Florida Surgeon General Dr. Joseph Ladapo on Friday announced new guidelines advising against COVID-19 mRNA vaccines for men ages 18-39, citing a Florida Department of Health study that some have said relies on flawed data and makes little to explain his methodology.
The move is the latest example 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 contradicted major national health groups. Florida was also the only state not to pre-order coronavirus vaccines for children under 5.
The state’s nonbinding recommendation says the risk of cardiac complications from the mRNA vaccine “likely” outweighs the benefits of vaccination, citing an increase in relative heart-related deaths among the men studied in the analysis. But some epidemiologists say that while the risks of heart problems do exist, the state study — whose authors have not been named — was too thin.
Jason Salemi, a University of South Florida epidemiologist, said he supports studying the risks and benefits of vaccination. But he said the department’s study focused only on risk.
“It’s not a complete picture,” Salemi said. “It’s taking a piece of it and using it seemingly in isolation to make a recommendation.”
The state study, which was not peer-reviewed, used death certificate records and information from the state’s reportable disease repository to analyze information on Floridians who died within 25 weeks of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 did not compare the risk of cardiac problems from the vaccine with the risk of cardiac and other adverse outcomes associated with contracting COVID-19 for men in the same age group. He also said the state’s use of death records instead of medical records provides a limited understanding of the cause of death and said the department should have pulled more detailed data instead.
Ladapo on Friday posted the instruction on his Twitter account and said “FL will not be silent about the truth”.
His tweet was temporarily removed for violating Twitter’s rules, but was later reinstated. A Twitter spokesperson gave few details on what happened, saying only that the company “took enforcement action on the Tweet you erroneously referenced, but the action was reversed.”
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“While it’s unfortunate that Twitter temporarily removed the tweet, the bigger conversation should be about how much opposing scientific views are feared today,” said Weesam Khoury, deputy chief of staff for the Department of Health. “It is unfortunate that science, which depends on the importance of debate and conversation, has become a new opportunity for the culture of cancellation.”
Ladapo took to Twitter Monday morning to respond to some criticisms of the study, including its small sample size.
“Isn’t it great when we discuss science transparently instead of trying to cancel each other out?” Ladapo said in one I tweet.
Daniel Salmon, director of the Vaccine Safety Institute at the Johns Hopkins School of Public Health, said the state report lacks key details. The methodology section is so short, Salmon said, that he can’t figure out what exactly the department did.
“If you submitted it to any good journal, it would almost certainly be rejected quickly,” Salmon said. “I think it’s irresponsible for a state government agency to release something like this without enough detail.”
Salmon said one of the keys to science is the ability to reproduce findings, but the Florida study lacks the ability to do so because of limited information. Salmon is leading a major global study looking into myocarditis and the coronavirus vaccine.
“I know these records very well,” he said. “Based on everything we know, I believe the benefits outweigh the risk.”
Salmon said his young adult sons, now 20 and 22, have been vaccinated, as well as his 16-year-old twins.
John Grabenstein, director of science communications at the nonprofit immunize.org, said the study’s conclusion is not seen elsewhere in the national record. He said that while it is clear that there is myocarditis, a heart condition, seen in some older teenagers and young adults who get the vaccine, “basically almost everyone recovers from it.”
“People should still be more afraid of the virus,” said Grabenstein, who previously worked in the US Army overseeing immunization.
For men who are concerned about the mRNA vaccine, there are other non-mRNA options, such as the Novavax and Johnson & Johnson vaccines, Grabenstein said.
