Pertagen Adverse Reactions

Summary of the safety profile: As there is no licensed monovalent pertussis comparator, the safety profile of Pertagen or vaccines containing Pertagen components (TdaP_gen and DTaP_gen) was compared to 2-, 3- or 5-component acellular pertussis-based vaccines (Tdap_chem and DTaP_chem) in eight randomized controlled trials including 1,035 participants ranging in age from 3 to 75 years old (126 children, 331 adolescents, 578 adults including 160 pregnant women and 60 older adults).
The most common adverse events within 7 days after vaccination were local injection site pain and systemic reactions (headache, fatigue, myalgia, malaise and arthralgia).
Pain at the injection site was reported significantly less frequently for Pertagen (55%) than Tdap_chem comparator vaccines (73%) in adults and elderly.
The frequency, severity and duration of adverse events were similar in participants vaccinated either with aP_gen-based or aP_chem-based comparator vaccine. Symptoms were mild and moderate in intensity and resolved without sequelae within a few days.
Table 4 presents the adverse events collected in 17,176 vaccinees (1,035 from eight clinical trials and 16,141 from active post marketing surveillance). (See Table 4.)

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The safety profile of Pertagen components combined to diphtheria and tetanus toxoids (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 16,141 vaccinees including 3,924 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).