Safety and reactogenicity assessments
ADVERSE EVENTS, ADVERSE EVENT, CHRONIC DISEASE
Participants were monitored for solicited and unsolicited adverse events (see Supplementary Fig. Additionally, the overall safety was analyzed, including unsolicited adverse events, medically attended adverse events, new onset chronic disease, serious adverse events, adverse events of special interest, potential immune-mediated medical conditions, and findings from targeted physical examinations, vital signs assessments, and clinical safety laboratory testing. The intensity of a solicited adverse event was graded according to United States Food and Drug Administration (FDA) standards (see Supplementary Table Safety reviews were performed by the independent Safety Review Committee according to the committee charter.