The Pfizer-BioNTech COVID-19 vaccine: Active Ingredients

 The document does provide some information on the composition of the Pfizer-BioNTech COVID-19 vaccine, specifically mentioning its mRNA-Lipid Nanoparticle (LNP) formulation. However, it does not provide a full detailed breakdown of every ingredient in the formulation. Here’s what is disclosed:

Key Ingredients Mentioned in the Document

1. mRNA (BNT162b2) – Encodes a modified SARS-CoV-2 Spike (S) protein.
2. Lipid Nanoparticles (LNPs) – Serve as a delivery system for the mRNA, allowing it to enter human cells. The document confirms the LNP formulation contains four different lipids in a specific ratio, but does not list them all.
3. Buffer Solution – The vaccine must be diluted with 0.9% sodium chloride (saline) injection before use.

Missing Detailed Ingredient List

The document does not disclose specific excipients, stabilizers, or the exact composition of the lipid nanoparticles (such as the exact lipids and their concentrations). The official FDA fact sheet or Pfizer’s own published documents typically list those ingredients.

Here's a detailed breakdown of its ingredients:

The Pfizer-BioNTech COVID-19 vaccine, also known as COMIRNATY, comprises several components designed to ensure its efficacy and stability. Here's a detailed breakdown of its ingredients:

Active Ingredient:

• Messenger RNA (mRNA): This is the core component that encodes the SARS-CoV-2 spike protein, prompting the body to produce an immune response.

Lipid Nanoparticles:

These lipids form a protective shell around the mRNA, facilitating its delivery into human cells:

1. ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate): A lipid that aids in forming the nanoparticle structure.

2. 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide: Enhances the stability and solubility of the lipid nanoparticles.

3. 1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC): A phospholipid that contributes to the structural integrity of the nanoparticles.

4. Cholesterol: Provides structural support to the lipid nanoparticles.

Additional Components:

Depending on the specific formulation, the vaccine includes:

• Buffering Agents:

  • Tromethamine and Tromethamine Hydrochloride: Maintain the vaccine's pH balance.

  • Potassium Chloride, Monobasic Potassium Phosphate, Sodium Chloride, and Dibasic Sodium Phosphate Dihydrate: These salts help stabilize the vaccine's pH and maintain isotonicity.

• Stabilizer:

  • Sucrose: Acts as a cryoprotectant, preserving the vaccine during freezing.

It's important to note that the specific combination of buffering agents can vary between different vaccine presentations. For instance, some formulations use tromethamine and tromethamine hydrochloride, while others incorporate potassium chloride and related salts. Additionally, the vaccine is free from preservatives and adjuvants.

For a comprehensive list of ingredients and detailed information, you can refer to the FDA's Fact Sheet for Recipients and Caregivers.

fda.gov