A public showdown with science in Florida has intensified in recent weeks – led by the state’s top health official.
General Surgeon Dr. Joseph Ladapo announced Florida would be the first state to recommend against COVID-19 vaccines for healthy children.
Ladapo has made it clear that he believes the science behind the COVID-19 recommendations from the US Centers for Disease Control and Prevention is lacking.
One week earlier, Ladapo was aiming to mask under a press conference on March 3rd. “No high quality data says this (a mask) saves any lives. It’s a lie and it should stop and people should not believe it,” he said.
Ladapo’s departure from the CDC guidelines is outside the norm for public health officials.
Until the COVID-19 pandemic, guidelines for general clinical practice from the CDC on things such as vaccinations, HIV or tuberculosis “have become local with minimal adjustments,” said Dr. Wafaa El-Sadr, Professor of Epidemiology and Medicine at Columbia University. She described Ladapo’s comments as “very unusual and worrying.”
Florida Chapter of the American Academy of Pediatrics called the Florida Recommendation against COVID-19 vaccinations for children “irresponsible.” The organization and the American Academy of Pediatrics recommend that all eligible children 5 years of age and older receive the COVID-19 vaccine as soon as possible, citing research showing that 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 views. The science of COVID-19 has evolved, so that policies and guidance have also evolved. Nevertheless, public health studies and expert assessments continue to strengthen the argument for vaccines and the applicability of masks to prevent spread in areas with high transmission.
Studies have not shown that vaccine risks outweigh the benefits
The Florida Department of Health released new guidelines for vaccines for children 8. Marchless than two weeks after Ladapo, a Harvard-educated doctor and former UCLA professor, was confirmed to his position as Florida Surgeon General.
“Healthy children aged 5 to 17 may not benefit from receiving the currently available COVID-19 vaccine,” the guide said. “The department recommends that children with underlying disorders be the best candidates for the COVID-19 vaccine.”
Ladapo emphasized personal choices in one statement submitted with the guidelines: “Based on currently available data, the risks of administering COVID-19 vaccination to healthy children may outweigh the benefits.”
When we asked for Ladapo’s evidence, spokesman Jeremy Redfern pointed us to two studies. None of the studies concluded that the risk of a severe reaction from a vaccine outweighed the risk of getting COVID-19.
In a, Researchers from the New York State Department of Health and State University of New York compared laboratory-confirmed COVID-19 results – including cases and hospitalizations – by vaccination status to estimate how effective vaccines were during an increase driven by the highly infectious omicron variant.
The study, which had not been peer-reviewed, found that between 13 December 2021 and 30 January 2022, vaccine efficacy against COVID-19 cases for fully vaccinated children aged 12 to 17 years fell from 66% to 51%. For children aged 5 to 11 years, it dropped from 68% to 12%. The data also showed a decrease in its effectiveness against hospitalizations, decreasing from 85% to 73% in the older children and from 100% to 48% in the younger group.
Nevertheless, the researchers still recommended vaccination for children 5-11, saying it “was protective against serious illness.”
The second study cited by Ladapo’s team, published in the New England Journal of Medicine, was a randomized clinical trial evaluating the efficacy of Pfizer and the BioNTech COVID-19 two-shot low-dose vaccine for children aged 5 to 11 years. the trial involved 2,268 children and finished that a two-dose COVID-19 vaccination given at 21-day intervals was “safe, immunogenic and effective in children aged 5 to 11 years.” No vaccine-related serious side effects were noted, the authors wrote.
Redfern, however, argued that the study was “underpowered” compared to a similar one clinical trials in adults who registered 43,548 participants.
The adult trials needed more participants to directly measure the effectiveness of the vaccine, according to National Institutes of Health. With efficacy established in adult trials, the clinical trial in children was smaller and focused on measuring the immune response to the vaccine and tracking effects.
Researchers behind the work Ladapo cited have since said that the general surgeon selected parts of studies that seemed to strengthen his pre-existing beliefs or pull 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 have never seen the extent of security surveillance that we see now,” she said. “What I see in my practice is a lot of children who come in with heart problems with acute COVID or with post-COVID syndrome. You don’t see them come in with vaccine-related problems – they do exist, but the chances of getting a side effect from the actual disease is much higher. ”
Robert Heimer, professor of epidemiology at the Yale School of Public Health, said the health risks of the vaccines “have been shown to be very rare and minor.” He said half of all children’s COVID-19 deaths have occurred since the omicron rise began.
Evidence suggests that masks provide protection
Ladapo based his claim that masks “do not save lives” primarily on available controlled clinical trials, which he referred to at 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 the results.
According to Ladapo, “one found nothing. Zero advantage. The other found a small advantage – like a small advantage that is a bit methodically shaky. And by the way, none of them found an advantage in young people. Not a single one found a benefit young people. “
None of the assessments accurately show the results of these studies.
The first, which was carried out in Denmark early in the pandemic, found that wearing masks did not provide a very high level of protection for mask wearers when they were in societies where it was not common practice to wear masks – but the data suggested that masks provided some degree of self-protection.
The other, from Bangladesh, concluded that the promotion of masks “increased mask use and reduced symptomatic SARS-CoV-2 infections, demonstrating that the promotion of community mask wearing can improve public health.” It also showed that surgical masks are more effective at preventing the infection of COVID-19 than fabric masks. Some researchers have since called its findings in doubthowever, due to concerns that the results might have been different if they had analyzed the raw data differently.
Redfern criticized other studies on the subject, saying they were observational or research studies that had greater potential for bias.
Kate Grabowski, an epidemiologist and assistant professor at Johns Hopkins University, said that “any study in itself has a number of weaknesses”, but “gathered by evidence strongly suggests ‘masking saves lives’.”
A January 2021 review of available mask literature by researchers from the University of San Francisco, Brown University, and elsewhere finished: “The preponderance of evidence indicates that mask wear reduces transmissibility per contact by reducing the transmission of infected respiratory particles in both laboratory and clinical settings.”
Dr. Monica Gandhi, a professor of medicine at the University of Southern California San Francisco, said that “most well-conducted studies” of mask mandates “do not show a link between mask mandates and the inclusion of proliferation or hospitalizations.”