Post-licensure safety surveillance of zoster vaccine live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006–2015

Miller, Elizabeth M.; Lewis, Paige; Shimabukuro, Tom T.; Su, John R.; Moro, Pedro L.; Woo, Emily Jane; Jankosky, Christopher; Cano, Maria

doi:10.1080/21645515.2018.1456598

Cited by 26 publications

(28 citation statements)

References 21 publications

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“…Herpes zoster and rash were commonly reported for ZVL, whereas systemic reactions including pyrexia and chills were commonly reported for RZV. Reporting rates for RZV were 136 per 100,000 doses distributed (all adverse event reports) and 4.0 per 100,000 (serious adverse event reports) versus 106 and 4.4, respectively, for ZVL ( 8 ). Because dose number in series (i.e., first or second) is not consistently reported in VAERS, the number of reports representing a person’s first or second exposure to RZV is unknown.…”

Section: Discussionmentioning

confidence: 99%

Postlicensure Safety Surveillance of Recombinant Zoster Vaccine (Shingrix) — United States, October 2017–June 2018

Hesse¹,

Shimabukuro²,

Su³

et al. 2019

MMWR Morb. Mortal. Wkly. Rep.

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Section: Discussionmentioning

confidence: 99%

Postlicensure Safety Surveillance of Recombinant Zoster Vaccine (Shingrix) — United States, October 2017–June 2018

Hesse¹,

Shimabukuro²,

Su³

et al. 2019

MMWR Morb. Mortal. Wkly. Rep.

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“…The most common adverse reactions were pyrexia (23.6%), injection site pain (22.5%), injection site erythema (20.1%), pain (19.5%), chills (19.3%), headache (16.7%), fatigue (15.8%), pain in extremity (15.8%), injection site swelling (13.4%), myalgia (12.1%). Compared to ZVL, for which HZ and rash were reported as common adverse reactions,59 RZV had a greater number of systemic reactions (e.g., fever).…”

Section: Recombinant Zoster Vaccinementioning

confidence: 86%

“…ZVL is effective in preventing the disease but the protection tends to decay over time 49,58. In general, ZVL is well tolerated, has few systemic adverse events and mild to moderate injection site adverse events 59,60…”

Section: Live Attenuated Hz Vaccinementioning

confidence: 99%

<p>Varicella zoster virus vaccines: an update</p>

Gabutti

Bolognesi

Sandri

et al. 2019

ITT

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Varicella zoster virus (VZV) is the etiological agent of varicella, a highly infectious, self-limiting disease with serious complications. The decline in cellmediated immunity (CMI) that occurs with aging or immunodepression causes a reactivation of the latent VZV as herpes zoster (HZ). Prevention of VZV through varicella vaccination strategies allows to avoid the primary infection in newborns and susceptible subjects. Available monovalent and combined VZV vaccines are effective, safe and generally well tolerated. Universal varicella vaccination has significantly impacted on incidence, complications and deaths related to this disease. Prevention of HZ through vaccination is a priority to avoid the significant burden of its incidence and complications. Currently two HZ vaccines are available. The recombinant zoster vaccine (RZV), approved by the FDA in 2017 and Zoster Vaccine Live (ZVL) licensed in the United States by the FDA in 2006. The advisory committee on immunization practices (ACIP) preferentially recommends RZV. ZVL remains an option for prevention of HZ in immunocompetent adults aged ≥60 years, although the CMI tends to wane a few years after vaccination.

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“… 25 Post-licensure safety monitoring through the Vaccine Adverse Event Reporting System (VAERS) reported rates of post-immunization herpes zoster of 6.1 cases per 100,000 (196/3,200,000) patients following Shingrix (October 2017–June 2018) compared to 12.7 cases per 100,000 (2781/21,846,030) patients following Zostavax (May 2006–February 2015). 10 , 26 …”

Section: Discussionmentioning

confidence: 99%

Acute retinal necrosis following recombinant subunit varicella-zoster virus vaccine

Chen

Deaner

Srivastava

et al. 2020

American Journal of Ophthalmology Case Reports

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Purpose Previously, secondary prevention of herpes zoster required live-attenuated vaccination, which is contraindicated in immunocompromised populations. More recently, a recombinant subunit vaccine (Shingrix, GlaxoSmithKline, Research Triangle Park, North Carolina) was approved by the Food and Drug Administration. Iatrogenic varicella-zoster virus (VZV) infection is theoretically impossible as it does not contain a live virus. We present a case of acute retinal necrosis (ARN) and disseminated zoster after receiving the recombinant subunit vaccine. Observations A 65-year-old woman with past medical history of multiple myeloma treated with a previous autologous hematopoietic stem cell transplant and now with daratumumab and pomalidomide developed disseminated zoster and subsequently acute retinal necrosis weeks after receiving the zoster subunit vaccine. Molecular testing confirmed the presence of VZV, and the absence of herpes simplex virus, cytomegalovirus, and toxoplasmosis. The VZV was found to be genotypically wildtype and not related to the Oka strain used in the live-attenuated zoster vaccine. She was treated with systemic valacyclovir and intravitreal foscarnet. Conclusions and importance This is the first report of VZV infection following the zoster subunit vaccine. The Advisory Committee on Immunization Practices (ACIP) has recommended the recombinant subunit vaccine over the live-attenuated vaccine due to its superior efficacy. The off-label use of the subunit vaccine in immunocompromised populations has been supported up to this point by studies demonstrating its relative safety. Though post-vaccination VZV infection or reactivation appears to be rare, clinicians should be aware of this potential complication to the recombinant subunit vaccine.

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Post-licensure safety surveillance of zoster vaccine live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006–2015

Cited by 26 publications

References 21 publications

Postlicensure Safety Surveillance of Recombinant Zoster Vaccine (Shingrix) — United States, October 2017–June 2018

Postlicensure Safety Surveillance of Recombinant Zoster Vaccine (Shingrix) — United States, October 2017–June 2018

<p>Varicella zoster virus vaccines: an update</p>

Acute retinal necrosis following recombinant subunit varicella-zoster virus vaccine

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