Characteristics and incidence of vaccine adverse events after Bacille Calmette–Guérin vaccination: A national surveillance study in Japan from 2013 to 2017

Autor: Hideo Okuno, Hiroshi Satoh, Saeko Morino, Satoru Arai, Masaki Ochiai, Kentaro Fujita, Seishiro Naito, Atsushi Kato, Koji Ishii, Kazunori Oishi, Motoi Suzuki, Keiko Tanaka-Taya
Rok vydání: 2022
Předmět:
Zdroj: Vaccine. 40:4922-4928
ISSN: 0264-410X
Popis: Japan amended the recommended age for the Bacille Calmette-Guérin (BCG) vaccination to less than 6 months after 2005, but subsequently amended the recommended age to 5-8 months (latest amendment,1 year) in April 2013 due to the increasing incidence of BCG-associated osteitis/osteomyelitis since 2005.We collected data on BCG-associated vaccine adverse events (VAEs) in the population aged1 year between April 2013 and March 2017. The incidence of BCG-associated VAE was analyzed using census and vaccine coverage data from the government website. We compared the incidence of VAEs in patients vaccinated at less than 6 months with those vaccinated at 6 months or older.Among the 581 BCG-associated VAEs recorded during the study period, 354 (61%) were male, and the average age at vaccination was 5.7 months. The incidence of VAEs per million population aged1 year at vaccination was highest for suppurative lymphadenitis (63.7), followed by skin lesions (38.4), and BCG-associated osteitis/osteomyelitis (3.1). Disseminated BCG and anaphylaxis were rare (1.1 and 1.6%, respectively). The incidence of VAEs in the population vaccinated at6 months of age was higher for BCG-associated osteitis/osteomyelitis (3.8) and disseminated BCG (1.3) than in the population vaccinated at ≥6 months.The population vaccinated at6 months of age was more likely to develop BCG-associated osteitis/osteomyelitis than the population vaccinated at ≥6 months of age, indicating that the change in the recommended vaccination age in 2013 might have contributed to the subsequent decrease in the incidence of BCG-associated osteitis/osteomyelitis.
Databáze: OpenAIRE