Elias Luke B, Jaber Aliya, Manzano Margarita, Leekoff Mark, Sylvester Andrew, Tremblay Matthew A
Multiple Sclerosis Comprehensive Care Center, RWJBarnabas Health, Livingston, NJ 07039, USA.
Vaccines (Basel). 2023 Dec 15;11(12):1855. doi: 10.3390/vaccines11121855.
Vaccines against the SARS-CoV-2 virus were authorized for use by the Food and Drug Administration (FDA) in the United States and have proven effective for the prevention of morbidity and death from COVID-19. Certain immunosuppressant medications prevent the development of protective immunity following COVID-19 vaccination. In December 2021, the FDA issued an emergency use authorization (EUA) for a monoclonal-antibody combination of tixagevimab and cilgavimab, under the brand name Evusheld, for pre-exposure prophylaxis (PrEP) against COVID-19 for individuals with moderate-to-severe immune compromise. While a 77% reduction in symptomatic COVID-19 was observed in the PROVENT study, the trial was conducted prior to emergence of the B.1.1.529 Omicron variant. We suspected reduced efficacy of PrEP against Omicron subvariants. We conducted a retrospective cohort study comparing the prevalence of symptomatic COVID-19 infections between 1 January 2022 and 1 July 2022 in eligible patients treated with PrEP versus untreated using a questionnaire administered with the REDCap survey tool. Responses from 235 participants were included in the final analysis, with 176 untreated respondents and 59 in the PrEP cohort. Symptomatic COVID-19 infections were reported in 50 (28.4%) untreated participants and only 9 (15.3%) of those who received PrEP ( = 0.0557; OR 0.4536; 95% CI 0.2046 to 0.9599). Only two participants were hospitalized for COVID-19 infection, both in the untreated cohort. The reduction in COVID-19 infections did not achieve statistical significance, indicating diminished efficacy against Omicron variants.
针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的疫苗已获美国食品药品监督管理局（FDA）批准使用，并已证明对预防2019冠状病毒病（COVID-19）导致的发病和死亡有效。某些免疫抑制药物会妨碍COVID-19疫苗接种后保护性免疫的形成。2021年12月，FDA发布了一项紧急使用授权（EUA），批准了替沙格韦单抗和西加韦单抗的单克隆抗体组合（商品名Evusheld），用于对中度至重度免疫功能低下个体进行COVID-19暴露前预防（PrEP）。虽然在PROVENT研究中观察到有症状的COVID-19感染减少了77%，但该试验是在B.1.1.529奥密克戎变异株出现之前进行的。我们怀疑PrEP对奥密克戎亚变体的疗效降低。我们进行了一项回顾性队列研究，使用REDCap调查工具通过问卷比较了2022年1月1日至2022年7月1日期间接受PrEP治疗的符合条件患者与未接受治疗患者中出现症状的COVID-19感染率。最终分析纳入了235名参与者的回复，其中176名未接受治疗的受访者和59名PrEP队列中的参与者。50名（28.4%）未接受治疗的参与者报告了有症状的COVID-19感染，而接受PrEP的参与者中只有9名（15.3%）报告了感染（P = 0.0557；比值比0.4536；95%置信区间0.2046至0.9599）。只有两名参与者因COVID-19感染住院，均在未接受治疗的队列中。COVID-19感染的减少未达到统计学显著性，表明对奥密克戎变异株的疗效降低。
