Boostagen Adverse Reactions

Summary of the safety profile: The safety profile of Boostagen or vaccine containing Boostagen antigen (Pediatric DTaPgen) was compared to licensed combined vaccine (2-, 3- or 5-component acellular pertussis-based vaccines) in six randomized controlled trials including 596 participants ranging in age from 3 to 75 years old (126 children, 150 adolescents, 320 adults including 120 pregnant women and 30 older adults).
The most common adverse events within 7 days after vaccination were local injection site pain and systemic reactions (headache, fatigue, myalgia and malaise).
Pain at the injection site was similar in frequency for Boostagen (77.50% and 60.00%) and licensed comparator vaccines (76.67% and 56.67%) in adults and the elderly, respectively.
The frequency, severity, and duration of other adverse events were similar in participants vaccinated with Boostagen based vaccine or licensed comparator vaccines. Symptoms were mild and moderate in intensity and resolved without sequelae within a few days.
Table 4 presents the adverse events collected in 11,323 vaccinees (596 from 6 clinical trials and 10,727 from active post marketing surveillance). (See Table 4.)

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The safety profile of DTaP_gen was also compared to 2-component acellular pertussis-based vaccine comparator in one trial in toddlers aged 15-36 months. One booster dose of DTaP_gen in children was found safe and well tolerated.
Data from post-marketing experience: Adverse events from active post-marketing pharmacovigilance were collected from 10,727 vaccinees including 1,499 pregnant women (see Table 4).
Adverse events reported through passive post-marketing surveillance only concerned local reactions, including induration, dermatitis and pain at injection site. Because these events were reported spontaneously, it is not possible to reliably estimate their frequency.
Reporting suspected adverse effects: Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions at Thai FDA (www.hpvcth.fda.moph.go.th).