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.
| Original language | English |
|---|---|
| Article number | 7711 |
| Journal | Nature Communications |
| Volume | 13 |
| Issue number | 1 |
| DOIs | |
| State | Published - 13 Dec 2022 |
| Externally published | Yes |
Bibliographical note
Publisher Copyright:© 2022, The Author(s).
Funding
We thank the Sheba HCW participating in the trial for their full cooperating. We thank the members of the safety monitoring committee, led by Naty Keller. We thank the Sheba management, particularly Dr. Amir Grinberg, Anat Peles, Limor Ben-David, Bella Ben Mordechai, and their team for their assistance. Vered Roa, Efrat Steinberg and Yael Beker-Ilani for coordinating the study, recruitment and follow-up. We thank the laboratory team for the laborious work, Limor Kliker, Nofar Atari, Ravit Koren, Tal Levin, Osnat Halpern, Yara Kanaaneh, Shiri Kats-Likvornik, Alex Aydenzon, Hanaa Jaber, Lilac Or, and Mayan Atias. Y.L. is a recipient of the Nehemia Rubin Excellence in Biomedical Research, the TELEM Program of Chaim, SMC. This study was fully funded by internal funding of the Sheba Medical Center. We thank the Sheba HCW participating in the trial for their full cooperating. We thank the members of the safety monitoring committee, led by Naty Keller. We thank the Sheba management, particularly Dr. Amir Grinberg, Anat Peles, Limor Ben-David, Bella Ben Mordechai, and their team for their assistance. Vered Roa, Efrat Steinberg and Yael Beker-Ilani for coordinating the study, recruitment and follow-up. We thank the laboratory team for the laborious work, Limor Kliker, Nofar Atari, Ravit Koren, Tal Levin, Osnat Halpern, Yara Kanaaneh, Shiri Kats-Likvornik, Alex Aydenzon, Hanaa Jaber, Lilac Or, and Mayan Atias. Y.L. is a recipient of the Nehemia Rubin Excellence in Biomedical Research, the TELEM Program of Chaim, SMC. This study was fully funded by internal funding of the Sheba Medical Center.
| Funders | Funder number |
|---|---|
| Nehemia Rubin Excellence in Biomedical Research | |
| Sheba Medical Center |
