Durability of Protection Post–Primary COVID-19 Vaccination in the United States

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Abstract

The durability of immune responses after COVID-19 vaccination will drive long-term vaccine effectiveness across settings and may differ by vaccine type. To determine durability of protection of COVID-19 vaccines (BNT162b2, mRNA-1273, and Ad26.COV2.S) following primary vaccination in the United States, a matched case-control study was conducted in three cohorts between 1 January and 7 September 2021 using de-identified data from a database covering 168 million lives. Odds ratios (ORs) for developing outcomes of interest (breakthrough SARS-CoV-2 infection, hospitalization, or intensive care unit admission) were determined for each vaccine (no direct comparisons). In total, 17,017,435 individuals were identified. Relative to the baseline, stable protection was observed for Ad26.COV2.S against infections (OR [95% confidence interval (CI)], 1.31 [1.18–1.47]) and hospitalizations (OR [95% CI], 1.25 [0.86–1.80]). Relative to the baseline, protection waned over time against infections for BNT162b2 (OR [95% CI], 2.20 [2.01–2.40]) and mRNA-1273 (OR [95% CI], 2.07 [1.87–2.29]) and against hospitalizations for BNT162b2 (OR [95% CI], 2.38 [1.79–3.17]). Baseline protection remained stable for intensive care unit admissions for all three vaccines. Calculated baseline VE was consistent with published literature. This study suggests that the three vaccines in three separate populations may have different durability profiles.

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  1. SciScore for 10.1101/2022.01.05.22268648: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: The collection and analysis of these data did not qualify as human subjects research under the Common Rule and were not subject to institutional review board assessment.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    No key resources detected.


    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:
    Several limitations should be considered when interpreting our results. First, direct comparisons between vaccines should be made with appropriate caution as there may remain baseline differences between the three vaccine cohorts. However, multiple sets of sensitivity analyses by age, comorbidities, and cohort entry time helped mitigate any observable differences. Second, although we reduced differences between cases and controls that could affect the probability of COVID-19-related outcomes through matching, there could be remaining unmeasured effects such as occupation-related exposure. Third, this study did not directly adjust for the strain of infection, although matching on calendar time and location likely accounted for that. However, observed vaccine waning may still be confounded by the reduction in protection against novel variants.48 Finally, this study relied primarily on open claims, which means other COVID-19-related medical encounters may have occurred within our population that we did not observe. However, individuals included in our study had observable vaccination records as well as healthcare utilization prior to vaccination, so observability should not be a significant limitation. In summary, durable protection against ICU admissions was observed for all three vaccines. However, the durability of protection against breakthrough infections and hospitalizations varied among the vaccines. We found that the level of VE at baseline against infections and hospita...

    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.