Li Yiming, Tao Wei, Dang Yifang, Chen Yong, Tao Cui
Res Sq. 2025 Mar 3:rs.3.rs-6096098. doi: 10.21203/rs.3.rs-6096098/v1.
To mitigate the spread of variants such as Omicron in COVID-19 pandemic, the development and utilization of COVID-19 bivalent vaccines have become essential. However, an expected subset of individuals may experience serious adverse events (AE) after receiving the COVID-19 bivalent vaccine.
In this research, we conducted an in-depth analysis of data obtained from the Centers for Disease Control and Prevention (CDC) and the Vaccine Adverse Event Reporting System (VAERS) to evaluate the safety of COVID-19 bivalent vaccines administered between 9/15/2022 and 9/1/2023. The Standard Federal Regions were used for region partitions. To broaden our understanding of post-vaccination AE, we performed temporal analysis to investigate the trends of Top 10 reported AE in all serious adverse event reports. We also examined the similarity of AE across diverse regions within the United States.
Our findings indicated that a relatively stably decreasing trend was observed over time, with four peaks in December 2022, February 2023, Mar 2023 and April 2023. In terms of spatial analysis, the middle and northern regions exhibited higher rates of reported AEs associated with COVID-19 bivalent vaccine. An obvious similar pattern of AE is observed across regions (III, IV, V, VI, VII).
Overall, our research underscores the ongoing need for vigilant post-licensure vaccine monitoring, emphasizing the continuous surveillance and analysis essential for upholding the safety and effectiveness of COVID-19 bivalent vaccines.
为减轻新冠疫情中奥密克戎等变体的传播,新冠二价疫苗的研发和使用变得至关重要。然而,一部分预期个体在接种新冠二价疫苗后可能会出现严重不良事件(AE)。
在本研究中,我们对从疾病控制与预防中心(CDC)和疫苗不良事件报告系统(VAERS)获得的数据进行了深入分析,以评估2022年9月15日至2023年9月1日期间接种的新冠二价疫苗的安全性。采用标准联邦区域进行区域划分。为更全面地了解接种疫苗后的不良事件,我们进行了时间分析,以调查所有严重不良事件报告中报告的前10种不良事件的趋势。我们还研究了美国不同地区不良事件的相似性。
我们的研究结果表明,随着时间的推移观察到相对稳定的下降趋势,在2022年12月、2023年2月、2023年3月和2023年4月出现了四个峰值。在空间分析方面,中部和北部地区报告的与新冠二价疫苗相关的不良事件发生率较高。各地区(III、IV、V、VI、VII)观察到明显相似的不良事件模式。
总体而言,我们的研究强调了在疫苗获得许可后持续进行警惕监测的必要性,强调了持续监测和分析对于维护新冠二价疫苗的安全性和有效性至关重要。