Palacka Patrik, Marusakova Elena, Rejlekova Katarina, Svobodova Alena, Skokanova Lucia, Vulganova Martina, Obertova Jana
2nd Department of Oncology, Faculty of Medicine, Comenius University, 833 10 Bratislava, Slovakia.
Department of Outpatient Chemotherapy, National Cancer Institute, 833 10 Bratislava, Slovakia.
Biomed Rep. 2025 May 20;23(1):120. doi: 10.3892/br.2025.1998. eCollection 2025 Jul.
BNT162b2 is a mRNA vaccine, approved by the US Food and Drug Administration and the European Medicines Agency that was designed to target Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the causative agent of Coronavirus disease 2019 (COVID-19). Despite its widespread use, predictors of humoral immune responses after BNT162b2 administration remain uncertain. Consequently, a case-control study was conducted involving 273 employees at the National Cancer Institute (Bratislava, Slovakia) for the present study. Specifically, the present study aimed to determine the incidence of symptomatic COVID-19. In addition, the association between the safety of the third-dose BNT162b2 and sex and body mass index (BMI) was assessed. The present study also explored the potential determinants of plasma IgG antibody levels following vaccination. In total, 294 participants were recruited and 273 met the inclusion criteria. At a median follow-up of 4.7 months, 38 participants had symptomatic SARS-CoV-2 infection after vaccination. The incidence of adverse events (AEs) was found to be significantly higher in female patients compared with that in male patients. Furthermore, patients with a high BMI (≥30 kg/m²) had higher number of AEs compared with those with low BMI (P<0.05). IgG levels were observed to be significantly higher in male patients compared with those in female patients, in participants with high BMI compared with those with low BMI, in those experiencing three or more AEs compared with those with fewer AEs and in participants who had contracted COVID-19 compared with those who had not (P<0.05 for all). Multivariate analysis identified sex, BMI, number of AEs and prior COVID-19 infection as independent predictors of IgG plasma level (P<0.05). Therefore, the present study found the low number of COVID-19 in the subjects vaccinated with the third dose of BNT162b2 and revealed that the safety profile of the vaccine is associated with sex and BMI. Higher IgG levels, indicating more efficient protection against SARS-CoV-2, were observed in male patients, in participants with high BMI, those experiencing a higher frequency of AEs and those who had previously contracted COVID-19 despite vaccination against SARS-CoV-2. These findings could lead to the stratification of subjects within future clinical studies and the development of specific vaccination protocols in regard to sex, BMI and history of SARS-CoV-2.
BNT162b2是一种mRNA疫苗，已获得美国食品药品监督管理局和欧洲药品管理局的批准，旨在针对2019冠状病毒病（COVID-19）的病原体严重急性呼吸综合征冠状病毒2（SARS-CoV-2）。尽管其已广泛使用，但BNT162b2接种后体液免疫反应的预测因素仍不确定。因此，本研究对斯洛伐克布拉迪斯拉发国家癌症研究所的273名员工进行了一项病例对照研究。具体而言，本研究旨在确定有症状COVID-19的发病率。此外，评估了第三剂BNT162b2的安全性与性别和体重指数（BMI）之间的关联。本研究还探讨了接种疫苗后血浆IgG抗体水平的潜在决定因素。总共招募了294名参与者，其中273名符合纳入标准。在中位随访4.7个月时，38名参与者在接种疫苗后出现了有症状的SARS-CoV-2感染。发现女性患者的不良事件（AE）发生率显著高于男性患者。此外，高BMI（≥30kg/m²）的患者与低BMI的患者相比，AE数量更多（P<0.05）。观察到男性患者的IgG水平显著高于女性患者，高BMI的参与者高于低BMI的参与者，经历三次或更多次AE的参与者高于AE较少的参与者，感染过COVID-19的参与者高于未感染过的参与者（所有P<0.05）。多变量分析确定性别、BMI、AE数量和既往COVID-19感染是IgG血浆水平的独立预测因素（P<0.05）。因此，本研究发现接种第三剂BNT162b2的受试者中COVID-19病例数较少，并揭示了该疫苗的安全性与性别和BMI有关。在男性患者、高BMI的参与者、经历AE频率较高的参与者以及尽管接种了SARS-CoV-2疫苗但先前感染过COVID-19的参与者中，观察到较高的IgG水平，表明对SARS-CoV-2有更有效的保护作用。这些发现可能会导致未来临床研究中对受试者进行分层，并制定关于性别、BMI和SARS-CoV-2病史的特定疫苗接种方案。
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