CoronaVac（Sinovac）Covid-19疫苗最近已被世界卫生组织批准用于紧急使用。然而,在现实世界中，关于其反应原性的数据很少。这项研究旨在比较CoronaVac和Comirnaty（Pfizer-BioNTech）之间自我报告的疫苗接种后不良反应。
我们采用了前瞻性队列研究设计，使用从第一剂疫苗接种当天开始的在线调查，并在第二剂疫苗接种后两周（11个时间点）进行强化随访。主要结局是不良反应（任何与无），次要结局是不良反应的子类别（局部，系统性，和严重的过敏反应）。跨多患病状态的潜在效应改变，年龄较大,性检查。
总共，包括2,098名计划完成第14天调查的参与者，46.2%的人接受了Comirnaty。第二次给药后两周的保留率CoronaVac组为81.0%，Comirnaty组为83.6%。在整个随访期间，接受Comirnaty的患者中有801例（82.7%），接受CoronaVac的患者中有543例（48.1%）报告了不良反应。调整后的分析表明，与Comirnaty相比，CoronaVac与任何不良反应的几率降低了83％[调整后的优势比（AOR）=0.17，95％置信区间（CI）0.15-0.20]，92％-局部不良反应的几率降低（AOR=0.08，95％CI0.06-0.09），全身不良反应的几率降低了76%（AOR=0.24，95%CI0.16-0.28）。没有发现显著的效果修饰。
这项上市后研究比较了Covid-19疫苗的反应原性，表明与Comirnaty相比，接种CoronaVac后自我报告的不良反应风险较低。
CoronaVac (Sinovac) Covid-19 vaccine has recently been approved for emergency use by the World Health Organization. However, data on its reactogenicity in real-world settings is scant. This
study aimed to compare self-reported post-vaccination adverse reactions between CoronaVac and Comirnaty (Pfizer-BioNTech).
We adopted a prospective cohort
study design using online surveys from the day of first-dose vaccination with intensive follow-up through two weeks after the second dose (11 time points). The primary outcome was adverse reactions (any versus none) and secondary outcomes were the sub-categories of adverse reactions (local, systemic, and severe allergic reactions). Potential effect modification across multimorbidity status, older age, and sex was examined.
In total, 2,098 participants who were scheduled to complete the 14th-day survey were included, with 46.2% receiving Comirnaty. Retention rate two weeks after the second dose was 81.0% for the CoronaVac group and 83.6% for the Comirnaty group. Throughout the follow-up period, 801 (82.7%) of those receiving Comirnaty and 543 (48.1%) of those receiving CoronaVac reported adverse reactions. Adjusted analysis suggested that compared with Comirnaty, CoronaVac was associated with 83%-reduced odds of any adverse reactions [adjusted odds ratio (AOR) = 0.17, 95% confidence interval (CI) 0.15-0.20], 92%-reduced odds of local adverse reactions (AOR = 0.08, 95% CI 0.06-0.09), and 76%-reduced odds of systemic adverse reactions (AOR = 0.24, 95% CI 0.16-0.28). No significant effect modification was identified.
This post-marketing
study comparing the reactogenicity of Covid-19 vaccines suggests a lower risk of self-reported adverse reactions following vaccination with CoronaVac compared with Comirnaty.
