‘EUA amendment request for Pfizer-BioNTech COVID-19 Vaccine for use in children 5 though 11 years of age‘

Vaccine formulation

Authorization is being requested for a modified formulation of the Pfizer‑BioNTech COVID-19 Vaccine. Each dose of this formulation contains 10 μg of a nucleoside-modified messenger RNA (mRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 that is formulated in lipid particles and supplied as a frozen suspension in multiple dose vials. To provide a vaccine with an improved stability profile, the Pfizer-BioNTech COVID-19 Vaccine for use in children 5-11 years of age uses tromethamine (Tris) buffer instead of the phosphatebuffered saline (PBS) as used in the previous formulation and excludes sodium chloride and potassium chloride. The packaged vials for the new formulation are stored frozen at -90°C to – 60°C. The frozen vials may be thawed and stored at refrigerator at 2°C to 8°C for up to 10 weeks. The Pfizer‑BioNTech COVID-19 Vaccine does not contain preservative. The vial stoppers are not made with natural rubber latex. For the 10-μg RNA dose, each 1.3-mL filled via vial must bediluted with 1.3mL 0.9% sodium chloride for injection to provide 10 doses at 10 μg RNA / 0.2 mL Injection volume. After dilution, the vials should be stored at 2°C to 25°C and should be used within 12 hours.

More info Via https://www.fda.gov/media/153447/download