Rousculp Matthew D, Hollis Kelly, Ziemiecki Ryan, Odom Dawn, Marchese Anthony M, Montazeri Mitra, Odak Shardul, Jackson Laurin, Beyhaghi Hadi, Toback Seth
Novavax, Inc., Gaithersburg, MD 20878, USA.
RTI Health Solutions, Research Triangle Park, NC 27709, USA.
Vaccines (Basel). 2024 Jul 19;12(7):802. doi: 10.3390/vaccines12070802.
Participants in studies investigating COVID-19 vaccines commonly report reactogenicity events, and concerns about side effects may lead to a reluctance to receive updated COVID-19 vaccinations. A real-world, post hoc analysis, observational 2019nCoV-406 study was conducted to examine reactogenicity within the first 2 days after vaccination with either a protein-based vaccine (NVX-CoV2373) or an mRNA vaccine (BNT162b2 or mRNA-1273) in individuals who previously completed a primary series. Propensity score adjustments were conducted to address potential confounding. The analysis included 1130 participants who received a booster dose of NVX-CoV2373 ( = 303) or an mRNA vaccine ( = 827) during the study period. Within the first 2 days after vaccination, solicited systemic reactogenicity events (adjusted) were reported in 60.5% of participants who received NVX-CoV2373 compared with 84.3% of participants who received an mRNA vaccine; moreover, 33.9% and 61.4%, respectively, reported ≥3 systemic reactogenicity symptoms. The adjusted mean (95% CI) number of systemic symptoms was 1.8 (1.6-2.0) and 3.2 (3.0-3.4), respectively. Local reactogenicity events (adjusted) were reported in 73.4% and 91.7% of participants who received NVX-CoV2373 and mRNA vaccines, respectively; the adjusted mean (95% CI) number of local symptoms was 1.5 (1.33-1.61) and 2.4 (2.31-2.52), respectively. These results support the use of adjuvanted, protein-based NVX-CoV2373 as an immunization option with lower reactogenicity than mRNAs.
调查新冠病毒疫苗的研究参与者普遍报告了反应原性事件，而对副作用的担忧可能导致人们不愿接种新冠病毒加强疫苗。开展了一项真实世界的事后分析观察性2019nCoV - 406研究，以检查先前完成基础免疫系列的个体接种基于蛋白质的疫苗（NVX-CoV2373）或mRNA疫苗（BNT162b2或mRNA-1273）后前两天内的反应原性。进行倾向评分调整以解决潜在的混杂问题。该分析纳入了1130名在研究期间接受了一剂NVX-CoV2373（n = 303）或mRNA疫苗（n = 827）加强针的参与者。在接种疫苗后的前两天内，接受NVX-CoV2373的参与者中有60.5%报告了诱发的全身反应原性事件（调整后），而接受mRNA疫苗的参与者这一比例为84.3%；此外，分别有33.9%和61.4%的参与者报告了≥3种全身反应原性症状。全身症状的调整后平均数量（95%CI）分别为1.8（1.6 - 2.0）和3.2（3.0 - 3.4）。接受NVX-CoV2373和mRNA疫苗的参与者中，分别有73.4%和91.7%报告了局部反应原性事件（调整后）；局部症状的调整后平均数量（95%CI）分别为1.5（1.33 - 1.61）和2.4（2.31 - 2.52）。这些结果支持使用含佐剂的、基于蛋白质的NVX-CoV2373作为一种反应原性低于mRNA的免疫接种选择。
