Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico
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Gene Tan
Review 1: "Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico"
Reviewers: Gene Tan (J Craig Venter Institute) | 📗📗📗📗◻️
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Gene Tan
Review of "Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico"
Reviewers: Gene Tan (J Craig Venter Institute) | 📗📗📗📗◻️
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SciScore for 10.1101/2021.10.05.21264567: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: Participants provided written informed consent before enrollment, were stratified by age (18 to ≤64 or ≥65 years), and randomized using a web-based interactive response system in a 2:1 ratio to receive two 0.5-mL intramuscular injections of either NVX-CoV2373 (5 μg rS SARS-CoV-2 vaccine adjuvanted with 50 μg Matrix-M™) or placebo 21 days apart.
Field Sample Permit: Site selection, monitoring, data collection and analysis, and preparation of the manuscript were conducted in collaboration with the Biomedical Advanced Research and Development Authority, the National Institute of Allergy and Infectious Diseases/National Institutes of Health (NIAID/NIH), the Covid-19 Prevention Network, …SciScore for 10.1101/2021.10.05.21264567: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: Participants provided written informed consent before enrollment, were stratified by age (18 to ≤64 or ≥65 years), and randomized using a web-based interactive response system in a 2:1 ratio to receive two 0.5-mL intramuscular injections of either NVX-CoV2373 (5 μg rS SARS-CoV-2 vaccine adjuvanted with 50 μg Matrix-M™) or placebo 21 days apart.
Field Sample Permit: Site selection, monitoring, data collection and analysis, and preparation of the manuscript were conducted in collaboration with the Biomedical Advanced Research and Development Authority, the National Institute of Allergy and Infectious Diseases/National Institutes of Health (NIAID/NIH), the Covid-19 Prevention Network, and trial co-chairs.
IRB: The protocol, amendments, and overall oversight were provided by institutional review boards/ethics committees according to local regulations.Sex as a biological variable not detected. Randomization TRIAL DESIGN, PARTICIPANTS, PROCEDURES, AND OVERSIGHT: A phase 3, randomized, observer-blinded, placebo-controlled trial conducted in 113 clinical sites in the United States and six in Mexico evaluated efficacy and safety of NVX-CoV2373. Blinding The trial is ongoing, and investigators and Novavax clinical team remain blinded to participant-level treatment assignments. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Whole-genome sequencing (WGS) and clade/lineage assignment were performed on RT-PCR-positive samples with sufficient viral RNA load (Supplementary Appendix). WGSsuggested: NoneResults 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:Several limitations of this study are noteworthy. EUA vaccines became available concurrently with PREVENT-19’s initiation, reducing elderly participant enrollment, resulting in only four end point cases in participants ≥65 years of age and preventing a meaningful estimation of VE. However, the UK phase 3 trial enrolled enough older adults to establish a VE of 88.9%, comparable to younger adults.13 PREVENT-19 was the first to implement a blinded crossover ≈3-4 months after the first vaccination series to allow all trial participants to receive NVX-CoV2373, once VE and required safety were established and reviewed by the DSMB. To address durability of VE and long-term safety after blinded crossover, hazard models have been proposed for subsequent analyses,22 which would allow comparisons between early- and later-vaccinated groups. Lastly, as with all major Covid-19 vaccine trials, VE was assessed over a relatively short time during a rapidly evolving pandemic. Initial mRNA vaccine trials in the United States2,3 tested VE largely against viral variants not significantly different from the source vaccine antigen, demonstrating a high degree of VE against Covid-19 of any severity and against severe disease. The VE results from PREVENT-19 not only recapitulate the overall high VE observed during those trials, but additionally demonstrated high VE regardless of causal strain; 100% against non-VOC/VOI and 92.6% against VOC/VOI predominating during the case-accruing period. NVX-CoV237...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04611802 Active, not recruiting A Study to Evaluate the Efficacy, Immune Response, and Safet… 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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