International Neurorehabilitation Institute, Lutherville, MD, United States.
International Neurorehabilitation Institute, Lutherville, MD, United States; John Hopkins University School of Medicine, Department of Neurology, Baltimore, MD, United States.
Mult Scler Relat Disord. 2023 Sep;77:104865. doi: 10.1016/j.msard.2023.104865. Epub 2023 Jul 2.
The coronavirus disease 2019 (COVID-19) pandemic created an urgency for an effective vaccine. The FDA approved vaccines offered by Pfizer-BioNTech (BNT162b2), ModernaTX (mRNA-1273) and Janssen/Johnson & Johnson (Ad26.COV2.S) have shown minimal side effects (SE) in general population studies. Multiple sclerosis (MS) patients were not specifically represented in the above studies. The MS community is interested in how these vaccines behave in people with MS. In this study, we compare the SE experienced by MS to that of the general population after SARS-CoV-2 vaccination and evaluate their risk of relapses or pseudo-relapses.
A retrospective, single-site, cohort study of 250 MS patients who received the initial cycle of FDA approved SARS-CoV-2 vaccines with 151 of whom also received an additional booster dose. SE resulting immediately after COVID-19 vaccination were collected as part of the standard clinical care during patient visits.
Out of the studied 250 MS patients, 135 received the first and second doses of BNT162b2 with less than 1% and 4% pseudo-relapses respectively and 79 received the third BNT162b2 dose with a pseudo-relapse rate of 3%. 88 received the mRNA-1273 vaccine with a pseudo-relapse frequency of 2% and 5% after the first and second doses respectively. 70 patients had the mRNA-1273 vaccine booster with a 3% pseudo-relapse rate. 27 received the Ad26.COV2.S first dose, 2 of whom received a second Ad26.COV2.S booster dose, with no reports of MS worsening. No acute relapses were reported in our patient population. All patients experiencing pseudo-relapse symptoms returned to baseline within 96 h.
COVID-19 vaccine is safe in patients with MS. Cases of temporary worsening of MS symptoms following SARS-CoV-2 are rare. Our findings support those reported by other recent studies and the CDC recommendation for MS patients to receive the FDA-approved COVID-19 vaccines, including the boosters.
2019 年冠状病毒病（COVID-19）大流行迫切需要有效的疫苗。辉瑞-生物技术公司（BNT162b2）、莫德纳公司（mRNA-1273）和杨森/强生公司（Ad26.COV2.S）提供的经 FDA 批准的疫苗在一般人群研究中显示出最小的副作用（SE）。多发性硬化症（MS）患者在上述研究中没有得到特别代表。MS 社区关心这些疫苗在 MS 患者中的表现。在这项研究中，我们比较了 MS 患者在接受 SARS-CoV-2 疫苗接种后的 SE 与一般人群的 SE，并评估了他们复发或假性复发的风险。
这是一项回顾性、单站点、队列研究，纳入了 250 名接受 FDA 批准的 SARS-CoV-2 疫苗初始周期接种的 MS 患者，其中 151 名患者还接受了额外的加强针。COVID-19 疫苗接种后立即出现的 SE 作为患者就诊期间标准临床护理的一部分进行收集。
在研究的 250 名 MS 患者中，135 名患者接受了 BNT162b2 的第一和第二剂，分别有不到 1%和 4%的患者出现假性复发，79 名患者接受了第三剂 BNT162b2，假性复发率为 3%。88 名患者接受了 mRNA-1273 疫苗接种，第一和第二剂的假性复发频率分别为 2%和 5%。70 名患者接受了 mRNA-1273 疫苗加强针，假性复发率为 3%。27 名患者接受了 Ad26.COV2.S 第一剂，其中 2 名患者接受了第二剂 Ad26.COV2.S 加强针，没有 MS 恶化的报告。我们的患者群体中没有报告急性复发。所有出现假性复发症状的患者在 96 小时内恢复到基线。
COVID-19 疫苗在 MS 患者中是安全的。SARS-CoV-2 后 MS 症状暂时恶化的病例很少见。我们的发现支持其他最近的研究和 CDC 关于 MS 患者接受 FDA 批准的 COVID-19 疫苗（包括加强针）的建议。
