From: "CDC-INFO" <CDCINFO@cdc.gov>
To: Twyla Ramos
Sent: Wednesday, November 07, 2007 2:57 PM
Subject: RE: YBFW: Mercury in vaccines

Thank you for your inquiry to CDC-INFO.  In response to your request for information on trace amount of thimerosal in some vaccines in the United States, we are pleased to provide you with the following relevant information.

Thimerosal is an organic mercury compound. It works very well as a preservative. It has been used in some vaccines and other products since the 1930s.

Thimerosal is made up of about 49 percent ethylmercury. The other 51 percent is a chemical that contains sulfur.

There is no evidence that the low doses of thimerosal in vaccines can cause any serious harm. However, it may cause minor allergic reactions, such as redness and swelling where the shot was given.

In July 1999, the Public Health Service (PHS) agencies, the American Academy of Pediatrics (AAP), and vaccine manufacturers agreed that thimerosal should be reduced or removed from vaccines. They did this to be extra careful, not because there was proof that thimerosal is harmful.

Until 1999, several vaccines given to infants in the United States contained thimerosal. These included vaccines against:
* diphtheria,
* tetanus,
* pertussis (whooping cough),
* Haemophilus influenzae type b (Hib), and
* hepatitis B.

Today, some influenza (flu) vaccines and the Td (tetanus and diphtheria) vaccine still contain thimerosal. However, thimerosal-free flu vaccine is available for both children and adults.

None of the other vaccines used today in the United States to protect infants and toddlers against infectious diseases contain thimerosal as a preservative. Thimerosal still may be used in the early stages of making certain vaccines. However, it is removed through a purification process.  When this process is complete, only trace, or insignificant, amounts of thimerosal are left (less than 0.3 mcg) and these amounts have no biological effect.

For more information about mercury and vaccines (thimerosal), please visit the CDC website:
http://www.cdc.gov/od/science/iso/concerns/thimerosal.htm

For more information about thimerosal content in some US vaccines, please visit the website:
http://www.vaccinesafety.edu/thi-table.htm

Links provided to non-Federal organizations are provided solely as a service to our users. These links do not constitute an endorsement of these organizations or their programs by CDC or the Federal Government, and none should be inferred. CDC is not responsible for the content of the individual organization web pages found at these links.

Thank you for contacting CDC-INFO Contact Center. Please do not hesitate to call 1-800-CDC-INFO, e-mail cdcinfo@cdc.gov or visit http://www.cdc.gov if you have any additional questions.


I emailed them a follow-up question:

From:  Twyla Ramos
Sent:  11/9/2007 09:24:08 AM
To:  <cdcinfo@cdc.gov>
Subject:  Re: YBFW: Mercury in vaccines

Thank you for this info.  I have a follow-up question.  You said, "Thimerosal still may be used in the early stages of making certain vaccines. However, it is removed through a purification process."  Does any government agency monitor and test to ensure that this purification process is effective, and that the final product contains only "less than 0.3 mcg"? Or do the pharmaceutical companies have sole responsibility for the testing and monitoring of this?


The CDC responded:

From: "CDC-INFO" <CDCINFO@cdc.gov>
To:  Twyla Ramos
Sent: Monday, November 12, 2007 11:42 AM
Subject: RE: Re: YBFW: Mercury in vaccines

Thank you for your inquiry to CDC-INFO.  In response to your follow-up request of information regarding monitoring the effectivity of the purification process of thimerosal in vaccines, please call the US Food and Drug Administration (FDA) at 1-888-INFO-FDA. FDA is the federal agency that regulates vaccine licensure and manufacture.

You may also want to visit their website about thimerosal in vaccines at:
http://www.fda.gov/cber/vaccine/thimerosal.htm

Thank you for contacting CDC-INFO Contact Center. Please do not hesitate to call 1-800-CDC-INFO, e-mail cdcinfo@cdc.gov or visit http://www.cdc.gov if you have any additional questions. 


I contacted the FDA and received this response:

From: Hill, Lanessa
To: Twyla Ramos
Sent: Wednesday, November 14, 2007 6:14 AM
Subject: RE: "Trace" amounts of Thimerosal in vaccines

Good morning Mrs. Ramos.

Thank you for your inquiry to FDA's Center for Biologics Evaluation and Research (CBER) regarding regulatory oversight of vaccines. 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.
 
Because of the complex manufacturing process for most biological products, each lot undergoes thorough testing by the manufacturer. The manufacturer performs specific tests as specified in their license application. The manufacturer submits samples of each licensed vaccine lot and the results of their own tests for potency, safety, and sterility to the Agency. The manufacturer may not distribute a lot of the product into interstate commerce until CBER releases it. CBER will also test the samples provided by the manufacturers for potency, safety and purity.  All vaccines are subject to lot release. The lot release program is part of FDA's multi-part strategy that helps assure biological product safety by providing a quality control check on product specifications.

The FDA continues to oversee the production of vaccines after the vaccine and the manufacturing processes are approved, in order to ensure continuing safety. After licensure, monitoring of the product and of production activities, including periodic facility inspections, must continue as long as the manufacturer holds a license for the product.

I hope this is helpful.
Best regards.
Lanessa Hill
Public Affairs Specialist
Consumer Affairs Branch
Division of Communication and Consumer Affairs
Center for Biologics Evaluation and Research
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.

I replied:
From: Twyla Ramos
To: Hill, Lanessa
Sent: Wednesday, November 14, 2007 7:40 AM
Subject: Re: "Trace" amounts of Thimerosal in vaccines

Thank you so much for this information.  Do these tests for safety include tests of mercury content?  My understanding is that removal of thimerosal is voluntary, so would this mean that testing for mercury content is not part of the agreed upon tests? 

Specifically, in cases where thimerosal is used in the manufacturing process but is removed by a purification process, is mercury content part of the safety testing?


I received this response:

----- Original Message -----
From: Harley, Patricia
To: Twyla Ramos
Sent: Thursday, November 15, 2007 12:18 PM
Subject: RE: "Trace" amounts of Thimerosal in vaccines
Mrs. Ramos:
Thank you for your inquiry to FDA's Center for Biologics Evaluation and Research (CBER) regarding thimerosal in vaccines. Your email has been forwarded to my office for reply.
The Center for Biologics Evaluation and Research (CBER) regulates vaccine products. Many of these are childhood vaccines that have contributed to a significant reduction of vaccine-preventable diseases. Vaccines, as with all products regulated by FDA, undergo a rigorous review of laboratory and clinical data to ensure the safety, efficacy, purity and potency of these products. Vaccines approved for marketing may also be required to undergo additional studies to further evaluate the vaccine and often to address specific questions about the vaccine's safety, effectiveness, or possible side effects.

The FDA continues to oversee the production of vaccines after the vaccine and the manufacturing processes are approved, in order to ensure continuing safety. After licensure, monitoring of the product and of production activities, including periodic facility inspections, must continue as long as the manufacturer holds a license for the product. If requested by the FDA, manufacturers are required to submit to the FDA the results of their own tests for potency, safety, and purity for each vaccine lot. They may also be required to submit samples of each vaccine lot to the FDA for testing. However, if the sponsor describes an alternative procedure which provides continued assurance of safety, purity and potency, CBER may determine that routine submission of lot release protocols (showing results of applicable tests) and samples is not necessary. Information on the Vaccine Product Approval Process is available on CBER's website at http://www.fda.gov/cber/vaccine/vacappr.htm.
Information on Thimerosal in Vaccines is available on CBER's website at http://www.fda.gov/cber/vaccine/thimerosal.htm#toc. 

If you have any additional questions, please feel free to call me.
Sincerely,
Patricia H. Harley
Consumer Safety Officer
Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Communication, Training and Manufacturers Assistance
Division of Communication and Consumer Affairs
phone: 301-827-2000 or 1-800-835-4709
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.

I responded:

----- Original Message -----
From: Twyla Ramos
To: Harley, Patricia
Sent: Friday, November 16, 2007 8:13 AM
Subject: Re: "Trace" amounts of Thimerosal in vaccines

Thank you for this information on your overall procedures.  I still don't know the answer to my question:  In cases where thimerosal is used in the manufacturing process but is removed by a purification process, is mercury content part of the safety testing? 

Could you please tell me whether a testing process is in place to ensure that mercury has been successfully removed from vaccines, after thimerosal is used in the early stages of making those vaccines.

Thank you very much,

Twyla Ramos


I received the following response:

From: Harley, Patricia
To: Twyla Ramos
Sent: Monday, November 19, 2007 4:19 AM
Subject: RE: "Trace" amounts of Thimerosal in vaccines

Twyla Ramos:
You can contact the manufacturer for processing procedures. If you have additional questions, please feel free to call me.

Sincerely,
Patricia H. Harley
Consumer Safety Officer
Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Communication, Training and Manufacturers Assistance
Division of Communication and Consumer Affairs
phone: 301-827-2000 or 1-800-835-4709

I responded:
From: Twyla Ramos
To: Harley, Patricia
Sent: Monday, November 19, 2007 8:19 AM
Subject: Re: "Trace" amounts of Thimerosal in vaccines

My question is not for the manufacturers.  My question is for the agencies that regulate the manufacturers.  I started with the CDC, and they referred me to the FDA.

The CDC says:  "Thimerosal still may be used in the early stages of making certain vaccines. However, it is removed through a purification process. When this process is complete, only trace, or insignificant, amounts of thimerosal are left (less than 0.3 mcg) and these amounts have no biological effect."

Are you saying that the FDA does not play a role in ensuring that the final product is either mercury-free or contains only a "trace" amount of mercury?  Is this left up to the manufacturers?

I understand (as you stated in your email) that the FDA has procedures in place to "ensure the safety, efficacy, purity and potency of these products" and that "manufacturers are required to submit to the FDA the results of their own tests for potency, safety, and purity for each vaccine lot. They may also required to submit samples of each vaccine lot to the FDA for testing."  Or an "alternative procedure" may be agreed upon.  What I am asking is whether testing of mercury content is a part of this process. 

Manufacturers are saying that they have a process in place to purify out the mercury.  Is the FDA verifying in any way that this is true?

I did try calling you Friday, but you were out of the office.

Ms. Harley responded:
From: Harley, Patricia
To: Twyla Ramos
Sent: Monday, November 19, 2007 8:35 AM
Subject: RE: "Trace" amounts of Thimerosal in vaccines

Please call me.
 
Sincerely,
Patricia H. Harley
Consumer Safety Officer
Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Communication, Training and Manufacturers Assistance
Division of Communication and Consumer Affairs
phone: 301-827-2000


So, I tried calling Ms. Harley again, and this time I reached her.  She continued to make general statements about validating the manufacturing process.   She said the following:

•     She does not know whether a company does a specific test.

•     They cannot check every single vaccine.  (Like, duh.)

•     There is a lot release requirement.  The company submits testing procedures and samples.   The FDA verifies that the product is safe, pure, potent, functioning.

•     She can't guarantee that there is a test for mercury.

•     She is not sure whether the FDA is measuring the mercury content.   They check the process.  "We have the understanding that this has been done, that the manufacturer has done it.  I doubt if any company would be trying to get away with that.   The consequences are major for any violations.  If the product does not conform to specifications it would be unlicensed product."

I really tried to get her to be more specific.  I gave the example of, if you gave a person a recipe to bake a cake, and you wanted to see if it came out well, wouldn't you taste the cake, and look at it to see if it is mushy or burned?   "The proof is in the pudding."  It's not enough for the person just to verify that they bought the right ingredients and measured them and set the oven at 350 degrees.   

She suggested that I check with state agencies.

So, in summary, neither the CDC nor the FDA could or would say that they are testing to be sure that the process of removing mercury from vaccines is working.

Why should they test for mercury?  They don't believe that thimerosal is harmful.  It is admittedly still being used in the vaccine manufacturing process, but then supposedly is being purified out.   If the purification process is not actually working, why should the CDC and the FDA care?  They don't believe thimerosal is harmful.

Yet, we know that even miniscule quantities of mercury are in fact harmful. 

My question is:  Is anyone out there testing today's vaccines for mercury?  Are the vaccines that are supposedly mercury-free really mercury-free?   How much mercury is actually in the vaccines which supposedly contain only a "trace" amount?

Do we trust the pharmaceutical companies to self-monitor on the issue of mercury content?

Supposedly mercury has been removed from vaccines, yet the autism rate is still high.  Possible explanations for this are:

•     Babies still receive an incredibly high number of vaccines, which include other potentially toxic and/or immune-system-disrupting ingredients such as aluminum and multiple live viruses.

•     There are many environmental pollutants, such as mercury from coal burning power plants, which are possible causes.

But perhaps we are overlooking another possible explanation:  Has mercury really been removed from vaccines?



Twyla Ramos and her husband have three children.  Their middle child, age 15, has both Autism and Williams Syndrome.  Twyla has a B.A. in English and works in the banking industry.  She serves on the board of the Foothill Autism Alliance, a nonprofit group providing support and information to the autism community.