Reactogenicity following two doses of the BNT162b2 mRNA COVID-19 vaccine: Real-world evidence from healthcare workers in Japan.
Reactogenicity following two doses of the BNT162b2 mRNA COVID-19 vaccine: Real-world evidence from healthcare workers in Japan.
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DOI：
10.1016/j.jiac.2021.09.009
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发表时间：
2022-01
期刊：
影响因子：
--
通讯作者：
Naito T
中科院分区：
文献类型：
--
作者：
Saita M;Yan Y;Ito K;Sasano H;Seyama K;Naito T
作为日本首个获批的COVID-19疫苗，BNT 162 b2 mRNA COVID-19疫苗被用于大规模接种。虽然疗效已得到证明，但仍需要日本人员中反应原性的真实证据，以使公众做好准备。日本一家大型学术医院的医护人员于2021年3月17日至5月19日接种了两剂辉瑞BioNTech疫苗。从第0天到第8天，在每次给药后向登记的接受者分发在线问卷。主要结局是反应原性的频率，包括局部和全身反应。还分析了缺勤时间。大多数接受者在首次给药后（97.3%; n = 3254;平均年龄[36.4]）和第二次给药后（97.2%; n = 3165;平均年龄[36.5]）自我报告了反应原性。第二剂后的全身反应明显高于第一剂，尤其是发热（OR，27.38; 95% CI，[22.00-34.06]; p < 0.001），寒战（OR，16.49; 95% CI，[13.53-20.11]; p < 0.001），关节疼痛（OR，8.49; 95% CI，[7.21-9.99]; p < 0.001）、疲劳（OR，7.18; 95% CI，[6.43-8.02]; p < 0.001）和头痛（OR，5.43; 95% CI，[4.80-6.14]; p < 0.001）。反应原性在年轻女性组中更常见。19.3%的参与者在第二次注射后休假（第一次注射后为2.2%），4.7%的人缺勤超过两天。虽然大多数参与者报告了反应原性，但严重病例有限。这项研究为日本和该地区其他国家的普通人群和组织准备BNT 162 b2 mRNA COVID-19疫苗接种提供了真实的证据。
As the first authorized COVID-19 vaccine in Japan, the BNT162b2 mRNA COVID-19 vaccine is utilized for mass vaccination. Although efficacy has been proved, real-world evidence on reactogenicity in Japanese personnel is needed to prepare the public. Healthcare workers in a large academic hospital in Japan received two doses of the Pfizer-BioNTech vaccine from March 17 to May 19, 2021. Online questionnaires were distributed to registered recipients following each dose, from day 0 through day 8. Primary outcomes are the frequency of reactogenicity including local and systemic reactions. Length of absence from work was also analyzed. Most recipients self-reported reactogenicity after the first dose (97.3%; n = 3254; mean age [36.4]) and after the second dose (97.2%; n = 3165; mean age [36.5]). Systemic reactions following the second dose were substantially higher than the first dose, especially for fever (OR, 27.38; 95% CI, [22.00–34.06]; p < 0.001), chills (OR, 16.49; 95% CI, [13.53–20.11]; p < 0.001), joint pain (OR, 8.49; 95% CI, [7.21–9.99]; p < 0.001), fatigue (OR, 7.18; 95% CI, [6.43–8.02]; p < 0.001) and headache (OR, 5.43; 95% CI, [4.80–6.14]; p < 0.001). Reactogenicity was more commonly seen in young, female groups. 19.3% of participants took days off from work after the second dose (2.2% after the first dose), with 4.7% absent for more than two days. Although most participants reported reactogenicity, severe cases were limited. This study provides real-world evidence for the general population and organizations to prepare for BNT162b2 mRNA COVID-19 vaccination in Japan and other countries in the region.
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DOI：
10.1056/nejmoa2034577
发表时间：
2020-12-31
期刊：
The New England journal of medicine
影响因子：
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作者：
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Kim SH
DOI：
10.1056/nejmoa2101765
发表时间：
2021-04-15
期刊：
The New England journal of medicine
影响因子：
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Balicer RD