Table 1.
Expected number of predefined outcomes and medical events of interest after two-dose RZV vaccination, based on background incidence rates
| Countrya | Risk period (year) | Time at riskb (year) | Age-adjusted IRc (per 100,000 py) | Expected number (per 100,000 vaccinated) | Reference for IR |
|---|---|---|---|---|---|
| Psoriasis | |||||
| USA | 0.49 | 0.66 | 82.3 | 54 | Icen et al. [49] |
| Canada | 0.49 | 0.66 | 85.1 | 56 | |
| Germany | 0.49 | 0.66 | 196.1 | 129 | Egeberg et al. [50] |
| Rheumatoid arthritis | |||||
| USA | 0.49 | 0.66 | 75.2 | 49 | Myasoedova et al. [51] |
| Canada | 0.49 | 0.66 | 72.2 | 47 | |
| Germany | 0.49 | 0.66 | 71.9 | 47 | Abhishek et al. [52] |
| Polymyalgia rheumatica | |||||
| USA | 0.49 | 0.66 | 80.5 | 53 | Raheel et al. [53] |
| Canada | 0.49 | 0.66 | 59.1 | 39 | |
| Germany | 0.49 | 0.66 | 56.9 | 37 | |
| Idiopathic thrombocytopenic purpura | |||||
| USA | 0.11 | 0.23 | 5.4 | 1 | Schoonen et al. [54] |
| Canada | 0.11 | 0.23 | 4.8 | 1 | |
| Germany | 0.11 | 0.23 | 4.5 | 1 | |
| Cutaneous leukocytoclastic vasculitis | |||||
| USA | 0.11 | 0.23 | 2.1 | 0 | Arora et al. [55] |
| Canada | 0.11 | 0.23 | 2.1 | 0 | |
| Germany | 0.11 | 0.23 | 3.02 | 1 | Garcia-Porrua and Gonzalez-Gay [56] |
| Multiple sclerosis | |||||
| USA | 0.49 | 0.66 | 3.3 | 2 | O’Connell et al. [57] |
| Canada | 0.49 | 0.66 | 14.1 | 9 | Al-Sakran et al. [58] |
| Germany | 0.49 | 0.66 | 4.6 | 3 | O’Connell et al. [57] |
| Guillain-Barré syndrome | |||||
| USA | 0.11 | 0.23 | 3.7 | 1 | Frenzen [42] |
| Canada | 0.11 | 0.23 | 2.8 | 1 | Hauck et al. [39] |
| Germany | 0.11 | 0.23 | 3.8 | 1 | Hense et al. [40] |
| Temporal arteritis | |||||
| USA | 0.16 | 0.33 | 23.6 | 8 | Chandran et al. [59] |
| Canada | 0.16 | 0.33 | 16.2 | 5 | |
| Germany | 0.16 | 0.33 | 3.7 | 1 | Reinhold-Keller et al. [60] |
| Bell’s palsy | |||||
| USA | 0.08 | 0.16 | 40.8 | 7 | Black et al. [32] |
| Canada | 0.08 | 0.16 | 39.3 | 6 | |
| Germany | 0.08 | 0.16 | 37.6 | 6 | |
| Mortality (all causes) | |||||
| USA | 0.02 | 0.04 | 2153.7 | 83 | CDC [61] |
| Canada | 0.02 | 0.04 | 1332.2 | 51 | STATCAN [62] |
| Germany | 0.02 | 0.04 | 1066.4 | 41 | GBE [63] |
CDC Centers for Disease Control and Prevention, GBE Gesundheitsberichterstattung des Bundes, IR incidence rates, py person-year, RZV recombinant zoster vaccine, STATCAN Statistics Canada
aCountry for which expected number analysis was performed. When background IR data were unavailable or unreliable, data from countries judged to have similar characteristics were used as proxy
bThe time a person is at risk equals the cumulative risk period after each dose when the risk period is < 2 months, 2 months being the time interval between two consecutive doses. When the risk period extends past 2 months, then the risk period after dose 1 temporally overlaps with the second dose and the cumulative time at risk for a person is 2 months after dose 1, to avoid double counting risk periods, added to a complete risk period after dose 2
cIn age-stratified analyses, each age stratum is provided a weight based on the age distribution of the exposed population. Therefore, the age-adjusted IR for individuals vaccinated with RZV has been estimated by taking the weighted average of the incidence rates within each age stratum