Safety of mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: an observational study of reports to the Vaccine Adverse Event Reporting System and v-safe
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SciScore for 10.1101/2021.10.26.21265261: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Both VAERS and v-safe conduct surveillance as a public health function and are exempt from institutional review board review. Sex as a biological variable not detected. Randomization not detected. Blinding not detected. 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:There are clear limitations in any review of preliminary mortality data. A comparison to national mortality data,20,50 suggests that certain …
SciScore for 10.1101/2021.10.26.21265261: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Both VAERS and v-safe conduct surveillance as a public health function and are exempt from institutional review board review. Sex as a biological variable not detected. Randomization not detected. Blinding not detected. 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:There are clear limitations in any review of preliminary mortality data. A comparison to national mortality data,20,50 suggests that certain causes of death such as accidents, suicides, or cancer, are less likely to be reported to VAERS. The predominance of heart disease as a cause of death reports to VAERS warrants continued monitoring and assessment, but may be driven by non-specific causes, like cardiac arrest, that might be chosen as a terminal event if no immediate explanation is available. Death certificate or autopsy reports were available only for a small proportion of deaths reported to VAERS. Finally, VAERS is designed as an early warning system to detect potential safety signals8 and VAERS data alone generally cannot establish causal relationships between vaccination and AEs. Other studies and surveillance systems, including the VSD, are needed to better understand patterns of mortality following mRNA COVID-19 vaccination.23,51 This study has several strengths, including the large population under surveillance and comprehensive capture of national data from two complementary surveillance systems. Because the U.S. government purchased all COVID-19 doses and collected administration data, we were able to calculate VAERS reporting rates using the number of mRNA vaccine doses administered.52 In contrast, past VAERS analyses for other vaccines could only use doses distributed, which are always greater than doses administered as denominators, underestimating vaccine adve...
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.
- Thank you for including a protocol registration statement.
Results from scite Reference Check: We found no unreliable references.
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