Table 1.
Overview of real-world evidence investigating the effectiveness of the recombinant zoster vaccinea.
| HZ incidence per 100,000 person-years (95% CI) |
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|---|---|---|---|---|---|---|---|
| Publication | Study type/period | Median (IQR) follow-up, months | Population | Sample size | Unvaccinated | Vaccinated | Adjusted or estimated vaccine effectiveness,b % (95% CI)c |
| Patients aged ≥ 50 years | |||||||
| Sun et al. Vaccine 202120 | Retrospective cohort study using EHR data from Kaiser Permanente Hawaii, USAd Jan 2018–Dec 2019 |
24 (24–24)[vaccinated] 24 (14.1–24.0)[unvaccinated] |
Aged ≥ 50 years | RZV – two doses: 11,864 Unvaccinated: 66,492 |
1063.3 (1006–1122.8) | Two doses: 325.6 (217.4–464.4)f | Two doses: 83.5 (74.9–89.2)f |
| Aged 50–59 years | Vaccinated: 196 PY Unvaccinated: 49,449 PY |
944.4 (861.3–1032.7) | Two doses: 0f | Two doses: 100f | |||
| Aged 60–69 years | Vaccinated: 717 PY Unvaccinated: 42,592 PY |
1037.7 (944–1137.5) | Two doses: 557.7 (173.1–1295.3)f | Two doses: 67.7 (11.8–88.1)f | |||
| Aged 70–79 years | Vaccinated: 4537 PY Unvaccinated: 17,914 PY |
1194.6 (1041.6–1361.9) | Two doses: 286.5 (157.6–471.7)f | Two doses: 83.3 (70.1–90.7)f | |||
| Aged ≥ 80 years | Vaccinated: 2841 PY Unvaccinated: 9764 PY |
1536.2 (1303.3–1795.4) | Two doses: 352.0 (176.4–617.3)f | Two doses: 86.4 (73.5–93.0)f | |||
| Aged ≥ 50 years with prior ZVL vaccinatione | Vaccinated: 184 PY Unvaccinated: 3695 PY |
703.6 (466.6–1009.7) | Two doses: 543.8 (31–2392.2)f | Two doses: 61.1 (–124.9–93.3)f | |||
| Aged ≥ 50 years with no prior ZVL vaccinatione | Vaccinated: 8107 PY Unvaccinated: 116,024 PY |
1074.8 (1016.2–1135.5) | Two doses: 320.7 (212.7–460.2)f | Two doses: 83.9 (75.2–89.5)f | |||
| Incidence of HZO | Vaccinated: 8404 PY Unvaccinated: 120,739 PY |
72.1 (58.0–88.3) | 11.9 (0.7–52.3)f | Two doses: 93.3 (48.7–99.1)f | |||
| Sun et al. Clin Infect Dis 202118 | Retrospective cohort study using claims and EHR data from OptumLabs Data Warehouse, USAd Jan 2018–Dec 2019 |
7.0 (2.8–13.0)[vaccinated] | Aged ≥ 50 years | RZV – two doses: 173,745 Unvaccinated: 4,596,074 |
893.1 (886.2–900.0) | Two doses: 258.8 (230.6–289.4)f | Two doses: 85.5 (83.5–87.3) |
| Aged 50–59 years | Vaccinated: 2019 PY Unvaccinated: 2,252,215 PY |
684.8 (674.1–695.7) | Two doses: <544.8 (282.9–933.0)f,g | Two doses: 85.6 (53.3–95.6) | |||
| Aged 60–69 years | Vaccinated: 22,934 PY Unvaccinated: 2,040,881 PY |
848.9 (836.4–861.7) | Two doses: >148.3 (103.8–203.8)f,g | Two doses: 87.7 (82.5–91.4)f | |||
| Aged 70–79 years | Vaccinated: 65,423 PY Unvaccinated: 1,926,358 PY |
1034.1 (1019.8–1048.5) | Two doses: 246.1 (210.0–286.1)f | Two doses: 86.5 (83.9–88.6)f | |||
| Aged ≥ 80 years | Vaccinated: 24,750 PY Unvaccinated: 965,456 PY |
1191.0 (1169.4–1212.9) | Two doses: 371.7 (300.8–452.9)f | Two doses: 80.3 (75.1–84.3)f | |||
| Aged ≥ 50 years with prior ZVL vaccinationh | NR | 754.5 (718.4–791.7) | Two doses: 239.4 (142.8–371.8)f | Two doses: 84.8 (75.3–90.7)f | |||
| Aged ≥ 50 years with no prior ZVL vaccinationh | NR | 908.1 (895.0–921.3) | Two doses: 260.9 (205.9–325.0)f | Two doses: 87.1 (83.4–89.9)f | |||
| Izurieta et al. Clin Infect Dis 202119 | Cohort study using Medicare claims and enrollment database analysis, USAd Nov 2017–Oct 2019 |
~~2.9 (one dose) ~~7.1 (two doses) |
Aged ≥ 65 years | RZV – one dose: 1,498,275 RZV – two doses: 1,006,446 Unvaccinated: 15,589,546 |
1032 (1028–1036) | One dose: 450 (431–469) Two doses: 309 (295–323) |
One dose: 56.9 (55.0–58.8) Two doses: 70.1 (68.6–71.5) |
| Aged 65–79 years | RZV – one dose: 1,222,612 RZV – two doses: 821,731 Unvaccinated: 11,486,608 |
1010 (1005–1014) | One dose: 429 (408–449) Two doses: 298 (282–313) |
One dose: 58.6 (56.5–60.7) Two doses: 70.6 (68.9–72.1) |
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| Aged ≥ 80 years | RZV – one dose: 275,663 RZV – two doses: 184,715 Unvaccinated: 4,102,938 |
1103 (1094–1111) | One dose: 538 (491–585) Two doses: 357 (322–391) |
One dose: 50.9 (46.2–55.1) Two doses: 68.5 (65.1–71.6) |
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| Aged ≥ 65 years with prior ZVL within 5 years of RZV | RZV – one dose: 269,852 RZV – two doses: 175,367 Unvaccinated: 2,075,196 |
852 (842–862) | One dose: 420 (376–463) Two doses: 315 (281–350) |
One dose: 51.0 (45.4–56.0) Two doses: 63.0 (58.3–67.2) |
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| Aged ≥ 65 years with no prior ZVL within 5 years of RZV | RZV – one dose: 1,128,423 RZV – two doses: 831,079 Unvaccinated: 13,514,350 |
1060 (1056–1064) | One dose: 456 (435–477) Two doses: 307 (292–323) |
One dose: 57.6 (55.4–59.6) Two doses: 71.1 (69.5–72.6) |
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| Aged ≥ 65 years and immunocompromised | RZV – one dose: 60,600 RZV – two doses: 40,442 Unvaccinated: 746,654 |
1715 (1690–1740) | One dose: 1034 (892–1175) Two doses: 585 (489–681) |
One dose: 37.0 (27.4–45.4) Two doses: 64.1 (57.2–69.8) |
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| Aged ≥ 65 years and not immunocompromised | RZV – one dose: 1,437,675 RZV – two doses: 966,004 Unvaccinated: 14,842,892 |
1001 (997–1005) | One dose: 424 (406–443) Two doses: 297 (283–311) |
One dose: 58.4 (56.4–60.3) Two doses: 70.5 (69.0–72.0) |
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| Aged ≥ 65 years with autoimmune disease | RZV – one dose: 92,069 RZV – two doses: 61,999 Unvaccinated: 886,123 |
1489 (1468–1509) | One dose: 625 (535–715) Two doses: 444 (377–512) |
One dose: 57.7 (50.9–63.6) Two doses: 68.0 (62.3–72.8) |
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| Incidence of HZO | RZV – one dose: 487,000 PY RZV – two doses: 618,000 PY Unvaccinated: 25,235,000 PY |
77 (75–78) | 40 (34–45) 25 (21–29) |
One dose: 44.7 (36.0–52.3) Two doses: 66.8 (60.7–72.0) |
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| Incidence of PHN | RZV – one dose: 295,000 PY RZV – two doses: 240,000 PY Unvaccinated: 19,857,000 PY |
99 (97–100) | 44 (37–52) 23 (17–29) |
One dose: 51.4 (42.0–59.2) Two doses: 76.0 (68.4–81.8) |
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| Bruxvoort et al. Open Forum Infect Dis 202221 | Retrospective cohort study using EHR data from Kaiser Permanente Southern California, USAd Apr 2018–Sept 2019 |
≥ 12 | Aged ≥ 50 years, with or without concomitant vaccination | RZV – two doses, with concomitant vaccinei: 12,898 RZV – two doses, without concomitant vaccinei: 28,353 |
NA | Two doses, with concomitant vaccinei: 220 (160–300) Two doses, without concomitant vaccinei: 340 (290–400) |
Adjusted HR: 0.75 (0.53–1.08)i |
| Khan et al. Clin Gastroenterol Hepatol 202222 | Retrospective cohort study using Veterans Affair Healthcare System data, USAd Jan 2018–Oct 2020 |
NR | Aged 50–60 years, with IBD | RZV – one dose: 358 RZV – two doses: 655 Unvaccinated: 5995 |
393 | One dose: 179 Two doses: 0 |
One dose: HR for HZ = 0.44 (95% CI: 0.06–3.17) One-dose VE: 56%j Two doses: HR for HZ = 0 (95% CI: 0–0) Two-dose VE: 100%j |
| Aged >60 years, with IBD | RZV – one dose: 1518 RZV – two doses: 4220 Unvaccinated: 20,554 |
457 | One dose: 248 Two doses: 180 |
One dose: HR for HZ = 0.52 (95% CI: 0.24–1.10) One-dose VE: 48.0%j Two doses: HR for HZ = 0.39 (95% CI: 0.19–0.80) Two-dose VE: 61.0%j |
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| Lu et al. Ophthalmol 202123 | Retrospective, observational cohort study using the OptumLabs Data Warehouse, USAd Jan 2018–Dec 2019 |
730 days (730–730) [vaccinated] | Aged ≥ 50 years | RZV – two doses: 177,289 Unvaccinated: 4,665,290 Vaccinated: 117,517 PY Unvaccinated: 7,374,053 PY |
76.7 (95% CI: 74.7–78.7) | 25.5 (95% CI: 17.4–35.8) | VE against HZO: 89.1% (95% CI: 82.9–93.0) |
| Patients aged ≥ 18 years undergoing HSCT | |||||||
| Baumrin et al. Blood Adv 202124 | Single-center prospective observational cohort study at Dana–Farber Cancer Institute, USA Dec 2018–Jun 2020 |
8.6 (5.7–11.5)[total vaccinated cohort] | Allogeneic HSCT recipients aged ≥ 18 years, 9–24 months after transplant | RZV – at least one dose: 158 RZV – two doses: 150 |
NA | At least one dose: 3669 Two doses only: 2834 HZ incidence was 4/157 in patients receiving at least dose and 3/144 in patients receiving two doses |
NA |
aExcluding case reports.
bAdjusted or estimated VE; for full details of the statistical methodology used, please refer to the relevant original study.
cUnless stated otherwise.
dHZ diagnosed according to International Classification of Diseases, 9th or 10th version (ICD-9 or ICD-10).
ePrior ZVL within 1 year of the index date, which was defined as the date on which both of the following were met: 1) the patient reached age ≥ 50 years in 2018 or 2019, and met age eligibility criteria for RZV; 2) the patient had at least 365 days of continuous enrollment in the Kaiser Permanente Hawaii database prior to becoming age-eligible for the RZV vaccine.
fAll patients received two doses; patients receiving a single dose were excluded.
gThe analysis reported these values using < or > symbols for reasons of patient privacy.
hPrior ZVL within 5 years of the index date, which was defined as the date on which both of the following were met: 1) the patient reached age 50 years in 2018 or 2019, and met age eligibility criteria for RZV; 2) the patient had at least 365 days of continuous enrollment in the OptumLabs Data Warehouse.
iConcomitant vaccination defined as any other vaccine received on the same day as either the first or second dose of RZV (most common types were influenza vaccines [65.9%] and pneumococcal vaccines [20.2%]). After adjusting for clinical and demographic covariates, the difference between the group with vs. without concomitant vaccination was not statistically significant (adjusted hazard ratio 0.75 [95% CI: 0.53–1.08]).
jVE calculated as (1 – HR) * 100%.
CI, confidence interval; EHR, electronic health record; HR, hazard ratio; HSCT, hematopoietic stem cell transplantation; HZ, herpes zoster; HZO, herpes zoster ophthalmicus; IBD, inflammatory bowel disease; IQR, interquartile range; NA, not applicable; NR, not reported; PHN, post-herpetic neuralgia; PY, person-years; RZV, recombinant zoster vaccine; VE, vaccine effectiveness; ZVL, zoster vaccine live.