Effectiveness of mRNA-1273 against SARS-CoV-2 Omicron and Delta variants

  1. Hung Fu Tseng
  2. Bradley K. Ackerson
  3. Yi Luo
  4. Lina S. Sy
  5. Carla A. Talarico
  6. Yun Tian
  7. Katia J. Bruxvoort
  8. Julia E. Tubert
  9. Ana Florea
  10. Jennifer H. Ku
  11. Gina S. Lee
  12. Soon Kyu Choi
  13. Harpreet S. Takhar
  14. Michael Aragones
  15. Lei Qian

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Abstract

Severe acute respiratory syndrome coronavirus 2 (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 variants determined by S gene target failure status (16% Delta and 84% Omicron). The two-dose VE against Omicron infection at 14–90 days was 44.0% (95% confidence interval, 35.1–51.6%) but declined quickly. The three-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 three-dose VE was 29.4% (0.3–50.0%) against Omicron infection in immunocompromised individuals. The three-dose VE against hospitalization with Delta or Omicron was >99% across the entire study population. Our findings demonstrate high, durable three-dose VE against Delta infection but lower effectiveness against Omicron infection, particularly among immunocompromised people. However, three-dose VE of mRNA-1273 was high against hospitalization with Delta and Omicron variants.

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  1. Version published to 10.1038/s41591-022-01753-y
  2. Version published to 10.1101/2022.01.07.22268919v3 on medRxiv
  3. Version published to 10.1101/2022.01.07.22268919v2 on medRxiv
  4. ScreenIT

    SciScore for 10.1101/2022.01.07.22268919: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsIRB: The study was approved by KPSC Institutional Review Board.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Experimental Models: Organisms/Strains
    SentencesResources
    Randomly sampled test negative controls were 5:1 matched to cases by age (18-44 years, 45-64 years, 65-74 years, and ≥75 years), sex, race/ethnicity (non-Hispanic White, non-Hispanic Black, Hispanic, non-Hispanic Asian, and other/unknown), and specimen collection date.
    non-Hispanic White
    suggested: None

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    This study provides novel data complementing recent reports of the effectiveness of other COVID-19 vaccines against omicron and has several strengths and limitations. Testing for SARS-CoV-2 infection was readily available among KPSC members, including drive-through testing and self-scheduled test appointments. Furthermore, we used a highly specific and sensitive RT-PCR test and monitored variant proportions at KPSC, allowing us to quickly assess VE of mRNA-1273 against omicron. Second, we considered all SGTF specimens as omicron, rather than specifying a Ct value threshold, although this may have overestimated omicron detection. Our rate of SGTF closely mirrored regional trends in omicron emergence from the CDC.11 Furthermore, based on whole genome sequencing results received for a subset of 227 positive specimens, we confirmed that all 6 omicron cases exhibited SGTF, and the remaining 221 delta cases were all negative for SGTF. Third, this study was representative of a large, diverse racial, ethnic, and socioeconomic population in Southern California, but may be less representative of other populations. However, analysis of the effectiveness of mRNA-1273 against delta and omicron in parallel provided an internal comparator that put results in context.12 Fourth, some immunocompetent members who received a third dose before the 10/21/2021 ACIP recommendation may have received a 100-µg dose rather than a 50-µg booster dose of mRNA-1273. However, we were not able to clearly asse...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

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  5. Version published to 10.1101/2022.01.07.22268919v1 on medRxiv