Adverse Events of Interest Following Influenza Vaccination in the First Season of Adjuvanted Trivalent Immunization: Retrospective Cohort Study

Simon De Lusignan*, Ruby S.M. Tsang, Oluwafunmi Akinyemi, Jamie Lopez Bernal, Gayatri Amirthalingam, Julian Sherlock, Gillian Smith, Maria Zambon, Gary Howsam, Mark Joy

*Corresponding author for this work

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Abstract

BACKGROUND: Vaccination is the most effective form of prevention of seasonal influenza; the United Kingdom has a national influenza vaccination program to cover targeted population groups. Influenza vaccines are known to be associated with some common minor adverse events of interest (AEIs), but it is not known if the adjuvanted trivalent influenza vaccine (aTIV), first offered in the 2018/2019 season, would be associated with more AEIs than other types of vaccines. 

OBJECTIVE: We aim to compare the incidence of AEIs associated with different types of seasonal influenza vaccines offered in the 2018/2019 season. 

METHODS: We carried out a retrospective cohort study using computerized medical record data from the Royal College of General Practitioners Research and Surveillance Centre sentinel network database. We extracted data on vaccine exposure and consultations for European Medicines Agency-specified AEIs for the 2018/2019 influenza season. We used a self-controlled case series design; computed relative incidence (RI) of AEIs following vaccination; and compared the incidence of AEIs associated with aTIV, the quadrivalent influenza vaccine, and the live attenuated influenza vaccine. We also compared the incidence of AEIs for vaccinations that took place in a practice with those that took place elsewhere. 

RESULTS: A total of 1,024,160 individuals received a seasonal influenza vaccine, of which 165,723 individuals reported a total of 283,355 compatible symptoms in the 2018/2019 season. Most AEIs occurred within 7 days following vaccination, with a seasonal effect observed. Using aTIV as the reference group, the quadrivalent influenza vaccine was associated with a higher incidence of AEIs (RI 1.46, 95% CI 1.41-1.52), whereas the live attenuated influenza vaccine was associated with a lower incidence of AEIs (RI 0.79, 95% CI 0.73-0.83). No effect of vaccination setting on the incidence of AEIs was observed. 

CONCLUSIONS: Routine sentinel network data offer an opportunity to make comparisons between safety profiles of different vaccines. Evidence that supports the safety of newer types of vaccines may be reassuring for patients and could help improve uptake in the future.

Original languageEnglish
Article numbere25803
JournalJMIR Public Health and Surveillance
Volume8
Issue number3
DOIs
Publication statusPublished - 28 Mar 2022

Bibliographical note

Funding Information: The principal funder of Royal College of General Practitioners Research and Surveillance Centre (RCGP RSC) is Public Health England.

SdL is the Director of the Royal College of General Practitioners Research and Surveillance Centre; has received funding through his University for studies from Eli Lilly, AstraZeneca, Sanofi, GSK, Seqirus, and Takeda; and has been a member of advisory boards for influenza for Seqirus and Sanofi.

Open Access: This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Public Health and Surveillance, is properly cited. The complete
bibliographic information, a link to the original publication on https://publichealth.jmir.org, as well as this copyright and license information must be included.

Publisher Copyright: ©Simon de Lusignan, Ruby S M Tsang, Oluwafunmi Akinyemi, Jamie Lopez Bernal, Gayatri Amirthalingam, Julian Sherlock, Gillian Smith, Maria Zambon, Gary Howsam, Mark Joy.

Citation: de Lusignan S, Tsang RSM, Akinyemi O, Lopez Bernal J, Amirthalingam G, Sherlock J, Smith G, Zambon M, Howsam G, Joy M. Adverse Events of Interest Following Influenza Vaccination in the First Season of Adjuvanted Trivalent Immunization: Retrospective Cohort Study. JMIR Public Health Surveill. 2022;8(3):e25803. doi: 10.2196/25803. PMID: 35343907

DOI: 10.2196/25803

Keywords

  • adverse events of interest
  • computerized medical record systems
  • influenza
  • influenza vaccines
  • sentinel surveillance

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