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

 

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AAP: Warning On Energy Drinks

 

 

# 5584

 

 

Credit- Wikipedia.

 

Over the past couple of years concerns have been raised over the consumption of so-called `energy drinks’, particularly among children and teenagers.

 

These drinks, which usually contain significant doses of caffeine and sugar, along with B vitamins, amino acids, and herbs like acai and Yerba Mate, are supposed to increase alertness and energy.

 

Some brands – which may only be legally sold to adults – contain 10%-12% alcohol.

 

Non-alcoholic versions are often used as `mixers’ for alcohol - a practice reportedly favored by college and teenage drinkers because the caffeine helps produce a `better buzz’.

 

The downside is, it can fool imbibers into believing they are sober when they are not, which can lead to even more drinking and risky behavior.

 

 

Last year these alcohol laced energy drinks came under heavy scrutiny when colleges and universities around the country began to report injuries and blackouts related to the drink's use.

 

The state of Washington banned an alcoholic energy drink called  Four Loko after nine under-aged university students (aged 17 – 19) from Central Washington University fell ill at a house party and were hospitalized. 

 

A number of colleges have recently banned these types of drinks from campus.

 

But even non-alcoholic energy beverages (EBs) have raised concerns. 

 

Excessive consumption has been linked to increased heart rates, hypertension, exacerbation of psychiatric symptoms, and very rarely - sudden cardiac death (cite - Mayo Clinic Proceedings Oct 29, 2010 :Energy Beverages: Content and Safety).

 

The Mayo report, which recommends the consumption of no more than 1 can (500ml) of EBs a day, concludes:

 

Limited ingestion of EBs by healthy people is not likely to cause major adverse effects, but binge consumption or consumption with alcohol may lead to adverse events. Individuals with medical illnesses, especially underlying heart disease, should check with their physician before using EBs, because they may exacerbate their condition.

 

Today, from the American Academy of Pediatrics, we get a stronger warning via this cautionary report on the the dangers inherent in the use of `energy & sports’ drinks by children and teenagers.  

 

The report – which is available online and for free – is called:

 

Clinical Report—Sports Drinks and Energy Drinks for Children and Adolescents: Are They Appropriate?

COMMITTEE ON NUTRITION AND THE COUNCIL ON SPORTS MEDICINE AND FITNESS

 

The `money quote’ from the abstract reads:

 

Rigorous review and analysis of the literature reveal that caffeine and other stimulant substances contained in energy drinks have no place in the diet of children and adolescents.

 

Furthermore, frequent or excessive intake of caloric sports drinks can substantially increase the risk for overweight or obesity in children and adolescents.

This report offers the following clinical guidance to pediatricians:

 

CLINICAL IMPLICATIONS: GUIDANCE FOR THE PEDIATRICIAN

Regarding consumption of sports and energy drinks by children and adolescents, the pediatrician is encouraged to:

● Improve the education of children and adolescents and their parents in the area of sports and energy drinks. This education must high-
light the difference between sports drinks and energy drinks and their associated potential
health risks.

 

● Understand that energy drinks pose potential health risks primarily because of stimulant con-
tent; therefore, they are not appropriate for children and adolescents and should never be consumed.

● Counsel that routine ingestion of carbohydrate-containing sports drinks by children and adolescents
should be avoided or restricted. Intake can lead to excessive caloric consumption and an increased risk
of overweight and obesity as well as dental erosion.

 

● Educate patients and families that sports drinks have a specific limited function for child and adolescent athletes. These drinks should be ingested when there is a need for more rapid replenishment of carbohydrates and/or electrolytes in combination with water during periods of prolonged, vigorous sports participation or other intense physical activity.

 

● Promote water, not sports or energy drinks, as the principal source of hydration for children and adolescents.

 

According to a Reuters report this weekend (Stay away from energy drinks, doctors say), the sale of non-alcoholic energy drinks will approach $9 billion dollars in the United States this year – with half of that sold to children and young adults.

 

A factoid that many parents are probably unaware of given that the use of these types of drinks appears to be a generational phenomenon. 

 

Hopefully this report, and the resultant press coverage, will serve as impetus for parents to discuss the risks of  consuming these types of beverages with their children.

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AAP: Recommends Mandatory Flu Vaccinations For HCWs

 

 

# 4887

 

The American Academy of Pediatrics is the latest professional medical organization to embrace the idea of making yearly influenza vaccinations a requirement for HCWs (Health Care Workers).

 

The AAP – which boasts a membership of roughly 60,000 pediatricians – released the following statement yesterday (slightly reparagraphed for readability).

  

 

AAP Recommends Mandatory Flu Vaccine for All Health Care Workers

---

For Immediate Release:

Health-care associated influenza outbreaks are a common and serious public health problem that contribute significantly to patient morbidity and mortality and create a financial burden on health care systems.

 

In a new policy statement, the American Academy of Pediatrics (AAP) recommends that all health care personnel should be required to receive an annual influenza vaccine. The policy, "Recommendation for Mandatory Influenza Immunization of All Health Care Personnel," published in the October 2010 print issue of Pediatrics (published online Sept. 13), states that "despite the efforts of many organizations to improve influenza immunization rates with the use of voluntary campaigns, influenza coverage among health care personnel remains unacceptably low."

(Continue . . . )

 

While there remains a good deal of opposition among the rank and file of HCWs to mandatory flu vaccinations, over the past year or two the idea has gained increasing support among professional organizations such as SHEA, IDSA, and APIC.

 

Earlier this summer the CDC released their proposed infection control guidelines, where they strongly urged – but did not mandate – flu vaccinations for HCWs.

 

In response to what many felt was a tepid policy, Richard Whitley, MD president of the Infectious Diseases Society of America (IDSA), wrote an open letter to CDC  director Thomas Frieden urging that these guidelines include mandatory influenza vaccination.

 

Less than two-weeks ago SHEA (Society for Healthcare Epidemiology of America) released a similar position paper (see SHEA: Mandatory Vaccination Of Health Care Workers).

 

While many infection control experts see this as a long overdue step in patient and co-worker protection, the obstacles that lay before these sorts of policies are substantial.

This is a hugely divisive issue, with many HCWs believing that it is an infringement of their rights to decide what will be injected into their bodies.

 

There will almost certainly be legal challenges, and possibly labor disputes as well.

 

Last year New York State attempted to require vaccination as a requirement to work as a HCW, but lawsuits and vaccine shortages forced them to abandon – at least temporarily – that mandate  (see New York Rescinds Mandatory Flu Shots For HCWs). 

 

I’ve covered HCW’s objections to forced flu shots in the past, including:

 

HCWs: Refusing To Bare Arms

HCWs: Developing a Different Kind Of Resistance

 

Only a handful of large hospitals have managed to implement mandatory flu vaccinations, including Seattle’s Virginia Mason Medical Center and BJC Heathcare of St. Louis, Missouri  which I blogged about here.

 

Details on how Virginia Mason Medical Center implemented mandatory HCW vaccinations can be read in the following  PDF.

 

 

 

The backing of AAP, IDSA, SHEA and APIC most certainly adds gravitas to the movement - but without government regulatory backing – it remains to be seen just how many health care facilities are going to be willing to pioneer these sorts of policies on their own.

 

But love the idea or hate it, this is an issue that isn’t going to be going away anytime soon.

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