Abstract
Recombinant zoster vaccine (RZV; Shingrix), an adjuvanted glycoprotein vaccine, was licensed by the Food and Drug Administration (FDA) and recommended by the Advisory Committee on Immunization Practices for adults aged ≥50 years in October 2017 (1). The previously licensed live-attenuated zoster vaccine (ZVL; Zostavax) is recommended for adults aged ≥60 years. RZV is administered intramuscularly as a 2-dose series, with an interval of 2-6 months between doses. In prelicensure clinical trials, 85% of 6,773 vaccinated study participants reported local or systemic reactions after receiving RZV, with approximately 17% experiencing a grade 3 reaction (erythema or induration >3.5 inches or systemic symptoms that interfere with normal activity). However, rates of serious adverse events (i.e., hospitalization, prolongation of existing hospitalization, life-threatening illness, permanent disability, congenital anomaly or birth defect, or death) were similar in the RZV and placebo groups (2). After licensure, CDC and FDA began safety monitoring of RZV in the Vaccine Adverse Event Reporting System (VAERS) (3). During the first 8 months of use, when approximately 3.2 million RZV doses were distributed (GlaxoSmithKline, personal communication, 2018), VAERS received a total of 4,381 reports of adverse events, 130 (3.0%) of which were classified as serious. Commonly reported signs and symptoms included pyrexia (fever) (1,034; 23.6%), injection site pain (985; 22.5%), and injection site erythema (880; 20.1%). No unexpected patterns were detected in reports of adverse events or serious adverse events. Findings from early monitoring of RZV are consistent with the safety profile observed in prelicensure clinical trials.
Highlights
Morbidity and Mortality Weekly ReportPostlicensure Safety Surveillance of Recombinant Zoster Vaccine (Shingrix) — United States, October 2017–June 2018
Several reports suggested that health care providers made clinical decisions to not administer the second dose of Recombinant zoster vaccine (RZV) after observing local or systemic reactions in patients
Approximately 17% of RZV recipients experienced grade 3 reactions [2,6,7]; these episodes were self-limited and resolved in a few days
Summary
Postlicensure Safety Surveillance of Recombinant Zoster Vaccine (Shingrix) — United States, October 2017–June 2018. CDC and FDA began safety monitoring of RZV in the Vaccine Adverse Event Reporting System (VAERS) [3]. VAERS is a national passive surveillance system for adverse events after administration of U.S.-licensed vaccines and is coadministered by CDC and FDA [3]. Physicians reviewed reports (as well as medical records and other documentation when available) for 22 prespecified outcomes, which included conditions of general interest for vaccine safety and conditions identified as possible or theoretical safety concerns from prelicensure clinical trials (Supplementary Table 1, https://stacks.cdc.gov/ view/cdc/62214) Empirical Bayesian data mining methods were used to identify RZV-adverse event pairings that were reported at least twice as frequently as were reported in all other U.S.licensed vaccines in the VAERS database [3].
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