Comparative Effectiveness and Harm of Seasonal Influenza Vaccines in Adults Who Are Not Pregnant or Immunocompromised: A Rapid Review for the American College of Physicians

Ann Intern Med. 2026 Jan;179(1):81-94. doi: 10.7326/ANNALS-25-04028. Epub 2025 Nov 18.

Abstract

Background: Seasonal influenza is a contagious viral respiratory illness that causes yearly epidemics.

Purpose: To assess the comparative effectiveness and harm of standard and newer and enhanced influenza vaccines in nonpregnant, nonimmunocompromised adults.

Data sources: Medline and Embase between May 2023 and July 2025, and a systematic review by the European Centre for Disease Prevention and Control (ECDC) to identify studies published before May 2023.

Study selection: Two investigators independently selected English-language randomized controlled trials (RCTs) and nonrandomized studies of interventions (NRSIs).

Data extraction: For newly included studies, one reviewer extracted data and assessed certainty of evidence (CoE), which was verified by a second reviewer; 2 reviewers independently assessed risk of bias. For studies from the ECDC report, original data and risk-of-bias assessments were used.

Data synthesis: The review included 35 RCTs and 5 NRSIs. Compared with standard vaccines, high-dose vaccines reduced laboratory-confirmed influenza in adults aged 65 years or older (high CoE) but increased the risk for fever in this group (high CoE). High-dose vaccines probably caused fewer serious adverse events in all adults and those aged 65 years or older (moderate CoE). Recombinant vaccines reduced laboratory-confirmed influenza in all adults and those younger than 65 years compared with standard vaccines (high CoE). Evidence from 2 RCTs indicated that mRNA vaccines may increase serious adverse events in all adults and those younger than 65 years compared with standard vaccines (low CoE).

Limitations: RCTs evaluating laboratory-confirmed influenza and influenza-related hospitalization or death are limited. Evidence was lacking for several comparisons and outcomes. Broad definitions of serious adverse events may have inflated risk estimates.

Conclusion: High-dose and recombinant vaccines improve protection compared with standard vaccines, but high-dose vaccines increase fever risk. Evidence for mRNA vaccines is limited and should be cautiously interpreted.

Primary funding source: American College of Physicians. (PROSPERO: CRD420251114496).

Publication types

  • Systematic Review

MeSH terms

  • Adult
  • Aged
  • Comparative Effectiveness Research
  • Humans
  • Immunocompromised Host
  • Influenza Vaccines* / administration & dosage
  • Influenza Vaccines* / adverse effects
  • Influenza, Human* / prevention & control
  • Seasons
  • United States
  • Vaccine Efficacy

Substances

  • Influenza Vaccines