Follmann Dean, Wang Xiaowei, Baden Lindsey R, El Sahly Hana M, Essink Brandon, Gilbert Peter, Janes Holly E, Kelley Colleen F, Berman Megan A, Frank Ian, Chu Eric, Deng Weiping, Priddy Frances, Dixit Avika, Tomassini Joanne E, Das Rituparna, Miller Jacqueline, Zhou Honghong
National Institute of Allergy and Infectious Diseases, Biostatistics Research Branch, Bethesda, Maryland, USA.
Moderna, Inc., Cambridge, Massachusetts, USA.
Open Forum Infect Dis. 2024 Nov 25;11(12):ofae689. doi: 10.1093/ofid/ofae689. eCollection 2024 Dec.
To help inform COVID-19 vaccination recommendations, we evaluated the impact of age and dosing interval on clinical benefit of a third dose of mRNA-1273.
Approximately 17 000 participants from the phase 3 Coronavirus Efficacy trial who previously received 2 doses of 100 µg mRNA-1273 were evaluated for COVID-19 between September 2021 and April 2022 during uptake of a third booster dose of 50 µg of mRNA-1273. Cox models assessed booster relative efficacy of a third dose.
Initial booster relative efficacy against Delta COVID-19 was 83% (95% confidence interval, 60-93) 14 days postdose and 83% (67-91) 60 days later. Initial booster efficacy against Omicron COVID-19 was 56% (44-65) at 14 days postdose and 4% (-27 to 28) 120 days later. For those aged ≥65 years, initial booster efficacy against Omicron COVID-19 was 86% (69-93) compared with 50% (36-61) for those <65 years. Placebo crossover to 2 doses of mRNA-1273 induced a median 5-month difference from the second to third dose between the original randomized arms. Postboost, the mRNA-1273 arm had a 24% (16%, 32%) lower risk of Omicron COVID-19 compared to the placebo-mRNA-1273 arm. Modeling predicted a 41% postboost reduction in Omicron COVID-19 for a 15- versus 7-month interval between the second and third doses.
Boosting reduced Delta COVID-19 risk by 83% through 2 months and reduced Omicron COVID-19 risk by 56% but declined by 4 months. A 15- versus 7-month dosing interval predicted a 41% postboost reduction in Omicron COVID-19 but increased preboost risk.
The National Institutes of Health/National Institute of Allergy and Infectious Diseases. ClinicalTrials.gov ID# NCT04470427.
为辅助制定新冠病毒病（COVID-19）疫苗接种建议，我们评估了年龄和接种间隔对第三剂mRNA-1273临床获益的影响。
在2021年9月至2022年4月期间，对大约17000名来自3期冠状病毒疫苗效力试验的参与者进行了评估，这些参与者之前接受了2剂100μg的mRNA-1273，在接种第三剂50μg的mRNA-1273加强针期间评估其COVID-19情况。Cox模型评估了第三剂加强针的相对效力。
接种第三剂加强针后14天，针对德尔塔变异株引起的COVID-19的初始加强针相对效力为83%（95%置信区间，60-93），60天后为83%（67-91）。接种第三剂加强针后14天，针对奥密克戎变异株引起的COVID-19的初始加强针效力为56%（44-65），120天后为4%（-27至28）。对于年龄≥65岁的人群，针对奥密克戎变异株引起的COVID-19的初始加强针效力为86%（69-93），而对于年龄<65岁的人群，这一效力为50%（36-61）。安慰剂组交叉接种2剂mRNA-1273后，原始随机分组组中从第二剂到第三剂的间隔时间中位数相差5个月。接种加强针后，与安慰剂-mRNA-1273组相比，mRNA-1273组感染奥密克戎变异株引起的COVID-19的风险降低了24%（16%，32%）。模型预测，第二剂和第三剂之间的间隔时间为15个月与7个月相比，接种加强针后感染奥密克戎变异株引起的COVID-19的风险降低41%。
接种加强针使德尔塔变异株引起的COVID-19风险在2个月内降低了83%，使奥密克戎变异株引起的COVID-19风险降低了56%，但在4个月后下降。第二剂和第三剂之间的间隔时间为15个月与7个月相比，预测接种加强针后感染奥密克戎变异株引起的COVID-19的风险降低41%，但会增加接种加强针前的风险。
美国国立卫生研究院/国家过敏和传染病研究所。ClinicalTrials.gov标识符：NCT04470427。
