Association Between SARS-CoV-2 Viral Load and COVID-19 Vaccination in 4 Phase 3 Trials

Author:

Janes Holly1,Fisher Leigh H1,Kee Jia Jin1,Parameswaran Lalitha2,Goepfert Paul A3,Falsey Ann R4,Ludwig James1,Magaret Craig A1,Gilbert Peter B1,Kublin James G1ORCID,Rouphael Nadine5ORCID,Sobieszczyk Magdalena E6,El Sahly Hana M7,Baden Lindsey R8,Grinsztejn Beatriz9,Walsh Stephen R8,Gray Glenda E10,Kotloff Karen L11,Gay Cynthia L12,Greninger Alexander L13,Tapia Milagritos D11ORCID,Hammershaimb E Adrianne11ORCID,Priddy Frances H14,Green Justin A15,Struyf Frank16,Dunkle Lisa17,Neuzil Kathleen M18,Corey Lawrence1,Huang Yunda1

Affiliation:

1. Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center , Seattle, Washington , USA

2. New York University Langone Vaccine Center, New York University Grossman School of Medicine , New York, New York , USA

3. Heersink School of Medicine, University of Alabama at Birmingham , Birmingham, Alabama , USA

4. Infectious Disease Division, University of Rochester , Rochester, New York , USA

5. Hope Clinic, Emory University , Atlanta, Georgia , USA

6. Department of Medicine, Columbia University Irving Medical Center , New York, New York , USA

7. Department of Molecular Virology and Microbiology, Baylor College of Medicine , Houston, Texas , USA

8. Division of Infectious Diseases, Brigham and Women's Hospital , Boston, Massachusetts , USA

9. Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation , Rio de Janeiro , Brazil

10. South African Medical Research Council , Cape Town , South Africa

11. Department of Pediatrics, Center for Vaccine Development and Global Health, University of Maryland School of Medicine , Baltimore, Maryland , USA

12. Division of Infectious Diseases, University of North Carolina School of Medicine , Chapel Hill, North Carolina , USA

13. Department of Medicine, Laboratory Medicine and Pathology, University of Washington Medical Center , Seattle, Washington , USA

14. Moderna, Inc , Cambridge, Massachusetts , USA

15. Vaccines and Immune Therapies, BioPharmaceuticals Research and Development, AstraZeneca , Cambridge , United Kingdom

16. Janssen Research and Development , Beerse , Belgium

17. Novavax, Inc , Gaithersburg, Maryland , USA

18. Center for Vaccine Development and Global Health, University of Maryland School of Medicine , Baltimore, Maryland , USA

Abstract

Abstract Coronavirus disease 2019 (COVID-19) vaccines reduce severe disease and mortality and may lessen transmission, measured by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load (VL). Evaluating vaccine associations in VL at COVID-19 diagnosis in 4 phase 3 randomized, placebo-controlled vaccine trials, July 2020 to July 2021, VL reductions were 2.78 log10 copies/mL (95% confidence interval [CI], 1.38–4.18; n = 60 placebo, 11 vaccine) and 2.12 log10 copies/mL (95% CI, 1.44–2.80; n = 594 placebo, 36 vaccine) for NVX-CoV2373 and mRNA-1273, respectively. Associations were not significant for AZD1222 (0.59 log10 copies/mL; 95% CI, −.19 to 1.36; n = 90 placebo, 78 vaccine) or Ad26.COV2.S (0.23 log10 copies/mL; 95% CI, −.01 to .47; n = 916 placebo, 424 vaccine). Thus, vaccines potentially decreased transmission when ancestral SARS-CoV-2 predominated. Clinical Trials Registration. NCT04470427, NCT04505722, NCT04516746, NCT04611802.

Funder

United States Government

Biomedical Advanced Research

and Development Authority

National Institute of Allergy and Infectious Diseases

Publisher

Oxford University Press (OUP)

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