1. Benefit–risk assessment for the Novavax COVID-19 vaccine (NVX-CoV2373).
- Author
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Fix, Jonathan, Christopher Mast, T., Smith, Katherine, and Baker, Nicole
- Subjects
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COVID-19 vaccines , *COVID-19 , *VACCINE effectiveness , *COVID-19 pandemic , *MYOCARDITIS - Abstract
• Rare cases of myocarditis/pericarditis after vaccination with COVID-19 vaccine NVX-CoV2373 have been documented. • This analysis provides a benefit-risk assessment for vaccination with NVX-CoV2373 based on data from clinical studies and recent real-world burden of disease data. • Results indicate that the benefits of vaccination with NVX-Cov2373 outweigh the risks of myocarditis/pericarditis. A benefit–risk assessment of NVX-CoV2373, a vaccine to prevent COVID-19, was conducted to determine if the benefits of vaccination outweigh the risks of myocarditis/pericarditis. This analysis used data on myocarditis/pericarditis cases observed in the NVX-CoV2373 clinical studies, real-world data of mRNA COVID vaccine effectiveness against predominant SARS-CoV-2 strains in early 2023, and recent COVID-19 burden of disease data from the United States. The benefits of NVX-CoV2373 vaccination were estimated as the number of COVID-19 cases, hospitalizations, and deaths prevented. The risks of myocarditis/pericarditis cases and related hospitalizations and deaths occurring within 7 days of vaccination were also estimated. In our analysis, vaccination with NVX-CoV2373, per 100,000 vaccinated, resulted in an estimated 1805 COVID-19 cases prevented compared with an estimated 5.3 excess myocarditis/pericarditis cases. The number of COVID-19 hospitalizations and deaths prevented were also greater than vaccine-associated myocarditis/pericarditis hospitalizations and deaths. Our analysis indicates a positive benefit–risk balance for NVX-CoV2373. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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