Safety of Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) Vaccine in Adults in Japan

Abstract

Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine is generally used for booster vaccination of infants in Europe and the United States to avoid increased reactogenicity after diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccination. However, Japan has extended the use of additional DTaP vaccination without reducing the antigen dose for diphtheria and pertussis in adolescents and adults, despite limited reports on its safety in adults. This prospective, observational, questionnaire-based study investigated the occurrence of adverse events (AEs) following DTaP vaccination between June 2018 and June 2019 in participants aged 10 years or older. Of the 250 eligible participants, 235 (94%) responded regarding AEs. Among them, 133 (56.6%) reported AEs, of which 39 reported systemic AEs (16.6%) and 120 reported local AEs (51.1%) attributed to DTaP vaccination. The incidence of local AEs was markedly higher with DTaP vaccination than with non-DTaP vaccination (51.1% vs. 10.5%), and AEs appeared later (P < 0.01) and lasted longer (P < 0.01) with DTaP vaccination. However, more than 75% of these AEs resolved within 7 days. DTaP vaccination was not associated with any serious AEs. These results indicate that the DTaP vaccine can be widely used as a booster in adults as an alternative to the Tdap vaccine.

A Phase I study to evaluate safety and tolerability of DTaP-IPV + Hib vaccine in healthy adult volunteers in India

“…Similar to our study, previous studies do not show any notable AEs with DTaP-based vaccines in adults [7] , [8] , [9] . In a prospective, observational study evaluating the safety of subcutaneously administered pediatric formulation of DTaP vaccine in Japanese adults, the incidence of local AEs was 51.1%, with the majority of these AEs resolving within 7 days [7] .…”

Maternal vaccination—current status, challenges, and opportunities

“…DTaP has a slightly different composition (full‐strength doses of diphtheria, tetanus, and pertussis antigens) than Tdap (full‐strength dose of tetanus antigen and smaller doses of diphtheria and pertussis antigens to maintain immunity), which is approved in the United States and the United Kingdom 23 . Ujiie et al reported that DTaP was well tolerated by Japanese adolescents and adults and could be widely used as a booster in adults as an alternative to the Tdap vaccine 16 …”

“…23 Ujiie et al reported that DTaP was well tolerated by Japanese adolescents and adults and could be widely used as a booster in adults as an alternative to the Tdap vaccine. 16 …”

“…The vaccination of pregnant women against COVID‐19 is endorsed by the Ministry of Health, Labour and Welfare (MHLW), Japan 15 . Although diphtheria, tetanus toxoid, and acellular pertussis (DTaP) vaccine is part of Japanese childhood vaccination, the Japanese Pharmaceuticals and Medical Devices Agency approved the extended use of DTaP to include additional vaccinations in adolescents and adults in 2016 and the vaccine has been available since January 2018 for this indication 16 . However, a Japanese study conducted during 2016–2018 revealed that approximately half of the mothers lacked protective antibodies against pertussis at the time of delivery, suggesting that maternal vaccination with a booster dose of the vaccine is needed to prevent the infection in the early stages of infancy 17 …”

“…15 Although diphtheria, tetanus toxoid, and acellular pertussis (DTaP) vaccine is part of Japanese childhood vaccination, the Japanese Pharmaceuticals and Medical Devices Agency approved the extended use of DTaP to include additional vaccinations in adolescents and adults in 2016 and the vaccine has been available since January 2018 for this indication. 16 However, a Japanese study conducted during 2016-2018 revealed that approximately half of the mothers lacked protective antibodies against pertussis at the time of delivery, suggesting that maternal vaccination with a booster dose of the vaccine is needed to prevent the infection in the early stages of infancy. 17 This review aims to describe the current status and challenges associated with maternal vaccination against seasonal influenza, pertussis, and COVID-19 in Japan and compare these with those in other countries, mainly the United States and the United Kingdom.…”