Boostagen-2 Adverse Reactions

Summary of the safety profile: The safety profile presented as follows is based on data from three clinical trials where Boostagen-2 was administered to adolescents and adults including non-pregnant and pregnant women (Table 5). Within 7 days after vaccination, the most common events occurring were local injection site reactions (pain, redness and pruritus at injection site) 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-2 or with two different Tdap_chem vaccines. These signs and symptoms were mostly mild and moderate in intensity and resolved without sequelae. (See Table 5.)

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In addition, data from active pharmacovigilance confirmed the safety profile of Boostagen (similar to Boostagen-2 but higher amount of PT_gen) in 9,782 individuals (adolescents, adults including pregnant women and elderly aged 65 years and above).