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Abstract

A working group convened by the Section of Multiple Sclerosis and Neuroimmunology of the Polish Neurological Society, the Polish Society of Family Medicine, and the Polish Society of Vaccinology has developed a consensus on supplementary data to the recommendations of the expert group of the Polish Society of Vaccinology, the Polish Society of Family Medicine, the Polish Dermatological Society, the Polish Association for the Study of Pain, and the Polish Neurological Society, and ECTRIMS/EAN of 2023 with regard to the currently available in Poland recombinant herpes zoster vaccine (RZV). It is intended for the prevention of herpes zoster and postherpetic neuralgia in individuals aged > 50 and individuals aged ≥ 18 who belong to herpes zoster risk groups. In Poland it is available with 50% reimbursement exclusively for patients aged 65 and older who have an increased risk of developing herpes zoster. This statement is based on the literature available as of 12 July 2024. The guidance will be updated as new data emerges. All data regarding the above-mentioned vaccine comes from clinical trials which have been reviewed, published and approved by the regulatory authorities and an increasing number of recommendations that might have an impact on real world data.

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Recombinant zoster vaccine (RZV; Shingrix), an adjuvanted glycoprotein vaccine, was licensed by the Food and Drug Administration (FDA) and recommended by the Advisory Committee on Immunization Practices for adults aged ≥50 years in October 2017 (1). The previously licensed live-attenuated zoster vaccine (ZVL; Zostavax) is recommended for adults aged ≥60 years. RZV is administered intramuscularly as a 2-dose series, with an interval of 2-6 months between doses. In prelicensure clinical trials, 85% of 6,773 vaccinated study participants reported local or systemic reactions after receiving RZV, with approximately 17% experiencing a grade 3 reaction (erythema or induration >3.5 inches or systemic symptoms that interfere with normal activity). However, rates of serious adverse events (i.e., hospitalization, prolongation of existing hospitalization, life-threatening illness, permanent disability, congenital anomaly or birth defect, or death) were similar in the RZV and placebo groups (2). After licensure, CDC and FDA began safety monitoring of RZV in the Vaccine Adverse Event Reporting System (VAERS) (3). During the first 8 months of use, when approximately 3.2 million RZV doses were distributed (GlaxoSmithKline, personal communication, 2018), VAERS received a total of 4,381 reports of adverse events, 130 (3.0%) of which were classified as serious. Commonly reported signs and symptoms included pyrexia (fever) (1,034; 23.6%), injection site pain (985; 22.5%), and injection site erythema (880; 20.1%). No unexpected patterns were detected in reports of adverse events or serious adverse events. Findings from early monitoring of RZV are consistent with the safety profile observed in prelicensure clinical trials.
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Background: The "exogenous boosting hypothesis" postulates that reexposure to circulating varicella zoster virus (VZV) over the life span inhibits reactivation of VZV. Consequently, if circulation of VZV is suppressed by introduction of chickenpox vaccination, incidences of herpes zoster may rise. Methods: We performed a systematic review and metaanalysis on impact of chickenpox vaccination on herpes zoster incidence and time trend, focusing on population-level effects by analyzing interrupted time-series (ITS) studies. We searched Medline and Embase for ITS reporting incidences of chickenpox and herpes zoster before and after implementation of chickenpox vaccination. Autoregressive integrated moving average models were calculated. Change in trend and incidence from studies were pooled. Results: Twelve studies were included, of which 6 were eligible for metaanalysis. Metaanalysis revealed a significant increase in chickenpox cases prior to implementation of chickenpox vaccination and a reversed trend thereafter, particularly in individuals aged 1-4 years. The increase in age-adjusted herpes zoster incidence before implementation of chickenpox vaccination did not change thereafter. However, separate analysis of age groups revealed a net increase of hospitalized herpes zoster cases in individuals aged 10-49 years after implementation of chickenpox vaccination. This very small effect (fewer than 2 additional cases per 100 000 persons) did not occur in other age groups. Conclusions: To date, no conclusive evidence exists that chickenpox vaccination has a substantial population-level impact on herpes zoster in nonvaccinated age groups. While exogenous boosting may exist, the effect size generated by chickenpox vaccination might be rather small on the population level.
Szczepienie przeciwko półpaścowi. Zalecenia grupy ekspertów Polskiego Towarzystwa Wakcynologii, Polskiego Towarzystwa Medycyny Rodzinnej, Polskiego Towarzystwa Dermatologicznego, Polskiego Towarzystwa Badania Bólu i Polskiego Towarzystwa Neurologicznego
  • E Kuchar
  • L Rudnicka
  • M Kocot-Kępska
Kuchar E, Rudnicka L, Kocot-Kępska M, et al. Szczepienie przeciwko półpaścowi. Zalecenia grupy ekspertów Polskiego Towarzystwa Wakcynologii, Polskiego Towarzystwa Medycyny Rodzinnej, Polskiego Towarzystwa Dermatologicznego, Polskiego Towarzystwa Badania Bólu i Polskiego Towarzystwa Neurologicznego, Med. Prakt. 2023; 5: 64-72.
Stwardnienie rozsiane
  • Nfz O Zdrowiu
  • Nfz Raport
NFZ o zdrowiu. Raport NFZ. Stwardnienie rozsiane, 2021. https:// ezdrowie.gov.pl/portal/home/badania-i-dane/zdrowe-dane/raporty/ nfz-o-zdrowiu-stwardnienie-rozsiane (12.07.2024).