Comparison between the homologous BNT162b2 and the heterologous Gam-COVID-Vac/BNT162b2 vaccine regimen in republic of North Macedonia

Stefan Nedelkoski, Vangel Ristovski, A. Petlichkovski, Meri Kirijas, Teodora Brnjarcevska, Gorjan Milanovski, Tamara Savevska, Kristina Mickovska
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Abstract

The medical and socio-economic consequences that stemmed from the COVID-19 pandemic, forced the healthcare policymakers in Republic of North Macedonia to rely on five different vaccines against the SARS-CoV-2 virus, in order to reach a satisfactory level of herd immunity. It is here where we got the idea to compare the heterologous Gam-COVID-Vac/BNT162b2 regimen to the homologous BNT162b2 regimen, with our main focus being the immunogenicity differences between the two of them. Additionally, we researched the variation in humoral immune response relative to age strata; the reactogenicity differences; and discrepancies in SARS-CoV-2 infection incidence between the two regimens. To achieve this, antibody titers in sera samples from fifty-three (53) healthcare workers, divided in heterologous and homologous group, were analysed at six different time checkpoints. Our results showed robust immunogenic response after the administration of the booster dose (4. 2-fold increase in antibody titers), followed by a slower-waning humoral immune protection in the heterologous regimen, compared to the homologous BNT162b2 schedule, furthermore confirmed by non-inferiority testing (Geometric Mean Ratio=0,98) at the final checkpoint. That, coupled with the similar reactogenicity (p=0,767) of both regimens, imply that the Gam-COVID-Vac/BNT162b2 combination might be a feasible approach in the effort to contain the COVID-19 pandemic.
北马其顿共和国同源BNT162b2与异源Gam-COVID-Vac/BNT162b2疫苗方案的比较
COVID-19大流行造成的医疗和社会经济后果迫使北马其顿共和国的卫生保健决策者依靠五种不同的SARS-CoV-2病毒疫苗,以达到令人满意的群体免疫水平。正是在这里,我们产生了将异源Gam-COVID-Vac/BNT162b2方案与同源BNT162b2方案进行比较的想法,我们的主要重点是两者之间的免疫原性差异。此外,我们还研究了不同年龄层体液免疫反应的变化;反应性差异;以及两种方案之间SARS-CoV-2感染发生率的差异。为了实现这一点,在6个不同的时间点分析了53名卫生保健工作者的血清样本中的抗体滴度,他们被分为异种组和同源组。我们的研究结果显示,在给予加强剂量后,免疫原性反应很强(4)。抗体滴度增加2倍),与同源的BNT162b2方案相比,异种方案的体液免疫保护减弱较慢,最后检查点的非劣效性检验进一步证实了这一点(几何平均比= 0.98)。再加上两种方案的反应原性相似(p= 0.767),这意味着Gam-COVID-Vac/BNT162b2组合可能是控制COVID-19大流行的可行方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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