ROCCA observational study: Early results on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino using active surveillance
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SciScore for 10.1101/2021.05.03.21256509: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
NIH rigor criteria are not applicable to paper type.Table 2: Resources
Software and Algorithms Sentences Resources All analyses were carried out using Stata software, version 15 (StataCorp, 2017, Stata Statistical Software: StataCorpsuggested: (Stata, RRID:SCR_012763)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:The ROCCA study protocol presents several limitations. Being the one we are presenting an interim analysis and considering that the vaccination campaign is still ongoing, …
SciScore for 10.1101/2021.05.03.21256509: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
NIH rigor criteria are not applicable to paper type.Table 2: Resources
Software and Algorithms Sentences Resources All analyses were carried out using Stata software, version 15 (StataCorp, 2017, Stata Statistical Software: StataCorpsuggested: (Stata, RRID:SCR_012763)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:The ROCCA study protocol presents several limitations. Being the one we are presenting an interim analysis and considering that the vaccination campaign is still ongoing, the sample of the study is limited. In particular, this compromises the possibility of fully detecting rare AEFI, especially for the subgroups of the population presenting specific comorbidities (eg. diabetes, neurological diseases). Moreover, the youngest age groups are inadequately represented in our sample, as the vaccination campaign is still in the early phases which prioritize the elderly, among others. We plan on resolving said issue as the campaign progresses towards the younger population as scheduled. Finally, our follow-ups still cover a short timeframe and might not be sufficiently distanced from the administration of the vaccine to reveal any delayed AEFI. The ROCCA vaccine-vigilance study represents the first attempt at investigating AEFI of the Sputnik V vaccine, excluding its phase 1, 2 and 3 trials. As stated earlier, follow-ups to at least 3 months after the administration of the first dose and the inclusion in the vaccination campaign of other age groups will allow us to have a representative sample of the whole population of the Republic of San Marino and to describe any other atypical/rare AEFI. Further studies on the efficacy and effectiveness are clearly needed to complete the overall picture of this vaccine. The vaccination campaign in the Republic of San Marino began later than in ot...
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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