I wrote an email to the FDA...

Date:   5/8/2009 12:01:09 PM ( 15 y ago)

I wrote an e-mail to the FDA

Sent: Friday, April 24, 2009 11:37 AM To: CBER OCOD Consumer Account Subject: What are the ingredients of vaccine adjuvants? There are a number of vaccines that list aluminum adjuvant as one of the ingredients. What are the ingredients of that adjuvant? Boostrix by GlascoSmithKline is one of them. What exactly is in the adjuvant? Thanks, Barbara Gregory

From: CBER OCOD Consumer Account <ocod@fda.hhs..gov> Subject: RE: What are the ingredients of vaccine adjuvants? Date: Thursday, April 30, 2009, 10:28 AM   Dear Ms. Gregory:   Thank you for your inquiry to the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER).  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.   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.   Information related to the adjuvant used in vaccines licensed by FDA can be found in the product labeling.  Most of the labels can be found on CBER’s list of licensed vaccines at  http://www.fda.gov/cber/vaccine/licvacc.htm.  For information not found in the labeling, you may contact the manufacturer of the product of interest directly for additional information.     Protecting and improving public and individual health is the Agency's primary mission.  As such, a commitment to ensuring the safety and efficacy of all biological products, including vaccines, is one of our highest priorities.  We hope this information is helpful.  Sincerely, H.A.  Consumer Safety Officer Consumer Affairs Branch Division of Communication and Consumer Affairs Center for Biologics Evaluation and Research US Food and Drug Administration   This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

Sent: Tuesday, May 05, 2009 8:59 PM To: CBER OCOD Consumer Account Subject: Please explain trade secrets Since you cannot tell me what the actual ingredients are in vaccine adjuvants, I would like to know what the law is as applied to vaccine manufacturers. Please explain what they can and cannot have in vaccines that can be a trade secret. Thank you, Barbara F. Gregory

Friday, May 8, 2009 Dear Ms. Gregory: To the best of my knowledge, aluminum in the form of aluminum hydroxide is the adjuvant used in the production of Boostrix.  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.  However, they are still required to provide data to FDA demonstrating that the amount of adjuvant, in this case aluminum, is necessary to enhance the antigenicity of the vaccine and that the vaccine containing this amount of aluminum is safe for the indicated use.   Federal regulations pertaining to biological products can be found in Title 21 Code of Federal Regulations (CFR) Parts 600-680.  Specific regulations regarding adjuvants can be found in 21 CFR 610.15.  I have provided the following links to the CFRs for your convenience.  [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm]   [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=610.15] We hope this information is helpful.  If you have further questions feel free to contact our office at ocod@fda.hhs.gov, or by phone 301-827-2000. Sincerely, H.A. Consumer Safety Officer Consumer Affairs Branch Division of Communication and Consumer Affairs Center for Biologics Evaluation and Research US Food and Drug Administration This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

[Code of Federal Regulations] [Title 21, Volume 7] [Revised as of April 1, 2008] [CITE: 21CFR610.15] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER F--BIOLOGICS PART 610 -- GENERAL BIOLOGICAL PRODUCTS STANDARDS Subpart B--General Provisions Sec. 610.15 Constituent materials. (a)Ingredients, preservatives, diluents, adjuvants. All ingredients used in a licensed product, and any diluent provided as an aid in the administration of the product, shall meet generally accepted standards of purity and quality. Any preservative used shall be sufficiently nontoxic so that the amount present in the recommended dose of the product will not be toxic to the recipient, and in the combination used it shall not denature the specific substances in the product to result in a decrease below the minimum acceptable potency within the dating period when stored at the recommended temperature. Products in multiple-dose containers shall contain a preservative, except that a preservative need not be added to Yellow Fever Vaccine; Poliovirus Vaccine Live Oral; viral vaccines labeled for use with the jet injector; dried vaccines when the accompanying diluent contains a preservative; or to an Allergenic Product in 50 percent or more volume in volume (v/v) glycerin. An adjuvant shall not be introduced into a product unless there is satisfactory evidence that it does not affect adversely the safety or potency of the product. The amount of aluminum in the recommended individual dose of a biological product shall not exceed: (1) 0.85 milligrams if determined by assay; (2) 1.14 milligrams if determined by calculation on the basis of the amount of aluminum compound added; or (3) 1.25 milligrams determined by assay provided that data demonstrating that the amount of aluminum used is safe and necessary to produce the intended effect are submitted to and approved by the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing addresses in 600.2 of this chapter). (b)Extraneous protein; cell culture produced vaccines. Extraneous protein known to be capable of producing allergenic effects in human subjects shall not be added to a final virus medium of cell culture produced vaccines intended for injection. If serum is used at any stage, its calculated concentration in the final medium shall not exceed 1:1,000,000. (c)Antibiotics. A minimum concentration of antibiotics, other than penicillin, may be added to the production substrate of viral vaccines. [38 FR 32056, Nov. 20, 1973, as amended at 46 FR 51903, Oct. 23, 1981; 48 FR 13025, Mar. 29, 1983; 48 FR 37023, Aug. 16, 1983; 49 FR 23834, June 8, 1984; 50 FR 4134, Jan. 29, 1985; 51 FR 15607, Apr. 25, 1986; 55 FR 11013, Mar. 26, 1990; 70 FR 14985, Mar. 24, 2005] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=610.15

Friday, May 9, 2009 I'm really not interested in the aluminum in the adjuvant. I am interested in the oils used in the adjuvant. The way I read the regulations, as long as the oil meets your purity standards it is fine to use and does not have to be listed on the package insert? And protein in the culture medium... the way I read that is the final culture medium is not to contain extraneous protein but the earlier culture mediums could contain a variety of protein? Thanks, Barbara F. Gregory

 

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