Consensus on COVID-19 Vaccination in Pediatric Oncohematological Patients, on Behalf of Infectious Working Group of Italian Association of Pediatric Hematology Oncology

  1. Simone Cesaro
  2. Paola Muggeo
  3. Daniele Zama
  4. Monica Cellini
  5. Katia Perruccio
  6. Antonella Colombini
  7. Francesca Carraro
  8. Maria Grazia Petris
  9. Valeria Petroni
  10. Maurizio Mascarin
  11. Francesco Baccelli
  12. Elena Soncini
  13. Rosamaria Mura
  14. Milena La Spina
  15. Nunzia Decembrino
  16. Roberta Burnelli
  17. Stefano Frenos
  18. Elio Castagnola
  19. Maura Faraci
  20. Cristina Meazza
  21. Federica Barzaghi
  22. Maria Rosaria D’Amico
  23. Maria Capasso
  24. Elisabetta Calore
  25. Ottavio Ziino
  26. Angelica Barone
  27. Francesca Compagno
  28. Laura Luti
  29. Federica Galaverna
  30. Raffaella De Santis
  31. Letizia Brescia
  32. Linda Meneghello
  33. Angelamaria Petrone
  34. Nagua Giurici
  35. Daniela Onofrillo
  36. Fabian Schumacher
  37. Federico Mercolini

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Abstract

Vaccines represent the best tool to prevent the severity course and fatal consequences of the pandemic by the new Coronavirus 2019 infection (SARS-CoV-2). Considering the limited data on vaccination of pediatric oncohematological patients, we developed a Consensus document to support the Italian pediatric hematological oncological (AIEOP) centers in a scientifically correct communication with families and patients and to promote vaccination. The topics of the Consensus were: SARS-CoV-2 infection and disease (COVID-19) in the pediatric subjects; COVID-19 vaccines (type, schedule); who and when to vaccinate; contraindications and risk of serious adverse events; rare adverse events; third dose and vaccination after COVID-19; and other general prevention measures. Using the Delphi methodology for Consensus, 21 statements and their corresponding rationale were elaborated and discussed with the representatives of 31 centers, followed by voting. A high grade of Consensus was obtained on topics such as the potential risk of severe COVID-19 outcome in pediatric oncohematological patients, the need for vaccination as a preventative measure, the type, schedule and booster dose of vaccine, the eligibility of the patients for vaccination, and the timing, definition, and management of contraindications and serious adverse events, and other general prevention measures. All 21 of the statements were approved. This consensus document highlights that children and adolescents affected by hematological and oncological diseases are a fragile category. Vaccination plays an important role to prevent COVID-19, to permit the regular administration of chemotherapy or other treatments, to perform control visits and hospital admissions, and to prevent treatment delays.

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  1. Version published to 10.3390/jcm11051235
  2. ScreenIT

    SciScore for 10.1101/2022.01.06.22268792: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: The strength of consent or non-consent was assessed by describing the frequencies of the individual scores for each sentence, being 5 the maximum score for consent and 1 for non-consent.
    Field Sample Permit: The choice of when to vaccinate a patient under treatment is under discussion as specific studies have not been conducted.
    Sex as a biological variableStatements: Rare adverse events: Although the safety and tolerability profile of mRNA vaccines is favorable, myocarditis and pericarditis have been reported as a rare complication, mainly in young male subjects less than 30 years of age who received the mRNA vaccines [43].
    RandomizationIn a randomized placebo-controlled study of 2260 subjects aged 12-15 years, 2 doses of BNT162b2 vaccine (Pfizer/BioNTech-Comirnaty), administered with an interval of 21 days, showed 100% efficacy against COVID-19, while the adverse events was mild to moderate, limited to the first 24-48 hours post-1st and 2nd dose (injection site pain 79-86%, fatigue 60-66%, headache 55-65%); no serious adverse events were recorded.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    No key resources detected.

    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.

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  3. Version published to 10.1101/2022.01.06.22268792v1 on medRxiv