Expected Rates of Select Adverse Events After Immunization for Coronavirus Disease 2019 Vaccine Safety Monitoring

  1. Winston E Abara
  2. Julianne Gee
  3. Mark Delorey
  4. Ye Tun
  5. Yi Mu
  6. David K Shay
  7. Tom Shimabukuro

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Abstract

Using meta-analytic methods, we calculated expected rates of 20 potential adverse events of special interest (AESI) that would occur after coronavirus disease 2019 (COVID-19) vaccination within 1-, 7-, and 42-day intervals without causal associations. Based on these expected rates, if 10 000 000 persons are vaccinated, (1) 0.5, 3.7, and 22.5 Guillain-Barre syndrome cases, (2) 0.3, 2.4, and 14.3 myopericarditis cases, (3) and 236.5, 1655.5, and 9932.8 all-cause deaths would occur coincidentally within 1, 7, and 42 days postvaccination, respectively. Expected rates of potential AESI can contextualize events associated temporally with immunization, aid in safety signal detection, guide COVID-19 vaccine health communications, and inform COVID-19 vaccine benefit-risk assessments.

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  1. Version published to 10.1093/infdis/jiab628
  2. ScreenIT

    SciScore for 10.1101/2021.08.31.21262919: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: This analysis was exempt from CDC Institutional Review Board review.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    The mortality rate attributed to sudden cardiac death was obtained from the American Heart Association’s Heart Diseases and Stroke Statistics 2020 update report (15).
    American Heart Association’s
    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:
    There are limitations to this analysis. We only calculated expected rates for a limited set of medical conditions considered as potential AESI based on the list developed by Gubernot and colleagues (13). This list does not represent the full spectrum of potential vaccine safety outcomes of concern. The generalizability of the expected rates of some potential AESI in this paper to certain subpopulations (e.g., by age, sex, and race/ethnicity) is limited because of lack of data and because rates of potential AESI can vary substantially, especially by age. We calculated expected rates of potential AESI based on background rates obtained from incidence studies, thus, there may be residual or confounding biases in the studies that we could not adequately control. The expected rates of AESI presented here are based on U.S. studies and may not be applicable to non-U.S. populations. At the time of this analysis, there were no published papers available that report the incidence estimates of TTS and myocarditis, AESI that have been associated with COVID-19 vaccination. We were therefore unable to calculate their background and expected rates. In conclusion, knowledge of expected rates of potential AESI in vaccinated persons in the general population is vital to COVID-19 vaccine safety monitoring, distinguishing vaccine-related events from coincident events that are temporally associated with but unrelated to vaccination, informing public health COVID-19 vaccine safety communication, p...

    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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  3. Version published to 10.1101/2021.08.31.21262919v1 on medRxiv