Dr. Ladapo, Florida State Surgeon General vs FDA/CDC

Timeline

2023-02-15 Dr. Ladapo letter to FDA/CDC
https://twitter.com/FLSurgeonGen/status/1626021529048809472

• Claims without evidence that increased rate of VAERS reports is not due to increased reporting, but is more likely to reflect a pattern of increased risk from mRNA based COVID-19 vaccines.
• References a "recent study" that was unauthored, unpublished, and not peer reviewed. According to MedPageToday, the "recent study" is this, discussed here and here

2023-03-10 CDC/FDA response to Dr. Ladapo's letter
https://www.cdc.gov/media/releases/2023/p0313-letter.html

• Points out Dr. Ladapo's misunderstandings of VAERS

2023-05-10 Dr. Ladapo letter to FDA/CDC
https://www.floridahealth.gov/_documents/newsroom/press-releases/2023/05/20230510-florida-department-of-health-letter-to-fda-and-cdc.pdf

• claims without evidence that FDA/CDC collectively decided to deny that natural immunity confers comparable or superior protection to COVID-19 vaccination
• claims without evidence that FDA/CDC collectively decided to delay acknowledging the risks of vaccine induced myocarditis
• claims without evidence that the number of VAERS reports suggest a poor safety profile.
• suggested that rates of "incapacitation" after mRNA vaccination were higher than other vaccines, but this was based entirely on AE reporting rates.
• relied on the widely discredited study: Fraiman J et al, Lancet. 2002
• made a series of demands.

2023-12-06 Dr. Ladapo letter to FDA/CDC
https://www.floridahealth.gov/about/_documents/12-06-2023-DOH-Letter-to-FDA-RFI-on-COVID-19-Vaccines.pdf?utm_source=floridahealth.gov&utm_medium=referral&utm_campaign=PressRelease&utm_content=Florida's_Future_Budget&url_trace_7f2r5y6=Press_Release_Template_fry_2023_alt.docx

• Expressed concern about DNA integration, referencing the preprint article (not peer reviewed) "DNA fragments detected in monovalent and bivalent Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines from Ontario, Canada: Exploratory dose response relationship with serious adverse events."
• Referenced 2007 FDA guidance on regulatory limits for DNA vaccines, suggesting that the concerns noted in that document apply to mRNA-based vaccines.
• Asked 3 questions in relation to the risks of DNA integration
• Demanded a response to this and the previous letter by 2023-12-13

2023-12-14 FDA response to Dr. Ladapo.
https://www.fda.gov/media/174875/download

• KEY POINT: Asserts that "No SV40 proteins are encoded for or are present in the vaccines". This does not dismiss the potential presence of SV40 promoter/enhancer. However, since the SV40 promoter/enhancer lacks the capacity to generate proteins, there is no conceivable pathway for harm to occur.
• Acknowledges the minute quantities of residual DNA fragments left over after DNAse treatment during manufacturing.
• KEY POINT: Based on fundamental principles of cellular biology ("on first principle..."), it is implausible that the residual small DNA fragments could get into the nuceus and be incorporated into chromosomal DNA.
• Animal studies involving all vaccine components including residual DNA have found no evidence of genotoxicity. This includes animal studies going back over the past decade.
• Global pharmacovigilance (safety monitoring) data after over one billion doses of mRNA vaccines show no evidence of harm to the genome (genotoxicity), such as increased rates of cancer.
• There are internationally agreed upon recommendations for the quantity of residual DNA present in all biological products including mRNA vaccines. A link to a 2010 guidance document is provided.
• The presence of residual DNA following DNAse treatment results in the presence of DNA fragments at a quantity that is less than three orders of magnitude lower than the quantity of the RNA dose by weight.
• Contamination with residual DNA fragments is monitored routinely using a validated quantitative PCR assay to ensure they are within the product specification.
• In a footnote, points out that the 2007 guidance referenced by Dr. Ladapo was developed for DNA vaccines, not for DNA as a contaminant in other vaccines. Therefore it is not applicable to mRNA COVID-19 vaccines.
• COVID-19 vaccines have saved and continue to save many lives.
• Misinformation results in lower vaccine uptake which is contributing to the continued death and serious illness toll of COVID-19.

2024-01-03 PRESS RELEASE: Florida State Surgeon General Calls for Halt in the Use of COVID-19 mRNA Vaccines
https://www.floridahealth.gov/newsroom/2024/01/20240103-halt-use-covid19-mrna-vaccines.pr.html

• This press release largely re-states the content of the December 6 letter.
• Suggests that the FDA is not following their own 2007 guidance, but neglected to mention that this guidance was for DNA vaccines, not mRNA vaccines, so it is not applicable.
• Incorrectly stated that "The FDA has provided no evidence that these risks have been assessed to ensure safety". In fact the FDA stated that there was no evidence of genotoxicity in a decade of mRNA vaccine animal studies, including studies with the complete COVID-19 vaccine including residual DNA. The FDA also stated that after over one billion doses, global pharmacovigilence data reveals no evidence of genotoxicity (such as increased cancer rates).
• Ignores that fact that basic principles of biology render the claimed risk entirely implausible.

Other resources

CDC, FDA Heads Fire Back at Ladapo Letter
https://www.medpagetoday.com/special-reports/features/103518 (2023-12-21)

No, COVID mRNA Vaccines Won’t Damage Your DNA
https://www.scientificamerican.com/article/no-covid-mrna-vaccines-wont-damage-your-dna1/ (2024-01-04))

Fact Check: No evidence for vaccine DNA risk raised by Florida Surgeon General
https://www.reuters.com/fact-check/no-evidence-vaccine-dna-risk-raised-by-florida-surgeon-general-2024-02-05/ (2024-02-05)