Department of Neurosciences, Drug and Child Health, University of Florence, Florence, Italy.
Department of Neurosciences, Drug and Child Health, University of Florence, Florence, Italy; Department of Neurology 2 and Tuscan Region Multiple Sclerosis Referral Centre, Careggi University Hospital, Florence, Italy.
Mult Scler Relat Disord. 2023 Apr;72:104582. doi: 10.1016/j.msard.2023.104582. Epub 2023 Feb 24.
Long-term data on the effectiveness and safety of the booster dose of anti-SARS-CoV-2 vaccines in people affected by multiple sclerosis (pwMS) are lacking, hence a retrospective monocentric study exploring these issues was undertaken.
PwMS who had received the booster dose of anti-COVID19 mRNA vaccines (either Comirnaty or Spikevax) according to the national regulation were included. The occurrence of adverse events or disease reactivation and SARS-CoV-2 infection were recorded up to last follow-up. Factors predictive of COVID-19 were explored using logistic regression analyses. A two-tailed p-value <0.05 was considered significant.
One hundred and fourteen pwMS were included: 80 females (70%); median age at the booster dose 42 years (range 21 - 73); 106/114 patients (93%) were receiving a disease-modifying treatment at vaccination. The median follow-up after the booster dose was 6 (range 2 - 7) months. Adverse events were experienced in 58% of the patients, being mild to moderate in most cases; 4 reactivations of MS were observed, two of which occurring within 4 weeks after the booster. SARS-CoV-2 infection was reported in 24/114 (21%) cases, occurring a median of 74 days (5-162) after the booster dose and requiring hospitalisation in 2 patients. Six cases received direct antiviral drugs. Age at vaccination and time between the primary vaccination cycle and the booster dose were independently and inversely associated with the risk of COVID-19 (HR 0.95 and 0.98, respectively).
The administration of the booster dose in pwMS showed an overall good safety profile and protected 79% of the patients from SARS-CoV-2 infection. The observed association between the risk of infection after the booster dose and both younger age at vaccination and shorter interval period to the booster dose suggest that unobserved confounders, possibly including behavioural and social factors, play a relevant role in determining the individual propensity to get infected with COVID-19.
目前缺乏关于接受新型冠状病毒肺炎（COVID-19）疫苗加强针的多发性硬化症（MS）患者的有效性和安全性的长期数据，因此进行了一项回顾性单中心研究来探讨这些问题。
本研究纳入了根据国家规定接受了抗 COVID-19 mRNA 疫苗（Comirnaty 或 Spikevax）加强针的 MS 患者。记录了截至最后随访时不良事件或疾病复发和 SARS-CoV-2 感染的发生情况。使用逻辑回归分析探讨了 COVID-19 的预测因素。双侧 p 值<0.05 被认为具有统计学意义。
本研究共纳入了 114 例 MS 患者：80 例女性（70%）；加强针时的中位年龄为 42 岁（范围 21-73 岁）；114 例患者中有 106 例（93%）在接种疫苗时正在接受疾病修正治疗。加强针后中位随访时间为 6 个月（范围 2-7 个月）。58%的患者出现了不良事件，大多数为轻度至中度；观察到 4 例 MS 复发，其中 2 例发生在加强针后 4 周内。114 例中有 24 例（21%）报告了 COVID-19 感染，中位时间为加强针后 74 天（5-162 天），其中 2 例需要住院治疗。6 例患者接受了直接抗病毒药物治疗。接种年龄和从初级疫苗接种周期到加强针的时间与 COVID-19 风险呈独立负相关（HR 分别为 0.95 和 0.98）。
在 MS 患者中接种加强针总体安全性良好，可使 79%的患者免受 SARS-CoV-2 感染。观察到加强针后感染风险与接种年龄较小和加强针间隔时间较短之间的相关性表明，未观察到的混杂因素，可能包括行为和社会因素，在决定个体感染 COVID-19 的易感性方面发挥了重要作用。
