FDA Lacks Adequate Safety Testing of Lipid Nanoparticles (LNPs) in COVID-19 Vaccines

Once more, FDA puts its zealous policy to vaccinate everyone ahead of health. As many are aware, both Pfizer’s and Moderna’s COVID-19 vaccines are designed with lipid nanoparticles (LNPs), which are essentially fatty droplets that surround, protect, and transport the mRNA into cells. The problem is that these LNPs have had very little safety testing, in part because COVID-19 vaccines are the first time LNPs have been used as an excipient in a vaccine– i.e., a substance that helps deliver the vaccine’s main ingredient.

When the FDA hosted an event called, “NanoDay Symposium” with presenters discussing the development of drugs and vaccines containing nanoparticles, ICAN watched with interest. Unfortunately, the presentations were full of misinformation, which prompted ICAN, through its attorneys, to write a letter confronting the FDA about the falsehoods and the egregious lack of safety testing for LNPs.

In the letter, ICAN makes what should have been an obvious point to the FDA: just because the LNP excipients assist with the delivery of the main ingredient in COVID-19 vaccine (mRNA), they are nonetheless a vaccine component that require safety testing.

In fact, the FDA’s own guidance document recommends extensive safety tests on all new excipients. But like so many things related to vaccines, the FDA dropped the ball on this crucial step and gave the manufacturers a pass on these testing requirements. ICAN’s letter therefore demanded that the FDA adhere to its own guidance by subjecting the LNPs to the whole gamut of tests required of every other “novel” excipient.

ICAN’s letter also hammered the presenters at FDA NanoDay for spreading misinformation about LNPs, including making the false claim that the changes they make to one’s genetic blueprint are safe, which is contradicted by mountains of evidence showing these alterations cause a possibly dangerous suppression of the immune system.

It is vitally important that the FDA recognize these errors and change course given that pharmaceutical companies have countless other vaccines in the works which utilize this same technology. The FDA simply cannot continue to lead the public into a false sense of security regarding safety. ICAN will stay on the case and keep you posted on updates as they happen. In the meantime, you can read ICAN’s letter here.

See below for more instances where ICAN sought to compel action of our health agencies: