Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, United States.
Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, United States.
Vaccine. 2021 Jun 8;39(25):3329-3332. doi: 10.1016/j.vaccine.2021.04.054. Epub 2021 Apr 30.
The objective of this study is to assess cases of thrombocytopenia, including immune thrombocytopenia (ITP), reported to the Vaccine Adverse Event Reporting System (VAERS) following vaccination with mRNA COVID-19 vaccines.
This case-series study analyzed VAERS reports of thrombocytopenia after vaccination with Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine.
Fifteen cases of thrombocytopenia were identified among 18,841,309 doses of Pfizer-BioNTech COVID-19 Vaccine and 13 cases among 16,260,102 doses of Moderna COVID-19 Vaccine. The reporting rate of thrombocytopenia was 0.80 per million doses for both vaccines. Based on an annual incidence rate of 3.3 ITP cases per 100,000 adults, the observed number of all thrombocytopenia cases, which includes ITP, following administration of mRNA COVID-19 vaccines is not greater than the number of ITP cases expected.
The number of thrombocytopenia cases reported to VAERS does not suggest a safety concern attributable to mRNA COVID-19 vaccines at this time.
本研究旨在评估接种 mRNA COVID-19 疫苗后通过疫苗不良事件报告系统(VAERS)报告的血小板减少症病例,包括免疫性血小板减少症(ITP)。
本病例系列研究分析了接种辉瑞-生物科技公司的 COVID-19 疫苗或 Moderna COVID-19 疫苗后 VAERS 报告的血小板减少症病例。
在 18841309 剂辉瑞-生物科技公司的 COVID-19 疫苗和 16260102 剂 Moderna COVID-19 疫苗中,共发现 15 例血小板减少症病例。两种疫苗的血小板减少症报告率均为每百万剂 0.80 例。根据成人每 10 万人中有 3.3 例 ITP 的年发病率,接种 mRNA COVID-19 疫苗后观察到的所有血小板减少症病例(包括 ITP)数量并不超过预期的 ITP 病例数量。
目前,VAERS 报告的血小板减少症病例数量并未表明与 mRNA COVID-19 疫苗有关的安全性问题。