New COVID Boosters Not Recommended By FL Surgeon General

FLORIDA — Despite the U.S. Food and Drug Administration's emergency authorization Monday of a new COVID-19 booster that will be available at the end of this week, Florida's surgeon general is recommending that anyone under age 65 years or older avoid getting the COVID-19 booster vaccine.

On Wednesday, Gov. Ron DeSantis held a discussion with State Surgeon General Dr. Joseph Ladapo and public health experts about the recent federally approved COVID-19 mRNA boosters.

While there, the surgeon general announced new COVID-19 booster guidance advising against the use of COVID boosters for people under the age of 65.

He said his recommendation is based on the fact that the newly approved Food and Drug Administration's COVID boosters lack a human clinical trial and evidence of benefit or efficacy.

The federal government has spent more than $30 billion on COVID-19 vaccines, including boosters, which Ladapo said have shown little to no benefit to prevent COVID-19 infection.

“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,” said DeSantis. “Once again, Florida is the first state in the nation to stand up and provide guidance based on truth, not Washington edicts.”

“Once again, the federal government is failing Americans by refusing to be honest about the risks and not providing sufficient clinical evidence when it comes to these COVID-19 mRNA shots, especially with how widespread immunity is now,” said Ladapo. “In Florida, we will always use common sense and protect the rights and liberties of Floridians, including the right to accurate information.”

Wednesday's announcement builds on actions taken by the DeSantis administration to push back on the FDA and CDC’s approval and mandates of COVID-19 vaccines during the pandemic. DeSantis said trials were rushed and "even when the evidence doesn’t line up."

In May, DeSantis signed legislation codifying permanent COVID-19 protections in the state that:

• Permanently prohibit COVID-19 vaccine passports in Florida;
• Permanently prohibit COVID-19 vaccine and mask requirements in all Florida schools;
• Permanently prohibit COVID-19 masking requirements at businesses;
• Permanently prohibit employers from hiring or firing based on mRNA shots.

Ladapo's caution goes against the National Institutes of Health's recommendation.

The NIH said clinical trials support emergency use authorization of COVID‐19 messenger RNA (mRNA) vaccines in the United States and that a two-dose series is 90 percent effective in preventing COVID-19 infections.

Similarly, the Centers for Disease Control and Prevention recommends that people ages 6 months and older receive at least one bivalent mRNA COVID-19 vaccine, and noted in its updated advisory that the new booster is expected to be available by the end of this week.

In a statement issued Monday, the U.S. Food and Drug Administration announced that it has authorized the emergency use of updated COVID-19 vaccines that are formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death.

This includes the 2023 mRNA vaccines manufactured by ModernaTX Inc. and Pfizer Inc.

The FDA is confident in the safety and effectiveness of these updated vaccines and the agency’s benefit-risk assessment demonstrates that the benefits of these vaccines for individuals 6 months of age and older outweigh their risks, said the FDA's director of biologics evaluation and research, Dr. Peter Marks.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Marks. "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.”

In new guidelines posted by the Florida Department of Health, however, Ladapo said the vaccines result in an increased risk of infection after four to six months, can cause myocarditis and other cardiovascular conditions among otherwise healthy people and can result in elevated levels of spike protein, which may carry health risks.