Table 1.

Safety profile of YFV-17D compared to withdrawn live vaccines, OPV and RotaShield

Adverse Event Classification	YFV-17D	OPV	RotaShield
Serious Adverse Events	13–51 per million doses administered1	9.0 per million doses administered2	90–214 per million doses administered3
Anaphylaxis	2.0–18 per million doses administered4	1.9 per million doses administered5	Not applicable
Neurological Disease	1.3–38.7 per million doses administered6	0.4–0.5 per million doses administered7	Not applicable
Viscerotropic Disease	0.7–4 per million doses adminstered8	Not applicable	Not applicable
Death	0.1–2.6 per million doses administered9	0.012–0.015 per million doses administered10	<1 per million doses administered11

¹Passive surveillance in non-endemic locations, including reported rates of 47 per million [62]; 13 per million, based on 42 total SAEs from 3.16 million administered doses (2.23 million civilian and 0.93 million military) [68]; 25 per million [69]; and a rate of 51 per million reported among non-endemic travelers [63]. Note that references [62] and [68] have overlapping datasets, but this does not impact reported rates of SAEs.

²Passive surveillance of non-fatal serious events from the US VAERS system [112].

³Defined as excess cases of intussusception [95,96].

⁴Passive surveillance in non-endemic locations including 7.6 per million, based on 40 cases from 5.24 million doses [113]; 18 per million [62]; and a rate of 2.0 per million from the non-endemic subpopulation [63].

⁵All cases occurred in patients that received concurrent administration of injectable vaccines including DTP-Hib, hepatitis B, and MMR [114].

⁶Passive surveillance in non-endemic locations, including rates of 8 per million [62]; 3.2 per million based on 10 reports from 3.16 million administered doses (2.23 million civilian and 0.93 million military) [68]; 1.3 per million [77]; and 1.5 per million among non-endemic populations [63], or endemic locations following enhanced surveillance to include neurological disorders such as aseptic meningitis (38.7 cases per million) [66]. The rate of aseptic meningitis is supported by similar results in a smaller non-endemic study, which reported rates as high as 99 per million [78].

⁷Defined as vaccine-associated paralytic poliomyelitis (VAPP) [90,91].

⁸Derived from studies performed in non-endemic locations, including 4 per million [62]; 2.5 per million based on 8 reports from 3.16 million administered doses (2.23 million civilian and 0.93 million military) [68]; 1.3 per million [77]; and 0.7 per million among non-endemic populations [63]. A smaller study of 47,742 people in Peru reported 116 cases per million doses [84].

⁹Passive surveillance in non-endemic locations, including 1.3 per million, based on 4 deaths associated with 1.53 million vaccinations [62]; 1.6 per million based on 5 vaccine-associated deaths from 3.16 million administered doses (2.23 million civilian and 0.93 million military) [68]; 0.33 per million based on 1 death reported among 3 million doses [77]; and a reported rate of 0.1 per million among non-endemic populations [63].

¹⁰Derived by applying an estimated 3% mortality rate [92] to the reported rate of VAPP following OPV vaccination [90,91].

¹¹Based on 1 death potentially associated with an estimated 1.5 million RotaShield vaccinations [97].