AAP: Systemic Review Finds Childhood Vaccines Very Safe (Again)

 

# 8798

 

The American Academy of Pediatrics (AAP) has announced today the early findings of a new systemic review of childhood vaccine safety research that will hopefully be reassuring to parents who still harbor concerns over vaccine safety. 

While no medicine – including vaccines – are 100% benign, or are without the risk of rare adverse effects, childhood vaccines have an enviable safety record. Something that this study proves out again.

 

First the press release from the AAP, then I’ll have a bit more.

Systematic Review of Vaccine Safety May Allay Parents' Concerns

7/1/2014
For Release: July 1, 2014

A systematic review of research on vaccine safety, published online July 1 in Pediatrics, updates a 2011 Institute of Medicine (IOM) report on the safety of vaccines recommended for children aged six years and younger. The study, "Safety of Vaccines Used for Routine Immunization of U.S. Children: ASystematic Review," to be published in the August 2014 Pediatrics, is part of a larger report on the safety of vaccines for adults, adolescents and children requested by the Agency for Healthcare Research and Quality.

Researchers from the RAND Corporation conducted a systematic review of the evidence published since the IOM report on vaccines for children under age 6, including DTaP (diphtheria, tetanus and acellular pertussis), hepatitis A, hepatitis B, influenza, meningococcal, MMR (measles, mumps and rubella), and varicella vaccines. The report also reviews the evidence on several childhood vaccines that were not studied in the 2011 IOM report, including Haemophilus influenza type b (Hib), pneumococcal, rotavirus, and inactivated poliovirus vaccines. The evidence is strong that MMR vaccine is not associated with autism, which is consistent with previous reviews on the topic. Researchers also identified strong evidence that MMR, DTaP, Td (tetanus), Hib and hepatitis B vaccines are not associated with childhood leukemia.

Studies did show an association of several serious adverse events with vaccines, but these events were very rare, such as intussusception after rotavirus vaccine. Researchers conclude the findings may allay concerns of some parents about vaccine safety.

 

The internet, and Hollywood, are filled with self-proclaimed experts claiming – despite all evidence to the contrary – that childhood vaccines cause autism.  And sadly, for some percentage of the population – who already distrust `big pharma’ -that message has stuck.

The real dangers come from the diseases that these vaccines are designed to prevent.

 

Just last week we saw a report  (see California DPH: Whooping Cough Epidemic Continues) on the resurgence of  a vaccine preventable disease that was all but wiped out in this country 30 years ago. But Pertussis is back with a vengeance – in part – due to a reluctance of parents to get their kids vaccinated. 

Similarly, we saw in late May from a CDC Telebriefing: Worst US Measles Outbreak In 20 Years, that this childhood scourge – declared eliminated 14 years ago in the United States – is raging once more:  This from Dr. Anne Schuchat, of the CDC:

 

“The current increase in measles cases is being driven by unvaccinated people, primarily U.S. residents, who got measles in other countries, brought the virus back to the United States and spread to others in communities where many people are not vaccinated.”

 

For those who may be convinced that measles is a `harmless’ childhood illness, we get this little factoid from the CDC:

 

About 30% of measles cases develop one or more complications, including

• Pneumonia, which is the complication that is most often the cause of death in young children.
• Ear infections occur in about 1 in 10 measles cases and permanent loss of hearing can result.
• Diarrhea is reported in about 8% of cases.

These complications are more common among children under 5 years of age and adults over 20 years old.

Even in previously healthy children, measles can be a serious illness requiring hospitalization. As many as 1 out of every 20 children with measles gets pneumonia, and about 1 child in every 1,000 who get measles will develop encephalitis. (This is an inflammation of the brain that can lead to convulsions, and can leave the child deaf or mentally retarded.) For every 1,000 children who get measles, 1 or 2 will die from it. Measles also can make a pregnant woman have a miscarriage, give birth prematurely, or have a low-birth-weight baby.

 

 

Frustratingly, this push back against childhood vaccines also extends to the yearly flu shot for adults (including pregnant women), which based on some of the research we’ve seen, may actually help reduce the incidence of autism and other developmental diseases in children.

 

• In 2012 research by a team at UC Davis found that fever (from any cause) during pregnancy more than doubled the odds of having a child with autism or developmental delays (see  Is Maternal Influenza or Fever During Pregnancy Associated with Autism or Developmental Delays? Results from the CHARGE (CHildhood Autism Risks from Genetics and Environment) Study Zerbo et al.) 
• In November of  2012, in Of Pregnancy, Flu & Autism, we saw a study that found a twofold increase in autism among children with prenatal influenza exposure, and a threefold increase in autism among children with prolonged prenatal fever exposure
• And just last year (May, 2013) we looked at a JAMA Psychiatry report that linked bipolar disorder (BD) to influenza exposure while still in the womb  (see Pregnancy, Influenza, & Bipolar Disorder In Offspring).

 

These studies are admittedly small and less than conclusive, and while they suggest an increase in relative risk over pregnancies without fever or viral infection – in terms of absolute risk – the odds that a mother’s fever or viral infection during pregnancy would result in a developmentally challenged child remains low. 

 

Maggie Fox, writing for NBC News, has the story from the AAP as well (Yes, Childhood Vaccines Are Safe, Review Finds)

 

For more on the safety of vaccines, you may wish to revisit:

 

JPeds: Autism NOT Linked To Timing & Number Of Childhood Vaccines

IOM Report On Vaccine Safety Concerns

AAP/CDC: New Guidance On For Antibiotics For Children

# 7989

 

As the graphic above shows, there is considerable geographic disparity in the amount of antibiotics being prescribed across this country, with doctors some parts of the country being much quicker write ABx scripts than doctors in other regions.

 

In an attempt to bring some sensible level of standardization to the prescribing these drugs – and in so doing, hopefully reduce the creation and spread of antibiotic resistant bacteria - the American Academy of Pediatrics (AAP) and the CDC have produced a new set of guidelines for doctors to encourage  the judicious use of antibiotics when treating children with suspected bacterial infections.

 

First, some excerpts from the CDC’s press release, and then a link to the article in the journal Pediatrics.

 

New guidance limits antibiotics for common infections in children

Get Smart About Antibiotics Week 2013 calls for responsible antibiotic prescribing

Every year as many as 10 million U.S. children risk side effects from antibiotic prescriptions that are unlikely to help their upper respiratory conditions. Many of these infections are caused by viruses, which are not helped by antibiotics.

This overuse of antibiotics, a significant factor fueling antibiotic resistance, is the focus of a new report Principles of Judicious Antibiotic Prescribing for Bacterial Upper Respiratory Tract Infections in Pediatrics by the American Academy of Pediatrics (AAP) in collaboration with the Centers for Disease Control and Prevention (CDC).

Released today during Get Smart About Antibiotics Week, the report amplifies recent AAP guidance and promotes responsible antibiotic prescribing for three common upper respiratory tract infections in children: ear infections, sinus infections, and sore throats.

Antibiotic resistance occurs when bacteria evolve and are able to outsmart antibiotics, making even common infections difficult to treat. According to a landmark CDC report from September 2013, each year more than two million Americans get infections that are resistant to antibiotics and 23,000 die as a result.

For Clinicians:

3 Principles of Responsible Antibiotic Use

1. Determine the likelihood of a bacterial infection: Antibiotics should not be used for viral diagnoses when a concurrent bacterial infection has been reasonably excluded.
2. Weigh benefits versus harms of antibiotics: Symptom reduction and prevention of complications and secondary cases should be weighed against the risk for side effects and resistance, as well as cost.
3. Implement accurate prescribing strategies: Select an appropriate antibiotic at the appropriate dose for the shortest duration required.

“Our medicine cabinet is nearly empty of antibiotics to treat some infections,” said CDC Director Tom Frieden, M.D., M.P.H.  “If doctors prescribe antibiotics carefully and patients take them as prescribed we can preserve these lifesaving drugs and avoid entering a post-antibiotic era.”

By providing detailed clinical criteria to help physicians distinguish between viral and bacterial upper respiratory tract infections, the recommendations provide guidance for physicians that will improve care for children. At the same time, it will help limit antibiotic prescriptions, giving bacteria fewer chances to become resistant and lowering children’s risk of side effects.

(Continue . . .)

 

The entire 11 page PDF is available online from the American Academy of Pediatrics (see link below).  The authors describe this guidance:

 

This clinical report focuses on antibiotic prescribing for key pediatric URIs that, in certain instances, may benefit from antibiotic therapy: AOM, acute bacterial sinusitis, and  pharyngitis. The specific recommendations are applicable to healthy children who do not have underlying medical conditions (eg, immunosuppression) placing themat increased risk of developing serious complications. The purpose of this report is to provide practitioners specific context using the most current recommendations and guidelines while applying 3 principles of judicious antibiotic use: (1) determination of the likelihood of a bacterial infection, (2) weighing the benefits and harms of antibiotics, and (3) implementing judicious prescribing strategies.

 

Follow the link to read and download the entire report:

 

Principles of Judicious Antibiotic Prescribing for Bacterial Upper Respiratory Tract Infections in Pediatrics

Adam L. Hersh, Mary Anne Jackson, Lauri A. Hicks and the COMMITTEE ON INFECTIOUS DISEASES

DOI: 10.1542/peds.2013-3260 ; originally published online November 18, 2013; Pediatrics

The online version of this article, along with updated information and services, is located on the World Wide Web at: http://pediatrics.aappublications.org/content/early/2013/11/12/peds.2013-3260

 

For more on this week’s focus on better stewardship of our antibiotic arsenal, you may wish to visit these recent blogs:

 

Surviving Winter’s Ills Without Abusing Antibiotics

The Lancet: Antibiotic Resistance - The Need For Global Solutions

ECDC: Antibiotic Resistance In the EU – 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
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

 

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.

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.