Table 5.

Summary of safety through month 24 (total vaccinated cohort)

	3-dose 20/20 M0,1,6	2-dose 20/20 M0,6	2-dose 40/40 M0,6	2-dose 40/40 M0,2
Number of subjects vaccinated	239	240	241	240
Deaths, n (%)*	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Subjects with non-fatal SAE, n (%)*	9 (3.8)	13 (5.4)	8 (3.3)	4 (1.7)
Number of non-fatal SAEs, n†	10	15	11	7
Subjects with AE leading to premature discontinuation of vaccine and/or study, n (%)*	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Subjects with medically significant condition, n (%)*	72 (30.1)	66 (27.5)	83 (34.4)	64 (26.7)
Number of medically significant conditions, n†	105	102	171	103
Subjects with new onset autoimmune disease‡, n (%)*	3 (1.3)	3 (1.3)	2 (0.8)	2 (0.8)
Number of new onset autoimmune diseases, n†	3	3	2	2

AE, adverse event; SAE, serious adverse event. Medically significant condition = AE prompting emergency room or physician visits that was not related to common diseases.

^*Number (percentage) of subjects with at least one event.

^†Number of events.

^‡New onset autoimmune diseases (which excluded allergy-related events or isolated signs and symptoms) were identified by comparing all reported AE s with a pre-defined list of potential chronic autoimmune events derived from the Medical Dictionary for Regulatory Activities.