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Page 14 in the Pfizer paperwork submitted to the FDA

 

www.fda.gov/media/153447/download

 

Authorization is being requested for a modified formulation of the Pfizer COVID-19 Vaccine. Each dose of this formulation contains 10 μg of a nucleoside-modified messenger RNA (mRNA) encoding the viral spike glycoprotein of SARS-CoV-2 that is formulated in lipid particles and supplied as a frozen suspension in multiple dose vials.

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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.

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Tromethamine is a blood acid reducer which is used to stabilize patients with heart attacks.

 

Side Effects — Respiratory depression, local irritation, tissue inflammation, injection site infection, febrile response, chemical phlebitis, venospasm (vein spasms), hypervolemia, IV thrombosis, extravasation (with possible necrosis and sloughing of tissues), transient decreases in blood glucose concentrations, hypoglycemia, and hepatocellular necrosis with infusion via low-lying umbilical venous catheters.

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