Arexvy Adverse Reactions

Summary of the safety profile: The safety profile presented in Table 3 is based on a placebo-controlled Phase III clinical study (conducted in Europe, North America, Asia and Southern hemisphere) in adults ≥60 years of age in which more than 12,000 adults received one dose of Arexvy and more than 12,000 received placebo with a follow-up period of approximately 12 months.
In study participants 60 years of age and older, the most commonly reported adverse reactions were injection site pain (61%), fatigue (34%), myalgia (29%), headache (28%), and arthralgia (18%). These adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination.
Most other adverse reactions were uncommon and similarly reported between the study groups.
Additionally, in a placebo-controlled Phase III clinical study (conducted in Europe, North America, Asia and Southern hemisphere), 769 participants 50 through 59 years of age (including 386 participants with pre-defined, stable, chronic medical conditions leading to an increased risk for RSV disease) and 381 participants 60 years of age and older received one dose of Arexvy. The reported adverse reactions were consistent with those presented in Table 3. There was a higher incidence of injection site pain, arthralgia, fatigue, myalgia, and headache in participants 50 through 59 years of age compared with those 60 years of age and older in the study. However, the duration and severity of these events were comparable across age groups in the study.
Tabulated list of adverse reactions: Adverse reactions are listed as follows by MedDRA system organ class and frequency: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000). (See Table 3.)

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Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.