Bruxvoort Katia J, Sy Lina S, Qian Lei, Ackerson Bradley K, Luo Yi, Lee Gina S, Tian Yun, Florea Ana, Takhar Harpreet S, Tubert Julia E, Talarico Carla A, Tseng Hung Fu
Kaiser Permanente Southern California, Pasadena, CA, USA.
University of Alabama at Birmingham, Birmingham, AL, USA.
Lancet Reg Health Am. 2022 Feb;6:100134. doi: 10.1016/j.lana.2021.100134. Epub 2021 Nov 25.
Phase 3 trials found mRNA-1273 was highly effective in preventing COVID-19. We conducted a prospective cohort study at Kaiser Permanente Southern California (KPSC) to determine the real-world vaccine effectiveness (VE) of mRNA-1273 in preventing COVID-19 infection and severe disease.
For this planned interim analysis, individuals aged ≥18 years receiving 2 doses of mRNA-1273 ≥24 days apart (18/12/2020-31/03/2021) were 1:1 matched to randomly selected unvaccinated individuals by age, sex, and race/ethnicity, with follow-up through 30/06/2021. Outcomes were COVID-19 infection (SARS-CoV-2 positive molecular test or COVID-19 diagnosis code) or severe disease (COVID-19 hospitalization and COVID-19 hospital death). Adjusted hazard ratios (aHR) and confidence intervals (CI) for COVID-19 outcomes comparing vaccinated and unvaccinated individuals were estimated by Cox proportional hazards models accounting for multiple comparisons. Adjusted VE was calculated as (1-aHR)x100. Whole genome sequencing was performed on SARS-CoV-2 positive specimens from the KPSC population.
This analysis included 352,878 recipients of 2 doses of mRNA-1273 matched to 352,878 unvaccinated individuals. VE (99·3% CI) against COVID-19 infection was 87·4% (84·8-89·6%). VE against COVID-19 hospitalization and hospital death was 95·8% (90·7-98·1%) and 97·9% (66·9-99·9%), respectively. VE was higher against symptomatic (88·3% [98·3% CI: 86·1-90·2%]) than asymptomatic COVID-19 (72·7% [53·4-84·0%]), but was generally similar across age, sex, and racial/ethnic subgroups. VE among individuals with history of COVID-19 ranged from 8·2-33·6%. The most prevalent variants were Alpha (41·6%), Epsilon (17·5%), Delta (11·5%), and Gamma (9·1%), with Delta increasing to 54·0% of variants by June 2021.
These interim results provide reassuring evidence of the VE of 2 doses of mRNA-1273 across age, sex, and racial/ethnic subgroups, and against asymptomatic and symptomatic COVID-19, and severe COVID-19 outcomes. Among individuals with history of COVID-19, mRNA-1273 vaccination may offer added protection beyond immunity acquired from prior infection. Longer follow-up is needed to fully evaluate VE of mRNA-1273 against emerging SARS-CoV-2 variants.
Moderna Inc.
3期试验发现mRNA-1273在预防新型冠状病毒肺炎（COVID-19）方面非常有效。我们在南加州凯撒医疗机构（KPSC）进行了一项前瞻性队列研究，以确定mRNA-1273在预防COVID-19感染和重症方面的真实世界疫苗效力（VE）。
对于这项计划中的中期分析，将年龄≥18岁、间隔≥24天接种2剂mRNA-1273（2020年12月18日至2021年3月31日）的个体，按年龄、性别和种族/民族与随机选择的未接种个体进行1:1匹配，并随访至2021年6月30日。结局为COVID-19感染（严重急性呼吸综合征冠状病毒2[SARS-CoV-2]核酸检测阳性或COVID-19诊断代码）或重症（COVID-19住院和COVID-19医院死亡）。通过Cox比例风险模型估计比较接种和未接种个体的COVID-19结局的调整风险比（aHR）和置信区间（CI），并考虑多重比较。调整后的VE计算为（1 - aHR）×100。对来自KPSC人群的SARS-CoV-2阳性标本进行全基因组测序。
该分析纳入了352,878名接种2剂mRNA-1273的个体，并与352,878名未接种个体进行匹配。预防COVID-19感染的VE（99.3%CI）为87.4%（84.8 - 89.6%）。预防COVID-19住院和医院死亡的VE分别为95.8%（90.7 - 98.1%）和97.9%（66.9 - 99.
