Scientists question Florida’s advice against COVID mRNA vaccines for some men

Florida Surgeon General Dr. Joseph Ladapo on Friday announced new guidance advising against COVID-19 mRNA vaccines for men aged 18-39, citing a Florida Department of Health study that some have said relies on imperfect data and does little to explain its methodology.

The move is the latest instance of Ladapo and the department recommending against coronavirus vaccines for certain age groups. Earlier this year, Florida became the first state to recommend against vaccines for healthy children, a recommendation that ran counter to major national health groups. Florida was also the only state to not preorder coronavirus vaccines for children under 5.

The state’s non-binding recommendation says the risk of cardiac complications from the mRNA vaccine “likely” outweigh the benefits of vaccination, citing an increase in relative cardiac-related death among men studied in the analysis. But some epidemiologists say that while risks of cardiac issues do exist, the state’s study — whose authors are not named — was too thin.

Jason Salemi, a University of South Florida epidemiologist, said he supports studying both the risks and benefits of vaccination. But he said the department’s study only focused on the risk.

“It’s not a complete picture,” Salemi said. “It’s taking one part of it and using that seemingly in isolation to make a recommendation.”

The state’s study, which was not peer-reviewed, used death certificate data and information from the state’s reportable disease repository to analyze information on Floridians who died within 25 weeks of receiving an mRNA vaccine.

Salemi said the study doesn’t compare the risk of cardiac issues from the vaccine to the risk of cardiac and other adverse outcomes associated with contracting COVID-19 for men in that same age group. He also said the state’s use of death records instead of medical records offers a limited understanding of the cause of death, and said the department should have pulled the more detailed records instead.

Ladapo on Friday posted the guidance to his Twitter account and said that “FL will not be silent on the truth.”

His tweet was temporarily removed for violating Twitter’s rules but was later restored. A Twitter spokesperson provided little detail on what happened, saying only that the company “took enforcement action on the Tweet you referenced in error, but the action was reversed.”

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“While it is unfortunate that Twitter had removed the tweet temporarily, the larger conversation should be surrounding how opposing scientific viewpoints are so feared today,” said Weesam Khoury, the deputy chief of staff for the Department of Health. “It is unfortunate that science, which is dependent on the importance of debate and conversation, has turned into a new opportunity for cancel culture.”

Ladapo returned to Twitter on Monday morning to respond to some critiques of the study, including its small sample size.

“Isn’t it great when we discuss science transparently instead of trying to cancel one another?” Ladapo said in a tweet.

Daniel Salmon, the director of the Institute for Vaccine Safety at the Johns Hopkins School of Public Health, said the state’s report is missing key details. The methodology section is so brief, Salmon said, that he cannot make out what exactly the department did.

“If you were to submit that to any decent journal it would be almost certainly rejected quickly,” Salmon said. “I think it’s irresponsible for a state government agency to put out something like that without sufficient detail.”

Salmon said one of the keys of science is the ability to reproduce the findings, but Florida’s study lacks the ability to do that because of limited information. Salmon is leading a large global study looking into myocarditis and the coronavirus vaccine.

“I know these data really well,” he said. “Based on everything we know, I believe the benefits outweigh the risk.”

Salmon said his young adult sons, now ages 20 and 22, are vaccinated, as are his 16-year-old twins.

John Grabenstein, the director for scientific communications at the nonprofit, said the study’s conclusion isn’t seen elsewhere in the national data. He said while it’s clear there is myocarditis, a cardiac condition, seen in some older teenagers and young adult men who get the vaccine, “essentially nearly everybody recovers from it.”

“People should still fear the virus more,” said Grabenstein, who previously worked in the U.S. Army overseeing immunization.

For men who are concerned about the mRNA vaccine, there are other non-mRNA options, like the Novavax and Johnson & Johnson vaccine, Grabenstein said.

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