Florida Dept of Health, Surgeon General, Joseph Ladapo, MD, Advises Against Use of mRNA C0\/lD \/a<<ines.
Updated Guidance for C0\/lD \/a<<ines B00sters for the Fall and Winter 2024–2025 Season
Tallahassee, Fla. – The Florida Department of Health (Department) is reminding health care providers of the importance of remaining up to date with current literature related to C0\/lD \/a<<ines and b00sters, and the importance of providing patients with informed consent. Click Here for Original Version.
On August 22, 2024, the United States Food and Drug Administration (FDA) approved and authorized updated versions of mRNA C0\/lD \/a<<ines from Pfizer-BioNtech and Moderna. The FDA approved the C0\/lD \/a<<ines for people 12 and older and provided emergency use authorization for children 6 months to 11 years old. The stated target of these boosters is the Omicron variant which is not causing a significant number of infections.
No Clinical Trial Data, No Protection for Current Dominant Strain
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 C0\/lD \/a<<ine manufacturers to demonstrate their boosters prevent hospitalizations or death from C0\/lD illness.
No Safety Nor Efficacy Data
Additionally, the federal government has failed to provide sufficient data to support the safety and efficacy of C0\/lD \/a<<ine boosters, or acknowledge previously demonstrated safety concerns associated with COVID-19 vaccines and boosters, including:
1) prolonged circulation of mRNA and spike protein in some vaccine recipients,
2) increased risk of lower respiratory tract infections, and
3) increased risk of autoimmune disease after vaccination.
Health care providers are encouraged to share information in this guidance in discussions with patients regarding the mRNA C0\/lD \/a<<ines and boosters.
Advises Against Use of mRNA C0\/lD \/a<<ines
Based on the high rate of global immunity and currently available data, the State Surgeon General advises against the use of mRNA C0\/lD \/a<<ines. Any provider concerned about the health risks associated with C0\/lD \/a<<ines for patients over the age of 65 or with underlying health conditions should prioritize patient access to non-mRNA C0\/lD \/a<<ines and treatment.
Safety and Efficacy Concerns
Providers and patients should be aware of outstanding mRNA COVID-19 vaccine safety and efficacy concerns:
1) The mRNA C0\/lD \/a<<ines present a risk of subclinical and clinical myocarditis and other cardiovascular conditions among otherwise healthy individuals.
2) The mRNA C0\/lD \/a<<ines may be associated with an increased risk of postural orthostatic tachycardia syndrome (POTS).
3) The mRNA C0\/lD \/a<<ines may be associated with an increased risk of autoimmune diseases including systemic lupus erythematosus (SLE), rheumatoid arthritis, and psoriasis.
4) Throughout the pandemic, studies across geographic regions found that the mRNA C0\/lD \/a<<ines 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.
5) Elevated levels of mRNA and spike protein from the mRNA C0\/lD \/a<<ines persist among some individuals for an indefinite period, which may carry health risks.
6) Potential DNA integration from the mRNA C0\/lD \/a<<ines 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 C0\/lD \/a<<ines recipients.
7) There is unknown risk of potential adverse impacts with each additional dose of the mRNA C0\/lD \/a<<ines; currently individuals may have received five to seven doses (and counting) of this vaccine over a 3-year period.
Health recommendations: Improving habits and overall health help manage and reduce the risk of heart disease, type 2 diabetes, and obesity, risk factors for serious illness from COVID-19.
The State Surgeon General and the Department continue to encourage Floridians to prioritize their overall health by:
Staying physically active,
Minimizing processed foods,
Prioritizing vegetables and healthy fats, and
Spending time outdoors to support necessary vitamin D levels.
On September 13, 2023, State Surgeon General Dr. Joseph A. Ladapo provided guidance against C0\/lD \/a<<ine boosters for individuals under 65 and younger. In addition to aforementioned concerns, providers and patients should be aware of outstanding safety and efficacy concerns outlined in the State Surgeon General’s previous booster guidance released in September 2023.
Header Images:
Official image of Joseph Ladapo, Florida State Surgeon General. Date 11 October 2022
Source State Surgeon General | Florida Department of Health
Author Florida Department of Health, public domain.
Courtesy of Wikimedia Commons
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Logo for the Florida Department of Health 25 April 2013
Source Own work, Author Jenn.case, Creative Commons Attribution-Share Alike 4.0 International license. Courtesy of Wikimedia Commons.
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The above is a public health announcement from the State of Florida Department of Health
Click Here to see the original announcement from the Department of Health.
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