A Reanalysis of the FDA's Benefit--Risk Assessment of Moderna's mRNA-1273 COVID Vaccine Based on a Model Incorporating Benefits Derived from Prior COVID Infection
Fuente:
arXiv
Guardado en:
| Autores principales: | , , , , , |
|---|---|
| Formato: | Preprint |
| Publicado: |
2024
|
| Materias: | |
| Acceso en línea: | |
| Etiquetas: |
Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
|
| _version_ | 1866918336063864832 |
|---|---|
| author | Bourdon, Paul S. Duriseti, Ram Gromoll, H. Christian Dalton, Dyana K. Bardosh, Kevin Krug, Allison E. |
| author_facet | Bourdon, Paul S. Duriseti, Ram Gromoll, H. Christian Dalton, Dyana K. Bardosh, Kevin Krug, Allison E. |
| contents | The United States Food and Drug Administration (FDA) conducted a benefit-risk assessment for Moderna's COVID vaccine mRNA-1273 prior to its full approval, announced 1/31/2022. The FDA's assessment focused on males of ages 18-64 years because the agency's risk analysis was limited to vaccine-attributable myocarditis/pericarditis (VAM/P) given the excess risk among males. The FDA's analysis concluded that vaccine benefits clearly outweighed risks, even for 18-25-year-old males (those at highest VAM/P risk). We reanalyze the FDA's benefit-risk assessment using information available through the third week of January 2022 and focusing on 18-25-year-old males. We use the FDA's framework but extend its model by accounting for protection derived from prior COVID infection, finer age-stratification in COVID-hospitalization rates, and incidental hospitalizations (those of patients who test positive for COVID but are being treated for something else). We also use more realistic projections of Omicron-infection rates and more accurate rates of VAM/P. With hospitalizations as the principal endpoint of the analysis (those prevented by vaccination vs. those caused by VAM/P), our model finds vaccine risks outweighed benefits for 18-25-year-old males, except in scenarios projecting implausibly high Omicron-infection prevalence. Our assessment suggests that mRNA-1273 vaccination of 18-25-year-old males generated between 8% and 52% more hospitalizations from vaccine-attributable myocarditis/pericarditis alone compared to COVID hospitalizations prevented (over a five-month period of vaccine protection assumed by the FDA). The preceding assessment derives from model inputs based on data available at the time of the FDA's mRNA-1273 assessment. Moreover, these inputs as well as model outputs are validated by subsequently available data. |
| format | Preprint |
| id |
arxiv_https___arxiv_org_abs_2410_11811 |
| institution | arXiv |
| publishDate | 2024 |
| record_format | arxiv |
| spellingShingle | A Reanalysis of the FDA's Benefit--Risk Assessment of Moderna's mRNA-1273 COVID Vaccine Based on a Model Incorporating Benefits Derived from Prior COVID Infection Bourdon, Paul S. Duriseti, Ram Gromoll, H. Christian Dalton, Dyana K. Bardosh, Kevin Krug, Allison E. Quantitative Methods 92-10, 92C50 The United States Food and Drug Administration (FDA) conducted a benefit-risk assessment for Moderna's COVID vaccine mRNA-1273 prior to its full approval, announced 1/31/2022. The FDA's assessment focused on males of ages 18-64 years because the agency's risk analysis was limited to vaccine-attributable myocarditis/pericarditis (VAM/P) given the excess risk among males. The FDA's analysis concluded that vaccine benefits clearly outweighed risks, even for 18-25-year-old males (those at highest VAM/P risk). We reanalyze the FDA's benefit-risk assessment using information available through the third week of January 2022 and focusing on 18-25-year-old males. We use the FDA's framework but extend its model by accounting for protection derived from prior COVID infection, finer age-stratification in COVID-hospitalization rates, and incidental hospitalizations (those of patients who test positive for COVID but are being treated for something else). We also use more realistic projections of Omicron-infection rates and more accurate rates of VAM/P. With hospitalizations as the principal endpoint of the analysis (those prevented by vaccination vs. those caused by VAM/P), our model finds vaccine risks outweighed benefits for 18-25-year-old males, except in scenarios projecting implausibly high Omicron-infection prevalence. Our assessment suggests that mRNA-1273 vaccination of 18-25-year-old males generated between 8% and 52% more hospitalizations from vaccine-attributable myocarditis/pericarditis alone compared to COVID hospitalizations prevented (over a five-month period of vaccine protection assumed by the FDA). The preceding assessment derives from model inputs based on data available at the time of the FDA's mRNA-1273 assessment. Moreover, these inputs as well as model outputs are validated by subsequently available data. |
| title | A Reanalysis of the FDA's Benefit--Risk Assessment of Moderna's mRNA-1273 COVID Vaccine Based on a Model Incorporating Benefits Derived from Prior COVID Infection |
| topic | Quantitative Methods 92-10, 92C50 |
| url | https://arxiv.org/abs/2410.11811 |