BLA VIOLATON

>>what does the purple pfizer cap edition say about saline?

For the Pfizer-BioNTech COVID-19 Vaccine (Purple Cap edition)—which is formulated for individuals 12 years of age and older and requires dilution prior to use—the handling and preparation instructions regarding saline state the following:

Diluent Requirement: Prior to administration, the vaccine must be mixed exclusively with 0.9% sodium chloride (normal saline, preservative-free) diluent.

Volume: Specifically, 1.8 mL of the normal saline must be added to each multi-dose vial of thawed purple-cap vaccine.

Strict Restrictions:

You must NOT use bacteriostatic normal saline or any other diluents.

Only preservative-free 0.9% sodium chloride is permitted.

>>what is the source of the saline - manufacturer

The Pfizer-BioNTech product instructions do not specify a single, branded manufacturer for the saline.

Instead, the official guidance states that healthcare providers must source standard, commercially available sterile 0.9% Sodium Chloride Injection, USP (preservative-free normal saline) independently. Because normal saline is a standard pharmaceutical commodity, it can be supplied by any standard pharmaceutical manufacturer that produces sterile, preservative-free 0.9% sodium chloride for injection (such as Hospira/Pfizer, Baxter, B. Braun, or Fresenius Kabi).

>>the BLA disagrees. redacted, but :

MANUFACTURING LOCATIONS

Under this license, you are approved to manufacture COVID-19 Vaccine, mRNA drug

substance at Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC, 1 Burtt Road,

Andover, Massachusetts.

The final formulated product will be manufactured, filled,

labeled and packaged at Pfizer Manufacturing Belgium NV, Rijksweg 12, Puurs,

Belgium and at Pharmacia & Upjohn Company LLC, 7000 Portage Road, Kalamazoo,

Michigan.

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The diluent, 0.9% Sodium Chloride Injection, USP, will be manufactured at

Hospira, Inc., and at Fresenius Kabi USA, LLC, .(b) (4)(b

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That excerpt is from the FDA Biologics License Application (BLA) approval letter or regulatory supplement for the Pfizer-BioNTech vaccine. It identifies the exact authorized suppliers for the required diluent:

Hospira, Inc. Fresenius Kabi USA, LLC (with the specific manufacturing site details redacted under Freedom of Information Act exemptions, denoted by the (b)(4) code for confidential commercial information).

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While healthcare providers generally source whatever stock is available in their local supply chain during day-to-day operations, the BLA legally designates these specific manufacturers as the approved sources of 0.9% Sodium Chloride Injection, USP for use with the product under its regulatory filing.

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BP