Disseminated varicella zoster virus infection following live attenuated herpes zoster vaccine: descriptive analysis of reports to Australia’s spontaneous vaccine pharmacovigilance system, 2016–2020

Abstract

ObjectivesTo examine the reported incidence and features of disseminated varicella zoster virus (VZV) infection following live attenuated herpes zoster vaccine live (ZVL: Zostavax, Merck) in immunocompromised people in Australia.Design and settingZVL was funded in 2016 in Australia for people aged 70 years, with a catch-up programme for those 71–79 years. From 2016 to 2020, three deaths due to disseminated vaccine-strain VZV infection occurred following inadvertent ZVL administration in individuals with varying levels of immunocompromise. This descriptive study examined 4 years of national surveillance data reported to the Therapeutic Goods Administration’s Adverse Event Monitoring System (AEMS). Denominator data for rates were from doses recorded in the Australian Immunisation Register.ParticipantsIndividuals vaccinated between 1 November 2016 and 31 December 2020 who experienced adverse event(s) following immunisation (AEFI) after ZVL recorded in the AEMS.Primary and secondary outcome measuresRates and outcomes of confirmed (Oka strain positive) or probable disseminated VZV infection, and inadvertent administration of ZVL in immunocompromised individuals.Results854 AEFI were reported from 1 089 966 doses of ZVL administered (78.4 per 100 000 doses). Of those, 14 were classified as confirmed (n=6, 0.55 per 100 000) or probable (n=8) disseminated VZV infection. The confirmed cases were all hospitalised, and most (5/6) were immunocompromised; three cases died. Thirty-seven individuals were reported as vaccinated despite a contraindication due to immunocompromise (3.4 per 100 000), with 12/37 (32%) hospitalised.ConclusionsDisseminated VZV is potentially life-threatening and occurs mostly in those with severe immunocompromise. Inadvertent administration of ZVL to immunocompromised individuals has occurred despite initial provider guidance and education. Multiple additional strategies to assist providers to identify contraindications have been implemented to prevent adverse outcomes.

Burden of Herpes Zoster in Individuals with Immunocompromised Conditions and Autoimmune Diseases in the Republic of Korea: A Nationwide Population-Based Database Study

“…The average HZ IR (95% CI) per 1000 persons among patients with IC/AID was 23.41 (22.21–24.62) and remained high across all age strata. The high HZ IRs among patients with IC/AID during the study period could be partially associated with the exclusive availability of live-attenuated zoster vaccines in ROK, which are contraindicated for patients with IC/AID because of the risk of developing HZ and other severe outcomes, including death [ 20 – 22 ].…”

Vaccination of Adults With Cancer: ASCO Guideline

“…Eleven cases of varicella (vOka) vaccine strain transmission are described in the published literature, but none occurred in immunocompromised patients. 181 Because vaccine strain can cause severe and fatal varicella in profoundly immunocompromised patients, [182][183][184][185][186] precautions are advised to avoid close contact with a person with vaccine-induced rash. The rash site should be covered, and intimate skin-to-skin contact should be avoided with the immunocompromised household member until healed.…”

Immunogenicity in Mice Immunized with Recombinant Adenoviruses Expressing Varicella-Zoster Virus Envelope Glycoprotein E

“…Zostavax ® reduced the frequencies of HZ by 51.3% and PHN by 66.5%, but its preventive effect on HZ declined with age. The published reports have already described the deaths of six people caused by viral sepsis with the live attenuated vaccine, Zostavax ® , who lived in countries with excellent healthcare systems: Canada, England, Sweden and Australia [8,9]. So, sale and use of the live attenuated vaccine, Zostavax ® , were discontinued in the United States on 1 July 2020 [7,[10][11][12][13].…”