Florida Department of Health

09/12/2024 | Press release | Distributed by Public on 09/13/2024 09:05

Updated Guidance for COVID-19 Boosters 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 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. The FDA approved the vaccine 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.

The most recent booster approvalwas 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.

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.