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To: CBER OCOD Consumer Account Subject: What are the ingredients of vaccine adjuvants? CBER, one of six centers within FDA, is responsible for the regulation of biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, and cell, tissue and gene therapy products.

There are a number of vaccines that list aluminum adjuvant as one of the ingredients. We hope that the following information helpful: Aluminum adjuvants are primarily used in vaccines to help enhance or direct an immune response.

Aluminum in the form of aluminum hydroxide, aluminum phosphate or alum has been commonly used as adjuvants in many vaccines licensed by FDA for over six decades.

A minimum concentration of antibiotics, other than penicillin, may be added to the production substrate of viral vaccines. Otherwise, you may contact our office directly toll free at 800-835-4709. Revised: 4/15/2010 Seems the FDA made peanut and soy oils GRAS and do not require them to be listed as an ingredient.

So actually, the FDA has no idea if there is oil in the adjuvants because it's not on the ingredient list that gets submitted to them!

As such, a commitment to ensuring the safety and efficacy of all biological products, including vaccines, is one of our highest priorities. Please explain what they can and cannot have in vaccines that can be a trade secret. The antigens used in the formulation are bound to the aluminum hydroxide in order to boost the immune response in the recipient.

The amount of adjuvant, as with any other ingredient, within a vaccine formulation may vary by manufacturer.

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