Serious adverse events
lethargy, death, Crohn’s disease, abscess
ADVERSE EVENT, ABSCESS
Overall, 38 participants reported a serious adverse event (SAE): 9 BCG recipients in Stage 1, 29 participants in Stage 2 including 20 in the BCG group and 9 in the placebo group (see Supplementary Table S2). All but two SAE were deemed ‘unrelated’ to the intervention by the study site investigator and the BRACE expert vaccine safety group (Table S1). One SAE (hospitalization in a participant with BCG injection site abscess and lethargy) was reported as a SUSAR, as aforementioned. Another BCG recipient was hospitalized and diagnosed with Crohn’s disease more than 2 months following vaccination, subsequently deemed ‘unlikely related’ to vaccination. There was one death (COVID-19 related) in a participant hospitalized with COVID-19 who had received placebo.