Experts refute latest Florida guidance on COVID vaccine as flawed and dangerous

Epidemiologists and federal health agencies have criticized new COVID-19 guidance from Florida Surgeon General Joseph Ladapo as “dangerous” and a repeat of “misleading and false statements about COVID-19 vaccines.”

The guidance, issued by the Florida Department of Health on Thursday, advises Florida doctors and other medical providers against giving updated mRNA vaccines manufactured by Pfizer and Moderna. Doctors concerned about protecting patients over 65 or with underlying health conditions that leave them vulnerable to the virus should use use the protein-based Novavax vaccine, the guidance states.

“Based on the high rate of global immunity and currently available data, the State Surgeon General advises against the use of mRNA COVID-19 vaccines,” it reads.

But the state’s message directly contradicts recommendations made by Centers for Disease Control and Prevention, which recommends the mRNA shots or the Novavax vaccine as protection against severe COVID-19 symptoms and hospitalization. All three vaccines were approved by the Food and Drug Administration in August to protect against newer variants.

The vaccines are being offered at major pharmacies in Florida, including CVS, Walgreens, Publix and Walmart and at doctor’s offices. Florida is the only state in the nation advising against the vaccines, which are also being used in other countries.

“This messaging is dangerous and it contradicts established scientific evidence and public health recommendations,” said Katrine Wallace, an epidemiologist at the University of Illinois, Chicago.

The guidance repeats claims made by Ladapo in January and in September 2023 when he advised against getting the COVID-19 vaccine. Many of those claims were debunked by experts.

Among Ladapo’s concerns was that the vaccine was approved despite not undergoing clinical trials. However, it is standard once a vaccine has been tested as safe that it can be modified to target new variants, Wallace said. The same process is used to produce a influenza vaccine every flu season, a shot that some Florida county health departments currently offer.

“The clinical trials are done on the vaccine product and each year you can tweak the target of the vaccine so it more closely matches the surface proteins of the circulating virus strains,” Wallace said.

Florida’s guidance cites a study that found that mRNA vaccines include fragments of DNA. Ladapo has previously said that the fragments pose a risk to people’s health and the “integrity of the human genome” and could affect newborns.

But experts have said the odds of such a limited DNA strand penetrating the nucleus of a cell and then matching to the correct section of more than 3 billion base pairs in the human genome are “infinitesimally small.”

Also, the quantity of DNA fragments found in the study cited by Ladapo was well within limits set by the FDA, said Jonathan Laxton, a physician and assistant professor of medicine at the University of Manitoba.

Ladapo also cites studies published in Switzerland and Thailand as evidence that the Pfizer and Moderna vaccines heighten the risk of developing myocarditis.

But the Swiss study had no patients that met the clinical definition of myocarditis and the Thai study only one, Laxton said.

“There are many, much better-done studies that address this issue and they do not show widespread ‘subclinical’ myocarditis or increased risk of death after COVID vaccination,” he said. “This guidance is a mess. It is based on cherry-picked data and misrepresentation of studies.”

Ladapo’s guidance also describes the new shot as a booster when it’s actually a revised version of the original vaccine amended to protect against current variants.

Ladapo’s guidance comes just ahead of flu season when the CDC is hoping that Americans will get COVID-19 shots at the same time as influenza ones. Nearly half of the United States reported “very high” levels of COVID-19 activity based on testing of wastewater data collected in the last week of August.

“COVID cases have been very high in the US recently and all these infections are at the very least disruptive to our lives, and are leading to hospitalizations,” said Matt Hitchings, an infectious disease epidemiologist and professor of biostatistics at the University of Florida. “More concerning is the use of this official announcement to repeat misleading and false statements about COVID-19 vaccines.”

A Harvard-trained doctor, Ladapo was appointed by Gov. Ron DeSantis as surgeon general in 2021. As a UCLA researcher, he had expressed skepticism that vaccines could help end the pandemic and penned op-eds in the Wall Street Journal challenging assertions by national health experts.

Since his appointment, he has clashed repeatedly with federal health agencies over guidance on masks and vaccines.

Florida was the only state that did not preorder the long-awaited COVID-19 vaccines for the nation’s youngest children after they were approved in 2022.

That same year, Ladapo said young men should not get the shot based on a state analysis showing an increased risk of heart-related deaths. But before publishing the analysis, the state removed data that showed that catching COVID-19 increases the chances of a cardiac-related death much more than getting the vaccine, a Tampa Bay Times investigation found.