Active Postlicensure Safety Surveillance for Recombinant Zoster Vaccine Using Electronic Health Record Data

Abstract

Recombinant zoster vaccine (RZV) (Shingrix; GlaxoSmithKline, Brentford, United Kingdom) is an adjuvanted glycoprotein vaccine that was licensed in 2017 to prevent herpes zoster (shingles) and its complications in older adults. In this prospective, postlicensure Vaccine Safety Datalink study using electronic health records, we sequentially monitored a real-world population of adults aged ≥50 years who received care in multiple US Vaccine Safety Datalink health systems to identify potentially increased risks of 10 prespecified health outcomes, including stroke, anaphylaxis, and Guillain-Barré syndrome (GBS). Among 647,833 RZV doses administered from January 2018 through December 2019, we did not detect a sustained increased risk of any monitored outcome for RZV recipients relative to either historical (2013-2017) recipients of zoster vaccine live, a live attenuated virus vaccine (Zostavax; Merck & Co., Inc., Kenilworth, New Jersey), or contemporary non-RZV vaccine recipients who had an annual well-person visit during the 2018-2019 study period. We confirmed prelicensure trial findings of increased risks of systemic and local reactions following RZV. Our study provides additional reassurance about the overall safety of RZV. Despite a large sample, uncertainty remains regarding potential associations with GBS due to the limited number of confirmed GBS cases that were observed.

Keywords: herpes zoster; managed-care programs; population surveillance; sequential analysis; shingles; vaccine safety; vaccines, combined; zoster vaccine.

Figure 1

Cumulative numbers of recombinant zoster vaccine (RZV) doses administered in a Vaccine Safety Datalink study cohort, by 10-year age group (A) and study site (B), January 2018–December 2019. (Study sites 1–7 cannot be identified because of data privacy concerns.)

Figure 2

Monthly estimated relative risk of Guillain-Barré syndrome (GBS) and Bell’s palsy over time as recombinant zoster vaccine (RZV) was administered in a Vaccine Safety Datalink study cohort, January 2018–December 2019. The large square indicates where the preliminary signal occurred.