Open Forum Infect Dis. 2019 Aug 01;6(8). doi: 10.1093/ofid/ofz295.
Varicella Virus Vaccine Live: A 22-Year Review of Postmarketing Safety Data.
Open forum infectious diseases
Meredith Woodward, Ann Marko, Susan Galea, Barry Eagel, Walter Straus
Affiliations
Affiliations
- Merck & Co., Inc., Kenilworth, New Jersey.
PMID: 31392326
PMCID: PMC6685817 DOI: 10.1093/ofid/ofz295
Abstract
BACKGROUND: Varicella, a contagious infectious disease caused by varicella zoster virus (VZV), can result in hospitalization and, occasionally, death. Varicella virus vaccine live (VVVL [VARIVAX]) was introduced in the United States in 1995.
METHODS: This comprehensive review of the VVVL safety profile is based on 22 years of postmarketing adverse event (AE) data received through spontaneous and noninterventional study reports submitted by health care providers and on a review of the published literature (cumulatively from March 17, 1995, through March 16, 2017, during which period >212 million doses were distributed globally).
RESULTS: The VVVL safety profile was consistent with previous publications, with common AEs including varicella, rash, and pyrexia. AE reports have decreased over time, from ~500 per million doses in 1995 to ~40 per million doses in 2016; serious AEs comprise 0.8 reports per million doses. Secondary transmission was rare (8 confirmed cases); polymerase chain reaction analysis indicated that 38 of the 66 reported potential secondary transmission cases of varicella were attributable to wild-type VZV. The prevalence of major birth defects in the Pregnancy Registry was similar to that in the general US population. In total, 86 cases of death were reported after vaccination with VVVL; immunocompromised individuals appeared to be most at risk for a fatal varicella- or herpes zoster-related outcome.
CONCLUSIONS: This comprehensive 22-year review confirms the overall safety profile for VVVL, with no new safety concerns identified. Since VVVL's introduction in 1995, notable declines in varicella cases and in varicella-related deaths have occurred compared with the prevaccination period.
© The Author(s) 2019. Published by Oxford University Press on behalf of Infectious Diseases Society of America.
Keywords: postmarketing; safety; varicella; varicella vaccine; varicella zoster vaccine
References
- Vaccine. 2000 Nov 22;19(7-8):916-23 - PubMed
- Lancet. 1952 Sep 20;2(6734):549-54 - PubMed
- J Virol. 1992 Feb;66(2):1016-20 - PubMed
- MMWR Recomm Rep. 2007 Jun 22;56(RR-4):1-40 - PubMed
- MMWR Morb Mortal Wkly Rep. 2008 Jan 11;57(1):1-5 - PubMed
- J Infect Dis. 2008 Mar 1;197 Suppl 2:S165-9 - PubMed
- Pediatrics. 1977 Jan;59(1):3-7 - PubMed
- Birth Defects Res A Clin Mol Teratol. 2009 Jan;85(1):20-9 - PubMed
- Pediatr Infect Dis J. 2011 Mar;30(3):266-8 - PubMed
- Vaccine. 2012 Aug 24;30(39):5791-8 - PubMed
- Semin Pediatr Neurol. 2012 Sep;19(3):124-9 - PubMed
- Ther Adv Vaccines. 2014 Mar;2(2):39-55 - PubMed
- MMWR Morb Mortal Wkly Rep. 2014 Aug 22;63(33):732-3 - PubMed
- Hum Vaccin Immunother. 2015;11(1):91-4 - PubMed
- J Pediatric Infect Dis Soc. 2016 Dec;5(4):395-402 - PubMed
- Hum Vaccin Immunother. 2016 Mar 3;12(3):651-4 - PubMed
- Pediatrics. 2016 Mar;137(3):e20153741 - PubMed
- MMWR Morb Mortal Wkly Rep. 2016 Sep 02;65(34):902-5 - PubMed
- PLoS Pathog. 2016 Oct 20;12(10):e1005892 - PubMed
- Expert Rev Vaccines. 2017 Apr;16(4):391-400 - PubMed
- Vaccine. 2017 Apr 25;35(18):2351-2357 - PubMed
- Vaccine. 2017 Dec 19;35(52):7231-7239 - PubMed
- Hum Vaccin Immunother. 2018;14(10):2460-2463 - PubMed
- Pediatrics. 1986 Oct;78(4 Pt 2):748-56 - PubMed
Publication Types