Critics Fire Back at Florida's COVID Vax Analysis

Florida's Surgeon General recommended against COVID-19 mRNA vaccines for men ages 18 to 39 late last week, based on an analysis of state data that many experts are calling flawed.

In a tweet that Politico reported was taken down on Friday but restored on Sunday, Florida Surgeon General Joseph Ladapo, MD, PhD, announced that men in this age group have an "increased risk of cardiac-related death," and linked to the guidance recommending against COVID mRNA vaccines in this group.

The guidance -- announced on Florida Department of Health letterhead with Ladapo and Gov. Ron DeSantis (R) listed at the top -- linked out to the unpublished, unauthored, non-peer-reviewed analysis.

Using a self-controlled case series, the paper looked only at individuals vaccinated against COVID-19 and reported an 84% increase in the relative incidence of cardiac-related deaths in men ages 18 to 39 within 28 days of mRNA vaccination, when compared with the same group over a 25-week follow-up period. No difference in all-cause mortality was observed between the two periods.

Experts swiftly took to #MedTwitter to criticize the paper. Most immediately pointed out the oddity of having no named authors on the paper, in addition to the fact that the paper was only published to Florida's COVID-19 website.

Kristen Panthagani, MD, PhD, of Yale University in New Haven, Connecticut, questioned the use of certain cardiac-related ICD codes, and why some diagnoses, such as ischemic heart disease, weren't included, while others were, such as cardiac arrest, which "can be the terminal event for many different diseases, not just cardiac issues."

"In short, this list is too broad to be meaningful, excludes some cardiac issues but not others, and most of the diagnoses are far more likely to be caused by other ongoing disease processes rather than vaccination," Panthagani tweeted.

Frank Han, MD, of Northwestern Medicine in Chicago, noted that the codes were included regardless of whether they were the primary cause of death, "meaning you can die of a blood clot but also have mild myocarditis."

The Florida Department of Health has the ability to review charts to corroborate the ICD codes from the death certificates used, but it didn't do that, Han said -- something that was admitted in the paper's limitation section.

Panthagani also noted that there were only 20 deaths among men ages 18 to 39 during the risk period, meaning that if "even just a few of these have another cause (which is highly likely), they lose statistical significance."

In addition, she added that the study didn't appropriately control for whether people had COVID-19, thus "susceptibility to COVID confounded their analysis, and COVID (not COVID vaccination) very well could have contributed to some of these deaths."

"Overall these results are largely unreliable, and personally I would not base any decisions on them," Panthagani concluded.

The paper itself did include a lengthy limitations section, which acknowledged the reliance on death certificate data instead of medical records and the small sample size for the 25- to 39-year-old age group, in addition to a host of other limitations.

Ladapo's original tweet also stated that, "FL will not be silent on the truth," but experts pointed out that the CDC has already acknowledged the risk of myocarditis and pericarditis in this age group.

This isn't the first time Florida has broken with federal recommendations on vaccination. In March, Ladapo announced that the state's health department would recommend against COVID vaccination in kids ages 5 to 17. Then in June, when vaccines were on the verge of authorization in kids under 5, Ladapo recommended against their use in this age group as well.

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