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Scientists say mRNA vaccine still safe despite Florida surgeon general's latest guidance

The state recommended against the vaccine for some men due to cardiac complications, according to their analysis, but scientists said it lacks evidence.

TAMPA, Fla. — Florida's surgeon general said men between the ages 18 to 39 should not take the COVID-19 mRNA vaccines, which are Pfizer or Moderna. 

The Florida Department of Health states the benefit of vaccination is "likely outweighed" by cardiac complications for this age group, according to its analysis released this past Friday

"Far less attention has been paid to safety and the concerns of many individuals have been dismissed," Florida surgeon general Dr. Joseph Ladapo stated in part.

Ladapo's latest guidance comes as some of the nation's top doctors recommend the new COVID-19 bivalent boosters to stop the spread of the current strains. In addition, some scientists are questioning the state's recommendation, citing an incomplete picture.

"I could not believe that he would make such an irresponsible recommendation to the people of the state of Florida. It goes really against all the evidence that's out there," Distinguished USF Health professor Dr. Tom Unnasch said.

Medical experts 10 Tampa Bay spoke with said the state's analysis looked at the risk, but ignored the rewards – preventing illness or death from COVID-19. Unnasch said that's the typical measure during an epidemiological study. 

RELATED: Ladapo pushes back on House subcommittee's criticism of Florida's handling of vaccines for kids

"That was missing from this report," Dr. Jason Salemi said. "If I could see those other analyses that were run, and balance the risks and benefits, then I feel like we can make an informed series of recommendations for people and then for healthcare providers to make sound decisions."

Salemi said it's important to note no vaccine comes with zero risk and applauds the FDOH for looking into cardiac-related death risks from the vaccine.

However, the evidence shows the benefits largely outweigh the risk, even for this age group.

Scientists also noted the methods used to complete the report. 

RELATED: FDA clears new COVID booster for kids 5 and older, but many haven't gotten initial shots

"What they did was not what I would have done in any way, shape, or form. So there's a lot of questions," Dr. Jill Roberts with USF Health said.

Unnasch said the U.S. is still seeing about 75 to 100 people die every day from COVID-19. 

Experts said the virus can still mutate and prevent immunity from waning, that's why it's important to be up to date with booster shots.

"We want to keep this thing beaten down, we don't want to take a chance on letting it get back up again," Unnasch said.

10 Tampa Bay reached out to the FDOH for comment but has not heard back.

In a statement, the U.S. Health and Human Services' Assistant Secretary for Public Affairs Sarah Lovenheim issued the following response in regard to Ladapo's guidance:

“This decision is flawed and a far cry from the science: COVID-19 vaccines have been proven safe and effective, and severe adverse reactions are rare. The benefits of COVID-19 vaccination – preventing death and hospitalization – are well-established and continue to outweigh any potential risks.

“Vaccines were evaluated in tens of thousands of participants in clinical trials and since then, tens of millions of Americans have received COVID-19 vaccines under the most intense safety monitoring in U.S. history. Florida’s public health recommendation is specifically for men age 18-39. Despite the fact that this age group is at lower risk of severe complications of COVID-19 than older Americans, CDC, FDA, and other federal agencies continuously have found that the evidence is clear: the benefits of vaccines  clearly outweigh any risks. This is why FDA authorized, and CDC recommended, that all individuals in this age group get vaccinated against COVID-19.  As is standard practice, CDC, FDA, and other federal agencies continue to review COVID-19 vaccine safety monitoring data regularly and present this information, as part of an open and transparent process to a working group of vaccine safety experts who provide  independent review.” 

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