Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID-19–Associated Emergency Department or Urgent Care Encounters and Hospitalizations Among Immunocompetent Adults — VISION Network, Nine States, September–November 2022

Tenforde, Mark W; Weber, Zachary A.; Natarajan, Karthik; Klein, Nicola P.; Kharbanda, Anupam B.; Stenehjem, Edward; Embí, Peter J.; Reese, Sarah E.; Naleway, Allison L.; Grannis, Shaun J.; DeSilva, Malini B.; Ong, Toan C.; Gaglani, Manjusha; Han, Jungmi; Dickerson, Monica; Fireman, Bruce; Dascomb, Kristin; Irving, Stephanie A.; Vazquez‐Benitez, Gabriela; Rao, Suchitra; Konatham, Deepika; Patel, Palak; Schrader, Kristin E.; Lewis, Ned; Grisel, Nancy; McEvoy, Charlene; Murthy, Kempapura; Griggs, Eric P.; Rowley, Elizabeth; Zerbo, Ousseny; Arndorfer, Julie; Dunne, Margaret M.; Goddard, Kristin; Ray, Caitlin; Zhuang, Yan; Timbol, Julius; Najdowski, Morgan; Yang, Deying; Hansen, John; Ball, Sarah; Link‐Gelles, Ruth

doi:10.15585/mmwr.mm715152e1

Cited by 104 publications

(100 citation statements)

References 9 publications

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“…95% CI width >50 percentage points. 42% (95% CI = 19%-58%) against COVID-19-associated hospitalization compared with ≥2 monovalent COVID-19 vaccine doses received 8-10 months earlier (9). Overall, these results were similar to the relative VE findings in the current study, suggesting that bivalent booster doses provide important benefits.…”

Section: Discussionsupporting

confidence: 83%

“…In the United Kingdom, among adults aged ≥50 years or those in clinical risk groups, a BA.1 bivalent booster dose was found to have a relative VE of 57% (95% CI = 48%–65%) compared with ≥2 COVID-19 vaccine doses received ≥6 months earlier ( 8 ). Similarly, a report among adults aged ≥18 years from the VISION Network in the United States using BA.4/BA.5 bivalent booster doses showed a relative VE of 42% (95% CI = 19%–58%) against COVID-19–associated hospitalization compared with ≥2 monovalent COVID-19 vaccine doses received 8–10 months earlier ( 9 ). Overall, these results were similar to the relative VE findings in the current study, suggesting that bivalent booster doses provide important benefits.…”

Section: Discussionmentioning

confidence: 93%

“…Recent findings from the United Kingdom and the United States have also demonstrated protection of a bivalent mRNA booster dose against COVID-19 hospitalization ( 8 , 9 ). The bivalent mRNA booster vaccine used in the United Kingdom contains spike protein mRNA from ancestral SARS-CoV-2 plus Omicron BA.1, in contrast to the bivalent booster vaccines used in the United States, which contain mRNA from ancestral SARS-CoV-2 and Omicron BA.4/BA.5.…”

Section: Discussionmentioning

confidence: 99%

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Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID-19–Associated Hospitalization Among Immunocompetent Adults Aged ≥65 Years — IVY Network, 18 States, September 8–November 30, 2022

Surie¹,

DeCuir²,

Zhu³

et al. 2022

MMWR Morb. Mortal. Wkly. Rep.

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100

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this report was posted as an MMWR Early Release on the MMWR website (https://www.cdc.gov/mmwr).Monovalent COVID-19 mRNA vaccines, designed against the ancestral strain of SARS-CoV-2, successfully reduced COVID-19related morbidity and mortality in the United States and globally (1,2). However, vaccine effectiveness (VE) against COVID-19associated hospitalization has declined over time, likely related to a combination of factors, including waning immunity and, with the emergence of the Omicron variant and its sublineages, immune evasion (3). To address these factors, on September 1, 2022, the Advisory Committee on Immunization Practices recommended a bivalent COVID-19 mRNA booster (bivalent booster) dose, developed against the spike protein from ancestral SARS-CoV-2 and Omicron BA.4/BA.5 sublineages, for persons who had completed at least a primary COVID-19 vaccination series (with or without monovalent booster doses) ≥2 months earlier (4). Data on the effectiveness of a bivalent booster dose against COVID-19 hospitalization in the United States are lacking, including among older adults, who are at highest risk for severe COVID-19-associated illness. During September 8-November 30, 2022, the Investigating Respiratory Viruses in the Acutely Ill (IVY) Network § assessed

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Section: Discussionsupporting

confidence: 83%

Section: Discussionmentioning

confidence: 93%

Section: Discussionmentioning

confidence: 99%

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Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID-19–Associated Hospitalization Among Immunocompetent Adults Aged ≥65 Years — IVY Network, 18 States, September 8–November 30, 2022

Surie¹,

DeCuir²,

Zhu³

et al. 2022

MMWR Morb. Mortal. Wkly. Rep.

Self Cite

100

View full text Add to dashboard Cite

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“…Since September 2022 a single boost of the bivalent mRNA vaccine has been recommended by the CDC. A recently published study showed the increased efficacy of the bivalent booster against COVID-19 in an emergency department/urgent care encounter or hospitalization compared to no vaccination in immunocompetent adults [ 33 ]. A similar study from Israel revealed the effectiveness of the bivalent vaccine among adult patients aged 65 years and older by demonstrating a decreased hospitalization and death rate due to COVID-19 [ 34 ].…”

Section: Discussionmentioning

confidence: 99%

Reduced Neutralization Efficacy against Omicron Variant after Third Boost of BNT162b2 Vaccine among Liver Transplant Recipients

Davidov

Indenbaum

Mandelboim

et al. 2023

Viruses

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The immune responses of liver transplant (LT) recipients after the third boost of the BNT162b2mRNA vaccine improved. This study evaluates the durability of the immune response of LT recipients after the third boost, its predictors, and the impact of emerging variants. The receptor-binding domain IgG was determined at median times of 22 (first test) and 133 days (second test) after the administration of the third boost. IgG antibody titers > 21.4 BAU/mL were defined as a positive response. The neutralization efficacies of the vaccine against the wild-type, Omicron, and Delta variants were compared in the first test. The 59 LT recipients were of a median age of 61 years (range 25–82); 53.5% were male. Following administration of the third dose, the positive immune response decreased from 81.4% to 76.3% between the first and second tests, respectively, (p < 0.0001). The multivariate analysis identified CNI monotherapy (p = 0.02) and hemoglobin > 12 g/dL (p = 0.02) as independent predictors of a maintained positive immune response 133 days after the third dose. The geometric mean titers of Omicron neutralization were significantly lower than the wild-type and Delta virus (21, 137, 128, respectively; p < 0.0001). The immune response after the third BNT162b2mRNA vaccine dose decreased significantly in LT recipients. Further studies are required to evaluate the efficacy of the fourth vaccine dose and the durability of the immune response.

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“…[1][2][3] Recent real-world evidence has shown that the BA.1 and BA.4/5 containing bivalent boosters provided additional protection against Covid-19 compared to those immunized with the original vaccine boosters or unvaccinated individuals. [7][8][9] However, effectiveness studies of the contemporaneous administration of the bivalent or original vaccine have not been undertaken. Safety and immunogenicity data from open-label studies, non-randomized, noncontemporaneously controlled studies have supported the authorization of mRNA-1273 omicrontargeting bivalent booster vaccines in rapid response to variant surges.…”

Section: Introductionmentioning

confidence: 99%

A Randomized Trial Comparing Omicron-Containing Boosters with the Original Covid-19 Vaccine mRNA-1273

Lee

Cosgrove

Moore

et al. 2023

Preprint

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BackgroundOmicron-containing bivalent boosters are available worldwide. Results of a large, randomized, active-controlled study are presented.MethodsThis phase 3, randomized, observer-blind, active-controlled trial in the United Kingdom evaluated the immunogenicity and safety of 50-μg doses of omicron-BA.1-monovalent mRNA-1273.529 and bivalent mRNA-1273.214 booster vaccines compared with 50-μg mRNA-1273 administered as boosters in individuals ≥16 years. Participants had previously received 2 doses of any authorized/approved Covid-19 vaccine with or without an mRNA vaccine booster. Safety and immunogenicity were primary objectives; immunogenicity was assessed in all participants, with analysis conducted based on prior infection status. Incidence of Covid-19 post-boost was a secondary (mRNA-1273.214) or exploratory (mRNA-1273.529) objective.ResultsIn part 1 of the study, 719 participants received mRNA-1273.529 (n=362) or mRNA-1273 (n=357); in part 2, 2813 received mRNA-1273.214 (n=1418) or mRNA-1273 (n=1395). Median durations (months [range]) between the most recent Covid-19 vaccine and study boosters were similar in the mRNA-1273.529 (4.0 [1.5-8.9]) and mRNA-1273 (4.1 [3.0-5.6]) (part 1), and mRNA-1273.214 (5.5 [0.4-13.3] and mRNA-1273 (5.4 [0.2-10.6]) groups (part 2). Both mRNA-1273.529 and mRNA-1273.214 elicited superior neutralizing antibody responses against omicron BA.1 with geometric mean ratios (95% CI) of 1.68 (1.45-1.95) and 1.53 (1.41-1.67) compared to mRNA-1273 at Day 29 post-boost. Although the study was not powered to assess relative vaccine efficacy, the incidence rates/1000 person years (95% CI) of Covid-19 trended lower with mRNA-1273.529 (670.5 [528.3-839.3]) than mRNA-1273 (769.3 [615.4-950.1]) and mRNA-1273.214 (633.0 [538.1-739.7]) than mRNA-1273 (711.6 [607.5-828.5]). Sequence analysis in part 2 showed that this was driven by lower incidence of Covid-19 in the mRNA-1273.214 cohort with BA.2 and BA.4 sublineages but not BA.5 sublineages. All study boosters were well-tolerated.ConclusionThe bivalent omicron BA.1 containing booster elicited superior neutralizing antibody responses against omicron BA.1 with acceptable safety results consistent with the BA.1 monovalent vaccine. Incidence rates for Covid-19 were numerically lower in participants who received mRNA-1273.214 compared to the original booster vaccine mRNA-1273, driven by the BA.2 and BA.4 sublineages.

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Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID-19–Associated Emergency Department or Urgent Care Encounters and Hospitalizations Among Immunocompetent Adults — VISION Network, Nine States, September–November 2022

Cited by 104 publications

References 9 publications

Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID-19–Associated Hospitalization Among Immunocompetent Adults Aged ≥65 Years — IVY Network, 18 States, September 8–November 30, 2022

Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID-19–Associated Hospitalization Among Immunocompetent Adults Aged ≥65 Years — IVY Network, 18 States, September 8–November 30, 2022

Reduced Neutralization Efficacy against Omicron Variant after Third Boost of BNT162b2 Vaccine among Liver Transplant Recipients

A Randomized Trial Comparing Omicron-Containing Boosters with the Original Covid-19 Vaccine mRNA-1273

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