FDA Fails to Address DNA Adulteration Concerns
It must be concluded that the risks associated with DNA plasmid fragment adulteration when delivered with the highly active lipid nanoparticle formulations of COMIRNATY and SPIKEVAX are both real and uncharacterized, and consistent with US Federal statute CFR Title 21, CHAPTER 9, SUBCHAPTER V § 351, the products must be withdrawn from the market until the necessary tests have been performed and safety demonstrated.