Estimates of Bivalent mRNA Vaccine Durability in Preventing COVID-19–Associated Hospitalization and Critical Illness Among Adults with and Without Immunocompromising Conditions — VISION Network, September 2022–April 2023

Link‐Gelles, Ruth; Weber, Zachary A.; Reese, Sarah E.; Payne, Amanda B.; Gaglani, Manjusha; Adams, Katherine; Kharbanda, Anupam B.; Natarajan, Karthik; DeSilva, Malini B.; Dascomb, Kristin; Irving, Stephanie A.; Klein, Nicola P.; Grannis, Shaun J.; Ong, Toan C.; Embí, Peter J.; Dunne, Margaret M.; Dickerson, Monica; McEvoy, Charlene; Arndorfer, Julie; Naleway, Allison L.; Goddard, Kristin; Dixon, Brian E.; Griggs, Eric P.; Hansen, John; Valvi, Nimish R; Najdowski, Morgan; Timbol, Julius; Rogerson, Colin; Fireman, Bruce; Fadel, William F.; Patel, Palak; Ray, Caitlin; Wiegand, Ryan E.; Ball, Sarah; Tenforde, Mark W

doi:10.15585/mmwr.mm7221a3

Cited by 61 publications

(44 citation statements)

References 4 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Other studies have assessed the real-world effectiveness of the Pfizer BA.4-5 bivalent booster vaccine and found broadly similar results to us; one study from the United States found the incremental effectiveness against hospitalisation of a BA.4-5 bivalent booster was 42% when the last dose was monovalent and given 5 to 7 months prior (23), while another found the relative effectiveness against hospitalisation was 52% when the last dose was monovalent (27). Meanwhile a recent Italian study found the relative effectiveness of bivalent BA.4-5 boosters was 50.6% against severe disease when the last dose was given at least 120 days prior (28).…”

Section: Discussionsupporting

confidence: 52%

Effectiveness of the adjuvanted Sanofi/GSK (VidPrevtyn Beta) and Pfizer-BioNTech (Comirnaty Original/Omicron BA.4-5) bivalent vaccines against hospitalisation amongst adults aged 75 years and older in England, estimated using a test-negative case control study design

Kirsebom,

Andrews,

Stowe

et al. 2023

Preprint

View full text Add to dashboard Cite

BackgroundIn England, the Joint Committee for Vaccination and Immunisation recommended a spring 2023 booster programme for all adults aged 75 years and older and the immunosuppressed. The vaccines advised were the Sanofi/GSK AS03-adjuvanted monovalent beta variant (VidPrevtyn Beta) booster vaccine and the Pfizer-BioNTech mRNA (Comirnaty Original/Omicron BA.4-5) bivalent vaccine. This is the first time an adjuvanted COVID-19 vaccine has been administered as part of a UK COVID-19 vaccination programme. In clinical trials, the antibody levels generated by the Sanofi/GSK vaccine were comparable to levels generated by COVID-19 mRNA vaccines but to date there are no real-world data on the effectiveness or duration of protection of this vaccine.MethodsWe used a test-negative case-control study design to estimate the incremental vaccine effectiveness of the Sanofi/GSK and Pfizer bivalent BA.4-5 boosters against hospitalisation amongst those aged 75 years and older in England. The study period for tests contributing to all analyses was from 3rd April 2022 to 27th August 2023. Vaccine effectiveness was estimated relative to those who had received at least two doses prior to their spring booster, with their last dose being an autumn 2022 booster given at least 3 months prior.FindingsOverall, there were 14,174 eligible tests from hospitalised individuals aged 75 years and older, with 3,005 being cases and 11,169 being controls. Effectiveness against hospitalisation was highest in the period 9 to 13 days post vaccination for both manufacturers at about 50%; 43.6% (95% C.I.; 20.1 to 60.2%) and 56.4% (95% C.I; 25.8 to 74.4%) for Sanofi/GSK and Pfizer BA.4-5, respectively. There was some evidence of waning with a reduction to about 30% for both manufacturers 5-9 weeks post vaccination.InterpretationTogether, these results provide reassuring evidence that both the adjuvanted Sanofi/GSK and Pfizer BA.4-5 booster vaccines provided a good boost to protection against hospitalisation amongst adults aged 75 years and older. The finding that the adjuvanted vaccine targeting the now distant Beta strain had similar effectiveness to the mRNA vaccine targeting more closely matched Omicron sub-lineages BA.4-5 during a period of Omicron circulation may reflect improved protection due to the adjuvant in the Sanofi/GSK product.FundingNo external funding.

show abstract

Section: Discussionsupporting

confidence: 52%

Effectiveness of the adjuvanted Sanofi/GSK (VidPrevtyn Beta) and Pfizer-BioNTech (Comirnaty Original/Omicron BA.4-5) bivalent vaccines against hospitalisation amongst adults aged 75 years and older in England, estimated using a test-negative case control study design

Kirsebom,

Andrews,

Stowe

et al. 2023

Preprint

View full text Add to dashboard Cite

show abstract

“…Also, we did not observe differences between the groups on HRQoL, differently from what observed for monovalent BNT162b2. Protection from COVID-19 bivalent vaccination has been observed to vary by Omicron sub-lineage, prior infection status, time since vaccination, time since prior infection, severity of infection and presence of risk factors [28,29]. Bivalent vaccination was targeted against BA.4/BA.5 Omicron sub-lineages and, while real-world evidence studies suggested cross-protection against successive sub-lineages, XBB was reported to be highly immune-evasive, triggering the need for a new, more closely matched, XBB vaccine formulation for 2023 / 2024 campaigns [30].…”

Section: Discussionmentioning

confidence: 99%

Impact of bivalent BA.4/5 BNT162b2 COVID-19 vaccine on acute symptoms, quality of life, work productivity and activity levels among symptomatic US adults testing positive for SARS-CoV-2 at a national retail pharmacy

Fusco,

Sun,

Anatale-Tardiff

et al. 2023

Preprint

View full text Add to dashboard Cite

Background: Evidence on the impact of COVID-19 vaccination on symptoms, Health-Related Quality of Life (HRQoL), Work Productivity and Activity Impairment (WPAI) is scarce. We analyzed associations between bivalent BA.4/5 BNT162b2 and these patient-reported outcomes (PROs). Methods: Symptomatic US adults who tested positive for SARS-CoV-2 were recruited between 03/02-05/18/2023. PROs were assessed using a CDC-based symptom questionnaire, EQ-5D-5L, WPAI-GH, and PROMIS Fatigue, from pre-COVID to Week 4 following infection. Multivariable analysis using mixed models for repeated measures was conducted, adjusting for several covariates. Results: The study included 641 participants: 314 vaccinated with bivalent BA.4/5 BNT162b2 and 327 unvaccinated/not up-to-date. Mean (SD) age was 46.5 years (15.9), 71.2% were female, 44.2% reported prior infection, 25.7% had ≥1 comorbidity. The BA.4/5 BNT162b2 cohort reported fewer acute symptoms through Week 4, especially systemic and respiratory symptoms. All PROs were adversely affected, especially at Week 1; however, at that time point, the bivalent BA.4/5 BNT162b2 cohort reported better work performance, driven by less absenteeism, and fewer work hours lost. No significant differences were observed for HRQoL. Conclusions: COVID-19 negatively impacted patient outcomes. Compared with unvaccinated/not up-to-date participants, those vaccinated with bivalent BA.4/5 BNT162b2 reported fewer and less persistent symptoms and improved work performance. Clinicaltrials.govNCT05160636Keywords: SARS-CoV-2; BA.4/5 BNT162b2; Bivalent; COVID-19; COVID-19 symptoms; HRQoL; Humanistic; Quality of life; WPAI; PROMIS Fatigue.

show abstract

“…However, protection against symptomatic infection is limited, and waning of immunity is a reality with the currently available vaccines. Among adults who are otherwise healthy (“immunocompetent”), recent estimates of vaccine effectiveness of a bivalent vaccine against hospitalization for COVID-19 were 62% compared with no vaccination in the 2 months after the bivalent dose but decreasing to 24% 4 to 6 months after the bivalent dose . The CDC considers an individual who has completed a primary series and received a single booster as “up to date” in their COVID-19 vaccination.…”

Section: What Is the Current Role Of Vaccination?mentioning

confidence: 99%

COVID-19 in the Fall of 2023—Forgotten but Not Gone

del Rio,

Malani

2023

JAMA

View full text Add to dashboard Cite

show abstract

Estimates of Bivalent mRNA Vaccine Durability in Preventing COVID-19–Associated Hospitalization and Critical Illness Among Adults with and Without Immunocompromising Conditions — VISION Network, September 2022–April 2023

Cited by 61 publications

References 4 publications

Effectiveness of the adjuvanted Sanofi/GSK (VidPrevtyn Beta) and Pfizer-BioNTech (Comirnaty Original/Omicron BA.4-5) bivalent vaccines against hospitalisation amongst adults aged 75 years and older in England, estimated using a test-negative case control study design

Effectiveness of the adjuvanted Sanofi/GSK (VidPrevtyn Beta) and Pfizer-BioNTech (Comirnaty Original/Omicron BA.4-5) bivalent vaccines against hospitalisation amongst adults aged 75 years and older in England, estimated using a test-negative case control study design

Impact of bivalent BA.4/5 BNT162b2 COVID-19 vaccine on acute symptoms, quality of life, work productivity and activity levels among symptomatic US adults testing positive for SARS-CoV-2 at a national retail pharmacy

COVID-19 in the Fall of 2023—Forgotten but Not Gone

Contact Info

Product

Resources

About