Table 3.
Age-, Sex-, and Site-Comparable Event Rates and Risk of Adverse Events for Recipients of Recombinant Zoster Vaccine Versus Recipients of Zoster Vaccine Live in a Vaccine Safety Datalink Study Cohort (Final Primary Sequential Analysis Results)a
Adverse Event Group |
Observed No.
of Events |
Observed Rate per 10,000 Doses of RZV |
Expected No.
of Events b |
Relative
Risk |
---|---|---|---|---|
Acute myocardial infarctionc | 320 | 4.94 | 379.83 | 0.84 |
Strokec | 287 | 4.43 | 376.19 | 0.76 |
Nonhemorrhagic | 267 | 4.12 | 321.04 | 0.83 |
Hemorrhagic | 41 | 0.63 | 77.21 | 0.53 |
Supraventricular tachycardia | 151 | 2.33 | 125.45 | 1.20 |
Polymyalgia rheumatica | 134 | 2.07 | 152.68 | 0.88 |
Convulsion-associated terms excluding epilepsy | 112 | 1.73 | 123.56 | 0.91 |
Bell’s palsyd | 86 | 1.33 | 95.72 | 0.90 |
Optic ischemic neuropathye | 37 | 0.57 | 52.61 | 0.70 |
Giant cell arteritise | 35 | 0.54 | 49.20 | 0.71 |
Anaphylaxise | 20 | 0.31 | 15.15 | 1.32 |
GBSd,f | 6 | 0.09 | 4.83 | 1.24 |
Abbreviations: GBS, Guillain-Barré syndrome; RZV, recombinant zoster vaccine; ZVL, zoster vaccine live.
a January 2018–December 2019 for the RZV group and January 2013–December 2017 for the historical ZVL group.
b The expected number of events following receipt of RZV was estimated from historical data on ZVL recipients, adjusting for site, age group, and sex.
c Results for acute myocardial infarction and stroke were also adjusted for diabetes and hypertension during the year prior to RZV or ZVL vaccination.
d In analysis 5, a preliminary safety signal was observed for Bell’s palsy (36 cases vs. 24 expected; RR = 1.51, adjusted P = 0.03), indicating a potentially elevated risk for RZV recipients versus historical ZVL recipients. In analysis 2, a preliminary safety signal was observed for GBS (3 cases vs. 0.6 expected; RR = 5.25, adjusted P = 0.02).
e Results for optic ischemic neuropathy, giant cell arteritis, and anaphylaxis were adjusted for site and age group (60–64, 65–74, or ≥75 years) only.
f GBS results were unadjusted.