BNT162b2 COVID-19 VACCINATION AND ITS EFFECT ON BLOOD PRESSURE

  1. Toh Leong Tan
  2. Sharifah Azura Salleh
  3. Zuraidah Che Man
  4. Michelle Hwee Peng Tan
  5. Rashid Kader
  6. Razman Jarmin

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Abstract

This study aims to explore the trends of systolic blood pressure (SBP), diastolic BP (DBP), mean arterial pressure (MAP) and pulse pressure (PP) before and 15-minutes after two doses of the BNT162b2 vaccine, which were administered 21 days apart. This vaccine safety active surveillance study was carried out on 15th-16th March (first dose) and 5th-6th April 2021 (second dose), in academic hospital.. Vaccinees above 18 years old, SBP, DBP, MAP and PP pre- and 15 minutes post-vaccination for both doses were analysed. Study outcomes were mean of BP, mean of BP changes, and BP trends measurements. A total of 287 vaccinees were included. A quarter (n=72) had decreased DBP ≥ 10mmHg (mean DBP deceased: 15mmHg, 95%CI: 14-17mmHg) after the first dose, and 12.5% post-second dose (mean DBP decreased: 13mmHg, 95%CI: 12-15mmHg). Post-first dose, 28.6% (n= 82) were found to have widened PP > 40mmHg. After the first dose, those who had elevated and decreased SBP ≥ 20mmHg were 5.2% and 4.9%, respectively. Eleven percent (n = 32) had decreased SBP ≥ 20mmHg post-second dose, nevertheless the psychology effect cannot be ruled out. The BNT162b2 vaccine was generally well tolerated. BP changes after vaccination emphasizes the need for monitoring.

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  1. ScreenIT

    SciScore for 10.1101/2021.06.16.21258803: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: Due to the retrospective nature of this study, it waived the need of informed consent.
    IRB: The study was approved by UKM Human Ethical Review Board (JEP-2021-302).
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power AnalysisThe sample size was calculated based on the interim data from our COVID-19 VSAS database.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Data Analysis: Data analysis was carried out using IBM SPSS for WINDOWS (version 25.0).
    SPSS
    suggested: (SPSS, RRID:SCR_002865)

    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:
    The limitation of this surveillance was that there were many original HCWs who rescheduled their second dose of vaccination due to unavoidable logistic reasons.

    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.

  2. Version published to 10.1101/2021.06.16.21258803v1 on medRxiv