Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates
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SciScore for 10.1101/2020.08.17.20176651: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IACUC: An internal review committee and an external data monitoring committee reviewed all safety data. Randomization Trial Procedures: Using an interactive web-based response technology system, study participants were randomly assigned to vaccine groups defined by vaccine candidate, dose level, and age range. Blinding not detected. Power Analysis not detected. Sex as a biological variable 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 …SciScore for 10.1101/2020.08.17.20176651: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IACUC: An internal review committee and an external data monitoring committee reviewed all safety data. Randomization Trial Procedures: Using an interactive web-based response technology system, study participants were randomly assigned to vaccine groups defined by vaccine candidate, dose level, and age range. Blinding not detected. Power Analysis not detected. Sex as a biological variable 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 study and interim report have several limitations. First, at the time of publication, data on immune responses or safety beyond 7 days after Dose 2 were not available. Second, we do not yet know the relative importance of humoral and cellular immunity in protection from COVID-19. Although strong cell-mediated immune responses (TH1-biased CD4+ and CD8+) elicited by BNT162b1 have been observed and reported from the German trial,2 cellular immune responses elicited by BNT162b2 are still being studied and will be reported separately. We anticipate that the full-length spike encoded by BNT162b2 will present a greater diversity of T-cell epitopes than does the much smaller RBD encoded by BNT162b1. This may lead to stronger and more consistent cellular responses to BNT162b2. Third, although the serum neutralizing responses elicited by the vaccine candidates relative to those elicited by natural infection are highly encouraging, the degree of protection against COVID-19 provided by this or any other benchmark is unknown. Finally, participants in this early-stage clinical study were healthy and in groups too small to reflect the diversity of those in need of a COVID-19 vaccine. Many of the limitations to this study are now being addressed in the global Phase 2/3 portion of this study, while we expand our RNA vaccine manufacturing and distribution capacity. In this pivotal study, we are assessing the safety and efficacy of 2 doses of 30 μg BNT162b2 in up to 30,000 participants (ra...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04368728 Active, not 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.
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