PMID- 36919537
OWN - NLM
STAT- MEDLINE
DCOM- 20230331
LR  - 20230428
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 19
IP  - 1
DP  - 2023 Dec 31
TI  - Enhanced passive safety surveillance of the MF59-adjuvanted quadrivalent 
      influenza vaccine in the elderly during the 2021/22 influenza season.
PG  - 2190279
LID - 10.1080/21645515.2023.2190279 [doi]
LID - 2190279
AB  - In accordance with European directives, each year the enhanced safety 
      surveillance (ESS) of seasonal influenza vaccines should be conducted in order to 
      detect any potential increase in reactogenicity when the vaccine composition is 
      updated or a new formulation becomes available. The objective of this passive ESS 
      (EPSS) was to assess the frequency of spontaneously reported adverse events (AEs) 
      following vaccination with the 2021/22 formulation of the MF59-adjuvanted 
      quadrivalent influenza vaccine (aQIV) among older adults in Italy through the 
      collection of data within a short time period (start of seasonal influenza 
      vaccination) in order to monitor the reactogenicity of aQIV early in the season. 
      All AEs reported within seven days following vaccination were analyzed by type 
      and seriousness. In all, 1,059 vaccination cards were distributed to individuals 
      aged >/=65 years. Only one, non-serious, spontaneous individual case safety report 
      was submitted, yielding an overall rate of 0.9 per 1,000 doses administered. This 
      report consisted of a reactogenic AE of pyrexia. The EPSS confirmed that the 
      reactogenicity profile of aQIV was consistent with the known safety profile of 
      the previous trivalent formulation. These optimal safety data could bolster 
      public confidence in influenza vaccination and help to improve vaccination 
      coverage.
FAU - Amicizia, Daniela
AU  - Amicizia D
AD  - Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.
AD  - Interuniversity Research Center on Influenza and Other Transmissible Infections 
      (CIRI-IT), Genoa, Italy.
FAU - Domnich, Alexander
AU  - Domnich A
AD  - Hygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and 
      Neurosciences, Genoa, Italy.
FAU - Lai, Piero Luigi
AU  - Lai PL
AD  - Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.
AD  - Interuniversity Research Center on Influenza and Other Transmissible Infections 
      (CIRI-IT), Genoa, Italy.
FAU - Orsi, Andrea
AU  - Orsi A
AD  - Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.
AD  - Interuniversity Research Center on Influenza and Other Transmissible Infections 
      (CIRI-IT), Genoa, Italy.
AD  - Hygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and 
      Neurosciences, Genoa, Italy.
FAU - Icardi, Giancarlo
AU  - Icardi G
AD  - Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.
AD  - Interuniversity Research Center on Influenza and Other Transmissible Infections 
      (CIRI-IT), Genoa, Italy.
AD  - Hygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and 
      Neurosciences, Genoa, Italy.
FAU - Tkach-Motulyak, Oksana
AU  - Tkach-Motulyak O
AD  - CSL Seqirus, Global Clinical Safety & Pharmacovigilance, Maidenhead, UK.
FAU - Panatto, Donatella
AU  - Panatto D
AUID- ORCID: 0000-0002-2677-0551
AD  - Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.
AD  - Interuniversity Research Center on Influenza and Other Transmissible Infections 
      (CIRI-IT), Genoa, Italy.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230315
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Influenza Vaccines)
RN  - 0 (MF59 oil emulsion)
RN  - 0 (Polysorbates)
RN  - 7QWM220FJH (Squalene)
RN  - 0 (Adjuvants, Immunologic)
RN  - 0 (Vaccines, Combined)
SB  - IM
MH  - Aged
MH  - Humans
MH  - *Influenza Vaccines/adverse effects
MH  - *Influenza, Human/prevention & control
MH  - Seasons
MH  - Polysorbates/adverse effects
MH  - Squalene/adverse effects
MH  - Adjuvants, Immunologic/adverse effects
MH  - Vaccination
MH  - Vaccines, Combined
PMC - PMC10072113
OTO - NOTNLM
OT  - Fluad Tetra(R)
OT  - Influenza
OT  - enhanced passive safety surveillance
OT  - influenza vaccines
OT  - the elderly
COIS- DA, PLL, AO, GI, DP are members of the scientific committee of CIRI-IT, which 
      received a grant for the EPSS. OT is employed by CSL Seqirus.
EDAT- 2023/03/16 06:00
MHDA- 2023/03/31 06:41
PMCR- 2023/03/15
CRDT- 2023/03/15 04:52
PHST- 2023/03/31 06:41 [medline]
PHST- 2023/03/16 06:00 [pubmed]
PHST- 2023/03/15 04:52 [entrez]
PHST- 2023/03/15 00:00 [pmc-release]
AID - 2190279 [pii]
AID - 10.1080/21645515.2023.2190279 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2023 Dec 31;19(1):2190279. doi: 
      10.1080/21645515.2023.2190279. Epub 2023 Mar 15.