TY - JOUR
T1 - Herpes zoster vaccine live
T2 - A 10 year review of post-marketing safety experience
AU - Willis, English D.
AU - Woodward, Meredith
AU - Brown, Elizabeth
AU - Popmihajlov, Zoran
AU - Saddier, Patricia
AU - Annunziato, Paula W.
AU - Halsey, Neal A.
AU - Gershon, Anne A.
N1 - Funding Information:
This research was funded by Merck & Co., Inc., Kenilworth, NJ, USA (sponsor). In conjunction with the external investigators, this research was designed, executed, and analyzed by the sponsor. Although the sponsor formally reviewed a penultimate draft of this manuscript, the opinions expressed are those of the authorship and may not necessarily reflect those of the sponsor. All co-authors approved the final version of the manuscript.
PY - 2017/12/19
Y1 - 2017/12/19
N2 - Background Zoster vaccine is a single dose live, attenuated vaccine (ZVL) indicated for individuals ≥50 years-old for the prevention of herpes zoster (HZ). Safety data from clinical trials and post-licensure studies provided reassurance that ZVL is generally safe and well tolerated. The objective of this review was to provide worldwide post-marketing safety information following 10 years of use and >34 million doses distributed. Methods All post-marketing adverse experience (AE) reports received worldwide between 02-May-2006 and 01-May-2016 from healthcare professionals following vaccination with ZVL and submitted to the MSD AE global safety database, were analyzed. Results A total of 23,556 AE reports, 93% non-serious, were reported. Local injection site reactions (ISRs), with a median time-to-onset of 2 days, were the most frequently reported AEs followed by HZ. The majority of HZ reports were reported within 2 weeks of vaccination and considered, based on time-to-onset, pathogenesis of HZ, and data from clinical trials, to be caused by wild-type varicella-zoster virus (VZV). HZ confirmed by PCR analysis to be VZV Oka/Merck vaccine-strain was identified in an immunocompetent individual 8 months postvaccination and in 4 immunocompromised individuals. Disseminated HZ was reported very rarely (<1%) with 38% occurring in immunocompromised individuals. All reports of disseminated HZ confirmed by PCR as VZV Oka/Merck vaccine-strain were in individuals with immunosuppressive conditions and/or therapy at the time of vaccination. Conclusions The safety profile of ZVL, following 10 years of post-marketing use, was favorable and consistent with that observed in clinical trials and post-licensure studies.
AB - Background Zoster vaccine is a single dose live, attenuated vaccine (ZVL) indicated for individuals ≥50 years-old for the prevention of herpes zoster (HZ). Safety data from clinical trials and post-licensure studies provided reassurance that ZVL is generally safe and well tolerated. The objective of this review was to provide worldwide post-marketing safety information following 10 years of use and >34 million doses distributed. Methods All post-marketing adverse experience (AE) reports received worldwide between 02-May-2006 and 01-May-2016 from healthcare professionals following vaccination with ZVL and submitted to the MSD AE global safety database, were analyzed. Results A total of 23,556 AE reports, 93% non-serious, were reported. Local injection site reactions (ISRs), with a median time-to-onset of 2 days, were the most frequently reported AEs followed by HZ. The majority of HZ reports were reported within 2 weeks of vaccination and considered, based on time-to-onset, pathogenesis of HZ, and data from clinical trials, to be caused by wild-type varicella-zoster virus (VZV). HZ confirmed by PCR analysis to be VZV Oka/Merck vaccine-strain was identified in an immunocompetent individual 8 months postvaccination and in 4 immunocompromised individuals. Disseminated HZ was reported very rarely (<1%) with 38% occurring in immunocompromised individuals. All reports of disseminated HZ confirmed by PCR as VZV Oka/Merck vaccine-strain were in individuals with immunosuppressive conditions and/or therapy at the time of vaccination. Conclusions The safety profile of ZVL, following 10 years of post-marketing use, was favorable and consistent with that observed in clinical trials and post-licensure studies.
KW - Herpes zoster
KW - Post-marketing
KW - Safety
KW - Shingles vaccine live
KW - Zoster vaccine live
UR - http://www.scopus.com/inward/record.url?scp=85034771901&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85034771901&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2017.11.013
DO - 10.1016/j.vaccine.2017.11.013
M3 - Article
C2 - 29174682
AN - SCOPUS:85034771901
VL - 35
SP - 7231
EP - 7239
JO - Vaccine
JF - Vaccine
SN - 0264-410X
IS - 52
ER -