Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months
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SciScore for 10.1101/2021.07.28.21261159: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Institutional Review Board or Ethics Committee approval was obtained for each site prior to enrollment of any study participant.
Consent: Safety analyses are presented for ≥16-year-olds without known HIV infection who provided informed consent and received ≥1 BNT162b2 or placebo dose.Sex as a biological variable not detected. Randomization Objectives, Participants, Oversight: This randomized, placebo-controlled, observer-blind phase 1/2/3 study assessed BNT162b2 safety, tolerability, efficacy, and immunogenicity in adolescents and adults (NCT04368728). Blinding Safety data are presented for blinded follow-up and open-label periods. Power Analysis not detected. Table 2: Resources
No key …
SciScore for 10.1101/2021.07.28.21261159: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Institutional Review Board or Ethics Committee approval was obtained for each site prior to enrollment of any study participant.
Consent: Safety analyses are presented for ≥16-year-olds without known HIV infection who provided informed consent and received ≥1 BNT162b2 or placebo dose.Sex as a biological variable not detected. Randomization Objectives, Participants, Oversight: This randomized, placebo-controlled, observer-blind phase 1/2/3 study assessed BNT162b2 safety, tolerability, efficacy, and immunogenicity in adolescents and adults (NCT04368728). Blinding Safety data are presented for blinded follow-up and open-label periods. Power Analysis not 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: We detected the following sentences addressing limitations in the study:This report has several limitations. Duration of protection and safety data that could be collected in a blinded, placebo-controlled manner were limited by the ethical and practical need to immunize eligible initial placebo recipients under EUA and according to public health authority recommendations. Data presented here do not address whether vaccination prevents asymptomatic infection, but evaluation of that question is ongoing in this study, and real-world data suggest that BNT162b2 prevents asymptomatic infection.32,33 Preliminary analyses of breakthrough cases have not yet identified a correlate of protection, as vaccine protection rates remain high. This report does not address VE and safety in pregnant women and in children younger than 12 years. Studies evaluating BNT162b2 in these populations are ongoing. The data in this report demonstrate that BNT162b2 prevents COVID-19 effectively for up to 6 months post-dose 2 across diverse populations, despite the emergence of SARS-CoV-2 variants, including the B.1.351 lineage, and the vaccine continues to show a favorable safety profile.
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04368728 Recruiting Study to Describe the Safety, Tolerability, Immunogenicity, … 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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