FDA Approves Moderna’s mRNA RSV Vaccine Without Any Long-Term Safety Data

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The mRNA product was approved for public use without genotoxicity, oncogenicity, or long-term safety studies.

FDA Approves Moderna’s mRNA RSV Vaccine Without Any Long-Term Safety Data

Many have approached me at large events and have expressed concerns that the vaccine manufacturers where going to use mRNA on a non-emergency basis to make new and routine vaccinations for children and adults.

Their concerns stem from the horrific safety profile of COVID-19 mRNA products and the complete lack of testing for genotoxicity, oncogenicity, and long-term side effects.

Moderna’s mRNA RSV Vaccine

Our great concern was that mRNA COVID-19 vaccines ushered in the context of an emergency would set a new precedent for more genetic vaccines that depart from all safety standards set forth previously by the US FDA.

On May 31, 2024, Moderna received FDA approval for their mRNA RSV (respiratory syncytial virus) Vaccine mRESVIA(R). This was done without the full dossier of safety information required for a routine approval including 2-3 years of observation for standard vaccines, and at least 5 to 15 years of observation for genetic transfer technology.

Moderna’s approval marks a clear inflection point for the US FDA—synthetic mRNA will not have to meet safety standards previously put forth by the agency. From Moderna’s press release:

Moderna’s approval marks a clear inflection point for the US FDA—synthetic mRNA will not have to meet safety standards previously put forth by the agency. From Moderna’s press release:

“The FDA’s approval of mRESVIA is based on positive data from the Phase 3 clinical trial ConquerRSV, a global study conducted in approximately 37,000 adults ages 60 years or older in 22 countries. The primary analysis with 3.7 months of median follow-up found a vaccine efficacy against RSV lower respiratory tract disease (LRTD) of 83.7% (95.88% CI 66.0%, 92.2%). These results were published in The New England Journal of Medicine. A follow-up analysis of the primary endpoint was performed during FDA review, including cases that started before the primary analysis cut-off date but were not confirmed until afterward. The results were consistent with the primary analysis [VE 78.7% (CI 62.9%, 87.8%)] and were included in the U.S. package insert. An additional longer-term analysis showed continued protection against RSV LRTD over 8.6 months median follow-up.”

The press release does not tell the public the absolute risk reduction for clinically significant outcomes was far below 1%, meaning this product will not have a significant clinical impact. Consumers should know that at the bare minimum, the following safety concerns exists for any pseudouridinated, synthetic mRNA product including mRESVIA(R):

  1. Myocarditis because mRNA of all types targets the heart as shown by Krauson et al
  2. Auto-immunity because of the generation of foreign RSV proteins and frameshifted peptides as shown by Boros et al
  3. Genomic integration as shown by Alden et al
  4. Oncogenicity as shown by Seneff et al

It may turn out that uncontrolled production of stabilized RSV prefusion F glycoprotein is far more toxic than the Wuhan Spike protein causing an entire array of new problems that we will encounter as more get vaccinated over time.

I suggest if an RSV vaccine is going to be taken, select an antigen-based product (ABRYSVO, AREXVY) and not genetic mRESVIA(R).

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Peter A. McCullough, MD, MPH – President, McCullough Foundation

How to Get Ready for the Next Pandemic by Peter A. McCullough, MD, MPH

Dr. McCullough on the Steve Gruber Show

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