Effectiveness of mRNA-1273 against SARS-CoV-2 omicron and delta variants
Open accessPreprint — published as 10.1038/s41591-022-01753-y · Paper page
Abstract
SARS-CoV-2 omicron (B.1.1.529) variant is highly transmissible with potential immune escape. We conducted a test-negative case-control study to evaluate mRNA-1273 vaccine effectiveness (VE) against infection and hospitalization with omicron or delta. The large, diverse study population included 26,683 SARS-CoV-2 test-positive cases with variant determined by spike gene status (16% delta, 84% omicron). The 2-dose VE against omicron infection at 14-90 days was 44.0% (95% CI, 35.1–51.6%) but declined quickly. The 3-dose VE was 93.7% (92.2–94.9%) and 86.0% (78.1–91.1%) against delta infection and 71.6% (69.7–73.4%) and 47.4% (40.5–53.5%) against omicron infection at 14-60 days and >60 days, respectively. The 3-dose VE was 29.4% (0.3–50.0%) against omicron infection in immunocompromised individuals. The 3-dose VE against hospitalization with delta or omicron was >99%. Our findings demonstrate high, durable 3-dose VE against delta infection but lower effectiveness against omicron infection, particularly among immunocompromised people. However, 3-dose VE was high against hospitalization with delta or omicron.
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For vaccine effectiveness against progression from oxygen use to mechanical ventilation or death, additional adjustments were made for use of antivirals, monoclonal antibody therapy, steroids, anti-inflammatory drugs, anticoagulation, and proning; these potential confounders were determined a priori based on published reports.
“To estimate VE against progression from oxygen use to mechanical ventilation or death among COVID-19 patients, additional adjustments were made for use of antivirals, monoclonal antibody therapy, steroids, anti-inflammatory drugs (tocilizumab or baricitinib), anticoagulation, and proning. These potential confounders were determined a priori based on published reports [8,9,15,17].”
From COVID-19 vaccine effectiveness against severe COVID-19 requiring oxygen therapy, invasive mechanical ventilation, and death in Japan: A multicenter case-control study (MOTIVATE study) (2024) · cites this paper as [15]
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Experimental — accuracy not yet measuredVE during Delta-dominant period was higher than during Omicron BA.1-dominant period for symptomatic infection.
“As documented in the literature [19,22,26], VE during the Delta-dominant period was higher compared to the Omicron BA.1-dominant period”
From Vaccine effectiveness and duration of protection of COVID-19 mRNA vaccines against Delta and Omicron BA.1 symptomatic and severe COVID-19 outcomes in adults aged 50 years and over in France (2023) · cites this paper as [22]
The Results report higher mRNA-1273 effectiveness against Delta infection than Omicron infection at comparable times after both two and three doses. However, the Discussion explicitly says the study did not evaluate effectiveness against symptomatic infection separately, so it does not support that qualifier. Page numbers were not supplied. (LLM, conf=0.89)
Experimental — accuracy not yet measuredUsing hospitalization as an outcome for severe disease during Omicron would underestimate vaccine effectiveness against severe disease because vaccine effectiveness is lower against infection than against severe disease and hospitalizations may be unrelated to COVID-19.
“Since VE is lower against infection than against severe diseases (i.e. a decoupling of VE against infection and VE against severe disease) [15,17,18], VE against severe disease via hospitalization outcome would be underestimated.”
Real-world vaccine effectiveness studies during Delta and Omicron circulation showed less vaccine-induced protection against Omicron than against Delta.
“Real-word VE studies published during the periods of circulation of these two variants showed differences in vaccine-induced protection against Delta and Omicron variants-related infections, with less protection against Omicron than Delta [18-22].”
The findings were consistent with those of other studies of vaccine effectiveness against omicron infection.
“Notwithstanding these limitations, findings were consistent with those of other studies of vaccine effectiveness against omicron infection (BA.1 or BA.2 subvariants were not specified).27,32-36”
From Effects of Previous Infection and Vaccination on Symptomatic Omicron Infections (2022) · cites this paper as [36]
Consistent findings were reached, indicating rapid waning of vaccine protection against symptomatic Omicron infection, consistent with findings of other studies for effectiveness against Omicron infection (with no BA.1/BA.2 subvariant specified).
“Notwithstanding these limitations, consistent findings were reached, indicating rapid waning of vaccine protection against symptomatic Omicron infection that are consistent with findings of other studies for effectiveness against Omicron infection (with no BA.1/BA.2 subvariant specified)42–48.”
From Duration of mRNA vaccine protection against SARS-CoV-2 Omicron BA.1 and BA.2 subvariants in Qatar (2022) · cites this paper as [47]
Administration of three doses of mRNA-1273 provided high and durable protection against Delta infection (95.2%) but lower protection against Omicron (62.5%).
“administration of three doses of mRNA-1273 provided a high and durable protection against Delta infection (95.2%) but lower protection against Omicron (62.5%).”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [421]
None of the vaccinated individuals with three doses of mRNA-1273 were hospitalized.
“However, none of the vaccinated individuals with three doses of mRNA-1273 were hospitalized, which indicates a promising alternative.421”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [421]
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References 18 · Cited by 541
- Authors
- Tseng, H. F., Ackerson, B. K., Luo, Y., Sy, L. S., Talarico, C. A., Tian, Y., Bruxvoort, K. J., Tubert, J. E., Florea, A., Ku, J. H., Lee, G. S., Choi, S. K., Takhar, H. S., Aragones, M., & Qian, L.
- Affiliations
- Kaiser Permanente (US)
- Moderna Therapeutics (United States) (US)
- University of Alabama at Birmingham (US)
- Corresponding author
- Tseng, Hung Fu
- ORCID
- Venue
- Nature Medicine
- Publisher
- openRxiv
- Published
- 2022-01-08
- Volume
- 28
- Issue
- 5
- Pages
- 1063-1071
- ISSN
- 1078-8956 (ISSN-L)
- PMC
- PMC9117141
- OpenAlex
- W4226090490
- Cited by
- 541
- References
- 18
- Citations by year
- 2026: 11 · 2025: 41 · 2024: 73 · 2023: 167 · 2022: 247 · 2021: 1 · 2013: 1
- FWCI
- 64.43
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by
- Locations
- Nature Medicine (publishedVersion, cc-by)
- medRxiv (acceptedVersion)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- Pancreatic Cancer Action Network
- Pfizer
- GlaxoSmithKline
- Gilead Sciences
- Kaiser Permanente
- Moderna
- Seqirus
- Genentech
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Physical Sciences › Mathematics › Modeling and Simulation › COVID-19 epidemiological studies
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Keywords
- mRNA-1273 vaccine, Omicron variant, Delta variant, vaccine effectiveness, breakthrough infection, hospitalization, immunocompromised patients, immune evasion, S-gene target failure, test-negative case-control
- MeSH terms
- COVID-19, SARS-CoV-2, COVID-19 Vaccines, 2019-nCoV Vaccine mRNA-1273, Hepatitis D, Humans, Case-Control Studies
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