LAU Gilbert and Rose-Marie Chagoury School of Medicine, Lebanese American University, Byblos, Lebanon.
Division of Public Health, Infectious Diseases, and Occupational Medicine, Mayo Clinic, Rochester, MN, USA.
Immunol Res. 2022 Dec;70(6):800-810. doi: 10.1007/s12026-022-09309-5. Epub 2022 Aug 18.
The Food and Drug Administration (FDA) approved the first SARS-CoV-2 mRNA vaccine (Pfizer-BioNTech) in December 2020. New adverse events have emerged since these vaccines have reached market. Although no clear association between messenger ribonucleic acid (mRNA) vaccines and autoimmunity has emerged, the significance of such an association warrants further exploration. After obtaining consent, a standardized survey on baseline characteristics and other relevant variables was conducted on unvaccinated individuals who were scheduled for vaccination and had not previously contracted COVID-19. Blood samples were collected from participants prior to the first dose, prior to the second dose, and 1 month after the second dose. All collected samples were tested for antinuclear antibody (ANA) titers using indirect immunofluorescence microscopy kits, and antiphospholipid (APS) immunoglobulin M (IgM) and immunoglobulin G (IgG) levels using an enzyme-linked immunoassay (ELISA) technique. ANA titers were positive for 9 participants out of 101 (8.9%) in the first pre-vaccination draw. For the second draw, the number of participants testing positive for ANA decreased to 5 (5%). For the last draw, 6 (5.9%) participants tested positive for ANA titers. One participant tested positive for APS IgM at the first pre-vaccination draw, 2 tested positive at the second draw, and 2 at the third draw. As for APS IgG titers, all participants tested negative in the three draws. McNemar's test for two dependent categorical outcomes was conducted on all variables and did not show a statistical significance. The McNemar test of these two composite variables (i.e., ANA/APS, first draw vs. ANA/APS, second and third draws) did not show statistical significance. The 2-sided exact significance of the McNemar test was 1.0. The Friedman test also showed no significance (p = 0.459). No association was found between BNT162b2 vaccine administration and changes in APS and ANA titers. The benefits of the BNT162b2 vaccine significantly outweigh any possible risk of autoimmune dysregulation considering the current evidence.
美国食品和药物管理局（FDA）于 2020 年 12 月批准了首款 SARS-CoV-2 mRNA 疫苗（辉瑞-生物科技）。自这些疫苗进入市场以来，新的不良事件已经出现。尽管信使核糖核酸（mRNA）疫苗与自身免疫之间没有明显的关联，但这种关联的意义值得进一步探讨。在获得同意后，对计划接种疫苗且以前未感染过 COVID-19 的未接种个体进行了关于基线特征和其他相关变量的标准化调查。在接种第一剂之前、第二剂之前和第二剂之后 1 个月从参与者身上采集血液样本。使用间接免疫荧光显微镜试剂盒检测所有采集样本的抗核抗体（ANA）滴度，并使用酶联免疫吸附试验（ELISA）技术检测抗磷脂（APS）免疫球蛋白 M（IgM）和免疫球蛋白 G（IgG）水平。在第一次接种前的抽血中，有 9 名参与者（101 人中有 8.9%）ANA 滴度阳性。在第二次抽血中，ANA 阳性的参与者人数减少到 5 人（5%）。在最后一次抽血中，有 6 人（5.9%）ANA 滴度阳性。一名参与者在第一次接种前的抽血中 APS IgM 阳性，2 名参与者在第二次抽血中阳性，2 名参与者在第三次抽血中阳性。至于 APS IgG 滴度，所有参与者在三次抽血中均为阴性。对所有变量进行了两个依赖的分类结果的 McNemar 检验，结果无统计学意义。对这两个复合变量（即 ANA/APS，第一和第二、第三抽血）的 McNemar 检验也无统计学意义。McNemar 检验的双侧精确显著性为 1.0。Friedman 检验也无显著性（p=0.459）。未发现 BNT162b2 疫苗接种与 APS 和 ANA 滴度变化之间存在关联。考虑到目前的证据，BNT162b2 疫苗的益处明显大于任何可能的自身免疫失调风险。
