Global Mercury Ban Exempts Thimerosol Preservatives

 

# 6875

 

In December of last year (see AAP Endorses SAGE Recommendations Keeping Thimerosal In Vaccines) I wrote on the debate over allowing the continued use of thimerosol in childhood vaccines used in many countries around the globe.

 

Thimerosol – which contains ethyl mercury - has strong antiseptic and antifungal properties and has used as a preservative to prevent contamination of multi-dose vials of vaccines for many decades.

 

Thimerosol use in the United States has been largely curtailed since 1999, when in the face of growing public concern - despite credible scientific evidence of harm – thimerosol was removed from most childhood vaccines.

 

Doing so has required the move to single-dose vaccines, a step that would prove both difficult and prohibitively expensive for many developing countries.

 

Over the past several years a global agreement banning the use of mercury has been in the works, and last week a treaty was approved. 

 

This from the UNEP.

 

Minamata Convention Agreed by Nations Sat, Jan 19, 2013

Global Mercury Agreement to Lift Health Threats from Lives of Millions World-Wide

Geneva/Nairobi, 19 January 2013 - International effort to address mercury-a notorious heavy metal with significant  health and environmental effects-was today delivered a significant boost with governments agreeing to a global, legally-binding treaty to prevent emissions and releases.

 

The Minamata Convention on Mercury-named after a city in Japan where serious health damage occurred as a result of mercury pollution in the mid-20th Century-provides controls and reductions across a range of products, processes and industries where mercury is used, released or emitted.

 

These range from medical equipment such as thermometers and energy-saving light bulbs to the mining, cement and coal-fired power sectors.

 

The treaty, which has been four years in negotiation and which will be open for signature at a special meeting in Japan in October, also addresses the direct mining of mercury, export and import of the metal and safe storage of waste mercury.

(Continue . . .)

 

 

Two medical exemptions were provided for in this treaty:

 

• Vaccines where mercury is used as a preservative have been excluded from the treaty as have products used in religious or traditional activities
• Delegates agreed to a phase-down of the use of dental fillings using mercury amalgam.

 

 

In a perfect world every vaccine would come in a single-dose vial or syringe, and there would be no need to add preservatives like thimerosol.

 

But in the world in which we live, the choice is either to use a preservative, or accept that far fewer children will receive potentially life-saving vaccines. 

AAP Endorses SAGE Recommendations Keeping Thimerosal In Vaccines

 

 

# 6786

 

In what some may regard as a controversial move, the AAP (American Academy of Pediatrics) has endorsed the recommendations put forth earlier this year by the World Health Organization’s  SAGE (Strategic Advisory Group of Experts) to keep thimerosol in childhood vaccines used in many countries around the globe.

Thimerosol – which contains ethyl mercury - has strong antiseptic and antifungal properties and has used as a preservative to prevent contamination of multi-dose vials of vaccines for many decades.

 

Its use in the United States has been greatly curtailed since 1999, when out of an abundance of caution and in response to growing public concern, thimerosol was removed from most childhood vaccines.

 

This step was taken even though there was (and remains) scant scientific data supporting the public’s concerns over the ingredient’s safety.  

 
Doing so has required the move to single-dose vaccines, which would prove both difficult, and prohibitively expensive, to be used in many developing countries.

 

Last May (No. 21, 2012, 87, 201–216), in the WHO’s WER (Weekly Epidemiological Record), SAGE provided numerous reasons to continue to use Thimerosol as a preservative in multi-dose vaccines.  

 

A few excerpts (reparagraphed, Bolding mine):

 

A WHO Informal Consultation from 3 to 4 April 2012
concluded that: replacement of thiomersal with an alternative preservative may affect the quality, safety and efficacy of vaccines; re-registration would be required by the National Regulatory Authority in each jurisdiction where a reformulated product was intended to be used; currently available alternative preservatives interacted in unpredictable ways with existing vaccines, and there are no consensus alternative preservatives for the near- or mid-term.

 

There is insufficient existing manufacturing capacity to remove thiomersal and switch to single-use vials. Such a switch would have significant cold chain, storage, and waste management implications
and would result in very large increases in costs for
immunization programmes. There would be a clear risk (if reformulation with alternative preservatives or withno preservatives is required) that some products would become unavailable – particularly the current low-cost vaccines (tetanus toxoid, diphtheria-tetanus-whole cell pertussis, hepatitis B).

 

There would be a high risk of serious disruption to routine immunization programmes and mass immunization campaigns if thiomersal- preserved multi-dose vials were not availablefor inactivated vaccines, with a predictable and sizable increase in mortality, for exceedingly limited environmental
benefit.

 

Beyond the difficulties, and likely increase in mortality and morbidity that would be produced, SAGE also reiterated the safety of the ingredient.

 

SAGE was gravely concerned that current global discussions may threaten access to thiomersal-containing vaccines without scientific justification. SAGE reaffirmed that thiomersal-containing vaccines were safe, essential and irreplaceable components of immunization programmes, especially in developing countries, and that removal of these products would disproportionately jeopardize the health and lives of the most disadvantaged children worldwide.

 

 

The AAP’s endorsement, which is very short, is part of today’s early release.

 

From the American Academy of Pediatrics

STATEMENT OF ENDORSEMENT

From the American Academy of Pediatrics: STATEMENT OF ENDORSEMENT: Recommendation of WHO Strategic Advisory Group of Experts (SAGE) on Immunization Pediatrics peds.2012-2262; published ahead of print December 17, 2012, doi:10.1542/peds.2012-2262

• Full Text (PDF)

The American Academy of Pediatrics endorsed the recommendation of the World Health Organization’s Strategic Advisory Group of Experts (SAGE) on Immunization pertaining to the use of thimerosal in vaccines.

The recommendation can be found on pages 215–216 at: http://www.who.int/wer/2012/wer8721.pdf. The Pediatric Infectious Diseases Society and the International Pediatric Association have also endorsed this recommendation.

 

In a perfect world every vaccine would come in a single-dose vial or syringe, and there would be no need to add preservatives like thimerosol.

 

But in the world in which we live, the choice is either to use a preservative, or accept that far fewer children will receive potentially life-saving vaccines. 

 

One need only look at the tragic outbreak of fungal meningitis in the United States this year – linked not to vaccines, but to contaminated steroids  - to understand how important maintaining sterility is in injectables.

 

Overnight the AAP released the following announcement, with links to a couple of editorials explaining their unanimous decision.

 

 

AAP Endorses WHO Statement on Thimerosal in Vaccines

12/17/2012

For Release:  December 17, 2012

The American Academy of Pediatrics (AAP) has endorsed the recommendation of the World Health Organization’s Strategic Advisory Group of Experts on Immunization regarding the use of thimerosal in vaccines. The AAP statement of endorsement is published in the January 2013 issue of Pediatrics and is released online Dec. 17, 2012.

This issue of Pediatrics also includes several commentaries that provide context and background on the endorsement:

• “Global Vaccine Recommendations and Thimerosal”
• “Ban on Thimerosal in Draft Treaty on Mercury: Why the American Academy of Pediatrics (AAP) Position in 2012 Is So Important”
• “Global Justice and the Proposed Ban on Thimerosal-Containing Vaccines”

For copies of the endorsement and commentaries, or to speak to an AAP spokesperson, contact the AAP Department of Communications

 

WHO: Safety & Importance Of Thiomersal In Vaccines

Photo Credit PHIL

# 6434

 

 

Thiomersal, better known in the U.S. as thimerosal, is an organomercury compound commonly used in multi-dose vials of vaccines as a preservative.  Unlike many other preservatives, it does not adversely affect the potency of the vaccine.

 

Its use has none-the-less been controversial, and despite reassuring data, over the past decade the United States and the European Union have been phasing out the use of Thiomersal in many pediatric vaccines in what was deemed a `purely precautionary measure’.   

 

Eliminating Thiomersal is an expensive proposition, however. It normally requires moving to single-dose injectables - something that may be feasible in richer countries - but not easily done in the developing world.

 

Next week’s  Weekly Epidemiological Record (7/20) will have details of a meeting between the WHO and the  Global Advisory Committee on Vaccine Safety (GACVS) which met last month to discuss Thiomersal preservatives.

 

Today, however, we get a preview from a Q&A FAQ on Thiomersal, posted on the World Health Organization’s  website.

 

Citing new studies that continue to show the safety of Thiomersal in vaccines, a lack of viable alternatives, and the exorbitant cost of moving to single-use injectable (which could reduce the total number of vaccinated each year), the WHO reaffirms the safety, and necessity of using Thiomersal in vaccines.

 

The entire FAQ: Questions and Answers on new facts and figures on vaccines and the global mercury treaty is worth reading, but they sum up their position by saying:

 

Based on multiple expert reviews, WHO concluded that there would be a clear risk (if reformulation with alternative preservatives or with no preservatives is required) that some products would become unavailable –  particularly the current low cost vaccines.

 

There would be a high risk of serious disruption to routine immunization programmes and mass immunization campaigns if currently thiomersal-
preserved vaccines  are not available. The consequences would be a negative health impact, due to the predictable and sizable increase in mortality through lack of access to vaccines, for very limited environmental impact.

   
WHO reaffirms that thiomersal-containing vaccines are very safe. They are essential and currently irreplaceable components of immunization programmes, especially in developing countries, and removal of these products would disproportionately jeopardize the health and lives of the most disadvantaged children worldwide.   

 

Given the widespread public angst over the use of Thiomersal in vaccines (even if the scientific data doesn’t support it) - were there a viable alternative -  I have to believe that this committee would have seized it.

 

But in a world with increasing global health problems and ever-shrinking global health budgets, moving to single-use injectables is a luxury that the WHO, and the millions of children who would be denied vaccination, simply cannot afford.