Post-marketing Surveillance of a Live Attenuated Herpes Zoster Vaccine (SKYZoster®) in Adults Aged ≥50 Years in Korea.

Abstract

Background: Herpes zoster (HZ; shingles) results from the reactivation of the varicella-zoster virus following a primary infection with varicella (chickenpox) in earlier life. Vaccination against HZ has been effective in preventing the disease. SKYZoster, a live attenuated zoster vaccine developed in Korea, was first licensed in Korea on September 29, 2017, and subsequently approved in Thailand (May 20, 2020) and Malaysia (December 13, 2022). This post-marketing surveillance (PMS) study aimed to assess and evaluate the safety profile of SKYZoster in adults who received the vaccine during a 4-year period in Korea.

Materials and methods: This PMS study was an open, non-comparative, multi-center study conducted from September 29, 2017, to September 28, 2021. Adults aged ≥50 years who were vaccinated with SKYZoster in Korea were enrolled in this study. Adverse events (AEs) that occurred during the first 42 days after vaccination were recorded and classified using the System Organ Class and Preferred Term using MedDRA 24.1.

Results: A total of 651 participants were included in the safety evaluation. Participants had a mean age of 62.15±8.59 years, with 55.30% of the participants being female and 1.69% (11 participants) had an allergy history. Overall, 121 AEs were reported in 76 participants (11.67%), including 51 adverse drug reactions (ADRs) in 37 participants (5.68%). Most AEs (120/121; 99.17%) were mild in severity and no serious AEs were reported. The most frequently reported ADRs were injection site reactions including vaccination site pain (2.92%), erythema (1.08%), and pruritus (0.46%). Multiple logistic regression analysis identified that allergy history (P=0.0001), concomitant medication use (P=0.0179) and current medical history (P=0.0351) were significantly associated with an increased AE incidence.

Conclusion: Over a 4-year post-marketing safety evaluation period, SKYZoster exhibited an acceptable safety profile in routine clinical practice in Korea. The vaccine was well-tolerated, with no serious adverse event reported, reaffirming its role in preventing HZ in adults.