Safety Assessment of BNT162b2 Vaccine in Adolescents Aged 12-15 Years

  1. Jayendrakumar Patel
  2. Bhavesh Bhavsar
  3. Shalin Parikh
  4. Nikunj Ladani

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Abstract

Present evidence of the safety of BNT162b2 Vaccine in adolescents of 12 to 15 years relies only on 2260 subjects involved in phase 3 study. Therefore, clinical and post-clinical safety assessment of BNT162b2 Vaccine in Age Group of 12 to 15 Years is urgently needed to make an accurate judgment for mass vaccination. A rapid systemic review was conducted to determine safety profile of BNT162b2 Vaccine in Age Group of 12 to 15 Years following the PRISMA guidelines. Published literature before August 15, 2021 were searched in PubMed, Scopus, Web of Science, Embase, the Cochrane library and MedRxiv, using the defined search words. 135 records found from 6 databases, of which 4 studies (2 studies from NEJM and 2 MMWR), total subject who received at least one dose of vaccine: 64969, were included in this systemic review per the inclusion criteria. The major events reported in clinical phase and post-authorisation observational studies are pain at injection site (local), fatigue (systemic), headache (systemic), chill (systemic), diarrhoea (systemic) and joint pain (systemic). Post-authorisation observational study (n = 62,709) reported about 50% lower major systemic events, specifically, fatigue, headache, chill, diarrhoea and join pain and about 25% lower major local event, specifically, pain at injection site, than phase 3 clinical study (n = 1,131). Our study suggest that higher adherence rate (>97 percent received second dose) in clinical phase 3 and significantly lower incident of major local and systemic events in post-authorisation observational study indicating that BNT162b2 vaccine has highly favourable safety profile.

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  1. ScreenIT

    SciScore for 10.1101/2021.11.06.21266016: (What is this?)

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

    Table 1: Rigor

    Ethicsnot detected.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Published literature before August 15, 2021 were searched by J.P. in PubMed, Scopus, Web of Science, Embase and the Cochrane library, using the search words “(Pfizer-BioNTech COVID-19 Vaccine) and (BNT162b2) and (Pfizer–BioNTech) and (SARS-CoV-2 or COVID-19 or 2019–nCoV) and (Vaccine) and (12 - 15 years) and (Adverse Events or Safety) and (Efficacy)”.
    PubMed
    suggested: (PubMed, RRID:SCR_004846)
    Embase
    suggested: (EMBASE, RRID:SCR_001650)
    Cochrane library
    suggested: (Cochrane Library, RRID:SCR_013000)

    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:
    Our research has a few limitations: First, our findings are based on very limited studies because the EUA for the BNT162b2 Vaccine in the age group of 12 to 15 years has been extended on May 10, 2021. Second, this study includes only short-term safety data for the BNT162b2 vaccine. Long-term safety data for the BNT162b2 vaccine in the age group of 12 to 15 years are not available. Third, v-safe safety data are taken into account for post-authorization observational studies. v-safe is a voluntary self-enrolment programme promoted by vaccine administrators that requires children aged below 15 years to be enrolled by a parent or guardian. As a result, v-safe data has some limitation to be generalizable to the entire population of vaccinated adolescents.

    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 10.1101/2021.11.06.21266016v1 on medRxiv