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<p>The association between vaccine efficacy (VE) and force of infection (FoI) remains incompletely understood. Previous analyses have been primarily based on trial-level summary data—not accounting for the effect of time and constrained by the number of trials. Here, we leverage individual-level data from three phase 3 randomized, placebo-controlled COVID-19 vaccine trials—the COVE trial (Moderna, CoVPN3001), the AZD1222 trial (AstraZeneca, CoVPN3002), and the ENSEMBLE trial (Janssen/Johnson &amp; Johnson, CoVPN3003)—and contemporaneous geographic-location-specific SARS-CoV-2 surveillance data from the start of the pandemic through November 14, 2021 (including the blinded follow-up periods of the trials) to conduct five cohort- and vaccine-specific analyses: COVE (U.S.), AZD1222 overall (U.S. + non-U.S.), AZD1222 U.S., ENSEMBLE overall (U.S. + non-U.S.), and ENSEMBLE U.S. In AZD1222 U.S., higher VE was associated with higher FoI (<i>p</i> = 0.01). In ENSEMBLE overall, lower VE was marginally associated with higher FoI (<i>p</i> = 0.21), further supported by a region-specific analysis. In COVE, AZD1222 overall, and ENSEMBLE U.S., no VE-FoI association was found. These findings highlighted a new perspective: the VE–FoI association appears complex, potentially influenced by FoI levels, with patterns suggesting an inverted U-shaped relationship, showing a positive association at low FoI levels and a negative association at high levels.</p>

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Association between COVID-19 vaccine efficacy and epidemic force of infection

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年1月17日

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  • Jing Xu,
  • M. Elizabeth Halloran,
  • Mia Moore,
  • Lily Zhang,
  • Ollivier Hyrien,
  • Alex Luedtke,
  • Hana M. El Sahly,
  • Lindsey R. Baden,
  • Paul A. Goepfert,
  • Glenda Gray,
  • Beatriz Grinsztejn,
  • Magdalena E. Sobieszczyk,
  • Ann R. Falsey,
  • Samuel T. Robinson,
  • Nina Marie G. Garcia,
  • Honghong Zhou,
  • Ilse van Dromme,
  • Carla Truyers,
  • Ian Hirsch,
  • Kathleen M. Neuzil,
  • Lawrence Corey,
  • James G. Kublin,
  • Dean Follmann,
  • Holly E. Janes,
  • Peter B. Gilbert,
  • Yunda Huang

摘要

The association between vaccine efficacy (VE) and force of infection (FoI) remains incompletely understood. Previous analyses have been primarily based on trial-level summary data—not accounting for the effect of time and constrained by the number of trials. Here, we leverage individual-level data from three phase 3 randomized, placebo-controlled COVID-19 vaccine trials—the COVE trial (Moderna, CoVPN3001), the AZD1222 trial (AstraZeneca, CoVPN3002), and the ENSEMBLE trial (Janssen/Johnson & Johnson, CoVPN3003)—and contemporaneous geographic-location-specific SARS-CoV-2 surveillance data from the start of the pandemic through November 14, 2021 (including the blinded follow-up periods of the trials) to conduct five cohort- and vaccine-specific analyses: COVE (U.S.), AZD1222 overall (U.S. + non-U.S.), AZD1222 U.S., ENSEMBLE overall (U.S. + non-U.S.), and ENSEMBLE U.S. In AZD1222 U.S., higher VE was associated with higher FoI (p = 0.01). In ENSEMBLE overall, lower VE was marginally associated with higher FoI (p = 0.21), further supported by a region-specific analysis. In COVE, AZD1222 overall, and ENSEMBLE U.S., no VE-FoI association was found. These findings highlighted a new perspective: the VE–FoI association appears complex, potentially influenced by FoI levels, with patterns suggesting an inverted U-shaped relationship, showing a positive association at low FoI levels and a negative association at high levels.