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Modifiers of COVID-19 vaccine efficacy: Results from four COVID-19 prevention network efficacy trials.

ABSTRACT: Questions remain regarding the effect of baseline host and exposure factors on vaccine efficacy (VE) across pathogens and vaccine platforms. We report placebo-controlled data from four Phase 3 COVID-19 trials during the early period of the pandemic. This was a cross-protocol analysis of four randomized, placebo-controlled efficacy trials (Moderna/mRNA1273, AstraZeneca/AZD1222, Janssen/Ad26.COV2.S, and Novavax/NVX-CoV2373) using a harmonized design. Trials were conducted in the United States and international sites in adults ≥ 18 years of age. VE was assessed for symptomatic and severe COVID-19. We analyzed 114,480 participants from both placebo and vaccine arms, enrolled July 2020 to February 2021, with follow up through July 2021. VE against symptomatic COVID-19 showed little heterogeneity across baseline socio-demographic, clinical or exposure characteristics, in either univariate or multivariate analysis, regardless of vaccine platform. Similarly, VE against severe COVID-19 in the single trial (Janssen) with sufficient endpoints for analysis showed little evidence of heterogeneity. COVID-19 VE is not influenced by baseline host or exposure characteristics across efficacy trials of different vaccine platforms and countries when well matched to circulating virus strains. This supports use of these vaccines, regardless of platform type, as effective tools in the near term for reducing symptomatic and severe COVID-19, particularly for older individuals and those with common co-morbidities during major variant shifts. Clinical trial registration numbers: NCT04470427, NCT04516746, NCT04505722, and NCT04611802.

SUBMITTER: Turley CB

PROVIDER: S-EPMC10288314 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature

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Modifiers of COVID-19 vaccine efficacy: Results from four COVID-19 prevention network efficacy trials.

Turley Christine B CB Tables LaKesha L Fuller Trevon T Sanders Lisa J LJ Scott Hyman H Moodley Amaran A Woodward Davis Amanda A Leav Brett B Miller Jacqueline J Schoemaker Kathryn K Vandebosch An A Sadoff Jerald J Woo Wayne W Cho Iksung I Dunkle Lisa M LM Li Sijia S van der Laan Lars L Gilbert Peter B PB Follmann Dean D Jaynes Holly H Kublin James G JG Baden Lindsey R LR Goepfert Paul P Kotloff Karen K Gay Cynthia L CL Falsey Ann R AR El Sahly Hana M HM Sobieszczyk Magdalena E ME Huang Yunda Y Neuzil Kathleen M KM Corey Lawrence L Grinsztejn Beatriz B Gray Glenda G Rouphael Nadine N Luedtke Alex A

Vaccine 20230623 33

Questions remain regarding the effect of baseline host and exposure factors on vaccine efficacy (VE) across pathogens and vaccine platforms. We report placebo-controlled data from four Phase 3 COVID-19 trials during the early period of the pandemic. This was a cross-protocol analysis of four randomized, placebo-controlled efficacy trials (Moderna/mRNA1273, AstraZeneca/AZD1222, Janssen/Ad26.COV2.S, and Novavax/NVX-CoV2373) using a harmonized design. Trials were conducted in the United States and ...[more]

PMID: 37385888

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Modifiers of COVID-19 vaccine efficacy: Results from four COVID-19 prevention network efficacy trials.

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Modifiers of COVID-19 vaccine efficacy: Results from four COVID-19 prevention network efficacy trials.

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