2017–2019 IBM MarketScan (patients’ age: 50–64 years) N=55,654
Real-world evidence for the recombinant zoster vaccine (RZV)
Since the first approval of the recombinant zoster vaccine (RZV) against herpes zoster (HZ) in 2017, evidence for its use in real-world settings has been generated through real-world studies. A key advantage of real-world studies is the heterogeneity of the populations involved (up to ~15 million individuals analysed1), the possibility to identify rare adverse events (AEs) and to detect events to an extent that would not be possible in clinical trials.2,3
This page summarises results of selected real-world effectiveness and safety studies in adults ≥50 years of age (YOA), including patients with underlying conditions. For an exhaustive summary of the RZV real-world evidence, please access the related publication in Human Vaccines & Immunotherapeutics.
Key learnings: Real-world studies have shown that the RZV is effective across the studied populations (adults aged ≤50 years and patients with immunodeficiencies or who are receiving immunosuppressive therapies). Real-world studies suggested that the RZV clinically acceptable safety profile is consistent with results from clinical trials.4
Quick Links
Overview of RZV real-world effectiveness studies
RZV real-world effectiveness: Results
RZV real-world effectiveness studies: Summary
Overview of RZV real-world safety studies
Real-world safety of RZV vaccination
RZV real-world safety studies: Summary
| Design | Population age (YOA) |
Follow-up (median) | Total N (Vaccinated; Unvaccinated) |
Location | |
|---|---|---|---|---|---|
| Sun5 (Jun 2021) |
Retrospective | ≥50 | 24 months | ~78,000 (~12k; ~66k) |
USA |
| Sun6 (Sep 2021) |
Retrospective | ≥50 | 7 months | ~4.7M (~173k; ~4.6M) |
USA |
| Izurieta1 (Sep 2021) |
Prospective | ≥65 including IC and AID |
7.1 months | ~11.7M (~978k†; ~10.3M) |
USA |
| Lu7 (Dec 2021) |
Retrospective | ≥50 | 24 months | ~4.8M (~177k; ~4.6M) |
USA |
| Bruxvoort8 (Feb 2022) |
Retrospective | ≥50 | 11–28 months* |
~41,000 vaccinated |
USA |
| Khan9 (Jul 2022) |
Retrospective | ≥50 with IBD |
Not reported | ~33,000 (~7k; ~26k) |
USA |
| Florea10 (Oct 2023) |
Retrospective | ≥50 | Not available | 19,890 (3978; 15,912) |
USA |
*Median follow-up not reported; †vaccinated refers to those who received 2 doses of the RZV; there were ~464k participants who received only 1 dose of the RZV.
Table created by GSK from the original data presented in Sun Y, et al. Vaccine. 2021;39:3974–3982; Sun Y, et al. Clin Infect Dis. 2021;73:949–956; Izurieta HS, et al. Clin Infect Dis. 2021;73:941–948; Lu A, et al. Ophthalmology. 2021;128:1699–1707; Bruxvoort K, et al. Open Forum Infect Dis. 2022;9(3):ofac011; Khan N, et al. Clin Gastroenterol Hepatol. 2022;20(7):1570–1578; Florea A, et al. Real-World Effectiveness of Recombinant Zoster Vaccine in Chinese Adults Aged ≥50 Years in the US [Abstract]. Presented at IDWeek; 11–15 October, 2023; Boston, Massachusetts, USA.
AID, autoimmune disease; IBD, inflammatory bowel disease; IC, immunocompromised; k, thousand; M, million; RZV, recombinant zoster vaccine; YOA, years of age.
Seven studies examined the real-world effectiveness of the RZV in various populations (including immunocompromised and comorbid individuals) and six studies focused on RZV use in adults ≥50 YOA5–10; the study by Izurieta et al. (2021) focused on adults ≥65 YOA.1 Collectively, RZV effectiveness against herpes zoster was high.1,5–10
Vaccine effectiveness was high across studies; the lower vaccine effectiveness in the Izurieta et al. (2021) study may be due to the older (≥65 YOA) and possibly more frail population.1,5,6,10
Figures contain heterogenous results and serve representative purposes only; they are not meant for head-to-head comparison between studies. Vaccine recipients received 2 doses of the RZV. *Approximately 464,000 recipients only received one dose of the RZV; †population ≥50 YOA; ‡population ≥65 YOA.
Figure created by GSK from the original data presented in Sun Y, et al. Vaccine. 2021;39(29):3974–3982, Sun Y, et al. Clin Infect Dis. 2021;73(6):949–956, Izurieta HS, et al. Clin Infect Dis. 2021;73(6):941–948 and Florea A. Real-World Effectiveness of Recombinant Zoster Vaccine in Chinese Adults Aged ≥50 Years in the US [Abstract]. Presented at IDWeek; 11–15 October, 2023; Boston, Massachusetts, USA.
CI, confidence interval; HZ, herpes zoster; M, million; N, number of participants; PY, person years; RZV, recombinant zoster vaccine; VEff, vaccine effectiveness; YOA, years of age.
Vaccine effectiveness of the RZV against herpes zoster remained high across all age strata, including persons aged 80 years and older.1,5,6
Figures contain heterogenous results and serve representative purposes only; they are not meant for head-to-head comparison between studies. Vaccine recipients received 2 doses of RZV. *Approximately 464,000 recipients only received one dose of RZV; †population ≥50 YOA; ‡population ≥65 YOA.
Figure created by GSK from the original data presented in Sun Y, et al. Vaccine. 2021;39(29):3974–3982, Sun Y, et al. Clin Infect Dis. 2021;73(6):949–956 and Izurieta HS, et al. Clin Infect Dis. 2021;73(6):941–948.
CI, confidence interval; HZ, herpes zoster; M, million; N, number of participants; PY, person years; RZV, recombinant zoster vaccine; VEff, vaccine effectiveness; YOA, years of age.
To read more about the clinical efficacy data obtained in the pivotal ZOE trials focusing on patients aged 50 years or older, please follow this link.
PHN and HZO are among the most common complications patients suffering from a herpes zoster episode can experience.11 The adjusted vaccine effectiveness against HZO was 93.3% (95% CI: 48.7–99.1) in Sun et al. (2021a)5, 66.8% (95% CI: 60.7–72.0) in Izurieta et al. (2021)1, and 89.1% (95% CI: 82.9–93.0) in Lu et al. (2021).7 Izurieta et al. (2021) was the only study that reported vaccine effectiveness against PHN: 76.0% (95% CI: 68.4–81.8%).1
Figure contains heterogenous results and serve representative purposes only; it is not meant for head-to-head comparison between studies. Vaccine recipients received 2 doses of RZV. *Approximately 464,000 recipients only received one dose of RZV; †population ≥50 YOA; ‡population ≥65 YOA.
Figure created by GSK from the original data presented in Sun Y, et al. Vaccine. 2021;39(29):3974–3982, Izurieta HS, et al. Clin Infect Dis. 2021;73(6):941–948 and Lu A, et al. Ophthalmology. 2021;128(12):1699–1707.
CI, confidence interval, HZ, herpes zoster; HZO, herpes zoster ophthalmicus; PY, person years; RZV, recombinant zoster vaccine; VEff, vaccine effectiveness; YOA, years of age.
Figure contains heterogenous results and serve representative purposes only; it is not meant for head-to-head comparison between studies. *Vaccine recipients received 2 doses of RZV, population ≥65 YOA.
Figure created by GSK from the original data presented in Izurieta HS, et al. Clin Infect Dis. 2021;73(6):941–948.
CI, confidence interval, HZ, herpes zoster; PHN, post-herpetic neuralgia; PY, person years; RZV, recombinant zoster vaccine; VEff, vaccine effectiveness; YOA, years of age.
Vaccine effectiveness against HZO remained high when stratified by age in a study by Lu A et. al (2021).7
*Incidence rates for age groups 60–69 years and 70–79 years were combined to protect patient privacy due to low incidence of HZO in these age groups.
Figure created by GSK from the original data presented in Lu A, et al. Ophthalmology. 2021;128(12):1699–1707.
CI, confidence interval; HZO, herpes zoster ophthalmicus; PY, person years; RZV, recombinant zoster vaccine; VEff, vaccine effectiveness; YOA, years of age.
The slightly lower vaccine effectiveness against herpes zoster for IC individuals compared with healthy individuals is consistent with reduced vaccine efficacy against herpes zoster seen in autologous haematopoietic stem cell transplant (auHSCT) recipients12 and among those with haematological malignancies when compared to immunocompetent older adults.13–15
*A similar statistical analysis was not provided for AID versus non-AID populations.
Figure created by GSK from the original data presented in Izurieta HS, et al. Clin Infect Dis. 2021;73(6):941–948.
AID, autoimmune disease; CI, confidence interval; HR, hazard ratio; HZ, herpes zoster; IC, immunocompromised; N, number of participants; PY, person years; RZV, recombinant zoster vaccine; VEff, vaccine effectiveness.
*Percentages calculated among all those with an IC condition, N=746,654; 0.4% had an intermediate IC condition.
Figure created by GSK from the original data presented in Izurieta HS, et al. Clin Infect Dis. 2021;73(6):941–948.
AIDS, acquired immune deficiency syndrome; HIV, human immunodeficiency virus; IC, immunocompromised; N, number of participants.
Individuals with IBD have an increased risk of HZ infection. RZV vaccination was associated with a significantly lower risk of HZ among the age groups 50–60 years and >60 years, although this was limited by low HZ event rates.9
Figure created from the original data presented in Khan N, et al. Clin Gastroenterol Hepatol. 2022;20(7):1570–1578.
CI, confidence interval; HZ, herpes zoster; IBD, inflammatory bowel disease; N, number of participants; PY, person-years; RZV, recombinant zoster vaccine; YOA, years of age.
Vaccine effectiveness was significantly higher against herpes zoster following 2 doses of RZV compared with a single dose, which was most pronounced for older adults (aged ≥80 years) and immunocompromised individuals.1 These results highlight the need to ensure adherence to the recommended 2-dose schedule with RZV.1
*The 2-dose series of RZV could be completed any time during the study period up to a maximum of 1 year (i.e., outside of the recommended 2–6-month dosing interval); †RZV is intended as a 2-dose series, vaccine effectiveness was calculated descriptively for patients who did not receive a second dose.
Figure created by GSK from the original data presented in Izurieta HS, et al. Clin Infect Dis. 2021;73(6):941–948.
CI, confidence interval; HZ, herpes zoster; IC, immunocompromised; M, million; N, number of participants; PY, person years; RZV, recombinant zoster vaccine; VEff, vaccine effectiveness; ZVL, zoster vaccine live.
PHN and HZO are among the most common complications patients suffering from a herpes zoster episode can experience.11 Vaccine effectiveness against both common complications was therefore also calculated and, as depicted above, was significantly higher following 2 doses of RZV compared with a single dose.1 These results highlight the need to ensure adherence to the recommended 2-dose schedule with RZV.1
*The 2-dose series of RZV could be completed any time during the study period (i.e., outside of the recommended 2–6-month post first dose window) up to a maximum of 1 year; †RZV is intended as a 2-dose series, vaccine effectiveness was calculated descriptively for patients who did not receive a second dose.
Figure created by GSK from the original data presented in Izurieta HS, et al. Clin Infect Dis. 2021;73(6):941–948.
CI, confidence interval; HZO, herpes zoster ophthalmicus; IC, immunocompromised; PHN, post-herpetic neuralgia; PY, person years; RZV, recombinant zoster vaccine; VEff, vaccine effectiveness.
Results from cohort studies are indicating the benefit of revaccination with RZV against HZ, in spite of previous ZVL vaccination.1,5–7
Figures contain heterogenous results and serve representative purposes only; they are not meant for head-to-head comparison between studies. *Receipt of ZVL was within the last year for Sun et al. (2021a)5 and Lu et al. (2021)7, and within 5 years for Sun et al. (2021b)6 and Izurieta et al. (2021)1; †in the vaccinated cohort, there was one case of HZ.5
Figures created by GSK from the original data presented in Sun Y, et al. Vaccine. 2021;39(29):3974–3982, Sun Y, et al. Clin Infect Dis. 2021;73(6):949–956, Izurieta HS, et al. Clin Infect Dis. 2021;73(6):941–948 and Lu A, et al. Ophthalmology. 2021;128(12):1699–1707.
CI, confidence interval; HZ, herpes zoster; HZO, herpes zoster ophthalmicus; N, number of participants; NR, not reported; PY, person years; RZV, recombinant zoster vaccine; VEff, vaccine effectiveness; ZVL, zoster vaccine live.
RZV effectiveness studies: Summary
- Overall, RZV effectiveness against herpes zoster was high across the real-world studies1,5–7,9,10
- The RZV also provided effective protection against PHN1 and HZO1,5,7
- Age, prior receipt of ZVL, presence of AID, or delayed receipt of the second dose of the RZV did not impact RZV effectiveness in most studies.1,4–10 However, effectiveness in IC individuals was lower, in line with the efficacy results observed in the Phase 3 clinical trials conducted in auHSCT and patients with haematological malignancies1,12,13
- Available real-world data indicate there is clinical benefit of revaccination against herpes zoster with the RZV in patients previously vaccinated with ZVL1,5,6
- Follow-up time was short (≤2–3 years) in early post-licensure RWE studies, limiting the time to track herpes zoster outcomes in the vaccinated population.1,5–7 Studies with longer duration of follow-up will help to inform on the long-term effectiveness of RZV in prevention of HZ
Overview of the RZV real-world safety studies
The safety of the RZV has been extensively studied in regulatory- and manufacturer-led, post-licensure surveillance, and other types of studies.16–23 These studies focused on RZV safety in specific populations and explored key areas of interest, such as the incidence of Guillain-Barré Syndrome (GBS).
| Design |
Population |
Follow-up | Sample size | Location | |
|---|---|---|---|---|---|
| Tavares-Da-Silva16 (Apr 2020) |
Post-marketing safety surveillance |
RZV recipients worldwide |
16 months | 15,638 spontaneous RZV reports | Worldwide |
| Gupta17 (Mar 2022) |
Medical records review |
Adults with rheumatic disease |
3 months | RZV - 1 dose: 31 RZV - 2 doses: 34 |
USA |
| Khan18 (Sep 2022) |
Retrospective | Patients with IBD | 3 months | RZV: 1677 Unvaccinated matched controls: 1677 |
USA |
| Lenfant19 (Nov 2021) |
Medical records review | Adults with or without IMID | 8.3 months | RZV - 1 dose: 146 RZV - 2 doses: 476 |
USA |
| Leung20 (Nov 2022) |
Medical claims data analysis | Aged ≥50 years with IMID | ≥6 months | ~80,000 | USA |
| Raza21 (Feb 2022) |
Retrospective | Patients with rheumatic disease after 2 doses of RZV | 4.8 months | 47 | USA |
| Satyam22 (Oct 2020) |
Prospective | Patients with IBD | 6.8 months | At least 1 RZV dose: 67 | USA |
| Stevens23 (Jun 2020) |
Retrospective | Patients with RA or other SRD | 3 months | At least 1 RZV dose: 403 | USA |
Examples of IMIDs include: ankylosing spondylitis; axial spondyloarthritis; calcium pyrophosphate deposition; Crohn’s disease; gout; IBD; inflammatory arthritis; psoriatic arthritis; psoriasis; rheumatoid arthritis; systemic lupus erythematosus; ulcerative colitis; vasculitis.19,20
Table created by GSK from the original data presented in Tavares-Da-Silva F, et al. Vaccine. 2020;38(18):3489–3500, Gupta S, et al. J Clin Rheumatol. 2022;28(2):e528–e531, Khan N, et al. J Crohns Colitis. 2022;16(9):1505–1507, Lenfant T, et al. Rheumatology. 2021;60(11):5149–5157, Leung J, et al. Arthritis Rheumatol. 2022;74(11):1833–1841, Raza S, et al. South Med J. 2022;115(2):125–128, Satyam VR, et al. Dig Dis Sci. 2020;65(10):2986–2991, Stevens E, et al. ACR Open Rheumatol. 2020;2(6):357–361.
IBD, inflammatory bowel disease; IMID, immune-mediated inflammatory disease; RA, rheumatoid arthritis; RZV, recombinant zoster vaccine; SRD, systemic rheumatic disease.
This page provides an overview of some of the key studies and results. Collectively, these real-world studies support the favourable benefit-risk profile of the RZV.
Tavares-Da-Silva (Apr 2020)
| Design16 |
Post-marketing safety surveillance |
|---|---|
| Population16 | RZV recipients worldwide |
| Primary objective16 | Review spontaneous data reported to GSK worldwide between 13th October 2017 and 10th February 2019 |
| Additional information16 |
|
Table created by GSK from the original data presented in Tavares-Da-Silva F, et al. Vaccine. 2020;38(18):3489–3500.
AE, adverse event; RZV, recombinant zoster vaccine.
Results
- 9,323,118 doses of the RZV were distributed globally, with 15,638 reports received and 37,697 total AEs documented16
- Most common reports: symptoms related to vaccine reactogenicity (e.g., injection-site reactions, pyrexia, chills, fatigue, etc.) with a reporting rate of ~50 reports per 100,000 doses distributed, duration: 3–4 days after vaccination16
- Among serious reports (5%), the most common events were herpes zoster (28% of reports), pyrexia (10%), pain in an extremity (9%) and pain (8%)16
- The observed all-cause mortality and incidences of the two most frequently reported IMIDs (GBS and Bell’s palsy) were not at a greater frequency following vaccination compared with the expected range in this population16
Conclusion
- The analysis of worldwide safety data from the GSK safety database demonstrated that the safety profile of the RZV was favourable and consistent with that observed in clinical trials16
Leung (Nov 2022)
Retrospective, observational cohort study to estimate RZV coverage among patients with IMIDs aged ≥50 years and a subgroup analysis using self-controlled case series to examine the risk of possible RZV-related flares20
IMIDs included: ankylosing spondylitis; axial spondyloarthritis; Crohn’s disease; inflammatory bowel disease; psoriatic arthritis; psoriasis; rheumatoid arthritis; systemic lupus erythematosus; ulcerative colitis.
CMS, Centers for Medicare and Medicaid Services; IMID, immune-mediated inflammatory disease; N, number of patients; RZV, recombinant zoster vaccine.
| Outcomes and patient data |
|---|
| Presumed flares defined as hospitalisation/emergency department visit for their respective IMIDs, or steroid treatment with a short-acting oral glucocorticoid or parenteral glucocorticoid injection |
| Monthly and cumulative frequencies of RZV administration (2018–2019) |
| Characteristics of patients who received ≥1 RZV dose |
| Self-controlled case series (SCCS) analysis to examine a temporal association between RZV and flares after the first and second dose of RZV |
IMID, immune-mediated inflammatory disease; RZV, recombinant zoster vaccine. The risk of flares was compared during a 42-day risk window (1–42 days after RZV vaccination) versus a 42-day control window (98–140 days prior to RZV vaccination).
Figure created by GSK from original data presented in Leung J, et al. Arthritis Rheumatol. 2022;74(11):1833–1841. The risk of flares was compared during a 42-day risk window (1–42 days after RZV vaccination) versus a 42-day control window (98–140 days prior to RZV vaccination).
Among enrolees with IMIDs, 14.8% of 55,654 MarketScan enrolees and 43.2% of 160,545 Medicare enrolees received ≥1 dose of RZV in 2018–2019. Two-dose series completion rates were 76.6% in MarketScan enrolees and 85.4% in Medicare enrolees.
Among MarketScan and Medicare enrolees, 10% and 13% developed flares in the control window, compared to 9% and 11–12% in the risk window following 1 or 2 doses of RZV, respectively.
Conclusion20
No statistically significant increase in presumed flares following RZV administration for any IMID in either age group was found.20
Among enrolees aged ≥50 years with IMIDs, a substantial proportion received RZV when compared with general zoster coverage estimates, and series completion rates were high.20
Background
- A study by Anderson TC, et al. supports an epidemiologic temporal association between HZ and GBS, albeit the underlying mechanism requires additional research24
- Studies have evaluated the potential risk of GBS following vaccination with RZV
Key results16,25–27
- Tavares-Da-Silva F, et al. Vaccine. 2020;38(18):3489–3500
- The authors found that the observed number of cases of GBS following RZV was not greater than expected in the patient population
- Haguinet F, et al. Pharmacoepidemiol Drug Saf. 2021;30(S1):3–400
- A self-controlled case-series analysis of data from two US claims databases suggested a confounding effect of herpes zoster episodes on the potential causal association between RZV vaccination and the risk of GBS
- Goud R, et al. JAMA Intern Med. 2021;181(12):1623–1630
- Medicare claims database analysis investigated the incidence of GBS following RZV vaccination in adults aged ≥65 years (1,318,004 doses in 849,397 patients)
- Increased risk of GBS identified (RR = 2.84; 95% CI: 1.53–5.27; P=0.001); excess of ~3 cases per million RZV doses during the 42-day period following vaccination
- Yih WK, et al. Am J Epidemiol. 2022;191(5):957–964
- A study using IBM MarketScan data for insured people in the USA aged ≥50 years
- Approximately 1 million RZV doses administered from January 2018 through May 2020
- The authors found no association between RZV and GBS
Conclusion
- One post-marketing data suggest a potentially increased risk of GBS
- Collective evidence is insufficient to determine a causal association between RZV and GBS25
- The benefits of vaccination with RZV continue to outweigh its risks28
RZV safety studies: Summary
- Collectively, real-world studies reaffirm the favourable benefit-risk profile of the RZV16–23
- An analysis of worldwide safety data from the GSK safety database demonstrated that the safety profile of the RZV was favourable and consistent with that observed in clinical trials16
- Between 13th October 2017 and 10th February 2019, an estimated 9.3 million doses were distributed and GSK received 15,638 spontaneous AE reports involving the RZV16
- Most common reports: symptoms related to vaccine reactogenicity (e.g., injection site reactions, pyrexia, chills, fatigue, etc.), reporting rate ~50 reports per 100,000 doses administered16
- Among serious reports (5%), the most common events were herpes zoster (28% of reports), pyrexia (10%), pain in an extremity (9%) and pain (8%)16
- As shown in a self-controlled case-series analysis by Leung J, et al. (2022), no increase in the risk of flares was identified in adults with IMIDs who had received at least 1 dose of the RZV20
- GBS following RZV administration is a rare event16,24–27
- In a post-marketing observational study in individuals aged 65 years or older, an increased risk of GBS (estimated 3 excess cases per million doses administered) was observed during the 42 days following vaccination with the RZV. Available information is insufficient to determine a causal relationship with the RZV
Abbreviations
AE, adverse event; AID, autoimmune disease; AIDS, acquired immune deficiency syndrome; auHSCT, autologous haemopoietic stem cell transplant; CI, confidence interval; CMS, Centers for Medicare and Medicaid Services; GBS, Guillain-Barré Syndrome; HIV, human immunodeficiency virus; HR, hazard ratio; HSCT, haematopoietic stem cell transplant; HZ, herpes zoster; HZO, herpes zoster ophthalmicus; IBD, inflammatory bowel disease; IC, immunocompromised; IMID, immune-mediated inflammatory disease; k, thousand; M, million; N, number of participants; NR, not reported; PHN, post-herpetic neuralgia; PY, person years; RA, rheumatoid arthritis; RZV, recombinant zoster vaccine; VEff, vaccine effectiveness; YOA, years of age; ZVL, zoster vaccine live.
References
- Izurieta HS, et al. Clin Infect Dis. 2021;73(6):941–948.
- Fiore J, et al. Ther Adv Vaccines Immunother. 2021;9:25151355211057479.
- Sturkenboom M, et al. Vaccine. 2020;38 Suppl 2:B1—B7.
- Parikh R, et al. Hum Vaccines Immunother. 2023, DOI:10.1080/21645515.2023.2263979
- Sun Y, et al. Vaccine. 2021;39(29):3974–3982.
- Sun Y, et al. Clin Infect Dis. 2021;73(6):949–956.
- Lu A, et al. Ophthalmology. 2021;128(12):1699–1707.
- Bruxvoort KJ, et al. Open Forum Infect Dis. 2022;9(3):ofac011.
- Khan N, et al. Clin Gastroenterol Hepatol. 2022;20(7):1570-1578.
- Florea A, et al. Real-world effectiveness of recombinant zoster vaccine in Chinese adults aged ≥50 years in the US. Presented at IDWeek; 11–15 October, 2023; Boston, Massachusetts, USA.
- Kawai K, et al. BMJ Open. 2014;4(6):e004833.
- Bastidas A, et al. JAMA. 2019;322(2):123–133.
- Dagnew AF, et al. Lancet Infect Dis. 2019;19(9):988–1000.
- Cunningham AL, et al. N Engl J Med. 2016;375(11):1019–1032.
- Lal H, et al. N Engl J Med. 2015;372(22):2087–2096.
- Tavares-Da-Silva F, et al. Vaccine. 2020;38(18):3489–3500.
- Gupta S, et al. J Clin Rheumatol. 2022;28(2):e528–e531.
- Khan N, et al. J Crohns Colitis. 2022;16(9):1505–1507.
- Lenfant T, et al. Rheumatology. 2021;60(11):5149–5157.
- Leung J, et al. Arthritis Rheumatol. 2022;74(11):1833–1841.
- Raza S, et al. South Med J. 2022;115(2):125–128.
- Satyam VR, et al. Dig Dis Sci. 2020;65(10):2986–2991.
- Stevens E, et al. ACR Open Rheumatol. 2020;2(6):357–361.
- Anderson TC, et al. Hum Vaccin Immunother. 2021;17(12):5304–5310.
- Yih WK, et al. Am J Epidemiol. 2022;191(5):957–964.
- Goud R, et al. JAMA Intern Med. 2021;181(12):1623–1630.
- Haguinet F, et al. Pharmacoepidemiol Drug Saf. 2021;30(S1):3–400.
- Food and Drug Aministration (FDA). FDA Requires a Warning about Guillain-Barré Syndrome (GBS) be Included in the Prescribing Information for Shingrix. 2021; https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-requires-warning-about-guillain-barre-syndrome-gbs-be-included-prescribing-information-shingrix. Accessed September 2023.
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