Florida health officials removed key data from COVID vaccine report

Florida Surgeon General Joseph Ladapo announced in October that young men should not get the COVID-19 vaccine, guidance that runs counter to medical advice issued by the Centers for Disease Control and Prevention.

His recommendation was based on a state analysis that showed the risk of cardiac-related deaths increased significantly for some age groups after receiving a vaccine. It has been criticized by experts, including professors and epidemiologists at the University of Florida, where Ladapo is employed as a professor.

Now, draft versions of the analysis obtained by the Tampa Bay Times show that this recommendation was made despite the state having contradictory data. It showed that catching COVID-19 could increase the chances of a cardiac-related death much more than getting the vaccine.

That data was included in an earlier version of the state’s analysis but was missing from the final version compiled and posted online by the Florida Department of Health. Ladapo did not reference the contradictory data in a release posted by the state.

The Times’ records request asked for all previous versions of the state analysis made public on Oct. 7. The documents show that, before the final version was released, at least five drafts had been produced. One version included a data table showing the number of cardiac-related deaths from infection. The conclusion in four of the drafts provided a counterpoint to Ladapo’s assertion about the vaccine.

Four epidemiologists who reviewed the drafts said the omission is inexplicable and flawed from a scientific standpoint. They said that, based on the missing data, Ladapo’s recommendation should be rescinded.

Matt Hitchings, an infectious disease epidemiologist and professor of biostatistics at the University of Florida, said it seems that sections of the analysis were omitted because they did not fit the narrative the surgeon general wanted to push.

“This is a grave violation of research integrity,” Hitchings said. “(The vaccine) has done a lot to advance the health of people of Florida and he’s encouraging people to mistrust it.”

The surgeon general and the state’s health department have frequently questioned the safety of messenger ribonucleic acid or mRNA vaccines developed to counter COVID-19. Last year, Florida became the first state to recommend against vaccines for healthy children and it was the only state to not preorder coronavirus vaccines for children under 5.

Ladapo declined to answer specific questions about why the data showing the higher risk to Floridians from infection was removed. In an emailed statement, he said that he stands by his guidance and that this is not the first time he has faced criticism for his approach to COVID-19.

“As surgeon general, my decisions continue to be led by the raw science — not fear,” he said. “Far less attention has been paid to safety of the COVID-19 vaccines and many concerns have been dismissed — these are important findings that should be communicated to Floridians.”

His statement also included a link to a Gov. Ron DeSantis news release from December announcing that the governor had petitioned the Florida Supreme Court to impanel a statewide grand jury to “investigate any and all wrongdoing in Florida with respect to COVID-19 vaccines.”

“It is irresponsible to roll over and allow the pharmaceutical companies to dictate health guidance that allows them to line their pockets when public health officials experience the severity of the impacts firsthand in their communities,” Ladapo said in his statement. The court has yet to take any action.

The published eight-page state analysis linked data from Florida’s reportable disease repository known as Merlin, the Florida State Health Online Tracking System, and death records from the state’s vital statistics bureau.

It examined cases of adult Floridians who died within a 25-week period from the start of the vaccination roll-out in December 2020 and detailed deaths occurring within 28 days of receiving a vaccination.

It reported that there was only a “modest” increased risk from the vaccine except for males ages 18 to 39, where it found an 84% higher incidence of cardiac-related deaths.

Ladapo cited that number in the state’s nonbinding recommendation, saying the “abnormally high” risk of cardiac complications from a COVID-19 shot “likely” outweighs the benefits of vaccination.

That finding was based on 20 deaths, too small a sample size for such a far-reaching conclusion, according to a column by four University of Florida epidemiologists that highlighted concerns and flaws with the analysis. The scientists also noted that Ladapo’s finding was not backed up with clinical data proving that the cause of deaths fits the criteria.

Further, the data on the risk of infection omitted from the published report shows that catching COVID presents a far greater risk for that same age group.

For Floridians ages 18 to 24, the incidence of cardiac-related deaths from infection was more than 10 times higher than from the vaccine and more than five times higher for ages 25 to 39. That data was not broken down by sex.

The state epidemiologists who worked on the report also arrived at a different conclusion than Ladapo, the drafts suggest.

“The risk associated with COVID-19 infection clearly outweighs any potential risks associated with mRNA vaccination,” one version states.

“The small risk associated with mRNA vaccination should be balanced against the much larger risk associated with COVID-19 infection,” another version says. A similar sentence appeared in the published conclusion but the “much larger” modifier had been removed.

The state’s analysis was also criticized for not including a sensitivity analysis, a method of proving that the results remain consistent even when changing some of the assumptions used in the calculations.

A sensitivity analysis was present in three versions of the draft and suggests that the increased risk for young men from the vaccine is not significant, said Jonathan Laxton, a physician and assistant professor of medicine at the University of Manitoba.

“It’s a double check that didn’t confirm that finding,” Laxton said.

Faculty at the University of Florida’s College of Medicine, including Hitchings, circulated a report in January that was critical of the published analysis. It characterized the research and the subsequent recommendation as being of “highly questionable merit” but concluded it did not rise to research misconduct.

David Norton, UF vice president for research, said in a statement that because Ladapo oversaw this research in his role with the state and not in his role as a faculty member, UF’s Office of Research Integrity, Security and Compliance “has no standing to consider the allegations or concerns regarding research integrity” mentioned in the report.

After reviewing the draft reports, Hitchings said the final analysis is akin to academic dishonesty.

“You can call it a lie by omission,” he said.

The downplaying of the elevated risk of cardiac-related deaths from infection remains the biggest concern for Katrine Wallace, an epidemiologist at the University of Illinois, Chicago. The state has denied Floridians the information they need to make an informed decision on the vaccine, she said.

“As a scientist, and as a parent, it would be important for me to know the cardiac risk from COVID versus that of the vaccine,” she said. “That context is huge — and it’s gone.”