Ito Suminobu, Tsuchida Nao, Kusunoki Susumu, Kaneko Yoshihiro, Naito Toshio, Hori Satoshi, Tobita Morikuni
Medical Technology Innovation Center, Juntendo University, 2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan.
Clinical Research Center, National Hospital Organization Headquarters, 2-5-21, Higashigaoka, Meguro-ku, Tokyo 152-0021, Japan.
Vaccine. 2025 Mar 7;49:126754. doi: 10.1016/j.vaccine.2025.126754. Epub 2025 Jan 28.
This study was conducted at 112 government and Juntendo University hospitals in February 2021 for the primary series of SARS-CoV-2 vaccinations. We compared the timing of solicited adverse event (AE) onset and prevalence of unsolicited AEs for Pfizer, Moderna, and AstraZeneca vaccines in a nationwide, large-scale prospective cohort study. The Pfizer and Moderna mRNA vaccines were associated with a higher frequency of fever after the second dose than after the first dose. The AstraZeneca viral vector vaccine resulted in more frequent side effects after the first dose. The side effects of mRNA vaccines were the most common on the day after vaccination and almost subsided by the fourth day. The incidence of systemic AEs, including fever of ≥37.5 °C, was the highest for Moderna, followed by AstraZeneca and Pfizer. Local reactions were less frequent with the AstraZeneca vaccine than with the Pfizer and Moderna vaccines but tended to last longer. The frequency of AEs was higher in women than in men. The odds ratio for age per year regarding systemic reactions (adjusted for sex) was the least for AstraZeneca, followed by Pfizer and Moderna (< 1), indicating a more pronounced decrease in the frequency of fever and systemic reactions with increasing age. Age effects varied among vaccines. Delayed skin reactions, appearing around the seventh day after the first dose (Day 8), were observed as itchy redness, particularly in women aged ≥30 with the Moderna vaccine and less often with the Pfizer vaccine. Over half of the delayed skin reactions involved local erythema immediately after the second dose, but these reactions mostly disappeared within approximately 10 days. Despite differences in the incidence of AEs among the three vaccines by age and sex, all vaccines were well-tolerated. These findings provide crucial safety information, supporting informed vaccination decisions and ongoing surveillance efforts.
2021年2月，在112家政府医院和顺天堂大学医院进行了针对SARS-CoV-2疫苗初次接种系列的研究。在一项全国性的大规模前瞻性队列研究中，我们比较了辉瑞、莫德纳和阿斯利康疫苗引发的不良事件（AE）开始时间以及非预期不良事件的发生率。辉瑞和莫德纳的mRNA疫苗在第二剂接种后发热频率高于第一剂。阿斯利康病毒载体疫苗在第一剂接种后产生的副作用更频繁。mRNA疫苗的副作用在接种后当天最常见，到第四天几乎消退。包括体温≥37.5°C发热在内的全身性不良事件发生率，莫德纳最高，其次是阿斯利康和辉瑞。阿斯利康疫苗引起的局部反应比辉瑞和莫德纳疫苗少，但持续时间往往更长。女性的不良事件发生率高于男性。阿斯利康疫苗关于全身性反应（经性别调整）的每年年龄优势比最小，其次是辉瑞和莫德纳（<1），表明随着年龄增长，发热和全身性反应频率的下降更为明显。不同疫苗的年龄效应有所不同。在第一剂接种后约第七天（第8天）出现的延迟性皮肤反应表现为瘙痒性红斑，特别是在≥30岁的接种莫德纳疫苗的女性中，接种辉瑞疫苗的情况较少。超过一半的延迟性皮肤反应在第二剂接种后立即出现局部红斑，但这些反应大多在约10天内消失。尽管三种疫苗的不良事件发生率在年龄和性别上存在差异，但所有疫苗的耐受性都良好。这些发现提供了关键的安全性信息，有助于做出明智的疫苗接种决策并持续进行监测工作。
