Experts call Florida's latest guidance on Covid vaccines flawed and dangerous

Epidemiologists and federal health agencies have Criticized Florida Surgeon General Joseph Ladapo's new COVID-19 guidance, calling it “dangerous” and a “repetition of misleading and false statements about COVID-19 vaccines.”

Guidance released Thursday by the Florida Department of Health advises Florida doctors and other medical providers against giving the updated mRNA vaccine made by Pfizer and Moderna. Doctors concerned about the safety of the vaccine for patients over the age of 65 or those with underlying health conditions should use the protein-based Novavax vaccine, the guidance says.

“Based on the high rate of global immunity and currently available data, the State Surgeons General advise against the use of mRNA COVID-19 vaccines,” It is written in it.

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

These vaccines are available at major pharmacies in Florida such as CVS, Walgreens, Publix and Walmart, as well as doctors' offices. Florida is the only state in the country that is advising against the use of these vaccines, although they are being used in other countries as well.

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

This guideline reiterates the claims made by Ladapo in January and September 2023 when he advised against getting the Covid-19 vaccine. Many of these claims were debunked by experts.

One of Ladapo's concerns was that the vaccine was approved without having gone through clinical trials. However, it's standard that once a vaccine is safe it can be modified to target new variants, Wallace said. The same process is used every flu season to make the influenza vaccine, a shot that some Florida county health departments currently provide.

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

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

But experts say the chances of such a limited DNA strand entering a cell's nucleus and then matching the correct part of the more than 3 billion base pairs in the human genome are “extremely small.”

Jonathan Laxton, a physician and assistant professor at the University of Manitoba, said the amount of DNA fragments found in the study cited by Ladapo was within the limit set by the FDA.

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

Luxton pointed out that the Swiss study had no patients who met the clinical definition of myocarditis, while the Thai study had only one patient.

“There are multiple, well-conducted studies addressing this issue and they do not show widespread ‘subclinical’ myocarditis or an increased risk of death following COVID vaccination,” he said. “This guidance is a mess. It is based on selective data and misrepresentation of studies.”

Ladapo's guidance also describes the new shot as a booster, when in fact it is a modified version of the original vaccine, modified to protect against current variants.

Ladapo's guidance comes just ahead of flu season, when the C.D.C. expects Americans to get vaccines for COVID-19 along with influenza. About 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 in the U.S. have been very high recently, and all of these infections are disrupting our lives to a minimum, and leading to hospitalizations,” said Matt Hitchings, an infectious disease epidemiologist and professor of biostatistics at the University of Florida. “Even more concerning is that this official announcement is being used to repeat misleading and false statements about COVID-19 vaccines.”

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

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

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

That same year, Ladapo said young men should not get the vaccine based on a state analysis that showed an increased risk of cardiovascular deaths. But before publishing the analysis, the state removed data that showed getting infected with COVID-19 increased the risk of cardiovascular death far more than getting the vaccine, a Tampa Bay Times investigation found.