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Introduction In February 2021, New Zealand began its largest ever immunisation programme with the BNT162b2 mRNA coronavirus disease 2019 (COVID-19) vaccine. Objective We aimed to understand the association between 12 adverse events of special interest (AESIs) and a primary dose of BNT162b2 in the New Zealand population aged ≥5 years from 19 February 2021 through 10 February 2022. Methods Using national electronic health records, the observed rates of AESIs within a risk period (1–21 days) following vaccination were compared with the expected rates based on background data (2014–2019). Standardised incidence ratios (SIRs) were estimated for each AESI with 95% confidence intervals (CIs) using age group-specific background rates. The risk difference was calculated to estimate the excess or reduced number of events per 100,000 persons vaccinated in the risk period. Results As of 10 February 2022, 4,277,163 first doses and 4,114,364 second doses of BNT162b2 had been administered to the eligible New Zealand population aged ≥5 years. The SIRs for 11 of the 12 selected AESIs were not statistically significantly increased post vaccination. The SIR (95% CI) for myo/pericarditis following the first dose was 2.3 (1.8–2.7), with a risk difference (95% CI) of 1.3 (0.9–1.8), per 100,000 persons vaccinated, and 4.0 (3.4–4.6), with a risk difference of 3.1 (2.5–3.7), per 100,000 persons vaccinated following the second dose. The highest SIR was 25.6 (15.5–37.5) in the 5–19 years age group, following the second dose of the vaccine, with an estimated five additional myo/pericarditis cases per 100,000 persons vaccinated. A statistically significant increased SIR of single organ cutaneous vasculitis (SOCV) was also observed following the first dose of BNT162b2 in the 20–39 years age group only. Conclusions A statistically significant association between BNT162b2 vaccination and myo/pericarditis was observed. This association has been confirmed internationally. BNT162b2 was not found to be associated with the other AESIs investigated, except for SOCV following the first dose of BNT162b2 in the 20–39 years age group only, providing reassurances around the safety of the vaccine. Supplementary Information The online version contains supplementary material available at 10.1007/s40264-023-01332-1.
Introduction In February 2021, New Zealand began its largest ever immunisation programme with the BNT162b2 mRNA coronavirus disease 2019 (COVID-19) vaccine. Objective We aimed to understand the association between 12 adverse events of special interest (AESIs) and a primary dose of BNT162b2 in the New Zealand population aged ≥5 years from 19 February 2021 through 10 February 2022. Methods Using national electronic health records, the observed rates of AESIs within a risk period (1–21 days) following vaccination were compared with the expected rates based on background data (2014–2019). Standardised incidence ratios (SIRs) were estimated for each AESI with 95% confidence intervals (CIs) using age group-specific background rates. The risk difference was calculated to estimate the excess or reduced number of events per 100,000 persons vaccinated in the risk period. Results As of 10 February 2022, 4,277,163 first doses and 4,114,364 second doses of BNT162b2 had been administered to the eligible New Zealand population aged ≥5 years. The SIRs for 11 of the 12 selected AESIs were not statistically significantly increased post vaccination. The SIR (95% CI) for myo/pericarditis following the first dose was 2.3 (1.8–2.7), with a risk difference (95% CI) of 1.3 (0.9–1.8), per 100,000 persons vaccinated, and 4.0 (3.4–4.6), with a risk difference of 3.1 (2.5–3.7), per 100,000 persons vaccinated following the second dose. The highest SIR was 25.6 (15.5–37.5) in the 5–19 years age group, following the second dose of the vaccine, with an estimated five additional myo/pericarditis cases per 100,000 persons vaccinated. A statistically significant increased SIR of single organ cutaneous vasculitis (SOCV) was also observed following the first dose of BNT162b2 in the 20–39 years age group only. Conclusions A statistically significant association between BNT162b2 vaccination and myo/pericarditis was observed. This association has been confirmed internationally. BNT162b2 was not found to be associated with the other AESIs investigated, except for SOCV following the first dose of BNT162b2 in the 20–39 years age group only, providing reassurances around the safety of the vaccine. Supplementary Information The online version contains supplementary material available at 10.1007/s40264-023-01332-1.
In Japan, cutaneous adverse events (AEs) following the coronavirus disease 2019 (COVID‐19) vaccination have been frequently described; however, a larger case series and literature review are lacking. There is an urgent need for an extensive investigation of new cases and previous reports to provide a thorough body of information about post‐COVID‐19 immunization cutaneous AEs. We aimed to analyze patients with cutaneous AEs after COVID‐19 vaccination in our hospital and review previous studies of cutaneous AEs. We analyzed post‐COVID‐19 vaccination cutaneous AEs in our department, the Japanese Registry, and previous literature. We enrolled 30 patients with cutaneous post‐vaccination AEs in our department over 2 years (April 1, 2021, to March 31, 2023). We also confirmed cases registered in the Ministry of Health, Labor, and Welfare COVID‐19 vaccine side effect reporting system (February 17, 2021–March 12, 2023). A total of 587 records were retrieved and 93 articles were included for data extraction. A total of 28 non‐injection‐site cutaneous AEs and two injection‐site AEs were identified. Six (20.0%) patients developed new‐onset erythematous eruptions, and five (16.7%) patients developed urticaria. Pruritic eruption, eczema, shingles, and sweating symptoms have also been reported. In previous studies on non‐injection‐site cutaneous AEs, individuals who received the BNT162b2 vaccine were older than those who received mRNA‐1273 (P < 0.01). Cutaneous AEs were mostly nonsignificant and self‐limiting reactions; however, rare, severe, or life‐threatening AEs were also reported. Physicians should be aware of the various possible cutaneous AEs associated with the COVID‐19 vaccination.
Cutaneous vasculitides encompass a heterogeneous group of clinicopathological entities, which may occur as single-organ vasculitis of the skin or present as skin-limited variant of systemic vasculitis (i.e., skin-limited ANCA-associated vasculitis), and are triggered by various factors, including infections, drugs and vaccines. The COVID-19 pandemic has challenged us with a variety of both disease- and vaccine-associated skin manifestations, including vasculitis. Among the latter, cutaneous small-vessel vasculitis, previously known as leukocytoclastic vasculitis, seems to be the most reported in either scenario, i.e., natural infection and vaccination. Vasculopathy without true vasculitic changes on histology develops in but a minority of cases, mostly severe/critical COVID-19 patients, and appears to be the result of endothelial injury due to pauci-immune thromboembolic mechanisms. Herein, we provide an overview of the available literature on COVID-19-associated and anti-SARS-CoV-2-vaccine-associated cutaneous vasculitis. Although evidence is mostly limited to isolated reports, with a proportion of cases lacking histopathological confirmation, ample overlap with pre-pandemic forms is shown.
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