Safety and efficacy of the mRNA BNT162b2 vaccine against SARS-CoV-2 in five groups of immunocompromised patients and healthy controls in a prospective open-label clinical trial
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SciScore for 10.1101/2021.09.07.21263206: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: All participants provided written informed consent. Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources Serum samples were analyzed using quantitative test Elecsys® Anti-SARS-CoV-2 S (Roche Diagnostics) on the Cobas 8000 e801pro for detection of antibodies to SARS-CoV-2 spike protein receptor binding domain (RBD). SARS-CoV-2 spike protein receptor binding domain (RBD).suggested: NoneResults from OddPub: Thank you for sharing your data.
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:There are several limitations of …
SciScore for 10.1101/2021.09.07.21263206: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: All participants provided written informed consent. Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources Serum samples were analyzed using quantitative test Elecsys® Anti-SARS-CoV-2 S (Roche Diagnostics) on the Cobas 8000 e801pro for detection of antibodies to SARS-CoV-2 spike protein receptor binding domain (RBD). SARS-CoV-2 spike protein receptor binding domain (RBD).suggested: NoneResults from OddPub: Thank you for sharing your data.
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:There are several limitations of this study. The trial had an open-label and non-randomized design. However, since the vaccine is approved and recommended by the Public Health Agency of Sweden, it was considered unethical to allocate patients to a non-treatment group. Furthermore, we did not pre-screen for SARS-CoV-2 antibodies. The 4·6% rate of seropositive cases at baseline was somewhat high, given the general recommendation of self-isolation for these patients. However, due to high prevalence of SARS-CoV-2 infection in the Stockholm region at the time of the study, the result should reflect the real-life situation. Finally, we did not include other immunological responses, such as T cell responses, in the predefined primary and secondary endpoints. There is a wide spectrum of immunosuppressive disorders and we studied only some of these. This study may, however, serve as a proof-of-concept study to analyze the impact of specific immunosuppression on the seroconversion rate in some patient groups. The results presented here show that many immunocompromised patients can respond to two doses of BNT162b2a vaccine against COVID-19. However, substantial proportions of these patients respond poorly and may therefore be in need of additional doses to boost the humoral immune response. Indeed, recent reports have shown that immunocompromised SOT-patients with negative antibodies after two doses of mRNA vaccine can respond to a third dose with production of specific antibodies 14,29...
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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