Omitted and misrepresented data as well as errors invalidate the FDA's benefit-risk assessment of Pfizer's Comirnaty COVID-19 vaccine relative to 16–17-year-old males

In March of 2022, the United States Food and Drug Administration (FDA) published in Elsevier’s Vaccine a benefit-risk assessment of Pfizer’s COVID-19 vaccine Comirnaty (CVmRNA), concluding “[T]he benefits of the CVmRNA vaccine clearly outweigh the risks even among the male adolescent population that is at higher risk of myocarditis/pericarditis.” However, the FDA’s analysis indicated that in 3 of 7 scenarios, the risk of hospitalization among 16–17-year-old males for vaccine attributable myocarditis/pericarditis (VAM/P) exceeded the hospitalizations-prevented benefit of vaccination. The FDA addressed this evidence that vaccination risks may exceed its benefits by making the claim that for 16–17–year-old males, “Hospitalizations associated with COVID-19 have more severe clinical outcomes than hospitalization due to myocarditis/pericarditis.” To support this hospitalizations-severity comparison, the FDA omitted contradictory data for VAM/P-ICU admissions, one of its four declared risk endpoints. Furthermore, the FDA misrepresented data from references used to support the comparison, e.g., suggesting a median COVID-hospitalization length of stay (LOS) for 16–17-year-old males of 3–6 days, while the only age-relevant data in the two cited references suggests a median LOS of 2.5 days. Finally, errors in the FDA’s analysis suggest that even in its most likely scenario (Scenario 2) vaccination benefits do not clearly outweigh VAM/P risks for 16–17-year-old males. In our paper, we describe in detail the data the FDA omitted and misrepresented as well as the agency's errors in analysis.