Florida’s top health official sent a letter this week to the heads of the Food and Drug Administration and the Centers for Disease Control and Prevention warning that mRNA COVID-19 vaccines could be dangerous.
It’s the latest instance of Surgeon General Joseph Ladapo, who runs the Florida Department of Health, questioning the safety of the vaccines. In the letter, he cites an increase in the number of reports from Florida submitted to the federal government’s Vaccine Adverse Event Reporting System, or VAERS, as evidence of a problem with the shots.
“Academic researchers throughout our country and around the globe have seen troubling safety signals of adverse events surrounding this vaccine. Their concerns are corroborated by the substantial increase in VAERS reports from Florida, including life-threatening conditions,” Ladapo wrote in the letter, dated Wednesday.
The CDC recommends everyone stay up to date with COVID-19 shots, which it says protect against severe disease, hospitalization and death in all age groups.
The letter — and a subsequent Department of Health news release — said Florida had seen a 4,400% increase in the VAERS reporting of “life-threatening conditions.”
Percentage increases do not alone provide an understanding of the magnitude of an event. According to the VAERS database, 14 life-threatening events following any vaccination (not just the coronavirus shots) were reported in Florida in 2020. In 2021, the number was 695, according to the database. In 2022, the number was 177. Nearly 42 million COVID-19 vaccine doses have been administered in Florida, according to the CDC.
A spokesperson for the Department of Health confirmed after this story was initially published that the VAERS numbers related to all vaccinations were the ones the state used to calculate the percentage increase Ladapo cited. The spokesperson noted that the increase in life-threatening events from 2020 to 2021 was roughly 4,900%.
Anyone can report a concerning medical condition to the federal database. The ailment may or may not be related to vaccination.
A spokesperson for the FDA noted that the federal government has seen an uptick in COVID-19 VAERS reports across the country. The spokesperson attributed that increase to the increased public awareness around the vaccines, and the fact that there are more stringent VAERS reporting requirements for the coronavirus shots than for other vaccines.
“COVID-19 vaccines have undergone—and continue to undergo—the most intense vaccine safety monitoring in U.S. history,” the spokesperson wrote in an email. “Clinical research has demonstrated the safety and effectiveness of the recommended COVID-19 primary series vaccines, as well as the recommended updated vaccines.”
William Schaffner, an infectious disease expert at Vanderbilt University Medical Center in Tennessee, said Ladapo’s letter “speaks (to) a misunderstanding of the VAERS data and how they are used, and that’s unfortunate.”
“Just looking at numbers of reports I think is interesting,” but it’s only the start of analyzing submissions, said Schaffner, a liaison to the federal Advisory Committee on Immunization Practices, a group of independent experts who make vaccine recommendations. “You don’t draw conclusions from that. That’s actually a misuse of VAERS data.”
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For example, if a death occurs four days after someone gets vaccinated, scientists can’t immediately conclude that the fatality was caused by immunization, he said.
“All you know is that you have two coincidental events,” he said. It’s a “logical fallacy” to conclude that “because ‘B’ follows ‘A,’ ‘A’ caused ‘B.’”
Ladapo is “strongly implying” a causal relationship between coronavirus vaccines and the spike in VAERS submissions, Schaffner said.
Two factors have “undoubtedly” led to a rise in reports to the database, Schaffner said: the sheer number of shots in arms during the vaccine rollout and the publicity surrounding the immunization campaign.
Ladapo’s letter said the increase in adverse events goes beyond what would be expected given the vaccination campaign.
“These findings ... more likely reflect a pattern of increased risk from mRNA COVlD-19 vaccines,” Ladapo wrote, calling for greater “transparency” from the federal government about the risks associated with the vaccines.
Ladapo, an appointee of Gov. Ron DeSantis, has gone further than most public health officials in advising against getting a COVID-19 vaccine. In March, he said healthy children should not get the shots. In October, the Department of Health released a study of death certificates that it used as justification for guidance warning men ages 18-39 against mRNA COVID-19 vaccines.
Those moves were heavily criticized by some members of the scientific community — including some of the researchers cited by the Department of Health as it made its recommendation for kids.
Ladapo, who is also a professor at the University of Florida, was also criticized by his university colleagues for the death certificate study. In a report created by a faculty committee, professors said the state’s work was of “highly questionable merit.”