TAMPA, Fla. — When the Florida Department of Health released new guidelines this week suggesting healthy children should not get the coronavirus vaccine, it cited several studies to back up the position.
But at least four of the experts whose research was cited say their work was taken out of context. They said they disagreed with Florida Surgeon General Joseph Ladapo’s conclusion that the vaccine was more dangerous than the virus for healthy children.
“I think there is cherry-picking of sentences to support what (the state) wanted,” said Kathryn Edwards, a pediatrics professor at Vanderbilt University Medical Center, who co-authored one of the papers cited in the guidance.
Each of the three studies cited by the state concluded vaccines are safe and effective. Florida health officials did not mention that in their two-page guidance.
All four experts contacted by the Tampa Bay Times disagreed with the recommendation and emphasized that the COVID-19 vaccine is the best way to prevent severe illness in children.
“You don’t just pick one sentence from one paper that agrees with what you think you want to say,” Edwards said. “That’s not what a health department is supposed to do.”
Since the start of the pandemic, nearly 13,000 children aged 17 and under have been hospitalized with COVID-19 in Florida. More than 40 have died. Only 22% of Florida children aged 5 to 11 have been vaccinated, the lowest share of any eligible age group in the state.
When asked about the researchers’ concerns, a Department of Health spokesperson said the agency stands by its recommendation.
“The researchers’ conclusions are their assessment of the data,” Jeremy Redfern wrote in an email. “The surgeon general disagrees.”
Redfern said Ladapo is a research scientist as well as a physician, and disagreements are a normal part of the scientific process.
That may be true, said Kawsar Talaat, a professor of international health at the John Hopkins Bloomberg School of Public Health, who co-authored a paper cited by the Department of Health, but it doesn’t justify Ladapo’s conclusions.
“There might be a scientist out there that says the world is flat,” she said. “It doesn’t mean that they’re right.”
Mark Sawyer, a pediatric infectious disease specialist at the University of California San Diego School of Medicine, said: “I’m distressed that my quote was used to support what I think is a bad policy decision.”
Sawyer had expressed concerns over potential side effects of the vaccine in an October meeting of the Food and Drug Administration’s Vaccine Advisory Committee, of which he is a member.
The state’s guidance quotes two sentences in which Sawyer raised concerns about the risk of myocarditis, a swelling of the heart muscle, in some patients. He also questioned whether the number of hospitalizations prevented by the vaccine was overestimated.
But Sawyer said Florida’s guidance took his words out of context.
“You raise all possible concerns in these meetings,” he said, “but we concluded, and I still agree, that the risk-benefit still favors vaccination.”
Neither the Department of Health nor the governor’s office contacted any of the researchers whose work was cited in the report or whose quotes were used as supporting evidence in favor of the recommendation, Redfern said.
Had the state contacted him, Sawyer said he would have told officials the quotes were both lacking context and out-of-date.
The risk of contracting myocarditis is a key part of Florida’s new guidance, according to the Department of Health.
To substantiate its advice, the state points to a single study published in the Journal of the American Medical Association earlier this year, which found the highest rate of post-vaccination myocarditis was in boys aged 12 to 17.
But it’s incorrect to claim a rare side effect should dissuade parents from vaccinating their children, said Buddy Creech, a professor of pediatric infectious diseases at the Vanderbilt Institute for Infection, Immunology and Inflammation, who co-authored the study.
The most important thing to know about myocarditis after vaccination, he said, is that it’s uncommon, tends to go away without treatment and does not appear to cause long-term damage.
The Centers for Disease Control and Prevention estimates that for every million vaccinations of children aged 12 to 17, about 70 will develop myocarditis. Reported rates for children aged 5 to 11 are substantially lower.
One study released in July 2021 estimated 633 children aged 12 to 17 would develop myocarditis because of COVID-19 for every million infections — a rate 9 times greater than because of vaccination.
The state’s guidance concluded there is “limited risk of severe illness due to COVID-19,” citing one paper published in January 2022 in the New England Journal of Medicine. The paper studied the efficacy of the Pfizer vaccine in nearly 2,300 children, none of whom suffered severe complications from a COVID-19 infection.
But the research “was not designed as an epidemiological study to look at the severity of COVID infection in children,” said Talaat, the John Hopkins epidemiologist who coauthored the paper.
Only a small number of people followed by the study were even infected with COVID-19, she said. “They’re twisting the results to fit with what they want as opposed to using the results to determine facts.”
The state’s guidance also relies heavily on a paper from the New York State Department of Health, which was released as a preprint in February and has not been peer-reviewed.
The study found the vaccine quickly lost its ability to prevent infection in children. Within 7 weeks after the second dose, efficacy fell to 51% for children aged 12 to 17 and to 12% for children aged 5 to 11.
“While our study showed waning effectiveness in preventing infection after several weeks,” said New York State Department of Health spokesperson Jeffrey Hammond, “the vaccine continues to offer kids aged 5 to 11 strong protection from serious illness and hospitalization.”
New York State health officials strongly encourage vaccination of eligible children as the best protection against COVID-19, he said.
A recent study from the CDC indicates vaccinations are more than 90% effective at preventing hospitalization in children aged 12 to 17 in the first five months, and more than 73% effective thereafter. The study also found that booster doses offered more protection in eligible children.
It’s understandable if parents are concerned and confused about the best course of care for their children, Edwards said. “That’s where you have to explain the risks and the benefits, you have to arm people with information.”
