TALLAHASSEE — Floridians under 65 should not get the new COVID-19 vaccine, according to a recommendation Florida Surgeon General Joseph Ladapo announced Wednesday afternoon that runs counter to federal guidance.
The U.S. Centers for Disease Control and Prevention on Tuesday recommended the vaccine for everyone 6 months and older ahead of an expected busy flu and COVID-19 season this fall. The updated vaccine, which is tailored to better protect against an omicron subvariant, was approved by the U.S. Food and Drug Administration on Monday.
Ladapo, who was appointed by Gov. Ron DeSantis, announced his recommendation at a Tallahassee roundtable discussion attended by the governor. It comes as cases of COVID-19 in Florida have risen over the summer, with almost 24,000 cases reported in the final week of August. That’s more than double the number from one month earlier, but infection levels remain far below those the state recorded during surges of both the delta and omicron variants.
His recommendation alleges that the new vaccine was approved without “meaningful” clinical trial data performed in humans and without proof of the vaccine’s safety and effectiveness. But it does not rule out the vaccine for Floridians 65 and older, instead stating that they should discuss getting the shot with their health care provider.
“I will not stand by and let the (Food and Drug Administration) and (Centers for Disease Control and Prevention) use healthy Floridians as guinea pigs for new booster shots that have not been proven to be safe or effective,” DeSantis said in a statement. “Once again, Florida is the first state in the nation to stand up and provide guidance based on truth, not Washington edicts.”
The recommendation against the vaccine comes despite the Florida Department of Health reporting more than 20,000 COVID-19 deaths among Floridians aged under 65 since the start of the pandemic. That’s roughly 22% of the roughly 90,000 total deaths in the state.
With cases and the number of hospitalizations rising again, the state should be encouraging residents to take every precaution, said Jason Salemi, an epidemiologist at the University of South Florida. Florida reported 18,871 new COVID hospital admissions for the week ending Sept. 2, an increase of 8.7% from the prior week and the second-highest number in the country, behind California, according to CDC data.
“There are many people under 65 who may still be at high risk for severe illness from COVID-19, including immunocompromised people, front-line health care workers and people with underlying medical conditions who also have the potential for high occupational exposure,” Salemi said.
Some of Ladapo’s previous recommendations on the COVID-19 vaccine have been widely criticized by epidemiologists. In October, he said young men should not get the shot based on a state analysis showing an increased risk of heart-related deaths. The state removed from its analysis data that showed that catching COVID-19 increases the chances of a cardiac-related death much more than getting the vaccine does, a Tampa Bay Times investigation found.
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The federal guidance highlights that COVID-19 vaccines, developed by Pfizer-BioNTech and Moderna, have proven effective in providing protection against severe COVID-19 symptoms that can result in hospitalization and death.
They remain the best way to give the body the ability to keep the virus from causing significant harm, CDC director Mandy K. Cohen said in an opinion piece published Wednesday in The New York Times.
“Even though many Americans have been exposed to previous versions of the virus because they’ve been infected, that protection decreases over time. This is partly why you can get COVID more than once and why you can still get very sick even if you had it before,” the opinion piece states.
While the new vaccine did not go through human clinical trials, it’s inaccurate to claim it’s untested on humans since it is merely a modification of earlier versions that went through extensive clinical trials required for different age groups, said Katrine Wallace, an epidemiologist at the University of Illinois, Chicago.
“The main benefit of the mRNA vaccine technology is that the spike protein target can be changed when the virus mutates,” she said. “Once changed, the underlying vaccine platform and ingredients are exactly the same. So, just like the flu shot, every year the vaccine can be updated to better match the circulating viral strains.”
During the roundtable, Stanford professor Jay Bhattacharya, who was an early skeptic of claims about the effectiveness of vaccines, said that the CDC’s statement was “absolutely not supported yet.” He said a small randomized study has shown that it increases antibody levels, but it’s not evidence that the new vaccine protects people from COVID-19.
”I’m not saying it’s not true,” he said of the CDC’s statement. “The answer is, we just don’t know.”
Ladapo noted that European governments have not recommended the new vaccines for as many people as the CDC did.
The European Centre for Disease Prevention and Control said vaccination programs in EU countries should prioritize people aged 60 and older as well as other vulnerable groups, according to a Reuters report.
The British government’s vaccine committee said only adults 65 and older and some other categories will be offered the shot, Reuters reported.
”I know that it is something that may be surprising to people who are hearing the CDC and the FDA say something very different, but you know, take a look at it,” Ladapo said. “Take a look at the fact that we are straight with people about data and about what is known and unknown and is best for you.”
Miami Herald health reporter Michelle Marchante contributed to this report.