Benefit-risk assessment of Covid-19 vaccine, MRNA (MRNA-1273) for males age 18–64 years

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

Vaccine: X (Aug 2023)

Benefit-risk assessment of Covid-19 vaccine, MRNA (MRNA-1273) for males age 18–64 years

Osman N. Yogurtcu,
Patrick R. Funk,
Richard A. Forshee,
Steven A. Anderson,
Peter W. Marks,
Hong Yang

Affiliations

Osman N. Yogurtcu: Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US FDA, Silver Spring, MD, USA
Patrick R. Funk: Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US FDA, Silver Spring, MD, USA
Richard A. Forshee: Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US FDA, Silver Spring, MD, USA
Steven A. Anderson: Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US FDA, Silver Spring, MD, USA
Peter W. Marks: 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
Hong Yang: Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US FDA, Silver Spring, MD, USA; Corresponding author at: Office of Biostatistics & Pharmacovigilance, FDA – Center for Biologics Evaluation and Research, 10903 New Hampshire Ave, WO71, Silver Spring, MD 20993-0002, USA.

Journal volume & issue: Vol. 14
p. 100325

Abstract

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Since the authorization of the Moderna mRNA COVID-19 vaccine, real-world evidence has indicated its effectiveness in preventing COVID-19 cases. However, increased cases of mRNA vaccine-associated myocarditis/pericarditis have been reported, predominantly in young adults and adolescents. The Food and Drug Administration conducted a benefit-risk assessment to inform the review of the Biologics License Application for use of the Moderna vaccine among individuals ages 18 and older. We modeled the benefit-risk per million individuals who receive two complete doses of the vaccine. Benefit endpoints were vaccine-preventable COVID-19 cases, hospitalizations, intensive care unit (ICU) admissions, and deaths. The risk endpoints were vaccine-related myocarditis/pericarditis cases, hospitalizations, ICU admissions, and deaths. The analysis was conducted on the age-stratified male population due to data signals and previous work showing males to be the main risk group. We constructed six scenarios to evaluate the impact of uncertainty associated with pandemic dynamics, vaccine effectiveness (VE) against novel variants, and rates of vaccine-associated myocarditis/pericarditis cases on the model results. For our most likely scenario, we assumed the US COVID-19 incidence was for the week of December 25, 2021, with a VE of 30% against cases and 72% against hospitalization with the Omicron-dominant strain. Our source for estimating vaccine-attributable myocarditis/pericarditis rates was FDA’s CBER Biologics Effectiveness and Safety (BEST) System databases. Overall, our results supported the conclusion that the benefits of the vaccine outweigh its risks. Remarkably, we predicted vaccinating one million 18–25 year-old males would prevent 82,484 cases, 4,766 hospitalizations, 1,144 ICU admissions, and 51 deaths due to COVID-19, comparing to 128 vaccine-attributable myocarditis/pericarditis cases, 110 hospitalizations, zero ICU admissions, and zero deaths. Uncertainties in the pandemic trajectory, effectiveness of vaccine against novel variants, and vaccine-attributable myocarditis/pericarditis rate are important limitations of our analysis. Also, the model does not evaluate potential long-term adverse effects due to either COVID-19 or vaccine-attributable myocarditis/pericarditis.

Published in Vaccine: X

ISSN: 2590-1362 (Online)
Publisher: Elsevier
Country of publisher: United Kingdom
LCC subjects: Medicine: Internal medicine: Specialties of internal medicine: Immunologic diseases. Allergy
Website: https://www.journals.elsevier.com/vaccine-x

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