On August 22, 2024, the U.S. Food and Drug Administration (FDA) approved updated mRNA COVID-19 vaccines from Pfizer-BioNTech and Moderna for individuals aged 12 and older, with emergency use authorization granted for children between 6 months and 11 years old. These new boosters are intended to target the Omicron variant, though this strain is not currently responsible for a significant number of infections in the United States.
The Florida Department of Health noted that the latest booster approval was made without clinical trial data specific to these boosters in humans. The department stated that "this booster does not protect against the currently dominant strain, accounting for approximately 37% of infections in the United States." According to their statement, there is limited information available about whether these boosters provide substantial protection against current or emerging variants.
The department also raised concerns regarding safety and efficacy data provided by federal authorities. It said, "the federal government has failed to provide sufficient data to support the safety and efficacy of COVID-19 boosters, or acknowledge previously demonstrated safety concerns associated with COVID-19 vaccines and boosters," including prolonged circulation of mRNA and spike protein in some recipients, increased risk of lower respiratory tract infections, and increased risk of autoimmune disease after vaccination.
Health care providers are encouraged by the department to share this guidance with patients when discussing mRNA COVID-19 vaccines and boosters. The State Surgeon General advises against using mRNA COVID-19 vaccines based on high global immunity rates and current data. Providers concerned about health risks for patients over age 65 or those with underlying conditions are advised to prioritize access to non-mRNA COVID-19 vaccines and treatments.
The department listed several ongoing concerns about mRNA vaccine safety and effectiveness:
"The mRNA COVID-19 vaccines present a risk of subclinical and clinical myocarditis and other cardiovascular conditions among otherwise healthy individuals."
"The mRNA COVID-19 vaccine may be associated with an increased risk of postural orthostatic tachycardia syndrome (POTS)."
"The mRNA COVID-19 vaccine may be associated with an increased risk of autoimmune diseases including systemic lupus erythematosus (SLE), rheumatoid arthritis, and psoriasis."
It further stated that studies across regions have shown "negative effectiveness after four to six months" for these vaccines as efficacy wanes, potentially increasing infection risk among vaccinated individuals. Concerns were also expressed about elevated levels of mRNA and spike protein persisting in some people indefinitely.
Additionally, potential DNA integration from these vaccines was described as posing unique risks to human health: "including the risk that DNA integrated into sperm or egg gametes could be passed onto offspring of mRNA COVID-19 vaccine recipients." The department highlighted unknown risks related to repeated dosing over three years.
The guidance also encourages Floridians to focus on overall health measures such as physical activity, reducing processed foods, prioritizing vegetables and healthy fats, and spending time outdoors for vitamin D.
On September 13, 2023, State Surgeon General Dr. Joseph A. Ladapo had already issued guidance against boosters for those under age 65. The department refers providers and patients back to previous statements outlining additional safety concerns from last year’s guidance.