Effectiveness of BBIBP-CorV, BNT162b2 and mRNA-1273 vaccines against hospitalisations among children and adolescents during the Omicron outbreak in Argentina: A retrospective cohort study

  1. Soledad González
  2. Santiago Olszevicki
  3. Alejandra Gaiano
  4. Ana Nina Varela Baino
  5. Lorena Regairaz
  6. Martín Salazar
  7. Santiago Pesci
  8. Lupe Marín
  9. Verónica V. González Martínez
  10. Teresa Varela
  11. Leticia Ceriani
  12. Enio Garcia
  13. Nicolás Kreplak
  14. Alexia Navarro
  15. Elisa Estenssoro
  16. Franco Marsico

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Abstract

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  1. Version published to 10.1016/j.lana.2022.100316
  2. ScreenIT

    SciScore for 10.1101/2022.04.18.22273978: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: mRNA-1273 (Spikevax) from Moderna and BNT162b2 (Comirnaty) from Pfizer-BioNTech were authorised for the use in adolescents (12-17 years) from 23 July and 28 May 2021 respectively by the Committee for Medicinal Products for Human Use (CHMP) from European Medicines Agency. Ethics: The Central Ethics Committee of the Ministry of Health of the Province of Buenos Aires evaluated and approved the protocol of the present study on 18 March 2022.
    Consent: Informed Consent: This study was exempted of informed consent due to its retrospective nature, and given it is a public health-related official programme.
    Sex as a biological variableDifferences in OR for hospitalisation between subgroups (3-11 years old against 12-17 years old, males against females, subjects with against subjects without comorbidities) were evaluated statistically with pairwise comparisons.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    All statistical analyses were performed with R (R Development Core Team, 3.6.1 version) software.
    R Development Core
    suggested: None

    Results from OddPub: Thank you for sharing your code.

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Limitations: The first limitation of this study lies in its observational nature. Therefore, If the vaccinated and unvaccinated groups are systematically different, VE might be affected. We addressed this problem by adjusting our risk estimation with the available confounders. However, residual confounders cannot be discarded. Second, in the 3-11-age subgroup we could only analyse VE for the BBIBP-CorV vaccine as it was the only vaccine available in Argentina. Third, we only were able to estimate VE in adolescents for the two vaccines of the mRNA vaccine platform without differentiating between them, due to the scarcity of events. Fourth, we could only assess VE of a two-dose schedule vaccination for a median time since vaccination of 114 days. Nevertheless, this limitation is akin to most studies conducted in children, given the recent start of the vaccination rollout. A longer follow-up period after vaccination will be crucial to evaluate the duration of the effectiveness against COVID-19– associated hospitalisation and death. Fifth, a certain degree of misclassification cannot be ruled out, especially concerning potential contamination by incidental COVID-19 cases. To deal with this issue, we considered only those hospitalisations occurring within 14 days from COVID-19 diagnosis. Sixth, we could not assess the effect of a booster dose on VE in adolescents, given that boosters were only recently authorised in this subgroup in February 2022. Seventh, notwithstanding the high...

    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 10.1101/2022.04.18.22273978v1 on medRxiv