Scientists dispute the Florida surgeon general's latest COVID-19 vaccine guidance for young men
Health experts say the data Ladapo based his guidance on is flawed. The unnamed authors of the study acknowledge its many limitations and call for more research.
Health experts and federal officials are criticizing Florida Surgeon General Joseph Ladapo's decision to advise men between 18 and 39 years old not to get COVID-19 vaccines, which goes against guidance from the Centers for Disease Control and Prevention.
His recommendation is based on an analysis the state health department published Friday that said these men had a "modestly increased" risk of cardiac-related deaths within a month of getting a messenger RNA, or mRNA, vaccine. The analysis was not peer-reviewed and its authors point out flaws that Ladapo didn't mention in his remarks.
Doctors and scientists from around the world took to social media following Ladapo's announcement. They have issues with the way the analysis was conducted and question the accuracy of the results.
Deleted my earlier post, as I wanted to correct it & do a a detailed debunk. It took me six reads to even start to understand what the authors had done, because the methodology makes little to no sense in many ways. Here goes- 🧵 pic.twitter.com/FqvnIsvMfg— Dr. Deepti Gurdasani (@dgurdasani1) October 8, 2022
The authors of this study, who are not named in the report and who Ladapo has since declined to reveal, acknowledge its many limitations.
They admit they couldn't determine what actually caused the deaths of the small group of 18- to 39-year-old men in Florida they looked at because they used death certificates to calculate how many were cardiac-related, not medical records.
Death certificates aren’t always accurate, explained Jason Salemi, an epidemiologist with the University of South Florida’s College of Public Health. He said given the small sample size of the study — less than 100 patients — researchers could have dug deeper.
“Why not review those medical records and make absolutely certain you know what caused these deaths and whether or not they were vaccine-related?” he said.
Salemi’s biggest concern was that the report failed to pay equal attention to examining the risks of COVID-19 infection and how well the vaccines performed at reducing the harmful effects of the virus.
Though they don’t present any research on the subject, the authors themselves say in their conclusion that health risks from getting COVID-19 are substantially higher than those associated with the vaccination.
“Risk for both all-cause and cardiac-related deaths was substantially higher 28 days following COVID-19 infection,” the authors said.
They also note that vaccination was not associated with an elevated risk for “all-cause mortality.”
Ladapo doesn't mention this in his guidance. He does echo the authors' call to weigh the risks of vaccination against the risks of infection.
2/ It is vitally important to look at risks and benefits of everything - very little in this world comes with zero risk.— Jason L. Salemi | PhD | FACE (@JasonSalemi) October 9, 2022
But where in the world is the analysis that looked at risk of these same outcomes in those with infection. I cannot fathom a world in which this was not done.
Salemi said he supports that kind of research, but said the health department had the tools to compare those risks before publishing this report — and should have.
“I’m worried that even if those other data are now supplied and let’s say that the benefits do seem for most people to outweigh the risks, it's now hard to walk that [Ladapo’s] recommendation back,” he said. “It’s hard to walk back the fear that people may now have, if you're a young man 18-39, the data are presented in a way that I would be absolutely frightened.”
The CDC acknowledges heart issues, like myocarditis and pericarditis, have been reported but are very rare and typically occur within a week of vaccination. In most cases, patients feel better quickly with treatment and rest.
Salemi said it's important people know those risks exist, but they need the full picture.
“Why would I assume that risk? Well if the vaccines can protect me from a lot of other adverse outcomes, then maybe those benefits far outweigh these risks,” he said.
Federal health officials continue to stress the vaccines are safe and effective at reducing severe illness in people as young as six months old. And research has shown the risk of myocarditis is much higher after COVID-19 infection.
Ladapo, whose original tweet announcing the revised guidance was temporarily removed on Twitter for misinformation but has since been restored, responded to the some of the criticism on social media. "Isn't it great when we discuss science transparently instead of trying to cancel each other," he said.
I love the discussion that we've stimulated.— Joseph A. Ladapo, MD, PhD (@FLSurgeonGen) October 10, 2022
Isn't it great when we discuss science transparently instead of trying to cancel one another?
I'm going to respond to the more substantive critiques.🧵
He addressed some of the methodological concerns raised about the study, but continued to ignore the risks associated with getting COVID-19.
The CDC has been urging Americans to get the updated booster shot designed to target both the original coronavirus strain and some omicron subvariants. But very few people have heeded the call.
Some public health experts are warning about a potential winter surge, as some European countries are starting to see cases and hospitalizations rise.