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E-mails to and from the FDA

Posted in Health,Peanut allergies by Administrator on the May 11th, 2009

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 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 , 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.[The problem with this is ANY protein along with the adjuvant can cause allergenic effects in human subjects!!! - bfg]

(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

Monday, June 15, 2009 1:51 PM

From:

"CBER OCOD Consumer Account" <ocod@fda.hhs.gov>

Dear Ms. Gregory:

First let me extend my sincerest apologies for the delayed response. Although we make every effort to respond to each inquiry that we receive in a timely manner, on occasion there are number of contributing factors that impede our ability to achieve that goal.

It is unclear from your email exactly what oil you are referring. Again, the aluminum is the adjuvant. Aluminum in the form of alum, aluminum hydroxide or phosphate is the only adjuvants used in U.S. licensed vaccines and there is no oil in those adjuvants. The adjuvant, as well as,

certain inactive ingredients

[That's right... only certain inactive ingredients not all of them. And peanut oil was considered totally safe for injection from the skin prick tests so it doesn't have to appear!! - bfg]
must appear on the package label. General requirements for the package labeling can be found in 21 CFR 610.61.

Regarding cell culture medium, 21 CFR 610.15 states, "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." It would be inaccurate to infer that earlier culture mediums used in production could contain various proteins.[How can it possibly be inaccurate? What do you feed bacteria and cells? PROTEIN!!! It isn't illegal. - bfg]

However, some of the package inserts for cell cultured vaccines do provide information on protein contents used in the manufacturing of the product

We hope this information is helpful.

Feel free to provide a contact number so that we can discuss your specific questions and/or concerns. Otherwise, you may contact our office directly toll free at 800-835-4709

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

Basically, I feel that they are either totally uninformed or perpetuating a lie or both.

If they make a distinction between the diluent and the adjuvant as being separate ingredients then perhaps you can say that the adjuvant does not contain any oil because it doesn’t contain the diluent.

Read the ingredients of the vaccines. They don’t say that they contain water or oil or any liquid. So how do you inject it without liquid?

Why would there be so many patents for adjuvants that contain oil? And if the ingredients are trade secrets like all the website I found quoting the vaccine manufacturers then how can the FDA say anything about the ingredients that they are not at liberty to disclose?

Don’t you have to have protein in the culture medium? How do you grow the bacteria without feeding it some form of protein?

I was kinda disgusted with the FDA so I wrote a letter to Merck:

Merck & Co., Inc.
One Merck Drive
P.O. Box 100
Whitehouse Station, NJ USA

Date: June 18, 2009

Re:Ingredients of vaccines

Hello,

I have a few questions regarding the ingredients of the vaccines that you manufacture.

Recombivax HB lists as ingredients: produced in yeast cells, cloned into yeast, complex fermentation medium which consists of an extract of yeast, soy peptone, adjuvanted with amorphous aluminum, hydroxyphosphate sulfate, may contain not more than 1% yeast protein

1. Won’t the combination of yeast and aluminum adjuvant cause a yeast allergy in some people?

2. Won’t the soy peptone and the aluminum adjuvant cause a soy allergy in some people?

3. What are the ingredients of the aluminum adjuvant? Does it include a liquid oil or water as an

Varivax lists monosodium L-glutamate as an ingredient.

1. Is that the same thing that people who have Chinese Restaurant Syndrome are sensitive to?

Thank you,

June 29, 2009

Dear Ms. Gregory:

Thank you for contacting Merck & Co., Inc.

As a pharmaceutical manufacturer, Merck is not in a position to provide general medical information regarding your inquiry. We encourage you to direct questions regarding disease and its management towards your physician.
If you have a question about a specific Merck product, please visit the Merck Product Information link at www.Merck.com or contact the Merck National Service Center at 1-800-NSC-MERCK (1-800-672-6372) and reference your service request number 1-3334249111.

Again, thank you for contacting Merck.

4 Comments

4 Responses to 'E-mails to and from the FDA'

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Amy S. said,

on July 9th, 2009 at 2:21 pm

Did they reply to your last email?
Administrator said,

on July 9th, 2009 at 3:10 pm

I posted the reply. Basically, they believe that all the ingredients are listed on the package insert.

All the ingredients are NOT listed on the package insert. I have shown that with all the patents for vaccine adjuvants.

You can not inject a thick batch of vaccine mixed with a gel and get something that can be injected easily. It won’t squirt out of the needle, will it?

============================================
“Aluminium hydroxide, Al(OH)3, is the most stable form of aluminium in normal conditions. It is found in nature as the mineral gibbsite (also known as hydrargillite) and its three, much more rare, polymorphs: bayerite, doyleite and nordstrandite. Closely related are aluminium oxide hydroxide, AlO(OH), and aluminium oxide, Al2O3, differing only by loss of water. These compounds together are the major components of the aluminium ore bauxite. Freshly precipitated aluminium hydroxide forms gels, which is the basis for application of aluminium salts as flocculants in water purification. This gel crystallizes with time.”

http://en.wikipedia.org/wiki/Aluminum_hydroxide

===================================
Amy S. said,

on July 9th, 2009 at 4:07 pm

Just fascinating. Of all of the research that I’ve done, I didn’t even begin to see any site that gave information on the oils being used in the vaccines in association to the food allergies that children are so rapidly being diagnosed with. You have opened my eyes to a whole other subject to google. I try to be an informed parent and unfortunately it seems as though Dr.’s aren’t allowed to pass this type of information on. And in the meantime so many children are being ‘injured’. It is so sad. Thank you so much for all of your information.
Amy S. said,

on July 9th, 2009 at 5:36 pm

“Adjuvant 65 trademark for a water-in-oil emulsion containing antigen in peanut oil with Arlacel A and aluminum monostearate as the emulsifying agent.”

Interesting

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E-mails to and from the FDA

4 Responses to 'E-mails to and from the FDA'

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