Author(s): Pellegrini M, Nicolay U, Lindert K, Groth N, Della Cioppa G
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Abstract BACKGROUND: Adding adjuvants such as MF59((R)) to influenza vaccines can enhance the immune response. This analysis evaluated the safety profile of MF59-adjuvanted [(+)MF59] compared with non-adjuvanted [(-)MF59] vaccines in a large clinical database. METHODS: Safety data were pooled from 64 clinical trials involving (+)MF59 seasonal and pandemic influenza vaccines. Safety outcomes were analysed in the overall population and in subjects aged > or =65 years, in all clinical trials and in controlled trials only. FINDINGS: Data from 20,447 (+)MF59 and 7526 (-)MF59 subjects were analysed. Overall, (+)MF59 subjects had lower risks than (-)MF59 subjects of experiencing any unsolicited adverse event (AE) (26.8\% vs 39.2\%; adjusted risk ratio [ARR] 0.65; 95\% CI 0.60-0.70), cardiovascular AEs (1.9\% vs 5.6\%; ARR 0.44; 95\% CI 0.35-0.55), new onset chronic diseases (1.3\% vs 1.9\%; ARR 0.71; 95\% CI 0.57-0.87) and death (0.8\% vs 1.2\%; ARR 0.67; 95\% CI 0.51-0.87). Few AEs of potential autoimmune origin were reported: 0.71 and 0.67 per 1000 with (+)MF59 and (-)MF59, respectively. As expected, (+)MF59 subjects had a higher risk of solicited local or systemic reactions within 3 days of vaccination (58.5\% vs 46.9\%, weighted RR 1.34; 95\% CI 1.28-1.40). Safety outcomes were consistent between total and elderly populations, and between all trials and controlled trials, although statistical significance was lost for some of the outcomes in the subgroups. INTERPRETATION: This large-scale analysis supports the good safety profile of (+)MF59 seasonal and pandemic influenza vaccines and suggests a clinical benefit over (-)MF59 influenza vaccines.
This article was published in Vaccine
and referenced in Journal of Clinical & Cellular Immunology