tetano
Editor, Senior Moderator
Nat Commun
. 2024 Aug 29;15(1):7469.
doi: 10.1038/s41467-024-50376-z. Long-term safety and effectiveness of mRNA-1273 vaccine in adults: COVE trial open-label and booster phases
Lindsey R Baden[SUP] #[/SUP][SUP] 1 [/SUP], Hana M El Sahly[SUP] #[/SUP][SUP] 2 [/SUP], Brandon Essink[SUP] 3 [/SUP], Dean Follmann[SUP] 4 [/SUP], Gregory Hachigian[SUP] 5 [/SUP], Cynthia Strout[SUP] 6 [/SUP], J Scott Overcash[SUP] 7 [/SUP], Susanne Doblecki-Lewis[SUP] 8 [/SUP], Jennifer A Whitaker[SUP] 2 [/SUP], Evan J Anderson[SUP] 9 [/SUP], Kathleen Neuzil[SUP] 10 [/SUP], Lawrence Corey[SUP] 11 [/SUP], Frances Priddy[SUP] 12 [/SUP], Joanne E Tomassini[SUP] 12 [/SUP], Mollie Brown[SUP] 12 [/SUP], Bethany Girard[SUP] 12 [/SUP], Dina Stolman[SUP] 12 [/SUP], Veronica Urdaneta[SUP] 12 [/SUP], Xiaowei Wang[SUP] 12 [/SUP], Weiping Deng[SUP] 12 [/SUP], Honghong Zhou[SUP] 12 [/SUP], Avika Dixit[SUP] 12 [/SUP], Rituparna Das[SUP] 12 [/SUP], Jacqueline M Miller[SUP] 12 [/SUP]; COVE Trial Consortium
Affiliations
Primary vaccination with mRNA-1273 (100-µg) was safe and efficacious at preventing coronavirus disease 2019 (COVID-19) in the previously reported, blinded Part A of the phase 3 Coronavirus Efficacy (COVE; NCT04470427) trial in adults (≥18 years) across 99 U.S. sites. The open-label (Parts B and C) primary objectives were evaluation of long-term safety and effectiveness of primary vaccination plus a 50-µg booster dose; immunogenicity was a secondary objective. Of 29,035 open-label participants, 19,609 received boosters (mRNA-1273 [n = 9647]; placebo-mRNA-1273 [n = 9952]; placebo [n = 10] groups). Booster safety was consistent with that reported for primary vaccination. Incidences of COVID-19 and severe COVID-19 were higher during the Omicron BA.1 than Delta variant waves and boosting versus non-boosting was associated with a significant, 47.0% (95% CI : 39.0-53.9%) reduction of Omicron BA.1 incidence (24.6 [23.4 - 25.8] vs 46.4 [40.6 - 52.7]/1000 person-months). In an exploratory Cox regression model adjusted for time-varying covariates, a longer median interval between primary vaccination and boosting (mRNA-1273 [13 months] vs placebo-mRNA-1273 [8 months]) was associated with significantly lower, COVID-19 risk (24.0% [16.0% - 32.0%]) during Omicron BA.1 predominance. Boosting elicited greater immune responses against SARS-CoV-2 than primary vaccination, irrespective of prior SARS-CoV-2 infection. Primary vaccination and boosting with mRNA-1273 demonstrated acceptable safety, effectiveness and immunogenicity against COVID-19, including emergent variants.
. 2024 Aug 29;15(1):7469.
doi: 10.1038/s41467-024-50376-z. Long-term safety and effectiveness of mRNA-1273 vaccine in adults: COVE trial open-label and booster phases
Lindsey R Baden[SUP] #[/SUP][SUP] 1 [/SUP], Hana M El Sahly[SUP] #[/SUP][SUP] 2 [/SUP], Brandon Essink[SUP] 3 [/SUP], Dean Follmann[SUP] 4 [/SUP], Gregory Hachigian[SUP] 5 [/SUP], Cynthia Strout[SUP] 6 [/SUP], J Scott Overcash[SUP] 7 [/SUP], Susanne Doblecki-Lewis[SUP] 8 [/SUP], Jennifer A Whitaker[SUP] 2 [/SUP], Evan J Anderson[SUP] 9 [/SUP], Kathleen Neuzil[SUP] 10 [/SUP], Lawrence Corey[SUP] 11 [/SUP], Frances Priddy[SUP] 12 [/SUP], Joanne E Tomassini[SUP] 12 [/SUP], Mollie Brown[SUP] 12 [/SUP], Bethany Girard[SUP] 12 [/SUP], Dina Stolman[SUP] 12 [/SUP], Veronica Urdaneta[SUP] 12 [/SUP], Xiaowei Wang[SUP] 12 [/SUP], Weiping Deng[SUP] 12 [/SUP], Honghong Zhou[SUP] 12 [/SUP], Avika Dixit[SUP] 12 [/SUP], Rituparna Das[SUP] 12 [/SUP], Jacqueline M Miller[SUP] 12 [/SUP]; COVE Trial Consortium
Affiliations
- PMID: 39209823
- PMCID: PMC11362294
- DOI: 10.1038/s41467-024-50376-z
Primary vaccination with mRNA-1273 (100-µg) was safe and efficacious at preventing coronavirus disease 2019 (COVID-19) in the previously reported, blinded Part A of the phase 3 Coronavirus Efficacy (COVE; NCT04470427) trial in adults (≥18 years) across 99 U.S. sites. The open-label (Parts B and C) primary objectives were evaluation of long-term safety and effectiveness of primary vaccination plus a 50-µg booster dose; immunogenicity was a secondary objective. Of 29,035 open-label participants, 19,609 received boosters (mRNA-1273 [n = 9647]; placebo-mRNA-1273 [n = 9952]; placebo [n = 10] groups). Booster safety was consistent with that reported for primary vaccination. Incidences of COVID-19 and severe COVID-19 were higher during the Omicron BA.1 than Delta variant waves and boosting versus non-boosting was associated with a significant, 47.0% (95% CI : 39.0-53.9%) reduction of Omicron BA.1 incidence (24.6 [23.4 - 25.8] vs 46.4 [40.6 - 52.7]/1000 person-months). In an exploratory Cox regression model adjusted for time-varying covariates, a longer median interval between primary vaccination and boosting (mRNA-1273 [13 months] vs placebo-mRNA-1273 [8 months]) was associated with significantly lower, COVID-19 risk (24.0% [16.0% - 32.0%]) during Omicron BA.1 predominance. Boosting elicited greater immune responses against SARS-CoV-2 than primary vaccination, irrespective of prior SARS-CoV-2 infection. Primary vaccination and boosting with mRNA-1273 demonstrated acceptable safety, effectiveness and immunogenicity against COVID-19, including emergent variants.