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

Patrick R Funk; Osman N Yogurtcu; Richard A Forshee; Steve A Anderson; Peter W Marks; Hong Yang

doi:10.1016/j.vaccine.2022.03.030

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

Vaccine. 2022 Apr 26;40(19):2781-2789. doi: 10.1016/j.vaccine.2022.03.030. Epub 2022 Mar 28.

Authors

Patrick R Funk¹, Osman N Yogurtcu¹, Richard A Forshee¹, Steve A Anderson¹, Peter W Marks², Hong Yang³

Affiliations

¹ Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US FDA, Silver Spring, MD, USA.
² Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, US FDA, Silver Spring, MD, USA; Office of the Center Director, Center for Biologics Evaluation and Research, US FDA, Silver Spring, MD, USA.
³ Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US FDA, Silver Spring, MD, USA. Electronic address: Hong.Yang@fda.hhs.gov.

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 scenarios including the high-risk subgroup, males 16-17 years old. Our worst-case scenario used sex and age subgroup-specific incidences for COVID-19 cases (47-98 per million per day) and hospitalizations (1-4 per million per day) which are the US COVID-19 incidences as of July 10, 2021, vaccine efficacy of 70% against COVID-19 cases and 80% against hospitalization, and unlikely, pessimistic, non-zero vaccine-attributable myocarditis death rate. For males 16-17 years old, the model predicts prevented COVID cases, hospitalizations, ICUs, and deaths of 13577, 127, 41, and 1, respectively; while the predicted ranges for excess myocarditis/pericarditis cases, hospitalizations, and deaths attributable to the vaccine are [98-196], [98-196], and 0, respectively, for the worst-case scenario. Considering the different clinical implications of hospitalization due to COVID-19 infection versus vaccine-attributable myocarditis/pericarditis cases, we determine the benefits still outweigh the risks even for this high-risk subgroup. Our results demonstrate that the benefits of the vaccine outweigh its risks for all age and sex subgroups we analyze in this study. Uncertainties exist in this assessment as both benefits and risks of vaccination may change with the continuing evolution of the pandemic.

Keywords: Adolescent; Benefit-risk analysis; COVID-19 vaccine; CVmRNA; FDA; Myocarditis; Pericarditis.

MeSH terms

Adolescent
Adult
BNT162 Vaccine
COVID-19 Vaccines / adverse effects
COVID-19* / epidemiology
COVID-19* / prevention & control
Humans
Male
Myocarditis* / epidemiology
Myocarditis* / etiology
Pericarditis* / epidemiology
RNA, Messenger
Risk Assessment
United States / epidemiology
Young Adult

Substances

COVID-19 Vaccines
RNA, Messenger
BNT162 Vaccine