Breakthrough SARS-CoV-2 infections after COVID-19 mRNA vaccination in MS patients on disease modifying therapies during the Delta and the Omicron waves in Italy

  1. Maria Pia Sormani
  2. Irene Schiavetti
  3. Matilde Inglese
  4. Luca Carmisciano
  5. Alice Laroni
  6. Caterina Lapucci
  7. Valeria Visconti
  8. Carlo Serrati
  9. Ilaria Gandoglia
  10. Tiziana Tassinari
  11. Germana Perego
  12. Giampaolo Brichetto
  13. Paola Gazzola
  14. Antonio Mannironi
  15. Maria Laura Stromillo
  16. Cinzia Cordioli
  17. Doriana Landi
  18. Marinella Clerico
  19. Elisabetta Signoriello
  20. Eleonora Cocco
  21. Jessica Frau
  22. Maria Teresa Ferrò
  23. Alessia Di Sapio
  24. Livia Pasquali
  25. Monica Ulivelli
  26. Fabiana Marinelli
  27. Matteo Pizzorno
  28. Graziella Callari
  29. Rosa Iodice
  30. Giuseppe Liberatore
  31. Francesca Caleri
  32. Anna Maria Repice
  33. Susanna Cordera
  34. Mario Alberto Battaglia
  35. Marco Salvetti
  36. Diego Franciotta
  37. Antonio Uccelli
  38. Alessandro Maglione
  39. Alessia Di Sapio
  40. Alessio Signori
  41. Alice Laroni
  42. Aniello Iovino
  43. Anna Maria Repice
  44. Antonio Mannironi
  45. Antonio Uccelli
  46. Carlo Serrati
  47. Carolina Gabri Nicoletti
  48. Caterina Lapucci
  49. Chiara Rosa Mancinelli
  50. Cinzia Cordioli
  51. Daiana Bezzini
  52. Daniele Carmagnini
  53. Davide Brogi
  54. Diego Franciotta
  55. Doriana Landi
  56. Eduardo Nobile Orazio
  57. Eleonora Cocco
  58. Elisabetta Signoriello
  59. Enri Nako
  60. Ester Assandrir
  61. Fabiana Marinelli
  62. Federica Baldi
  63. Filippo Ansaldi
  64. Francesca Bovis
  65. Francesca Caleri
  66. Gabriele Siciliano
  67. Gaia Cola
  68. Germana Perego
  69. Giacomo Lus
  70. Giampaolo Brichetto
  71. Giancarlo Icardi
  72. Gianmarco Bellucci
  73. Giorgio Da Rin
  74. Girolama Alessandra Marfia
  75. Giulia Vazzoler
  76. Giuseppe Liberatore
  77. Giuseppe Trivelli
  78. Graziella Callari
  79. Ilaria Gandoglia
  80. Ilaria Maietta
  81. Irene Schiavetti
  82. Jessica Frau
  83. Laura Sticchi
  84. Livia Pasquali
  85. Lorena Lorefice
  86. Luca Carmisciano
  87. Lucia Ruggiero
  88. Marcello Manzino
  89. Marco Salvetti
  90. Margherita Monti Bragadin
  91. Maria Chiara Buscarinu
  92. Maria Gagliardi
  93. Maria Laura Stromillo
  94. Maria Pia Sormani
  95. Maria Teresa Ferrò
  96. Maria Teresa Rilla
  97. Marinella Clerico
  98. Mario Alberto Battaglia
  99. Marta Ponzano
  100. Marzia Fronza
  101. Massimo Del Sette
  102. Matilde Inglese
  103. Matteo Scialabba
  104. Michele Bedognetti
  105. Monica Ulivelli
  106. Nicola De Rossi
  107. Nicola De Stefano
  108. Paola Gazzola
  109. Rachele Bigi
  110. Raffaele Dubbioso
  111. Roberta Reniè
  112. Rosa Iodice
  113. Sabrina Fabbri
  114. Sarah Rasia
  115. Simona Rolla
  116. Stefan Platzgummer
  117. Susanna Cordera
  118. Tiziana Tassinari
  119. Valentina Carlini

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Abstract

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  1. Version published to 10.1016/j.ebiom.2022.104042
  2. ScreenIT

    SciScore for 10.1101/2021.12.23.21268177: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: The protocol is approved by the regional (CER Liguria: 5/2021 - DB id 11169-21/01/2021) and the centralized national ethical committee AIFA/Spallanzani (Parere n 351, 2020/21).
    Consent: Written informed consent was obtained from all participants before starting any study procedures.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Adult pwMS, with or without a previous SARS-CoV-2 infection, who were scheduled for SARS-CoV-2 vaccination, were included in the study. mRNA vaccines BNT162b2 (Pfizer Inc, and BioNTech), or mRNA-1273 (Moderna Tx, Inc) as per clinical practice and regional indications were allowed.
    BioNTech
    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:
    This study has some limitations. First, incidence data of breakthrough infections in the general population, as well as those of non-breakthrough infections in unvaccinated people, were not available for comparing these rates with those of our pwMS cohort. In solid organ transplant recipients, the diminished antibody responses to SARS-CoV-2 resulted in 41-to-82-fold (depending on the statistical approach) higher risk of breakthrough infection vs general population17. Second, we have no data on SARS-CoV-2 molecular characterization, as the Delta variant reduces vaccine effectiveness17, but high enough SARS-CoV-2 antibody titers can protect against infection and severe outcomes18. In conclusion, the results of this study suggest that the rates of breakthrough infections in pwMS on DMTs at least partially depends on the level of humoral immunity to SARS-CoV-2, which, is reduced in patients under specific DMTs and that declines over time. Larger cohorts are needed to understand the protective role of vaccination for severe Covid-19 in pwMS under different DMTs. It is likely that the protection from Covid-19 might increase after breakthrough infections, or after subsequent vaccine doses. Identifying the frequency, severity, and predisposing factors of breakthrough infections in frail patients may inform how to protect them with anticipates boosting doses of vaccines. The recommended safety precautions, such as masks and distancing, should remain a mainstay to reduce the incidence ...

    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 10.1101/2021.12.23.21268177v1 on medRxiv