Key result
Moderna vaccine prevents ~4,766 COVID-19 hospitalizations per million young males, far outweighing vaccine-attributable myocarditis.
Why the study?
Reports of increased mRNA vaccine-associated myocarditis and pericarditis, predominantly in young adults and adolescents, prompted a benefit-risk assessment to inform review of the Biologics License Application for the Moderna vaccine.
Do the benefits of the mRNA-1273 COVID-19 vaccine outweigh the risks of vaccine-associated myocarditis/pericarditis in males aged 18-64 years?
Do the benefits of the mRNA-1273 COVID-19 vaccine outweigh the risks of vaccine-associated myocarditis/pericarditis in males aged 18-64 years?
The benefits of the mRNA-1273 COVID-19 vaccine in preventing COVID-19 hospitalizations and deaths significantly outweigh the risks of vaccine-attributable myocarditis/pericarditis in young males.
Supports mRNA vaccination in young males; leaves open need for updated analyses with evolving variants and long-term data.
Since 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 benefit-risk assessment to inform review of the Biologics License Application for use of the Moderna vaccine among individuals ages 18 years and older. We modeled 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, and 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.
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Yoğurtçu et al. (2022) studied COVID-19. Moderna mRNA COVID-19 Vaccine (mRNA-1273) vs. Unvaccinated was evaluated on COVID-19 outcomes prevented vs. vaccine-attributable myocarditis/pericarditis outcomes per 1 million vaccinated. Vaccinating one million 18-25 year-old males with the Moderna vaccine prevents 4,766 COVID-19 hospitalizations and 51 deaths, compared to 128 vaccine-attributable myocarditis cases and 0 deaths.
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