On August 22, 2024, the U.S. Food and Drug Administration (FDA) approved updated mRNA COVID-19 vaccines from Pfizer-BioNTech and Moderna for people aged 12 and older, with emergency use authorization extended to children between 6 months and 11 years old. The stated target of these boosters is the Omicron variant, which currently does not account for a significant number of infections.
The Florida Department of Health has raised concerns regarding the recent booster approval process. According to the department, “The most recent booster approval was granted in the absence of booster-specific clinical trial data performed in humans. Furthermore, this booster does not protect against the currently dominant strain, accounting for approximately 37% of infections in the United States. There are currently limited data to inform whether these boosters offer any substantial protection against the virus and subsequent circulating variants. Although randomized clinical trials are normally used to approve therapeutics, the federal government has not required COVID-19 vaccine manufacturers to demonstrate their boosters prevent hospitalizations or death from COVID-19 illness.”
The department also notes that “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,” listing issues such as prolonged circulation of mRNA and spike protein in some recipients, increased risk of lower respiratory tract infections, and higher risk of autoimmune disease after vaccination.
Health care providers are encouraged by state officials to discuss this guidance with patients considering mRNA COVID-19 vaccines or boosters.
Based on current global immunity rates and available data, State Surgeon General Dr. Joseph A. Ladapo advises against using mRNA COVID-19 vaccines. The guidance states: “Any provider concerned about the health risks associated with COVID-19 for patients over the age of 65 or with underlying health conditions should prioritize patient access to non-mRNA COVID-19 vaccines and treatment.”
The department highlights several ongoing safety and efficacy concerns related to mRNA vaccines:
“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.
Throughout the pandemic, studies across geographic regions found that the mRNA COVID-19 vaccines are associated with negative effectiveness after four to six months. As efficacy waned, studies showed that COVID-19 vaccinated individuals developed an increased risk for infection.
Elevated levels of mRNA and spike protein from the mRNA COVID-19 vaccine persist among some individuals for an indefinite period, which may carry health risks.
Potential DNA integration from the mRNA COVID-19 vaccines pose unique and elevated risk to human health and to the integrity of the human genome, including the risk that DNA integrated into sperm or egg gametes could be passed onto offspring of mRNA COVID-19 vaccine recipients.
There is unknown risk of potential adverse impacts with each additional dose of the mRNA COVID-19 vaccine; currently individuals may have received five to seven doses (and counting) of this vaccine over a 3-year period.”
Officials continue encouraging Floridians to focus on overall health measures such as regular physical activity, reducing processed foods intake, eating more vegetables and healthy fats, and spending time outdoors for vitamin D support.
This updated guidance follows previous recommendations issued by Dr. Ladapo on September 13, 2023 against use of boosters for those under age 65.
