Monday, December 17, 2012

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


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


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

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: 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


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:

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


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