND: Trivalent adjuvanted influenza vaccine (aIIV3; Fluad(R)) was approved 
      in the United States (U.S.) in 2015 for adults aged >/=65 years and has been in use 
      since the 2016-17 influenza season. METHODS: We analyzed U.S. reports for aIIV3 
      submitted from July 1, 2016 through June 30, 2018 to the Vaccine Adverse Event 
      Reporting System (VAERS), a national spontaneous reporting system. Medical 
      records were reviewed for serious reports. Among individuals >/=65 years of age, 
      the relative frequency of the most commonly reported adverse events (AEs) after 
      aIIV3 were compared with non-adjuvanted inactivated influenza vaccines given to 
      adults aged >/=65 years, high-dose trivalent influenza vaccine (IIV3-HD) and 
      trivalent or quadrivalent vaccines (IIV3/IIV4). Data mining analyses were 
      undertaken to identify whether AEs for aIIV3 occurred disproportionately more 
      than expected compared to all influenza vaccines. RESULTS: VAERS received 630 
      reports after aIIV3, of which 521 (83%) were in adults aged >/=65 years; 79 (13%) 
      in persons <65 years and in 30 (5%) reports age was missing; 19 (3%) reports were 
      serious, including two deaths (0.4%) related to myocardial infarction and 
      Sjogren's syndrome. The most common AEs reported in adults aged >/=65 years were 
      injection site pain (21%) and erythema (18%), with similar proportions reported 
      for IIV3-HD (17% and 19%, respectively) and for IIV3/IIV4 (15%, each). Except for 
      reports related to vaccination of inappropriate age (n = 79) and syringe 
      malfunction (n = 6), data mining did not identify other disproportionately 
      reported AEs. CONCLUSIONS: Although our review of aIIV3 in VAERS did not identify 
      any unexpected health conditions of concern, we observed more than twice the 
      expected number of reports with administration of the vaccine to persons outside 
      of the age range for which the vaccine is approved in the U.S. Health care 
      providers should be educated on the age groups for whom aIIV3 is recommended.
CI  - Copyright (c) 2019 Elsevier Ltd. All rights reserved.
FAU - Haber, Penina
AU  - Haber P
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, United States. Electronic address: phaber@cdc.gov.
FAU - Moro, Pedro L
AU  - Moro PL
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, United States.
FAU - Ng, Carmen
AU  - Ng C
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, United States.
FAU - Dores, Graca M
AU  - Dores GM
AD  - Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for 
      Biologics Evaluation and Research, Food and Drug Administration, United States.
FAU - Lewis, Paige
AU  - Lewis P
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, United States.
FAU - Cano, Maria
AU  - Cano M
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, United States.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
DEP - 20190207
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Influenza Vaccines)
RN  - 0 (fluad vaccine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - Child
MH  - Child, Preschool
MH  - Data Mining
MH  - Female
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Influenza Vaccines/administration & dosage/*adverse effects/classification
MH  - Influenza, Human/*prevention & control
MH  - Injection Site Reaction
MH  - Male
MH  - Middle Aged
MH  - *Product Surveillance, Postmarketing
MH  - United States
MH  - Vaccination
MH  - Young Adult
OTO - NOTNLM
OT  - Adjuvanted influenza vaccine MF59(R) (Fluad)
OT  - Attenuated influenza vaccine
OT  - Post-licensure surveillance
OT  - Vaccine adverse event reporting system
OT  - Vaccine safety
EDAT- 2019/02/12 06:00
MHDA- 2020/08/05 06:00
CRDT- 2019/02/12 06:00
PHST- 2018/11/02 00:00 [received]
PHST- 2019/01/14 00:00 [revised]
PHST- 2019/01/17 00:00 [accepted]
PHST- 2019/02/12 06:00 [pubmed]
PHST- 2020/08/05 06:00 [medline]
PHST- 2019/02/12 06:00 [entrez]
AID - S0264-410X(19)30128-8 [pii]
AID - 10.1016/j.vaccine.2019.01.052 [doi]
PST - ppublish
SO  - Vaccine. 2019 Mar 7;37(11):1516-1520. doi: 10.1016/j.vaccine.2019.01.052. Epub 
      2019 Feb 7.