Sex: U
Vaccine: UNK, VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Vaccination failure; Herpes zoster ophthalmicus; This case was reported in a literature article and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, more than 2 months after receiving Shingrix and more than a month after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was reported in a literature article and described the vaccination failure in a patient aged 50-year-old or older of unspecified gender, who was vaccinated with Shingrix (GlaxoSmithKline) for prophylaxis. This case corresponds to table 3 reported in this literature article. The patient was a part of retrospective cohort study that aimed to assess the effectiveness of the recombinant zoster vaccine against herpes zoster (HZ) and herpes zoster ophthalmicus (HZO) in immunocompetent, vaccine age-eligible individuals without a prior history of HZ, who were continuously enrolled for more than 365 days prior to becoming age-eligible for RZV between 1st January 2018, through 31st December 2019. [In this study, patients became eligible for inclusion in this study based on two criteria: (1) turned 50 or were 50 years of age or older in 2018 or 2019, meeting age eligibility for RZV based on recommendations from the Agency; (2) had at least 365 days of continuous enrollment prior to becoming age-eligible for the RZV vaccine. The date on which these two criteria were met was defined as a patient's index date. ]. Patients aged 50 or older who joined study on or after 1st January 2018 were excluded from the final cohort because of the possibility that they may have received RZV prior to joining. A total of 44 individuals who received their first dose of RZV prior to 1st January 2018 (0.05% of the total vaccinated cohort) were excluded. Patients who had only received a single dose of RZV were also excluded. Patients with HZ occurring between the first and second dose of RZV and up to 30 days after the second dose of RZV were excluded due to inadequate time for a protective immune response to develop after RZV. Patients who received their second dose of RZV less than 30 days or greater than 210 days after the first dose were excluded because the second dose fell outside of the recommended time frame for vaccination by the Agency. Patients who were diagnosed with HZ, as determined by an International Classification of Disease (ICD) 10th revision code (ICD-10 B02.xx), and individuals who were immunocompromised within 1 year prior to the index date were excluded.]. The patient was immunocompetent. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 1st January 2018 and 31st December 2019, the patient received 2 doses of Shingrix (administration route and site unspecified; batch number not provided). The patient received second dose of Shingrix more than 30 days or less than 210 days after the first dose as per the recommended time frame for vaccination by the Agency. The age at vaccination not reported. [In this study, Patients who had only received a single dose of Shingrix (RZV) or with 2 valid doses but started the first dose before index date were also excluded. Two valid doses of recombinant zoster vaccine were defined as receiving the second dose between 30 and 210 days after the first dose].].  On an unspecified date between 1st January 2018 and 31st December 2019, more than 30 days after the 2nd dose of vaccination, the patient experienced herpes zoster ophthalmicus. This case was considered as vaccination failure [In this study, the patients became eligible for inclusion based on two criteria: (1) turned 50 or were 50 years of age or older in 2018 or 2019, meeting age eligibility for RZV based on recommendations from the Agency; (2) had at least 365 days of continuous enrollment prior to becoming age-eligible for the RZV vaccine. The date on which these two criteria were met was defined as a patient's index date. The patient with at least one ICD-10 code for HZ within one year of the index date were excluded]. This case was  considered as serious due to vaccination failure. Treatment was unknown. Outcome was not reported.  The authors commented, "We found no evidence for age-specific differences in vaccine effectiveness among age strata where there were a sufficient number of events to estimate vaccine effectiveness with precision. Our prior study using data suggested that RZV may have lower effectiveness in individuals aged 80 and older, but the results from Agency support comparable efficacy in this oldest age group compared with younger age groups. There were no HZ cases reported in the vaccinated cohort for the 50-59-year-old age group, perhaps due to relatively small sample size, short follow- up time since vaccination, and the strong protection the vaccine provided. Thus, vaccine effectiveness was reported as 100% for this subgroup, however, we were not able to calculate a confidence interval for this estimate. Our estimated vaccine effectiveness for study enrollees more than or equal to 50 years old identifying as race was 88.1%), which is in-line with our previous study claims-based study and post-hoc analyses of study randomized trials. This finding is reassuring that vaccine effectiveness in individuals of race is comparable to other racial groups. Given that both clinical trials and real-world studies have demonstrated high efficacy and effectiveness of RZV for the race, clinicians could provide strong recommendations to this racial minority group. The incidence rate of HZO was 72.1 cases per 100 000 person-years among those unvaccinated and 11.1 cases per 100 000 person-years among those vaccinated, with only 1 case of HZO reported in the vaccinated cohort..." The authors concluded, "RZV has demonstrated high effectiveness both in and outside of a clinical trial setting. Vaccine coverage is low emphasizing the need for public health efforts to increase vaccination to reduce morbidity due to HZ and HZO. Areas for future research include assessing long-term vaccine effectiveness and waning and identifying barriers to RZV vaccination coverage." This is 1 of the 2 valid cases reported in the same literature article.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021GSK140868:Same reporter