Safety of COVID-19 vaccines in pregnancy: a Canadian National Vaccine Safety (CANVAS) network cohort study

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Abstract

No abstract available

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  1. SciScore for 10.1101/2022.02.22.22271358: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: Ethics: All participants provided informed consent electronically.
    IRB: Each study site has Research Ethics Board approvals for the project (UBC Children’s & Women’s, CIUSSS de l’Estrie – CHUS, Health PEI
    Sex as a biological variableAnalytic samples and study variables: For the purposes of this analysis, we included all females reporting a pregnancy on any survey, and non-pregnant females in the same age groups (15-49 years), as of 4th November 2021 (Figure 1).
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Data cleaning was done in SAS version 9.4 (SAS Institute Inc.) and analysis was completed in R software version 4.1.1
    SAS Institute
    suggested: (Statistical Analysis System, RRID:SCR_008567)

    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:
    Our study has a number of strengths and limitations. It is a multi-centre study from across Canada and thus includes broad representation of individuals, although the majority of participants who reported ethnicity were White and these data may thus not be fully generalizable to other populations. Participants were enrolled from all trimesters in pregnancy and this was included as a co-variate in the MV models. A significant advantage over other similar studies is the contemporaneous recruitment of non-pregnant vaccinated individuals, enabling a robust direct comparison in significant AEFIs between pregnant and non-pregnant individuals. In this study we have focused on events occurring within the first seven days following vaccination and thus acute and local reactions. Longer-term follow-up of this cohort is ongoing and we will be able to comment on health events that occur on a longer time frame after vaccination once those data are available. CANVAS is based on self-report from study participants, without verification from medical records. This is subjective and may be subject to recall bias, but has been shown to be reliable for short time periods, such as used in this study21,22. The study relied on individuals having an email address and actively enrolling. Such individuals may differ in health seeking behavior from the rest of the population, but at least for our comparisons between groups it would be expected that they would be similarly affected. Finally, our sample ...

    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

    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.