# Immunogenic Properties and Safety of a Quadrivalent Inactivated Subunit Adjuvanted Influenza Vaccine in Adults Aged 18 to 85 Years at the End of the COVID-19 Pandemic in the 2022–2023 Season

## TL;DR

This study evaluated a flu vaccine's effectiveness and safety in adults aged 18–85 during the 2022–2023 season, finding it generally effective and well-tolerated despite possible immune changes from the pandemic.

## Contribution

The study provides new evidence on influenza vaccine performance in a post-COVID-19 context across a broad adult age range.

## Key findings

- The vaccine met immunogenicity criteria in both younger and older adults, though seroprotection rates were lower for certain strains in older adults.
- Adverse events were mild and resolved quickly, indicating good safety across age groups.
- Seroconversion for B/Phuket was insufficient in older adults, highlighting age-related differences in immune response.

## Abstract

Background: SARS-CoV-2 infection has raised concerns about altered immune responses, creating a need to evaluate influenza vaccine performance in the post-COVID period. This study aimed to compare the immunogenicity and safety of a quadrivalent inactivated subunit adjuvanted influenza vaccine in adults aged 18–85 years during the 2022–2023 season. Methods: A total of 144 adults were enrolled: group 1, aged 18–59 years (n = 124), and group 2, aged 60–85 years (n = 20). All received a quadrivalent inactivated subunit adjuvanted vaccine containing 5 μg of each influenza antigen and 500 μg of Azoximer bromide. IgG antibodies to vaccine strains were measured at baseline and days 30–32 using the hemagglutination inhibition assay. Participants were actively monitored for adverse events by telephone. Results: The Geometric Mean Fold Increase (GMFI) met the efficacy criteria in both age groups (≥2.5 for 18–59 years and ≥2.0 for 60–85 years), with no significant differences. The seroprotection rate reached accepted thresholds for most strains but was below criteria for B/Victoria in the 18–59 group (48%) and for B/Phuket in the 60–85 group (35%). Significant between-group differences were observed for B/Victoria (p = 0.01) and B/Phuket (p = 0.007). Seroconversion met criteria for all strains in younger adults, but for older adults, it was insufficient for B/Phuket (20%, below the ≥30% threshold; p = 0.05 vs. 18–59 years). Local reactions occurred in 24.2% and systemic in 11.3% of younger adults; in older adults, in 20% and 15%, respectively. All resolved spontaneously within 1–3 days. Conclusions: The quadrivalent adjuvanted influenza vaccine demonstrated acceptable immunogenicity and safety in adults aged 18–85 years despite potential post-COVID immune alterations.