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E-mail to the FDA
I wrote an email to the FDA...
Date: 5/8/2009 12:01:09 PM ( 15 y ) ... viewed 4422 times
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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?
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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
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.
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.
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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.
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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.
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.
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.
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| [Code of Federal Regulations] |
| [Title 21, Volume 7] |
| [Revised as of April 1, 2008] |
| [CITE: 21CFR610.15] |
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CHAPTER I--FOOD AND DRUG
ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES |
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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]
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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?
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