Side effects and antibody titer transition of the BNT162b2 messenger ribonucleic acid coronavirus disease 2019 vaccine in Japan.

Side effects and antibody titer transition of the BNT162b2 messenger ribonucleic acid coronavirus disease 2019 vaccine in Japan.
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DOI:
10.1016/j.resinv.2021.06.003
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发表时间:
2021-09
影响因子:
3.1
通讯作者:
Inomata M
Inomata M
中科院分区:
其他
文献类型:
--
作者:
Izumo T;Kuse N;Awano N;Tone M;Sakamoto K;Takada K;Muto Y;Fujimoto K;Saiki A;Ito Y;Matsumoto H;Inomata M

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冠状病毒病(新冠肺炎)已经困扰着世界各地的大量人口。尽管疫苗引起了很大的期望,但它们对日本人的副作用以及接种后抗体效价的变化尚不清楚。对在本中心接种BNT162b2mRNA新冠肺炎疫苗的受试者进行不良反应调查。一些参与者还接受了抗体效价转换的调查。在这项研究中,983名日本参与者和798名日本参与者分别对第一和第二剂疫苗做出了反应。757名(77.0%)和715名(90.0%)的受试者在第一次和第二次注射后出现副作用。未发生4级不良反应。第二次注射的副作用明显多于第一次(P&lt;0.001)。571名女性(92.1%)和178名男性(80.1%)在第二次服药后出现副作用。女性参与者的副作用发生率高于男性参与者(P&lt;0.001)。各年龄组间比较差异有统计学意义(P=0.018),不良反应发生率随年龄增长而降低。23名受试者参加了抗体滴度转换调查。第二次免疫后,抗体效价中位数分别为3.76和0.07AU/mL。免疫球蛋白和免疫球蛋白M效价在研究期间均有显著增加(P<0.001)。BNT162b2mRNA新冠肺炎疫苗对日本人可能是安全的,接种两次后抗体效价升高。为了验证这些发现,需要进行更大规模的全国性研究。
The coronavirus disease (COVID-19) has afflicted large populations worldwide. Although vaccines aroused great expectations, their side effects on Japanese people and the antibody titer transition after vaccination are unclear. The side effects of the BNT162b2 mRNA COVID-19 vaccine in participants who received vaccination at our center were investigated. Some participants were also surveyed for the antibody titer transition. In this study, 983 and 798 Japanese participants responded to the first and second doses, respectively. Side effects occurred in 757 (77.0%) and 715 participants (90.0%) after the first and second doses, respectively. No Grade 4 side effects occurred. The second dose had significantly more side effects than the first dose (p < 0.001). Side effects occurred after the second dose in 571 female (92.1%) and 178 male participants (80.1%). Female participants had a higher incidence of side effects than the male participants (p < 0.001). A comparison among the age groups showed significant differences (p = 0.018), and the frequency of side effects decreased with age. Twenty-three individuals participated in the survey of antibody titer transition. After the second vaccine dose, the median antibody titers for IgG and IgM were 3.76 and 0.07 AU/mL, respectively. Both IgG and IgM titers showed a significant increase over the study period (p < 0.001). The BNT162b2 mRNA COVID-19 vaccine might be safe for Japanese people, and the antibody titer increased with two doses of vaccination. Larger nationwide studies are warranted to verify these findings.
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