FDA FAILS TO REBUT EVIDENCE THAT LIPID NANOPARTICLES USED IN PFIZER’S AND MODERNA’S COVID-19 VACCINES POSE A SAFETY RISK

On January 5,2020, ICAN, through its attorneys, wrote to Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, to demand a response to the question of whether or not lipid nanoparticles used in both of the currently authorized COVID-19 vaccines are safe.

ICAN is aware that both Pfizer and Moderna have used lipid nanoparticles (“LNPs”) in their vaccines – LNPs are what the manufacturers use to surround the RNA so that it does not fall apart when injected and before reaching its target cells.  Some have compared these LNPs to a fatty envelope or a delivery vehicle to get the mRNA into the human body in one piece.

A concern arose when ICAN was alerted to a study published in 2018 titled Lipid Nanoparticles: A Novel Approach for Brain Targeting.  The study states: “…lipid nanoparticles are taken up readily by the brain because of their lipophilic nature. The bioacceptable and biodegradable nature of lipid nanoparticles makes them…suited for brain targeting.” The article also states, “these nanostructures need to be investigated intensively to successfully reach the clinical trials stage.”

ICAN wants to fully understand whether the evidence that these LNPs are easily taken up and end up in the brain is a safety concern with these two particular vaccines. ICAN, through its attorneys, has therefore sent a letter to Dr. Peter Marks, the Director of the Food and Drug Administrations’ Center for Biologics Evaluation and Research.  Dr. Marks has referred to himself as “the FDA point person on COVID-19 vaccines” and has assured Americans that the FDA “will make sure they’re safe and effective.”

ICAN therefore asked Dr. Marks: If LNPs from the vaccine, which contain mRNA, are entering brain tissue, and an immune reaction is occurring during the second dose to these LNPs, does this pose a safety concern for vaccine recipients?  ICAN asked Dr. Marks to consider the question posed and provide support for the substance of any response he provides.

On February 19, 2021, Dr. Marks provided a two-page response letter.  While it said a lot of random things about COVID-19 vaccines, it failed in any way to answer the question posed in our opening letter: “If LNPs from the vaccine, which contain the mRNA, are entering brain tissue and an immune reaction is occurring during the second dose to these LNPs, does this pose a safety concern to vaccine recipients?”

ICAN, through its attorneys, therefore sent a follow-up letter to Dr. Marks on March 12, 2021 which again asked him to answer this question.  It also provided an additional study conducted by Moderna which showed that intramuscular injection of mRNA vaccine resulted in its delivery into the brain.

As of May 5, 2021, the date this post is written, there has been no response.

The lack of response to this inquiry from Dr. Marks is highly concerning and we sure hope that he stands by his promise that he and the FDA “uphold globally respected standards for product quality, safety, and efficacy” and his statement that he would resign if “something that was unsafe or ineffective [] was being put through.”