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Based on the high rate of global immunity and currently available data, the State Surgeon General advises against the use of mRNA COVID-19 vaccines. • Staying physically active, • Minimizing processed foods, • Prioritizing vegetables and healthy fats, and • Spending time outdoors to support necessary vitamin D levels. Florida Department of Health, 12th September 2024 https://content.govdelivery.com/accounts/FLDOH/bulletins/3b56786?s=08 Updated Guidance for COVID-19 Boosters for the Fall and Winter 2024–2025 Season The Florida Department of Health is reminding health care providers of the importance of remaining up to date with current literature related to COVID 19 vaccines and boosters, and the importance of providing patients with informed consent. On August 22, 2024, the United States Food and Drug Administration (FDA) approved and authorized updated versions of mRNA vaccines from Pfizer-BioNtech and Moderna. https://www.fda.gov/news-events/press-announcements/fda-approves-and-authorizes-updated-mrna-covid-19-vaccines-better-protect-against-currently?utm_medium=email&utm_source=govdelivery The FDA approved the vaccine for people 12 and older and provided emergency use authorization for children 6 months to 11 years old. • Unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the updated, authorized Pfizer-BioNTech COVID-19 Vaccine or two doses of the updated, authorized Moderna COVID-19 Vaccine. The stated target of these boosters is the Omicron variant which is not causing a significant number of infections. https://publichealth.jhu.edu/2024/what-to-know-about-updated-covid-vaccines-for-2024-25?utm_medium=email&utm_source=govdelivery 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. Florida references FDA again, https://covid.cdc.gov/covid-data-tracker/?utm_medium=email&utm_source=govdelivery#variant-summary There are currently limited data to inform whether these boosters offer any substantial protection against the virus and subsequent circulating variants. https://www.idsociety.org/covid-19-real-time-learning-network/diagnostics/covid-19-variant-update/?utm_medium=email&utm_source=govdelivery#/+/0/publishedDate_na_dt/desc/ 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. Additionally, 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 vaccine recipients, • increased risk of lower respiratory tract infections, and • 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 COVID-19 vaccines and boosters. Based on the high rate of global immunity and currently available data, the State Surgeon General advises against the use of mRNA COVID-19 vaccines. 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. Safety and Efficacy Concerns Providers and patients should be aware of outstanding mRNA COVID-19 vaccine safety and efficacy concerns: • The mRNA COVID-19 vaccines present a risk of subclinical and clinical myocarditis and other cardiovascular conditions among otherwise healthy individuals. https://onlinelibrary.wiley.com/doi/10.1002/ejhf.2978?url_trace_7f2r5y6=booster-covid19.docx&utm_campaign=PressRelease&utm_content=FL_SSG_COVID-19_Boosters&utm_medium=email&utm_source=govdelivery https://www.mdpi.com/2414-6366/7/8/196?url_trace_7f2r5y6=booster-covid19.docx&utm_campaign=PressRelease&utm_content=FL_SSG_COVID-19_Boosters&utm_medium=email&utm_source=govdelivery • The mRNA COVID-19 vaccine may be associated with an increased risk of postural orthostatic tachycardia syndrome (POTS). https://www.nature.com/articles/s44161-022-00177-8?utm_medium=email&utm_source=govdelivery • The mRNA COVID-19 vaccine may be associated with an increased risk of autoimmune diseases including systemic lupus erythematosus (SLE), rheumatoid arthritis, and psoriasis. https://www.nature.com/articles/s41467-024-50656-8?utm_medium=email&utm_source=govdelivery
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