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Ladapo has recently said masks “are not saving lives,” and announced his state would become the first to recommend that healthy children over age 5 not receive the COVID-19 vaccine. He has said the science behind Centers for Disease Control recommendations to the contrary is lacking.
Dr. Wafaa El-Sadr, a professor of epidemiology and medicine at Columbia University, said that Ladapo’s comments are outside the norm for public health officials, who usually apply CDC guidelines “locally with minimal adjustments.”
A public reckoning with science in Florida has intensified in recent weeks — led by the state’s top health official.
Surgeon General Dr. Joseph Ladapo announced Florida would be the first state to recommend against COVID-19 vaccines for healthy children.
Ladapo has made it clear he believes the science behind COVID-19 recommendations from the U.S. Centers for Disease Control and Preventions is lacking.
A week earlier, Ladapo took aim at masking during a March 3 press conference. "No high-quality data says that this (a mask) saves any lives. It’s a lie, and it needs to stop, and people need to unbelieve it," he said.
Ladapo’s departure from CDC guidelines is outside the norm for public health officials.
Until the COVID-19 pandemic, general clinical practice guidelines from the CDC about things like vaccinations, HIV or tuberculosis, for example, "have been applied locally with minimal adjustments," said Dr. Wafaa El-Sadr, a professor of epidemiology and medicine at Columbia University. She described Ladapo’s comments as "highly unusual and concerning."
The Florida Chapter of the American Academy of Pediatrics called Florida’s recommendation against COVID-19 vaccinations for kids "irresponsible." The organization and the American Academy of Pediatrics recommend that all eligible children age 5 and older get the COVID-19 vaccine as soon as possible, citing research that shows vaccines reduce serious illness, hospitalizations and long-term COVID-19 symptoms.
We reached out to Ladapo’s team to try to understand what evidence supports these positions. The science surrounding COVID-19 has evolved, so the policies and guidance have evolved as well. Still, public health studies and expert review continue to bolster the case for vaccines and the usefulness of masks in stemming spread in high-transmission areas.
The Florida Department of Health released new guidelines on vaccines for kids on March 8, less than two weeks after Ladapo, a Harvard-educated doctor and former UCLA professor, was confirmed to his position as Florida’s surgeon general.
"Healthy children aged 5 to 17 may not benefit from receiving the currently available COVID-19 vaccine," the guidance read. "The Department recommends that children with underlying conditions are the best candidates for the COVID-19 vaccine."
Ladapo emphasized personal choice in a statement issued with the guidelines: "Based on currently available data, the risks of administering COVID-19 vaccination among healthy children may outweigh the benefits."
When we asked for Ladapo’s evidence, spokesperson Jeremy Redfern pointed us to two studies. Neither study concluded that the risk of a severe reaction from a vaccine outweighed the risk of contracting COVID-19.
In one, researchers from the New York State Department of Health and the State University of New York compared laboratory-confirmed COVID-19 outcomes — including cases and hospitalizations — by vaccination status to estimate how effective vaccines were during a surge fueled by the highly infectious omicron variant.
The study, which had not been peer-reviewed, found that between Dec. 13, 2021, and Jan. 30, 2022, vaccine effectiveness against COVID-19 cases for fully-vaccinated children ages 12 to 17 declined from 66% to 51%. For children ages 5 to 11, it dropped from 68% to 12%. The data also showed declines in its effectiveness against hospitalizations, dropping from 85% to 73% in the older children and from 100% to 48% in the younger group.
Nevertheless, the researchers still recommended vaccination for kids 5-11, saying that it "was protective against severe disease."
The second study Ladapo’s team cited, this one published in the New England Journal of Medicine, was a randomized clinical trial evaluating the effectiveness of the Pfizer and BioNTech COVID-19 two-shot, low-dose vaccine in children ages 5 to 11. The trial involved 2,268 children and concluded that a two-dose COVID-19 vaccination administered 21 days apart was "safe, immunogenic, and efficacious in children 5 to 11 years of age." No vaccine-related serious adverse events were noted, the authors wrote.
Redfern argued, however, that the study was "underpowered" compared with a similar clinical trial for adults that enrolled 43,548 participants.
The adult trials needed more participants to directly measure the effectiveness of the vaccine, according to the National Institutes of Health. With the effectiveness established in adult trials, the clinical trial for kids was smaller and focused on measuring immune response to the vaccine and tracking effects.
Researchers behind the work Ladapo cited have since said the surgeon general cherry-picked parts of studies that seemed to bolster his pre-existing beliefs or pulled their words out of context, according to Tampa Bay Times reporting.
Dr. Adriana Cadilla, a pediatric infectious disease physician at Nemours Children's Hospital in Orlando, Florida, told PolitiFact that the safety of the COVID-19 vaccine was well documented.
"We’ve never seen the extent of safety monitoring like we’re seeing now," she said. "What I see in my practice is a lot of kids coming in with heart problems with acute COVID or with post-COVID syndrome. You don't see them coming in with vaccine-related problems — they exist, but the chances of having an adverse event from the actual disease is much higher."
While research suggests the COVID-19 vaccines can cause a slightly increased risk of myocarditis — inflammation of the heart — in some adolescents, it is rare.
Robert Heimer, a professor of epidemiology at the Yale School of Public Health, said that the health risks of the vaccines "have been shown to be very infrequent and minor." He said that half of all childhood COVID-19 deaths have occurred since the omicron surge began.
Ladapo based his claim that masks "are not saving lives" primarily on available controlled clinical trials, which he referred to in the press conference as the "highest level of evidence."
Controlled clinical trials sort participants into two groups — an experimental group and a control group — to study the effect of a particular variable on outcomes.
His team pointed to a Danish study from 2020 known as DANMASK-19 and another from Bangladesh that was published in December 2021.
According to Ladapo, "one found nothing. Zero benefit. The other found a small benefit — like a tiny benefit that’s a little bit methodologically shaky. And by the way, none of them found a benefit in young people. Not a single one found a benefit in younger people."
Neither assessment accurately portrays the findings of those studies.
The first, conducted in Denmark early in the pandemic, found that wearing masks did not offer a very high level of protection to mask wearers when they were in communities where wearing masks was not common practice — but the data suggested masks did provide some degree of self-protection.
The second, from Bangladesh, concluded that promoting masks "increased mask usage and reduced symptomatic SARS-CoV-2 infections, demonstrating that promoting community mask-wearing can improve public health." It also showed that surgical masks are more effective at preventing COVID-19 transmission than cloth masks. Some researchers have since called its findings into question, however, because of concerns that the results might have been different had they analyzed the raw data differently.
Redfern criticized other studies on the subject, saying they were observational or survey studies that had higher potential for bias.
Kate Grabowski, an epidemiologist and assistant professor at Johns Hopkins University, said "any one study on its own has a number of weaknesses" but "the body of evidence together strongly suggests ‘masking saves lives.’"
A January 2021 review of available mask literature conducted by researchers from the University of San Francisco, Brown University and elsewhere concluded: "The preponderance of evidence indicates that mask wearing reduces transmissibility per contact by reducing transmission of infected respiratory particles in both laboratory and clinical contexts."
Dr. Monica Gandhi, a professor of medicine at the University of California San Francisco, said that "most well done studies" of mask mandates "do not show an association between mask mandates and the containment of spread or hospitalizations."
"However, that doesn’t mean masks ‘don’t work’ at the individual level," Gandhi said. She noted that research shows masks protect those who wear them.
RELATED: What pediatricians want parents to know about the upcoming COVID-19 shots for children under 5
RELATED: No, a Danish study didn’t prove wearing masks is ineffective
RELATED: Why randomized controlled trials on mask wearing and the coronavirus are scant
CORRECTION (March 19, 2022): Monica Gandhi is a professor of medicine at the University of California San Francisco. An earlier version of this story had the university name wrong.
WFLA, "DeSantis, Florida Surgeon General push bill that would protect medical workers from censorship," March 3, 2022
Email exchange and phone interview with Jeremy Redfern, a spokesperson for Dr. Joseph Ladapo, March 3 and 10, 2022
Email interview with Dr. Monica Gandhi, a professor of medicine at the University of California San Francisco, March 4, 2022
Email exchange with Kate Grabowski, an epidemiologist and an assistant professor in pathology at Johns Hopkins University, March 4, 2022
Email interview with Jill Roberts, associate professor at the University of South Florida’s College of Public Health, March 3, 2022
Email interview with Dr. Wafaa El-Sadr, a professor of epidemiology and medicine and the director of the Mailman School of Public Health’s Global Health Initiative at Columbia University, March 11, 2022
Email interview with Robert Heimer, a professor of epidemiology and pharmacology at the Yale School of Public Health, March 14, 2022
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