Experts express confusion, concern as Surgeon General Ladapo begins new COVID-19 study

Florida Surgeon General Joseph Ladapo announced this week that he is embarking on yet another study of COVID-19 vaccination and myocarditis, a form of heart disease caused by inflammation of heart muscles.

During a roundtable on Tuesday with medical professionals and Gov. Ron DeSantis, he explained he plans to work with the University of Florida to assess sudden deaths of otherwise-healthy individuals shortly after COVID-19 vaccination using autopsy results.

“It is a question that I’m sure keeps the CEOs of Pfizer and Moderna up late at night, hoping no one ever looks,” Ladapo said. “But we’re going to look here in Florida.”

Some medical professionals and researchers worry Ladapo may be doing harm by stoking fear about vaccines without sufficient evidence.

“I have no issue with him investigating further, we need more data on covid and correlates of covid. I am worried about the messaging to our communities and perhaps causing concern when there in fact may be no issue,” Elena Cyrus, an epidemiologist from the University of Central Florida, said in an email Wednesday.

Clinical trials and large observational studies on hundreds of millions of vaccine recipients suggest a slightly increased risk of myocarditis following COVID-19 vaccination — something vaccine companies, health care providers and federal agencies advertise.

Despite the small risk of myocarditis, major medical organizations including the American Heart Association are all in consensus that the benefits of COVID-19 vaccination outweigh the risk.

“I’m so upset,” said Dr. Frederick Southwick, an infectious disease specialist and member of the Committee to Protect Health Care, a progressive advocacy group. “Every infectious disease doctor [and] epidemiologist is taken aback. It’s just really, really frustrating that a national figure like this would be carrying science in the way that he is doing.”

Southwick said he thinks Ladapo is doing biased research by cherry-picking a small minority of people and searching for side effects, rather than letting the data speak for itself.

A study of over 40 million people in England over 13 who got the vaccine, published in September, found 0.007% of people experienced myocarditis.

In 7 million mRNA vaccine doses administered in the U.S. from December 2020 to May 2022, there were 224 confirmed myocarditis or pericarditis cases reported to the Centers for Disease Control and Prevention.

In a statement, Pfizer spokeswoman Sharon J. Castillo told the Washington Post that COVID-19 vaccines “have saved hundreds of thousands of lives, tens of billions of dollars in health care costs, and enabled people worldwide to go about their lives more freely.”

During Tuesday’s roundtable, Ladapo said his decision to investigate sudden deaths for signs of myocarditis was inspired by a study from Germany, published in Clinical Research in Cardiology.

The small study found evidence of myocarditis in autopsies in five out of 25 people who died suddenly after taking the COVID-19 vaccine. These people died at home, rather than at a hospital, which means they may not be included in studies that use medical records rather than autopsy reports to track deaths.

The authors note that this type of study is unable to make any conclusions about whether the patients’ myocarditis was due to vaccination or was unrelated, nor can it determine the risk or incidence of myocarditis.

They added that other evidence suggests a COVID-19 infection poses more of a risk of hospitalization and death than the vaccine.

“The reported incidence of (epi-)myocarditis after vaccination is low and the risks of hospitalization and death associated with COVID-19 are stated to be greater than the recorded risk associated with COVID-19 vaccination,” they write.

Dr. David Winchester, president of the Florida chapter of the American College of Cardiology, declined to give an opinion on state policy positions or priorities but also emphasized the risks of myocarditis appear to pale in comparison to the risks of COVID-19 given current available evidence.

“The data does suggest that there’s a modest increase in risk for myocarditis after vaccination. But that risk has to be put in the context of the absolute risk of myocarditis, which is relatively low in the population,” Winchester said.

Myocarditis isn’t typically a life-threatening condition, he added.

Symptoms of heart inflammation can feel like the flu, and most often, they go away on their own after a few weeks, the National Heart, Lung, and Blood Institute reports. Sometimes symptoms include chest pain or severe shortness of breath, which require immediate medical attention. In rare cases, heart surgery is needed.

Winchester also pointed to another study suggesting a myocarditis case is 10 times more likely to kill someone who caught COVID-19 than someone who developed the condition after vaccination.

“Vaccines work. They really do. Even so, I recognize that you may still have questions about whether it’s right for you. Avoid misinformation online and talk to your health care provider instead,” tweeted Food and Drug Administration Commissioner Robert Califf on Wednesday.

This isn’t the first time Ladapo’s research plans have drawn a reaction from the medical community.

In October, he recommended against COVID-19 mRNA vaccines for men age 18-39 after saying he found an increased risk of cardiac-related death in that group.

Researchers and medical professionals were concerned that Ladapo’s paper was not peer-reviewed, didn’t compare the number of deaths after vaccination to deaths caused by COVID-19, didn’t make data available, and did not check to confirm deaths were cardiac-related, among other issues.

“[The study] lacked the quality of analysis that you need to draw a conclusion,” Califf previously told the Orlando Sentinel.

Ccatherman@orlandosentinel.com; @CECatherman Twitter