Arexvy Adverse Reactions

Summary of the safety profile: The safety profile presented as follows is based on a pooled analysis of data generated in two placebo-controlled Phase III clinical studies (conducted in Europe, North America, Asia and Southern hemisphere) in adults ≥ 60, and 50 through 59 years of age.
In study participants 60 years of age and older (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), 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.
In study participants 50 through 59 years of age (769 participants, including 386 participants with pre-defined, stable, chronic medical conditions leading to an increased risk for RSV disease), a higher incidence of injection site pain (76%), fatigue (40%), myalgia (36%), headache (32%), and arthralgia (23%) was observed, compared with those 60 years of age and older (381 participants) in the same 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.