Immunogenicity and efficacy of fourth BNT162b2 and mRNA1273 COVID-19 vaccine doses; three months follow-up

Michal Canetti, Noam Barda, Mayan Gilboa, Victoria Indenbaum, Michal Mandelboim, Tal Gonen, Keren Asraf, Yael Weiss-Ottolenghi, Sharon Amit, Ram Doolman, Ella Mendelson, Dror Harats, Laurence S. Freedman, Yitshak Kreiss, Yaniv Lustig and Gili Regev-Yochay ()
Additional contact information
Michal Canetti: The Infection Prevention & Control Unit, Sheba Medical Center, Tel Hashomer
Noam Barda: ARC Innovation Center, Sheba Medical Center, Tel Hashomer
Mayan Gilboa: The Infection Prevention & Control Unit, Sheba Medical Center, Tel Hashomer
Victoria Indenbaum: Tel-Aviv University
Michal Mandelboim: Tel-Aviv University
Tal Gonen: The Infection Prevention & Control Unit, Sheba Medical Center, Tel Hashomer
Keren Asraf: Tel-Aviv University
Yael Weiss-Ottolenghi: The Infection Prevention & Control Unit, Sheba Medical Center, Tel Hashomer
Sharon Amit: Tel-Aviv University
Ram Doolman: Tel-Aviv University
Ella Mendelson: Tel-Aviv University
Dror Harats: General Management, Sheba Medical Center, Tel Hashomer
Laurence S. Freedman: Biostatistics and Biomathematics Unit, Gertner Institute of Epidemiology and Health Policy Research, Sheba Medical Center
Yitshak Kreiss: Tel-Aviv University
Yaniv Lustig: Tel-Aviv University
Gili Regev-Yochay: The Infection Prevention & Control Unit, Sheba Medical Center, Tel Hashomer

Nature Communications, 2022, vol. 13, issue 1, 1-10

Abstract: Abstract Booster doses for the ongoing COVID-19 pandemic are under consideration in many countries. We report a three-month follow-up of 700 participants in a fourth vaccine dose study, comparing BNT162b2 and mRNA1273, administered four months after a third BNT162b2 dose. The primary outcomes are the levels of IgG, neutralizing antibodies, and microneutralization and the secondary outcomes are the levels of IgA and T cell activation, and clinical outcomes of SARS-CoV-2 infection and substantial symptomatic disease. Waning of the immune response is evident during follow-up, with an 11% (β = 0.89, 95% CI, 0.88–0.9) and 21% (β = 0.79, 95% CI, 0.76–0.82) multiplicative decay per week of IgG and neutralizing antibodies, respectively, in the mRNA1273 group, and of 14% (β = 0.86, 95% CI, 0.86–0.87) and 26% (β = 0.74, 95% CI, 0.72–0.76), respectively, in the BNT162b2 group. Direct neutralization of Omicron variants is low relative to ancestral strains. Cumulatively over the study period, both vaccines show little efficacy against infection but were highly efficacious against substantial symptomatic disease [89% [(IRR 0.11, 95% CI, 0.02–0.37) and 71% (IRR 0.29, 95% CI, 0.13–0.57) for mRNA1273 and BNT162b2, respectively]. These results are informative for further boosting policy-making. Trial registration numbers (clinicaltrials.gov): NCT05231005 and NCT05230953.

Date: 2022
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DOI: 10.1038/s41467-022-35480-2

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