Q: I was sent the bulletin from the Florida Health Department regarding 2024-2025 COVID-19 vaccines. It contains a lot of confusing and concerning pieces of information. Can you help me understand it?
A: The Florida Department of Health’s bulletin contains a lot of misleading and inaccurate statements. They fail to mention the risks of infection compared to the vaccine. The available data supports that the COVID-19 vaccines are safe and effective.
On Thursday, September 12th, the Florida Department of Health released a bulletin about the Fall 2024-2025 COVID-19 vaccines. Unfortunately, the bulletin contains a significant amount of misleading and inaccurate information. Below we address the claims made in the bulletin.
In the beginning of the bulletin there were some general points raised that are addressed below:
🔷 The new COVID-19 vaccines from Pfizer, Moderna, and Novavax target specific strains: KP.2 for Pfizer and Moderna, and JN.1 for Novavax. Contrary to what the bulletin suggests, these vaccines are not targeting the original Omicron variant. These variants are descendants of omicron that are currently circulating.
The updated vaccines are closely aligned with the variants currently circulating. Data from previous years has shown that getting an annual COVID-19 vaccine provides a significant boost in protection even if they are not a perfect match.
🔷 Data from the vaccine manufacturers show that the new vaccines increase the production of antibodies that target the current circulating variants.
🔷 The bulletin stated that the COVID-19 vaccines were not tested through randomized control trials (RCTs). RCTs are essential for approving new vaccines, and we have this type of data for the original COVID-19 vaccines. However, when vaccines are updated, a full RCT measuring outcomes like hospitalization is not required again. Instead, manufacturers can use markers from the blood to show the vaccine generates an immune response. Pfizer, Moderna and Novavax provided this data to the FDA for this year’s COVID-19 vaccines This is like how we update flu vaccines every year. Flu vaccines are designed to target the strains that are expected to circulate, but they aren’t always a perfect match. Despite this, we don’t need hospitalization or death data before approving updated flu vaccines.
The bulletin then listed claims regarding the safety and efficacy of the COVID-19 vaccines. Overall, the bulletin overlooks the significant risks of COVID-19 infection, which are much greater than the risks associated with vaccination. It fails to mention these infection risks altogether.
Each claim outlined is addressed below:
🔶 Myocarditis: There is a low risk of myocarditis after receiving a COVID-19 vaccine, especially in young males. But the risk of developing myocarditis from a COVID-19 infection is higher. Additionally, a recent study compared myocarditis outcomes from COVID-19 infection, vaccination, and other causes. The results showed that individuals who developed myocarditis from the vaccine were less likely to die, be rehospitalized, or experience other serious cardiovascular events.
🔶 Postural Orthostatic Tachycardia Syndrome (POTS): The referenced study does suggest a possible link between POTS and COVID-19 vaccination. However, the same research shows that individuals diagnosed with COVID-19 are five times more likely to develop POTS. The study authors emphasized that “while we see a potential link between COVID-19 vaccination and POTS, preventing COVID-19 through vaccination is still the best way to reduce your risk of developing POTS”
🔶 Autoimmunity: The study cited in the bulletin was misinterpreted. The study authors write in the abstract that “that the risk of developing most autoimmune diseases did not increase following mRNA vaccination”. In the few cases where it did find an association they didn’t factor in whether participants had been infected with COVID-19. This is a serious issue because many studies now show that COVID-19 infection is linked to autoimmunity. There is also evidence that COVID-19 vaccines can reduce this risk.
🔶 Effectiveness: The COVID-19 vaccines wane over time, but they do not increase the likelihood of infection. Data from prior years shows that COVID-19 vaccines do increase protection against symptomatic infection, severe disease, and hospitalization. Even once protection against infection has waned in about 2-6 months, protection against severe illness remains.
🔶 mRNA persistence: A virus cannot reproduce without infecting a host cell and using that cell to make more of itself. When someone is infected with SARS-CoV-2, the virus brings the RNA instructions to produce 29 different proteins. The virus then replicates and spreads, infecting more cells throughout the body. In contrast, the COVID-19 vaccine contains only one piece of mRNA that instructs the body to make just one protein. mRNA is unstable and once the vaccine mRNA is broken down it cannot be remade because the vaccine cannot reproduce. As a result, during a SARS-CoV-2 infection, you are exposed to far more RNA and proteins than from the vaccine. Additionally, data shows that SARS-CoV-2 can persist in some people long after infection, which may contribute to the development of long COVID.
🔶 DNA integration: The bulletin references a preprint regarding DNA in COVID-19 vaccines. This preprint is problematic and presents unreliable data. Regulatory agencies, like the FDA, set strict limits for DNA content in vaccines, which are measured using a standard technique called quantitative polymerase chain reaction ( qPCR). The authors tried to use non-standard, unvalidated techniques for measurement to state this was an issue. However, the preprint shows that all their samples were below the regulatory limit when they were measured by qPCR.
Additional Point:
♦️ Long COVID: The Florida bulletin failed to mention long COVID, which remains a significant risk after infection. Many studies have shown that vaccines help reduce the risk of developing long COVID, even in children.
Nothing in life is completely risk-free. However, it’s important to consider the risks of COVID-19 infection when deciding whether to vaccinate. This doesn’t mean the vaccine is without risk, and for those who experience a rare side effect, it can be life-altering. This can distort their perception of risk, but it doesn’t change the overall data. The data shows that COVID-19 infection poses a greater likelihood of risk than the vaccine.
References (in order of post content):
1. Florida Health: Updated Guidance for COVID-19 Boosters for the Fall and Winter 2024–2025 Season
2. FDA: FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants
3. FDA: FDA Authorizes Updated Novavax COVID-19 Vaccine to Better Protect Against Currently Circulating Variants
4. CDC: COVID Data Tracker
5. CDC: Effectiveness of COVID-19 (2023-2024 Formula)Vaccines
6. NIH: Methodological Analysis: Randomized Controlled Trials for Pfizer and Moderna COVID-19 Vaccines
7. NEJM: Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
8. NEJM: Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months
9. NEJM: Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine
10. HHS & FDA: Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines
11. FDA: Moderna COVID-19 Vaccines Update
12. FDA: 2024-2025 COVID-19 Vaccine Formula: Pfizer/BioNTech Clinical and Preclinical Supportive Data
13. FDA: Novavax Data in Support of 2024-2025 Vaccine Update
14. CDC: Morbidity and Mortality Weekly Report 2/1/24
15. FDA: Moderna COVID-19 Vaccines Update
16. JAMA Network: Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021
17. NIH PubMed: Risk of Myocarditis After Sequential Doses of COVID-19 Vaccine and SARS-CoV-2 Infection by Age and Sex
18. JAMA Network: Long-Term Prognosis of Patients With Myocarditis Attributed to COVID-19 mRNA Vaccination, SARS-CoV-2 Infection, or Conventional Etiologies
19. Nature: Apparent risks of postural orthostatic tachycardia syndrome diagnoses after COVID-19 vaccination and SARS-Cov-2 Infection
20. Cedars Sinai: COVID Infection, Vaccination Linked to Heart Condition
21. Nature: Long-term risk of autoimmune diseases after mRNA-based SARS-CoV2 vaccination in a Korean, nationwide, population-based cohort study
22. Nature: High risk of autoimmune diseases after COVID-19
23. The Lancet: Risk of autoimmune diseases following COVID-19 and the potential protective effect from vaccination: a population-based cohort study
24. Nature: Structure genomics of SARS-CoV-2 and its Omicron variant: drug design templates for COVID-19
25. Nature: Deaths in children and young people in England after SARS-CoV-2 infection during the first pandemic year
26. The Lancet: Plasma-based antigen persistence in the post-acute phase of COVID-19
27. Science: Tissue-based T cell activation and viral RNA persist for up to 2 years after SARS-CoV-2 infection
28. Journal of Medical Virology: Persistent circulation of soluble and extracellular vesicle-linked Spike protein in individuals with postacute sequelae of COVID-19
29. OSF Preprints: 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.
30. The Lancet: Effectiveness of COVID-19 vaccines to prevent long COVID: data from Norway
31. NEJM: Postacute Sequelae of SARS-CoV-2 Infection in the Pre-Delta, Delta, and Omicron Eras
32. Cambridge University Press: The effectiveness of COVID-19 vaccine in the prevention of post-COVID conditions: a systematic literature review and meta-analysis of the latest research
33. Nature: Persistence in risk and effect of COVID-19 vaccination on long-term health consequences after SARS-CoV-2 infection
34. American Academy of Pediatrics: Vaccine Effectiveness Against Long COVID in Children
