Safety and effectiveness of Recombinant Zoster Vaccine (RZV) in adults ≥18 years of age with Systemic lupus erythematosus (SLE) or Multiple sclerosis (MS)

Inclusion criteria (for the assessment of risk of severe SLE flares or any MS relapses after RZV):

• Age ≥18 years at the index date.
• Received at least 1 dose of RZV (for vaccinated individuals) on or after 01 January 2018.
• For sentinel data partners: 365 days of continuous enrolment with medical and prescription coverage (allowing ≤45-day administrative gaps in coverage) prior to the index date (baseline period). For Medicare: continuous enrolment in Medicare part A/B/D (with no part C) 1 year prior to the index date (allowing 1 month gap in enrolment).
• Met criteria for SLE or MS prior to the index date. Inclusion criteria (for the assessment of RZV vaccine effectiveness):
• Age ≥18 years at the index date.
• Met criteria for SLE or MS prior to the index date.
• For sentinel data partners: 365 days of continuous enrolment (allowing administrative gaps ≤45 days) prior to the index date (baseline period) to 30 days after the index date. For Medicare: continuous enrollment in Medicare part A/B/D (with no part C) one-year prior to the index date (allowing 1 month gap in enrollment).
• For vaccinated patients only: Received 2 doses of RZV starting on or after 01 January 2018, separated by ≥28 days (recommendations for the general population are for RZV doses to be separated by 2 to 6 months but shorter dosing intervals of 1-2 months are an option for immunocompromised patients).

Exclusion criteria (for the assessment of risk of severe SLE flares or any MS relapses after RZV):

• Any previous RZV doses prior to the index date using all available data (for comparator patients only) or a first RZV dose prior to 01 January 2018 (for vaccinated patients).
• Severe SLE flares or any MS relapses in the 90 days prior to the index date (to ensure capture of incident severe SLE flares or MS relapses).
• Diagnosis of HIV/AIDs, cancer and solid organ transplant or stem cell transplant during the baseline period. Exclusion criteria (for the assessment of RZV vaccine effectiveness):
• Any previous RZV doses prior to the index date (for unvaccinated patients) or a first RZV dose prior to 01 January 2018 (for vaccinated patients) using all available data.
• Receipt of RZV doses < 28 days apart.
• Receipt of ZVL (Zoster Vaccine Live, Zostavax) during the baseline period since this may affect rates of HZ.
• Diagnoses of HZ or PHN during the baseline period.
• Prescription fill for oral acyclovir, valacyclovir, or famciclovir during the baseline period to avoid patients with prior HZ diagnoses and because of challenges in ascertaining new episodes of HZ in patients receiving these therapies chronically for other indications.
• Diagnoses of HZ or PHN or prescription fills for oral acyclovir, valacyclovir, or famciclovir within 30 days after the index date.
• Censoring events (i.e., loss of enrollment, death, end of data/study period, ZVL vaccination) within 30 days after the index date (before the start of follow-up).
• Diagnosis of HIV/AIDs, cancer and solid organ transplant or stem cell transplant during the baseline period.