mRNA COVID‐19 vaccine effectiveness against SARS‐CoV‐2 infection in a prospective community cohort, rural Wisconsin, November 2020 to December 2021

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Abstract

Reduced COVID‐19 vaccine effectiveness (VE) has been observed with increasing predominance of SARS‐CoV‐2 Delta (B.1.617.2) variant. Two‐dose VE against laboratory‐confirmed SARS‐CoV‐2 infection (symptomatic and asymptomatic) was estimated using Cox proportional hazards models with time‐varying vaccination status in a prospective rural community cohort of 1266 participants aged ≥12 years. Between November 3, 2020 and December 7, 2021, VE was 56% for mRNA COVID‐19 vaccines overall, 65% for Moderna, and 50% for Pfizer‐BioNTech. VE when Delta predominated (June to December 2021) was 54% for mRNA COVID‐19 vaccines overall, 59% for Moderna, and 52% for Pfizer‐BioNTech.

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  1. SciScore for 10.1101/2021.12.14.21267809: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: MCRI)’s Institutional Review Board reviewed and approved the study protocol.
    Sex as a biological variablenot detected.
    RandomizationStudy population: Participants were randomly sampled community-dwelling individuals living in the Marshfield Epidemiologic Study Area (central region), a 14 zip code region in central Wisconsin that includes Marshfield and surrounding area.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Serum samples collected at the time of enrollment were tested for SARS-CoV-2 antibodies using an enzyme-linked immunosorbent assay (ELISA) that targeted the SARS-CoV-2 receptor-binding domain, the full-length spike (S1S2) protein, and nucleocapsid protein following standard procedures at the Influenza Research Institute at University of Wisconsin-Madison [3].
    SARS-CoV-2
    suggested: None
    S1S2) protein,
    suggested: None
    Software and Algorithms
    SentencesResources
    Analyses were conducted using SAS (version 9.4; SAS institute).
    SAS institute
    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 had several limitations. Relatively few cases occurred during the follow-up period with most vaccinated cases occurring when Delta predominated. The small sample size led to wide confidence intervals and limited our ability to control for potential confounding factors in VE estimates such as preexisting conditions, occupation, and behaviors, which may be associated with vaccination status, vaccine product received, and infection risk. Finally, the study population is largely non-Hispanic White and from a single rural community in central Wisconsin so findings may not be generalizable to other rural communities or other racial and ethnic groups. Strengths of this study include active follow-up of participants for new illness that included weekly respiratory samples collection for SARS-CoV-2 testing for half of the participants during most of the follow-up period. Weekly surveillance combined with clinical SARS-CoV-2 test results available from linked health records allowed comprehensive capture of SARS-CoV-2 infections. Second, MCHS’s data exchange with the Wisconsin Immunization Registry allowed more accurate classification of vaccination status over time and product received. Third, our analysis included adolescents and rural community members, who have been underrepresented to date. Finally, prior SARS-CoV-2 infections were captured by self-report and serologic testing, reducing the potential for biased VE estimates. This study demonstrates that two doses of mRNA...

    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.
    • Thank you for including a protocol registration statement.

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


    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.