FDA and Pfizer Data Allegedly Missing IMPORTANT Blood Brain Barrier Data – Letter

Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER)

Food and Drug Administration

Dept. of Health and Human Services (HHS)

Peter.Marks@fda.hhs.gov

April 16, 2022

 

Dear Dr. Marks, 

I’ve just read an article stating highly inflammatory lipid nanoparticles (LNP)s “could be responsible for adjuvanticity and some of the side effects” of certain covid vaccines. 1 Certainly inflammation is a known culprit in blood-brain barrier (BBB) injury. 2

In reviewing the article’s references, I was taken aback at the following from Moderna’s vaccine European Public Assessment Report (EPAR): “Low levels of mRNA could be detected in all examined tissues except the kidney. This included heart, lung, testis and also brain tissues, indicating that the mRNA/LNP platform crossed the blood/brain barrier, although to very low levels (2-4% of the plasma level).” 3 Notably, the quantitative amount of mRNA/LNP crossing the BBB is not specified, and the “levels” only in relation to plasma. 

 

A look at the EPAR for Pfizer confirmed this phenomenon: “Several literature reports indicate that LNP-formulated RNAs can distribute rather non-specifically to several organs such as spleen, heart, kidney, lung and brain.” 4

 

Both the Pfizer-BioNTech and Moderna vaccines are LNP-formulated, nucleoside-modified mRNA vaccines. 5

 

Due to the critical, life-preserving function of the BBB, FDA regulations, appropriately so, require drug and biologic labeling to specifically address the BBB under Clinical Pharmacology: 6

“21 CFR 201.80 Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not described in § 201.56(b)(1). 

(b) Clinical Pharmacology. 

(1) Under this section heading, the labeling shall contain a concise factual summary of the clinical pharmacology and actions of the drug in humans. The summary may include information based on in vitro and/or animal data if the information is essential to a description of the biochemical and/or physiological mode of action of the drug or is otherwise pertinent to human therapeutics. Pharmacokinetic information that is important to safe and effective use of the drug is required, if known, e.g., degree and rate of absorption, pathways of biotransformation, percentage of dose as unchanged drug and metabolites, rate or half-time of elimination, concentration in body fluids associated with therapeutic and/or toxic effects, degree of binding to plasma proteins, degree of uptake by a particular organ or in the fetus, and passage across the blood brain barrier. Inclusion of pharmacokinetic information is restricted to that which relates to clinical use of the drug. If the pharmacological mode of action of the drug is unknown or if important metabolic or pharmacokinetic data in humans are unavailable, the labeling shall contain a statement about the lack of information.”

None of the Moderna or Pfizer package inserts or fact sheets contain known BBB data. 7,8,9,10

Current FDA draft guidance states “nanomaterial excipients can be used as adjuvants for vaccines or for delivery of antigens or genetic material. Excipients (e.g., polymers, targeting agents, coating agents, and lipids) are also used as matrices to assemble structures or to stabilize more complex nanomaterials…A nanomaterial can sometimes cross biological barriers in greater amounts than the larger particle size version. This can lead to increased safety concerns in some cases, such as increased penetration of the blood-brain barrier, or the placenta. If a drug product contains nanomaterials as excipients, including excipients that function as drug carriers, the biological fate of the carriers and their potential impact on safety may need to be determined in addition to those of the active ingredient.” 11

 

In my personal evaluation, the aforementioned vaccines should have never been authorized or approved. Still, in light of the thousands of neurological adverse event reports to VAERS, DMED, and respective vaccine manufacturers, and as a stopgap measure, I ask you to urgently add all known blood brain barrier data to current labeling; a Dear Health Care Provider (DHCP) letter sent immediately could suffice in the interim. Additionally, it will be important to add all data regarding the presence of mRNA/LNP in the circulation and multiple organs to the Clinical Pharmacology section.

 

Sincerely,

Carol Taccetta, MD, FCAP

 

References

1. https://www.sciencedirect.com/science/article/pii/S2589004221014504
2. https://faculty.washington.edu/chudler/bbb.html
3. https://www.ema.europa.eu/en/documents/assessment-report/spikevax-previously-covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf
4. https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf
5. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html – appendix-f
6. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-201/subpart-C/section-201.80
7. https://www.fda.gov/media/151707/download
8. https://www.fda.gov/media/153713/download
9. https://www.fda.gov/media/155675/download
10. https://www.fda.gov/media/157232/download
11. https://www.fda.gov/media/109910/download