Last Friday, Dr. Joseph Ladapo, the surgeon general of Florida and professor of medicine at the University of Florida, announced new guidance from the Florida Department of Health that recommends against vaccination with COVID-19 mRNA vaccines for men between 18 and 39 years old. As infectious disease epidemiologists, we are concerned that the guidance relies on, and appears to gain legitimacy from, an analysis that does not support it.
The Department of Health’s new guidance claims to be based on an analysis that examines the timing of non-COVID-19 deaths relative to vaccination. The aim was to see if deaths were more likely to occur soon after vaccination relative to later in time, a trend which could indicate that the deaths were possibly triggered by vaccination. Based on this study, according to the guidance, “the benefit of vaccination is likely outweighed by (an) abnormally high risk of cardiac-related death among men in this age group.”
Weighing risks and benefits is a necessary and proper function of our public health authorities. In this case, however, Dr. Ladapo and his department have misstated the risks of vaccination while completely failing to evaluate its benefits.
First, the Department of Health’s guidance is directly contradicted by the same data on which is relies. It is true that the analysis found that, compared to other periods of time, vaccinated individuals were more likely to die of heart-related issues in the period immediately following vaccination, particularly men aged 18 to 39 years old. Crucially, however, the study found that the rate of death from all causes other than COVID-19 was no different for individuals immediately following vaccination, in any age group. In other words, the study showed no heightened risk of death due to vaccination.
Second, the guidance relies on a study where benefits of vaccination were not even measured. The Department of Health study was designed to focus exclusively on risks of vaccination, by omitting from the analysis anyone who died from COVID-19. This study cannot support the guidance because it explicitly does not consider the benefits of vaccination. Put simply, this supposed “risk-benefit” analysis considers only risks.
Spend your days with Hayes
Subscribe to our free Stephinitely newsletter
You’re all signed up!
Want more of our free, weekly newsletters in your inbox? Let’s get started.Explore all your options
Third, the Department of Health’s guidance ignored explicit, significant limitations that were listed in the study. The largest concern here is that the study’s key finding, that cardiac mortality risk is elevated immediately following mRNA vaccination in men aged 18 to 39 years old, is based on just 20 deaths. If just two or three of these deaths had some other primary cause — for example, a cardiac event that was the result of some other illness or even undiagnosed COVID-19 — the study results would be completely different. The small sample size is a particular issue here because the study neither clearly defined “cardiac-related deaths” nor presented clinical data for persons categorized as having such deaths. Overall, key details typically reported from studies such as this are missing, limiting our ability to evaluate it.
Finally, this analysis reaches a conclusion that opposes other, larger studies, that have been conducted across the world. No previous, well-conducted study has found an increase in all-cause or cardiac-related mortality following mRNA COVID-19 vaccination in any age group. Taken together with the concerns that we and the study authors have outlined, this divergence should at least give us (and certainly the FDoH) pause.
Floridians deserve to have the best information available to make the choices that are right for themselves and their families. We feel compelled to speak out because we fear that this guidance and the surrounding press will unduly serve to undermine public trust in mRNA vaccines, without which hundreds of thousands of people now living would have died of COVID-19. This is not the first proclamation from the surgeon general that uses insufficient or no evidence to undermine COVID-19 vaccines. We hope it will be the last.
• Matt Hitchings is an infectious disease epidemiologist and professor of biostatistics at the University of Florida.
• Derek Cummings is an infectious disease epidemiologist and professor of biology at the University of Florida.
• Ira Longini is a professor of biostatistics at the University of Florida and he carries out research on the transmission and control of infectious disease threats such as COVID-19, ebola, dengue, influenza and cholera.
• Dr. Glenn Morris is a professor of medicine and specialist in infectious diseases at the University of Florida.