boostagen Adverse Reactions

Summary of the safety profile: The safety profile presented as follows is based on data from 5 clinical trials where Boostagen was administered to children and adolescents (between 3 and 17 years of age) and adults including pregnant women (Table 5). Within 7 days after vaccination, the most common events occurring were local injection site reactions (pain, redness and induration) and systemic reactions (headache, fatigue, myalgia, malaise and arthralgia). The frequency, severity and duration of adverse events were similar in subjects vaccinated either with Boostagen or with two different Tdap_chem or with pediatric DTaP_chem vaccines. These signs and symptoms were mostly mild and moderate in intensity and resolved without sequelae. (See Table 5.)

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Data from post-marketing experience: Data from active pharmacovigilance confirmed the safety profile of Boostagen in 9,782 individuals aged 11 years to 65 years and older. Boostagen was given to 650 healthcare workers and to 1,069 pregnant women.