Department of Neurology and Psychiatry, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
Secretaría de Salud, Gobierno de México, Mexico.
Clin Immunol. 2021 Aug;229:108786. doi: 10.1016/j.clim.2021.108786. Epub 2021 Jun 18.
mRNA vaccines against SARS-CoV-2 are remarkably effective. Limited information exists about the incidence of adverse events following immunization (AEFI) with their use. We conducted a prospective observational study including data from 704,003 first-doses recipients; 6536 AEFI were reported, of whom 65.1% had at least one neurologic AEFI (non-serious 99.6%). Thirty-three serious events were reported; 17 (51.5%) were neurologic (observed frequency, 2.4/100,000 doses). At the time of writing this report, 16/17 cases had been discharged without deaths. Our data suggest that the BNT162b2 mRNA COVID-19 vaccine is safe; its individual and societal benefits outweigh the low percentage of serious neurologic AEFI. This information should help to dissipate hesitancy towards this new vaccine platform.
mRNA 疫苗对 SARS-CoV-2 具有显著的有效性。关于使用这些疫苗后接种不良反应（AEFI）的发生率，目前信息有限。我们开展了一项前瞻性观察性研究，纳入了 704003 名首剂接种者的数据；报告了 6536 例 AEFI，其中 65.1%至少有一种神经系统 AEFI（非严重的占 99.6%）。报告了 33 例严重事件；其中 17 例（51.5%）为神经系统（观察到的频率为 2.4/10 万剂）。在撰写本报告时，17 例中的 16 例已出院，无死亡病例。我们的数据表明，BNT162b2 mRNA COVID-19 疫苗是安全的；其个体和社会效益超过了少数严重神经系统 AEFI 的发生。这些信息应该有助于消除人们对这一新疫苗平台的犹豫。
