Benefit-risk assessment of COVID-19 vaccine, mRNA (Comirnaty) for age 16-29 years.

ABSTRACT: Since authorization of the Pfizer-BioNTech COVID-19 Vaccine, mRNA (Comirnaty), real-world evidence has indicated the vaccines are effective in preventing COVID-19 cases and related hospitalizations and deaths. However, increased cases of myocarditis/pericarditis have been reported in the United States associated with vaccination, particularly in adolescents and young adults. FDA conducted a benefit-risk assessment to determine whether the benefits of vaccination outweigh the risks among various age (16-17, 18-24, 25-29) and sex (M/F) subgroups being considered for approved use of the vaccine. We conducted a simulation study with sensitivity analysis of the benefits and risks of the vaccine across possible pandemic scenarios. The model results show benefits outweigh the risks for all scenar

SUBMITTER: Funk PR 

PROVIDER: S-EPMC8958165 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature