Florida health officials have removed key information from the Covid vaccine report

Florida Surgeon General Joseph Ladapo announced in October that youth should not receive the COVID-19 vaccine, guidelines that run counter to medical advice issued by the Centers for Disease Control and Prevention.

His recommendation was based on a state analysis that showed a significantly increased risk of cardiac-related death 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 a professor.

Now, draft versions of the analysis obtained by the Tampa Bay Times show that the recommendation was made even though the state is conflicted The data showed this That getting Covid-19 may increase the chance of dying from heart disease much more than getting the vaccine.

This information 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. A release posted by the Ladapo state did not mention the conflicting information.

A Times records request for all previous versions of the state analysis was made on Oct. 7. One version included a data table showing the number of cardiac-related deaths from infections. The four draft conclusions provided a counterpoint to Ladapo’s claims about vaccines.

Four epidemiologists who reviewed the drafts said the omission was inexplicable and flawed From a scientific point of view. They said, based on this In missing data, the recommendation for LADAPO should be discarded.

Matt Hitchings, an infectious disease epidemiologist and professor of biostatistics at the University of Florida, said it appears parts of the analysis were excluded because they did not fit the surgeon general’s description. wanted to push

“This is a serious breach of research integrity,” Hitching said. “(The vaccine) has done a lot to improve the health of people in Florida, and he’s encouraging people to disbelieve it.”

Surgeon General Dr And state health departments have often questioned the safety of messenger ribonucleic acid, or mRNA, vaccines that have been developed to combat COVID-19. Last year, Florida became the first state to recommend against the vaccine for healthy children and was the only state not to pre-order the coronavirus vaccine for children under 5.

Ladapo declined to answer specific questions about why the data showing Floridians’ elevated risk of infection was removed. In an emailed statement, he said 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 are guided by raw science — not fear,” he said. “The safety of COVID-19 vaccines has received little attention and many concerns have been dismissed — these are important findings that should be communicated to Floridians.”

His statement also included a link to Gov. Ron DeSantis’ news release from December announced that the governor had petitioned the Florida Supreme Court to impanel a statewide grand jury “to investigate any and all wrongdoing in Florida regarding the Covid-19 vaccine.”

“Allowing pharmaceutical companies to dictate health guidelines is irresponsible and allows public health officials to line their pockets when they feel the severity of the effects directly in their communities,” Ladapo said in his statement. The court has not yet taken any action.

The published eight-page state analysis combined data from Florida’s Reportable Disease Repository, Merlin, the Florida State Health Online Tracking System and death records from the state’s Bureau of Vital Statistics.

It examined cases of adult Floridians who died within 25-weeks of the start of the vaccine roll-out in December 2020 and detailed deaths that occurred within 28 days of receiving a vaccine.

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

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

that According to a column by four epidemiologists at the University of Florida, the sample size was too small for a far-reaching conclusion, based on 20 deaths, highlighting concerns and flaws with the analysis. The scientists also pointed out that Ladapo’s finding was not backed up with clinical data that proved the cause of death fit the criteria.

Furthermore, data on risk of infection omitted from published reports show that catching Covid presents a much higher risk for the same age group.

For Floridians aged 18 to 24, the incidence of cardiac-related deaths due to infection was 10 times higher than for the vaccine, and more than five times higher for those aged 25 to 39. This data is not broken down by gender.

State epidemiologists working on the report also reached different conclusions than Ladapo, the drafts suggest.

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

“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 was removed.

State’s analysis was also criticized for not including a sensitivity analysis, a method of proving that the results remain consistent even after 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 to young people 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 doesn’t confirm this finding,” Laxton said.

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

David Norton, UF The vice president for research, said in a statement that since Ladapo conducted the 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 complaints or concerns. on research integrity” the report states.

After reviewing the draft report, Hitchings said the final analysis amounted to academic dishonesty.

“You can fake it by omission,” he said.

Reducing the elevated risk of cardiac-related death from infection is the biggest concern for Kathryn Wallace, an epidemiologist at the University of Illinois at Chicago. The state has denied Floridians the information they need to make an informed decision about vaccines, he said.

“As a scientist and as a parent, it’s important for me to know the cardiac risk from vaccines versus Covid,” he said. “That context is huge — and it’s gone.”