Pfizer Vax Ingredient ALC-0315 Is ‘Not for Human Use’: OSHA

The package insert for Pfizer Inc.’s mRNA vaccine reveals the drug contains an ingredient listed as “[n]ot for human or veterinary diagnostic or therapeutic use” in a technical data sheet referencing the U.S. Occupational Safety and Health Administration (OSHA).

Pfizer’s vaccine contains 0.43 mg of a synthetic lipid called ALC-0315, listed as “((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)” on page 19 of the drug’s package insert.

ALC-0315 “is for research use” and is “[n]ot for human or veterinary diagnostic or therapeutic use,” according to a data safety sheet from an American biotechnology company called Cayman Chemical updated June 2022.

The Cayman Chemical safety sheet indicates that it received the information regarding ALC-0315 from OSHA’s Hazard Communication Standard (HCS), which requires chemical manufacturers and importers to evaluate the hazards of the chemicals they produce or import and provide information about them through labels and safety data sheets, according to the U.S. Department of Labor. Employers are obligated to have this information available for their workers and provide training on how to handle the chemicals safely.

Moreover, Cayman Chemical’s product information sheet for ALC-0315 dated November 2022 explains how the substance is used in the creation of lipid nanoparticles that are used to deliver a vaccine for the coronavirus (SARS-CoV-2) to the body. The vaccine, delivered through these particles, causes the body to make antibodies that help fight the virus, according to the sheet.

However, at the bottom of the technical sheet is a warning that reads in all caps, “THIS PRODUCT IS FOR RESEARCH ONLY – NOT FOR HUMAN OR VETERINARY DIAGNOSTIC OR THERAPEUTIC USE.”

Underneath the warning is more safety data explaining that ALC-0315 is dangerous and should not be touched, eaten, breathed in, or allowed to contact an individual’s eyes, skin, or clothes.

“This material should be considered hazardous until further information becomes available. Do not ingest, inhale, get in eyes, on skin, or on clothing,” the sheet reads. “Wash thoroughly after handling. Before use, the user must review the complete Safety Data Sheet.”