Candidate vaccine manufacturing contamination adverse events signatures

Serious adverse events (SAEs) occur post COVID-19 immunization for some vaccinees. In a retrospective study of VAERS menstrual adverse events (AEs) post immunization, statistical differences were observed for different manufacturing lots of COVID-19 Pfizer-BioNTech and COVID-19 Moderna vaccines. Manufacturing contaminants (e.g., endotoxins) are likely causative candidates consistent with the observed data for menstrual AEs. Are there possible pattern signatures of safety signal associated with these candidate manufacturing contaminants? This retrospective study identified candidate pattern signatures for the most frequently reported AEs to VAERS for identified COVID-19 vaccines lots associated with these menstrual AEs. Six candidate pattern signatures were identified: hemorrhage (female), gynecologic (including hemorrhage pattern), myopericarditis (male-biased), MCHPV, neuropathy, and fetus patterns (female). The hemorrhage (only) pattern was identified in six vaccines (4 influenza). The gynecologic pattern was identified in seven vaccines (3 COVID-19 and 3 HPV). And, the myopericarditis pattern was identified in 14 vaccines (5 COVID-19 vaccines including 2 bivalent and 3 Smallpox vaccines). The four MCHPV AEs are elevated primarily with HPV vaccines. One or more of the five MCneuropathy AEs were elevated in 11 vaccines. One or more of the MCfetus AEs were elevated in 11 vaccines.

部分新冠疫苗接种者在接种后会出现严重不良事件（SAEs）。本研究针对疫苗不良事件报告系统（VAERS）收录的新冠疫苗接种后月经不良事件（AEs）开展回顾性分析，结果显示不同生产批次的辉瑞-生物科技（Pfizer-BioNTech）新冠疫苗与莫德纳（Moderna）新冠疫苗的不良事件发生情况存在统计学差异。结合本次观测数据，生产污染物（如内毒素）或为月经不良事件的潜在致病诱因。那么，与这些潜在生产污染物相关的安全信号是否存在特征模式？本回顾性研究针对关联上述月经不良事件的新冠疫苗批次，为VAERS中报告频次最高的不良事件识别了特征模式候选集。最终共识别出6种特征模式候选：女性相关出血、妇科（含出血特征模式）、男性偏倚性心肌炎-心包炎、MCHPV、神经病变以及女性相关胎儿特征模式。其中仅出血特征模式在6款疫苗中被检出（含4款流感疫苗）；妇科特征模式在7款疫苗中被检出（含3款新冠疫苗与3款人乳头瘤病毒（HPV）疫苗）；男性偏倚性心肌炎-心包炎特征模式在14款疫苗中被检出（含5款新冠疫苗，其中2款为二价疫苗，以及3款天花疫苗）。4例MCHPV相关不良事件主要在HPV疫苗接种后出现升高信号；11款疫苗中出现5种MC神经病变相关不良事件中的至少1种升高信号；11款疫苗中出现至少1种MC胎儿相关不良事件升高信号。