Safety and immunogenicity of the Pfizer/BioNTech SARS-CoV-2 mRNA third booster vaccine dose against the BA.1 and BA.2 Omicron variants

  1. Yohei Seki
  2. Yasuo Yoshihara
  3. Kiyoko Nojima
  4. Haruka Momose
  5. Shuetsu Fukushi
  6. Saya Moriyama
  7. Ayumi Wagatsuma
  8. Narumi Numata
  9. Kyohei Sasaki
  10. Tomoyo Kuzuoka
  11. Yoshiyuki Yato
  12. Yoshimasa Takahashi
  13. Ken Maeda
  14. Tadaki Suzuki
  15. Takuo Mizukami
  16. Isao Hamaguchi

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Abstract

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  1. Version published to 10.1016/j.medj.2022.04.013
  2. ScreenIT

    SciScore for 10.1101/2022.01.20.22269587: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: This study was approved by the MMC-NHO (#21-01, #21-04, #21-08) and NIID Institutional Review Boards (#1270, and #1339).
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Cell Line Authenticationnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Study design and sample collection: This study was part of a long-term safety and immunogenicity study (LT-SI study) aimed at evaluating anti-spike antibody titers (anti-SAb) and NTs after vaccination for comparison with the adverse event rate during three-dose vaccinations with the Pfizer/BioNTech SARS-CoV-2 mRNA vaccine (Comirnaty) in healthcare workers.
    anti-spike
    suggested: None
    anti-SAb
    suggested: None
    The study design is shown in Figure 1, and we first evaluated the anti-SAb IgG and neutralization antibody titers (NTs) at an average of 20 days after the first and 12 days after the second vaccination (1st VAX and 2nd VAX).
    anti-SAb IgG
    suggested: (Thermo Fisher Scientific Cat# PA5-100332, RRID:AB_2849846)
    According to the manufacturer’s guidelines, sample values of ≥0.8□AU/mL were classified as positive for anti-SARS-CoV-2 antibodies.
    anti-SARS-CoV-2
    suggested: None
    Experimental Models: Cell Lines
    SentencesResources
    The virus-serum mixture was placed on VeroE6/TMPRSS2 cells (JCRB1819) seeded into 96-well plates and cultured at 37 °C with 5% CO2 for 5 days.
    VeroE6/TMPRSS2
    suggested: JCRB Cat# JCRB1819, RRID:CVCL_YQ49)
    Software and Algorithms
    SentencesResources
    Fluorescence intensities were measured using a Bio-Plex MAGPIX multiplex reader (Bio-Rad) and the data were analyzed using Bio-Plex Manager Software version 6.0.
    Bio-Plex Manager
    suggested: None
    Statistics: All statistical experimental designs and data analyses were performed using JMP software version 14.2.0 (SAS Institute, Cary, NC, USA) and GraphPad Prism 9.0.2 software (GraphPad, Inc., San Diego, CA, USA)
    JMP
    suggested: (JMP, RRID:SCR_014242)
    SAS Institute
    suggested: (Statistical Analysis System, RRID:SCR_008567)
    GraphPad Prism
    suggested: (GraphPad Prism, RRID:SCR_002798)
    GraphPad
    suggested: (GraphPad Prism, RRID:SCR_002798)

    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    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.

  3. Version published to 10.1101/2022.01.20.22269587v1 on medRxiv