DeSantis' administration advises against updated COVID shots for people under 65

Florida Gov. Ron DeSantis’ administration on Wednesday advised against the updated COVID-19 shots for people under the age of 65 -- a rebuke to federal agencies, which greenlit the shots for anyone 6 months and older earlier this week.

“I will not stand by and let the FDA and CDC use healthy Floridians as guinea pigs for new booster shots that have not been proven to be safe or effective,” the governor said in a statement Wednesday. “Once again, Florida is the first state in the nation to stand up and provide guidance based on truth, not Washington edicts.”

At a virtual roundtable discussion DeSantis hosted Wednesday with State Surgeon General Dr. Joseph Ladapo and outside health experts, Ladapo said he has already taken action on the Governor’s words.

Ladapo has espoused vaccine-skeptical ideas and landed in hot water earlier this year for allegedly altering data to suggest vaccines pose a higher health risk for young men than they really do. At the time, Ladapo released a statement to Politico reading: “To say that I ‘removed an analysis’ for a particular outcome is an implicit denial of the fact that the public has been the recipient of biased data and interpretations since the beginning of the mRNA COVID-19 vaccine campaign.”

At Wednesday’s roundtable, Ladapo explained what he is having his department do.

“What I have directed our department to do is to provide guidance that really recommends and advises against the use of these mRNA COVID-19 vaccines for anyone under 65,” Ladapo said.

“I just think that at this point, with the amount of immunity that’s in the community, with virtually every walking human being having some degree of immunity, and the questions we have about safety and about effectiveness – especially about safety – my judgment is that it is not a good decision for young people and for people who are not at high risk, at this point in the pandemic,” he added.

Florida is defending its position because the updated shots “recommendation was based on the fact that the newly FDA approved COVID boosters lack a human clinical trial and evidence of benefit or efficacy,” according to the Florida news release.

Similar to the flu shot, the updated COVID vaccines were adjusted to match current subvariants – the safety profile of the vaccines is based on rigorous clinical trials with tens of thousands of participants conducted in 2020 and continuous safety monitoring since then.

On Wednesday night, Centers for Disease Control Director Dr. Mandy Cohen responded to Florida’s surgeon general’s comments, calling the boosters shots “proven safe,” “effective,” and “thoroughly and independently reviewed by the FDA and CDC.”

“Public health experts are in broad agreement about these facts, and efforts to undercut vaccine uptake are unfounded and dangerous," she said in a statement.

COVID vaccines have been through rigorous safety and efficacy standards through clinical trials involving tens of thousands of participants, according to the Centers for Disease Control and Prevention. The shots have also been under the most intense safety monitoring in U.S. history, and millions of people have been vaccinated, the agency says.

"The public can be assured that these updated vaccines have met the agency's rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement.

Florida’s guidance comes after the U.S. Food and Drug Administration authorized the shots for kids 6 months to 11 years old and approved it for those 12 years and older, and the Centers for Disease Control and Prevention recommended it for Americans at least 6 months old.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement after the agency approved the booster.

Florida’s guidance could prove politically timely for DeSantis, a presidential candidate who fueled his rise in the Republican Party largely by bucking federal guidance on COVID-19.

On the campaign trail, he vows to bring “accountability” to the agencies and officials who advocated for COVID mitigation policies DeSantis disagreed with.

“We are going to usher in a reckoning for the federal government and its associated agencies’ handling of the COVID-19 pandemic,” he said at an event in Gardnerville, Nevada, in June.