Vaccine Trials & the Use of Placebos

When reviewing published literature on vaccine safety you’ll undoubtedly find yourself examining vaccine trials.

You can review the safety trials in the package insert which are briefly described for that particular vaccine.

Here is some information in understanding vaccine trials and how they go about proving safety.

What is a clinical trial?

A research study conducted on human volunteers is considered a clinical trial. The trial is designed to answer specific question about a vaccine, such as how safe and effective they are.

The best way to determine if a vaccine or any therapy s effective and safe is to perform and test it in a randomized, controlled, double-blind clinical trial over a substantial period of time. This type is trial is referred to as the gold standard in research and presents the strongest evidence for efficacy.[1]

Clinical trials are conducted commonly in 3 phases. There is a fourth stage which can occur after a vaccine has been licensed, but this stage is not always required or completed.[2]

Vaccine Trial - Phase I

This trial is includes a small group of test subjects (averaging between 20-80 people). When the vaccine is intended for pediatric use, adults are tested and then there is a step down in age range. Interesting to note that the Hepatitis B vaccine given at birth, Merck’s Recombivax was never tested in newborns. [3][4]

Measures of efficacy used in trial phases are assessing the level of T-cells or antibody titers generated.[5]

The ultimate objective in phase I is to evaluate safety and determine the immune response of the vaccine.[2]

Vaccine Trial – Phase II

Once a vaccine has gone through phase I, a larger group participates in testing. This group usually consists of several hundred. Differing dosage levels are tested in this phase.[5]  

The trials in phase II are often randomized and include a placebo group. It is imperative to note that there are no regulations that govern the composition of a placebo. The majority of clinical trials use either another vaccine or a solution with an adjuvant (such as aluminum).

For example, the Pediarix vaccine (DTap+HepB+IPV) given to infants in 3 doses (2mo, 4mo, 6mo) used the following as placebos in its trials: Hib vaccine GlaxoSmithKline, Hib vaccine of Wyth Pharmaceuticals (no longer licensed in the US), Hib vaccine of Merck, Infanrix vaccine, oral poliovirus vaccine (OPV), and a pneumococcal vaccine. None of the placebos used contains a saline solution. [6]

This is not an exception, rather it is the norm.

Another example is Prevnar 13 (the newest Pneumococcal  vaccine) which used the old Prevnar vaccine as the placebo in its 13 clinical trials.[7] You may ask then what the placebo was for the old Prevnar vaccine – the answer is an investigational meningococcal group C vaccine.[8]

The goal of the second phase of vaccine trials is to study safety, dosage, immunogenicity, method of delivery and schedule of immunizations.[2]  

Vaccine Trial – Phase III

These trials may contain thousands of subjects and test the vaccine, again, in a randomized, double blind fashion using the same type of placebos in phase II.

Phase III is important because of it’s utilization of a larger sample size which has the ability to reflect adverse events that might occur in 1 of every 10,000 people. To detect such a statistical variance for such a low-frequency event, the clinical trial must include at least 60,000 subjects, which half of them would be in the control group. [2][9]

Conclusion

I hope this information sheds some light on what clinical trials are, how they are performed and what is assessed at each phase. A fantastic website to review past and current trials used by the government is at clinicaltrials dot gov.  Enjoy – and never stop learning about health!

References

[1]  http://www.iavireport.org/vax-primers/clinical-trials/Pages/VAX-Primer-randomized-controlled-clinical-trials.aspx

[2] Vaccine Development, Testing and Regulation. The College of Physicians of Philadelphia. http://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation

[3] List of clinical trials for Recombivax from the US National Institutes of Health http://clinicaltrials.gov/ct2/results?term=recombivax

[4] Merck, Inc. package insert for Recombivax http://www.merck.com/product/usa/pi_circulars/r/recombivax_hb/recombivax_pi.pdf

[5] Clinical Trials. Crucell 2009 http://www.crucell.com/R_and_D-Clinical_Trials

[6] GlaxoSmithKline package insert for Pediarix http://us.gsk.com/products/assets/us_pediarix.pdf

[7] Pfizer package insert for Prevnar 13 http://labeling.pfizer.com/showlabeling.aspx?id=501

[8] Pfizer package insert for Prevnar  http://labeling.pfizer.com/showlabeling.aspx?id=134

[9] Plotkin SA et al. Vaccines, 5^th ed. Philadelphia: Saunders, 2008

Pictures from drsophiayin.com and hpathy.com 

Mommy Guilt and UnCrunchy Things I Admit To

I think we’ve all been there...

The “I-wish-I-didn’t-know-better” blues.

Whether you consider yourself an alternative momma (aka crunchy) or not, there’s no doubt that it’s easy to beat yourself up about the things that we know we are cabable of but aren’t doing currently in our life.

A blog I follow recently addressed this titled, “I Want Out Of The Hippie Club”. She went on to describe her feelings as such:

“Sometimes I get so overwhelmed.  Sometimes I wish I didn't know better about stuff.”

“I used to like being a crunchy mom.  I still mostly like it.  But sometimes?  It suffocates me.  It's overwhelming.  It's just. so. heavy.  And I fail so. often.”


”So, sometimes, I want out of the hippie club.  Just for one night I'd like to not care about this heavy stuff.  Just for one night, I'd like to know what it's like to be clueless and careless.”

I think it’s improtant to realize we all feel overwhelmed at times and it’s ok. Give yourself enough room to breathe and realize what this feeling actually is – it’s growth..it’s personal development….it’s the realization that you are better then yesterday and will be better tomorrow then you are today.

It can be overwhelming, but think of the alternative- becoming stagnate or even regressing. What does that teach yourself, your children, your partner or your friends?

When you have a rough day or get the “I-wish-I-didn’t-know-better” blues remember no parent is doing this perfect in respect to the cookie cutter-imagine we should be…but we are living perfectly in respect of our individual intention and purpose…as long as we continue to put effort into growth and happiness – no matter if that means cloth diapers or disposibles; babywearing or using a stroller; buying organic, local strawberries or settling for the ones shipped up from Mexico.

The following list is dedicated to the High Heelwearing Hippie Mommy. Don’t forget we are all on this journey together! You and your blog inspire me and I know that inspiration shines through me to others – you are touching more people then you realize!


NonCrunchy Things I Totally Admit To:

I totally dye my hair.

I did not eat, bury or keep my placenta. I have no idea what happened to the thing.

I was not brave enough to even try EC.

I sometimes still use hot water in my washing machine, even when I buy the cold water detergent.

I paint my daughter’s nails with regular nail polish.

I serve hot dogs from time to time.

I wear make-up that isn’t even close to being made with natural ingredients.

I use non-stick pans even when I have regular pans available.

I sometimes use the lotion that has chemicals in it to turn your skin tan.

I use plug-in air fresheners in my home and do not own soy candles (which I’m pretty sure isn’t crunchy).



I know just because I admit to the above actions doesn’t mean I’m going to do these for the rest of my life nor that I won’t add to this list. For me, feeling guilty or regretful doesn’t serve any purpose in my life. Guilt and regret are only present when graditute is absent.

Advice for those “I-wish-I-didn’t-know-better” moments? Remember your blessings and remember we never stop growing, even if we are the parents now. It doesn’t mean it’s going to be easy, in fact, it’s not going to be – but believe me, it’s worth trying.

What noncrunchy things do you admit to??

“It's not only children who grow. Parents do too. As much as we watch to see what our children do with their lives, they are watching us to see what we do with ours.

I can't tell my children to reach for the sun. All I can do is reach for it myself”

– Joyce Maynard

Picture: The book ‘ Love Me Mom: A Guilt-Free Guide to Honoring Yourself and Empowering Your Kids’ explores the importance of falling in love with yourself and parenting from a perspective of self-care and personal responsibility.

Sh*t Crunchy Mamas Say Part 2

And in case you missed Part 1 :

You can see more at MamaNaturalBlog Channel on Youtube.

"In an artificial and processed world, this it a refuge and community for natural mamas."

"Each TUESDAY I post a funny or how-to video. Each THURSDAY I post the Mama Natural Show, the biggest (okay, only) weekly news show for crunchy mamas like you!"

Aluminum Adjuvants and The Rising Prevelance of Autism

I had to admit I was hesitant to comment and offer the following article, but there are a few reasons why I am. First, the article is fairly recent (published in Aug 2011) and  appears in the Journal of Inorganic Biochemistry. Secondly, this isn’t the first time I have been exposed to these assertions (Al adjuvants and immuno-neurological implications) and I feel compelled to share the information discussed by the authors.

The follow excerptions are from a PDF article titled, “Do Aluminum Vaccine Adjuvants Contribute to the Rising Prevalence of Autism?” from the Journal of Inorganic Biochemistry. [*]

I urge you to read the article in its entirety. I also included information regarding the quthors of the publication at the bottom of this post. Until then, here are a few excerpts from what I highlighted and found interesting along with some comments.

Al is an experimentally demonstrated neurotoxin whose ability to impact the human nervous system has been known for decades.

This shouldn’t surprise anyone. Of course the heavy metal is going to be hazardous when injected into the human body. Not to mention a newborn or an unborn baby (via prenatal vaccination).

The mechanisms by which Al adjuvants interact with the immune system remain far from clear. In this regard it is notable that many vaccine trials usually use an Al adjuvant containing “placebo” or another vaccine as the “control” group”, rather than a saline control. This study design has not allowed a direct comparison of the efficacy and safety of the antigen alone versus the Al adjuvant.

Two things to note here.

One: no regulations govern placebo composition. The composition of placebos can influence trial outcomes and should merit reporting.[*]

Two: when a doctor states that aluminum adjuvants have been tested and are safe, they are mistaken. In fact, experimental research, clearly shows that aluminum adjuvants have a potential to induce serious immunological disorders in humans (carrying risk for autoimmunity, long-term brain inflammation and associated neurological complications).[*]

Al has been shown to persist at the site of injection from several months up to 8-10 years following vaccination in patients suffering from macrophagic myofasciitis (an auto immune disease linked to Al vaccine adjuvants).

Once injected into tissues, aluminum hydroxide forms a deposit, damages the injected tissue, elicits danger signals from stressed cells, attracts inflammatory and antigen-presenting cells and is subject to phagocytosis (process by which cells ingest or engulf other cells).[*]  

An infant’s vaccine-derived Al exposure is equivalent to that from 10 Hepatitis B (HB) vaccines given in a single day to an adult.

The vaccine-derived Al exposure in a 2 month old is equivalent to that from 24 HB vaccines given in a single day to an adult.

Is there currently any regulation or limit to the amount of aluminum adjuvants injected in vaccine?   

Nope.

It is also of note that the FDA requires limits on Al parenteral (injection) feeding solutions and requires warning labels about potential Al hazards, while setting no safety limits or issuing warning for Al in vaccines.

Even if you are a proponent for vaccines, you can’t deny that there should be some regulation of aluminum used as a vaccine adjuvant.

Children from countries with the highest ASD prevalence appear to have a much higher exposure to Al from vaccines, particularly at 2 months of age. In this respect, we note that several prominent milestones of brain development in humans coincide with these periods. These include the onset of synaptogenesis (birth), maximal growth velocity of the hippocampus (2-3 postnatal months) and the onset of the amygdale maturation (8 weeks postnatal age).

…there is also major development in many bio-behavioral systems including sleep, temperature regulation, respiration and brain wave patterns. Many of these aspects of brain function are known to be impaired in autism.

This is where the study begins to address the autism correlation. You’ll see further down that the article references Hill’s criteria – in which the authors attempt to establish causality between exposure and outcome. I am not, and neither are the authors, blatantly stating that vaccines cause autism, only that more rigorous evaluation and standards need to be placed to confirm Al adjuvant safety.

Children are regularly exposed to much higher levels of Al adjuvants than adults while practically nothing is known about the pharmacokinetics and toxicodynamics of Al adjuvants in children and paradoxically, evaluation of pharmaco-and toxicokinetics is not required for vaccine licensing purposes.

If you are unsure, let me explain exactly what pharmacokinetics is and why it’s frightening that no clinical research exists regarding its safety. Firstly, it is the action of drugs in the body over a period of time, including the processes of absorption, distribution, localization in tissues, biotransformation, and excretion.[*]

It is demonstrated that even a fully developed BBB (Blood brain barrier) does not impede Al access to the brain tissue. Al is known to disrupt the BBB and can increase its permeability by increasing the rate of trans-membrane diffusion and by selectively altering saturable transport systems.

Despite a prevalent view that the peripheral immune responses do not affect brain function, overwhelming research suggests that neuro-immune cross talk may be the norm rather then the exception. It is clearly established that this bi-directional neuro-immune cross-talk plays crucial roles in immuno-regulation and brain function.  

Ok, this excerpt is remarkable in a few ways. First off, aluminum has been documented in crossing the BBB which means, in laymen’s terms, aluminum can enter the brain tissue. Secondly, aluminum can increase the ability for other agents to cross the BBB. Thirdly, aluminum promotes brain inflammation by penetrating the BBB and could play a critical role in autoimmunity.

Epidemiological studies implicate HB vaccination as a risk factor for ASD. For example, in the US, males 0-9 years who received a complete triple series of HB vaccine were found to be significantly more susceptible to developmental disabilities, while those aged 3-17 years who received HB vaccination during the first month of life had a 3-fold greater risk of ASD the unvaccinated males.

The Hepatitis B vaccine series totals 750 micrograms of aluminum (250 each dose).

The implications of this will be summed up a bit further down…but first, the authors briefly address the issue of aluminum ingestion versus injection and toxicological risk.

This notion contradicts basic toxicological principles. For instance, it should be obvious that the route of exposure which bypasses the protective barriers of the gastrointestinal tract and/or the skin will likely require a lower does to produce a toxic outcome.

The half life of aluminum injected into the blood stream is thought to be short, but….

…the same cannot be assumed for adjuvant-Al because to sizes of most antigen-Al complexes are higher then the molecular weight cut-off of the glomerulus kidney which would excrete the Al adjuvant.

In fact, a longer elimination period is one the major properties of effective vaccine adjuvants, including Al salts.

Now for the correlation….(study results in relation to Hill’s criteria)

The positive correlation between Al exposure from vaccines and prevalence of ASD does not necessarily imply causation. However, if the correlation is strong (criterion 1), consistent (criterion 2), and if there is a biologically plausible mechanism by which it can be explained (criterion 6), as well as an appropriate temporal relationship between the proposed cause and the outcome (criterion 4), then the satisfaction of these criteria supports the notion that the two events may indeed be causally related.

Our results satisfy not only ALL FOUR of the criteria applicable for establishing causation in neuropsychiatry, BUT ALSO FOUR OTHERS. These additional criteria are: biological gradient, coherence with the current knowledge, experimental or semi-experimental evidence and the analogy with similar evidence.

***I understand that correlation is not causation. It still does not mean that aluminum adjuvants in vaccines should not be looked at critically.

Al adjuvants have all the necessary biochemical properties needed to induce neurological and immune disorder. In this regard, it is interesting to note that autism is a multisystem disorder characterized by dysfunctional immunity and impaired CNS (central nervous system) function.

Given that the scientific evidence appears to indicate that vaccine safety is not as firmly established as often believed, it would seem ill advised to exclude pediatric vaccination as a possible cause of adverse long-term neurodevelopmental outcomes, including those associated with autism.

Again, I was hesitant to share this with you due to the nature of the volatile subject matter but I think I made the right decision and I anticipate you to research more into the use of aluminum adjuvants.

Consider this: If you decide to vaccinate, there are several vaccines that do not contain aluminum.



About the authors of this review:

Lucija Tomljenovic

Dr. Lucija Tomljenovic is an early career postdoctoral fellow. She was awarded a PhD in 2009 in Biochemistry, from the Comparative Genomics Centre at James Cook University in Townsville, Australia.

In 2010, she joined the Neural Dynamics Research Group at the University of British Columbia (Chris Shaw’s lab) and is currently researching the neurotoxic effects of aluminum vaccine adjuvants.

Tomljenovic has recently become an Associate Editor of the Journal of Alzheimer’s Disease.


Christopher Shaw

Shaw a Professor in the Department of Ophthalmology and Visual Sciences at the University of British Columbia and holds cross appointments with the Department of Experimental Medicine and the Graduate Program in Neuroscience.

He is the author of more than 100 peer-reviewed articles as well as numerous book chapters and special reviews. Shaw has edited four books on neuroscience themes. The main focus of his research has been on the Guamanian neurological disease spectrum, ALS-parkinsonism dementia complex (ALS-PDC). Recent work in the laboratory has developed animal models of the disease that are able to recapitulate all the essential behavioral and pathological features. The model is also being used to understand gene-toxin interactions, define neurodegeneration pathways involved, and to attempt therapeutic interventions at early, mid and late time points.

Work in the laboratory also provided one of the first models of aluminum adjuvant-induced neuropathology and these studies have become a new research direction.

He is the founder and a former director of Neurodyn, a biotechnology company based out of Prince Edward Island. Neurodyn's efforts are directed at early phase detection and treatment for age-related neurological disorders.

5 Things I’ve Learned In 5 Months

Having a sister is a powerful bond.

Something I never had the joys of experiencing first hand, until now that is. Of course, I could provide examples of what I see as an outsider, and as a mother – but the connection, attachment, and friendship between my two young daughters I would never attempt to say I understand completely.

Even at such a young age – I assumed that they would eventually build a relationship over time, but I never realized how immediate and intense the union between them would develop.

It’s amazing and it only makes my life even more full.

Watching a father with his daughter is amazing, but with two daughters, it’s astonishing.

Witnessing a boy become a man and a father is marvelous, especially if you are their lending support and encouragement in the process (particularly when it’s reciprocated as well). With a second child, the father already exists but this time you get to observe his love in a different perspective.

I can’t begin to describe in words how overwhelmingly blessed I feel, my heart begs to explode, when I think of my girls with their father. With one daughter, my heart could barely contain the sound of giggles and excitement when her ‘papa’ would build princess forts, play Barbies and horseys, or dress up in playdoo necklaces. With two, I’ve given up hope containing my heart. It no longer exists in my body.

The remaining sanity I did have from my first child has completely deteriorated when having a second.

It’s a weird thing with kids. The only way I can describe it for myself is like the space-time continuum has folded up onto itself and opposite-world prevails.

Typically during the week, I have no idea what day it is and I really could care less. I never find myself worrying over things; frankly, it seems I just don’t have time to. I don’t mind that either.

There really is enough love.

More then enough. It’s seems cliché but the love with two is really multiplied – like shining a light into a prism. The prism with one child has 10 sides, bouncing light and love – but with 2 children there are 10,000 sides. The mirrored effect of love shining through that prism is blinding.

How can one person continue to” have it all”, everyday? I no longer question it or fear it vanishing – I only embrace it. Every moment.

If I die today, that would be ok.

I know I’ve heard the term, “Live life like there’s no tomorrow.” In the past, I had thought this meant living life recklessly, wildly. But I’ve learned that’s not it at all.

If you think about it logically, there is no tomorrow. Only today.

What does that mean…..

Living, really living – and enjoying my life, today – has become effortless. I’m not sure if that would be the case if any other path was chosen for me. Of course, no other path exist other then this one before me. What is someone to think when everything in their life feels so… right?

I’m not saying that I don’t get upset, disappointed or sad. But now that I have everything I could have ever imagined (and more), it’s challenging to hold a grudge for any amount of time. Forgive, and move on. Apologize, and move on. That’s all we really can do in life. That and of course be unconditionally, unreservedly grateful for each breath.

Hand Sanitizer VS Hand Washing

Infectious diseases are the 3^rd leading cause of death in the United States according to the CDC which has many people running to purchase anything that will kill off scary bacteria. [1]

You see hand sanitizers everywhere. Most schools now list them as a requirement for school supplies. They have convenient small travel sizes, fun holiday scents, some that are moisturizes, and don’t forgot those cute rubber holders that hook onto the diaper bag or purse.

Manufactures state that these products kill 99.9% of germs. So one would assume that when they are used on the hands they are killing 99.9% of germs-but this is extremely misleading and recent research suggests that this is not the case.

Tests for Efficacy 

Did you know when the tests are performed to prove efficacy of 99.9%, these products are tested on inanimate surfaces, not human skin or hands. Human skin and hands are definitely not anywhere near an inanimate surface. Sebum is the oil secreted by the pores that forms a protective layer for the skin. Hand sanitizers strip away the sebum oil on the skin to kill the bacteria that resides there.

Research from Purdue University states that “hand sanitizers do not significantly reduce the number of bacteria on the hand and in some cases may potentially increase the amount.” [2]

Washing your hands uses more friction then hand sanitizers. The friction used has the ability to dislodge a virus and send it spiraling in to the sink where it can be removed. Superficially rubbing your hands to together with a sanitizer can spread the virus if the sanitizer doesn’t kill it. Not to mention, you just end up with a bunch of dead viruses and bacteria on your hands on all.

There is no doubt that hand sanitizers, acting in conjunction with hand washing, are a benefit. But the false security many place in these products alone has the potential to be dangerous.

Squirt, Rub, Done.

I’m not denying that I have used hand sanitizers when soap and water were not available (such as at the gas station, ew). With researching a bit more on the topic though, I found out that I had been using them improperly this whole time.

To maximize effectiveness with sanitizers, you must make sure you are using them correctly. First make sure it contains at least 60% alcohol (not all sanitizers are up to this requirement). On a side note, definitely avoid sanitizers that contain Triclosan since this chemical has been documented in disrupting hormonal balance and has been linked to allergies, asthma and eczema.[3] Then use a dime size amount and rub the hands for 30 seconds. According to the CDC, if your hands are dry within 15 seconds, you haven’t used enough.

After I read this, I started to be more mindful of how I was using these sanitizers. I actually counted the 30 seconds and if you’ve never done this before – it is a lot longer then I expected to be rubbing my hands together. I doubt I had ever used a hand sanitizer correctly before that time.

There’s Good Bacteria on My Hands, Say What?

The goal of hand sanitizers are to, not remove, but kill bacteria on your hands. There is a dilemma in this practice because sanitizers are not selective when it comes to good and bad bacteria. There are some bacteria that we definitely do not want on our bodies, but there are some that actually protect our immune system. We definitely do not want to kill that bacteria.

More importantly, there is considerable evidence out there that some exposure to bacteria in our environment is actually beneficial in the development of our immune system. There are studies now demonstrating the effects of sterile environments on allergies and asthma.[4][5]

I’m not saying that kids shouldn’t wash their hands but using alcohol and other harsh chemicals to kill agents on the surface of the skin a few times a day, is safe to say, probably not helping a child’s immune system.

Bottom line? If you’re worried about germs, then wash your hands.

Reference:

[1]Fauci, Anthony, Nancy Touchette and Gregory Folkers. Emerging Infectious Diseases: a 10-Year Perspective from the National Institute of Allergy and Infectious Diseases. Vol. 11, No 4, Apr 2005.  http://wwwnc.cdc.gov/eid/article/11/4/pdfs/04-1167.pdf

[2] Hand Sanitizers Bo Substitute For Soap. Science Daily. Feb 18, 2000. http://www.sciencedaily.com/releases/2000/02/000218061254.htm

[3] Epstein, Samuel.The Dangers of Triclosan: A Common Anti-Bacterial Ingredient. Huffington Post. Mar 24 2010

[4] Anderson, Aoife. Sterile environments 'causing' allergies. Independent.ie. Jul 4 2006

[5] Delespesse, Guy.Why are allergies increasing?.Health and Medicine. Apr 13 2010

2012 Changes To the Immunization Schedule

Every year, the Advisory Committee on Immunization Practices (ACIP) evaluates the current CDC's recommended immunization schedule.

Less then 2 years ago (October 2010), the ACIP had recently adopted an “evidence-based” process that considers quality of evidence, benefits & risks, preferences of affected populations, and of course economic impact. Interestingly, the first exercise of this approach for this year was for the committee to vote to expand routine HPV vaccination to males and to add the tetanus, diphtheria and acellular pertussis vaccine for expecting mothers. 

But first, let’s learn more about the ACIP….

About the ACIP

Some may think that the CDC’s recommended schedule is backed solely on scientific evidence. But consider this, less then 2 years ago (October 2010), the ACIP had recently adopted an “evidence-based” process that considers quality of evidence, benefits & risks, preferences of affected populations, and of course economic impact. Makes me wonder what process was in effect prior to 2010.

It also makes me wonder, is the scientific evidence and benefits the same in Japan since they have a very different schedule then ours. One example is the varicella vaccine. It is kind of ironic that the first varicella vaccine was developed in Japan and was licensed in Japan in 1988, but still isn't on their routine immunization schedule. Also, interesting to note that Japan recently (March 2011) suspended use of the Hib vaccine (ActHIB) and Prevnar. One large discrepancy as well is that Japan did not immunize children under 2 years of age until recently (1995), of which children under 24 months receive at most 6 injections versus more then double that (13) here in the United States. [1]

Moving forward, the ACIP consists of 15 professionals that provide a vote on the guidance given to the CDC. These individuals hold credentials specifically associated with immunization (not neurology, gastrology or toxicology) and they have been precisely selected by the Secretary of the US Department of Health.

The ACIP is the only entity within the federal government that makes recommendation for routine administration of vaccines to children and adults, which also determines number of doses, intervals, precautions and contraindications.

Would like to know more about this group? Here are the conflicts of interest listed directly on the Annals of Internal Medicine site publishing the update 2012 immunization schedule. [2] [3]

-Dr. Bennett: Consultancy: Greater Rochester Health Foundation, NYU Columbia University; Employment: University of Rochester; Grants/grants pending (money to institution): National Institutes of Health, NYS, Centers for Disease Control and Prevention, Greater Rochester Health Foundation.

-Dr. Coyne-Beasley: Grants/grants pending (money to institution): Merck.

Dr. Ehresmann: Support for travel to meetings for the study or other purposes: Centers for Disease Control and Prevention; Employment: State of Minnesota; Grants/grants pending (money to institution): Centers for Disease Control and Prevention, Environmental Protection Agency; Payment for lectures including service on speakers bureaus: National Foundation for Infectious Diseases.

-Dr. Jenkins: Consulting fee or honorarium: Centers for Disease Control and Prevention/ACIP; Support for travel to meetings for the study or other purposes: Centers for Disease Control and Prevention/ACIP.

-Dr. Keitel: Consulting fee or honorarium: Centers for Disease Control and Prevention; Support for travel to meetings for the study or other purposes: Centers for Disease Control and Prevention; Grants/grants pending: Novartis; Payment for lectures including service on speakers bureaus: National Foundation for Infectious Diseases, American Society for Microbiology, Infectious Diseases Society of America, Centers for Disease Control and Prevention, European Society of Clinical Microbiology and Infectious Diseases, International Society for Influenza and other Respiratory Virus Diseases, Options for the Control of Influenza.

-Dr. Marcy: Employment: Southern California Permanente Group per diem, Vaccine Safety Datalink Project; Expert testimony: Pediatric Stevens-Johnson case, Pediatric E. coli infection case; Payment for lectures including service on speakers bureaus: Medical Education Speakers Network, American Academy of Pediatrics, National Foundation for Infectious Diseases, Symposia Medicus; Stock/stock options: IRA and investments under control of financial consultant Smith Barney.

-Dr. Rosenbaum: Consulting fee or honorarium: ACIP; Support for travel to meetings for the study or other purposes: ACIP.

-Dr. Vasquez: Payment for lectures including service on speakers bureaus: Merck.

Onto The Recommendations….

Tetanus, Diphtheria and Acellular Pertussis Vaccine For Pregnant Mothers

Some of the most important changes for physicians in the 2012 immunization schedule involve the tetanus, diphtheria and acellular pertussis vaccine for pregnant women which is designed to protect infants from pertusiss. According to the 2012 schedule, women should receive the vaccine during pregnancy, preferably after 20 weeks of gestation. Pregnant women not vaccinated during pregnancy should receive Tdap immediately postpartum. [2] [4] [5]

“It’s a twofer,” said ACIP chairwoman Carol Baker, MD, professor of pediatrics at Baylor College of Medicine, Houston. “By vaccinating in the late second or third trimester, you protect the mother and you protect the infant.” [6]

One might assume that this recommendation for pregnant mothers was made after meticulous clinical studies of the positive and negative effects on the developing immune system and neurological system of unborn babies or pregnant mothers. Especially since the ACIP adopted an “evidence-based” process that declares the review of quality evidence.  Nope – nothing.

Even the head of the ACIP (Committee Chair Carol Baker ) admits the absence of data for the tetanus-diphtheria-pertussis vaccine and its use in pregnant women because this population is typically excluded from clinical trials, which creates a burden when trying to make recommendations on vaccine use in pregnant women.

.“Pregnant women are orphans when it comes to medication and vaccination research,” [6] [7] - Carol Baker  professor of pediatrics at Baylor College of Medicine and the Committee Chair of the 2012 ACIP

No peer-reviewed, published studies illustrate it is safe or effective to give tdap to unborn babies and pregnant mothers.

None.

Yet the ACIP voted 14 to 1 for this recommendation.[7]   

HPV4 Vaccine for Boys

One of the biggest changes to the new 2012 immunization schedule was the addition of the HPV vaccination recommendations. The ACIP now recommends routine HPV4 vaccination in boys 11 to 12 years of age, with catch-up vaccinations at age 13 to 21. However, HPV4 vaccination may start as early as young as 9 years of age in boys. [2]

There is not one scientific study or documented clinical trial to evaluated Gardasil’s potential carcinogenity or genotoxicity.

There is currently no way of knowing how the HPV vaccine affects fertility, birth defects, cancer, if it can pass through breast milk, or if it can alter your genes or the genes of your future children (genotoxicity).

The panel voted 13-0, with one abstention, to make HPV4 vaccination with Gardasil (Merck) routine for boys aged 11 to 12 years.

This decision was, no doubt, made in reaction to a 2011 trial, sponsored and designed by Merck & Co, Inc. This study did not use a saline solution placebo group (an amorphous aluminum hydroxyphosphate sulfate (AAHS) adjuvant was used as the placebo group). The study also does not attempt to say Gardasil prevents cancer in boys, instead the vaccine is stated as preventing HPV-6, 11, 16, or 18 – which causes external genital warts not cancer. [8] [9]

The authors of the study state that further clinical trials should be performed.

The authors noted that while they find it likely that the prevention of HPV infection and disease in men may have additional benefits, such as preventing anal, genital and throat cancers, these benefits need to be directly demonstrated through further clinical trials.[9]

“It shows that if we vaccinate males early enough, we should be able to prevent most cases of external genital warts in this population." [9]

“Palefsky noted that warts are a common problem in young people and are often associated with depression, social stigma and loss of self-esteem.” [9]

Interesting to note that in 2009, a study funded by the National Cancer Institute and the American Cancer Society states that vaccinating boys against HPV is not cost-effective.[10] 

May want to consider that it is believed that smoking has more to do with the progression of an HPV infection to cervical cancer than any other single factor, as smokers with HPV go on to develop cervical cancer much more frequently than infected non-smokers.

Cervical cancer is also well documented to be caused by an infection acquired through sexual contact. So in addition to avoiding smoking and eating a nutritious diet, it is behaviorally avoidable.

 

Other Changes

Another big change in the schedule is a switch in the meningococcal vaccine, which expands vaccination down to age 9 months for certain children at increased risk.

The ACIP now recommends vaccination against Hepatitis B for adults younger than age 60 who have type 1 and type 2 diabetes, as soon as possible after diabetes is diagnosed.

Clarification is provided for administration of hepatitis B vaccine and hepatitis B immune globulin to infants weighing <2000 g and for infants weighing ≥2000 g who are born to hepatitis B surface antigen-positive mothers.

Egg allergy is no longer a contraindication for the influenza vaccine. Adult patients should continue to be vaccinated against the flu annually.

I urge you to the read the full 2012 Recommended Immunization Schedule here .

References:

 

[1] Japan Halts Use of Two Vaccines After Deaths. Mar 8 2011. http://online.wsj.com/article/SB10001424052748704041504576185611566311144.html  

[2] Recommended Adult Immunization Schedule: United States, 2012. Advisory Committee on Immunization Practices. Annal of Internal Medicine Jan 31, 2012. http://www.annals.org/content/early/2012/01/30/0003-4819-156-3-201202070-00388.full

[3] Annals of Internal Medicine. ICMJE Forms. https://www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M11-2988

[4] Brown, Matt. Changes to Tdap, HPV, Hepatitis B Vaccine Recommendations Among 2012 Schedule Highlights. AAFP. Feb 1 2012. http://www.aafp.org/online/en/home/publications/news/news-now/health-of-the-public/20120201immunrecs.html

[5] 2012 Adult Immunization Schedule Broadens Recommendations for HPV and Hepatitis B Vaccinations. Infection Control Today. http://www.infectioncontroltoday.com/news/2012/02/2012-adult-immunization-schedule-broadens-recommendations-for-hpv-and-hepatitis-b-vaccinations.aspx

[6] DeNoon, Danial. CDC Committee: To Stop Deadly Infant Whooping Cough, Give Vaccine Late in Pregnancy. WebMD Health News. Jun 23 2011

[7] ACIP Recommends Expectant Mothers Receive Pertussis Vaccine. Infectious Diseases In Children. July 2011

[8] Efficacy of Quadrivalent HPV Vaccine against HPV Infection and Disease in Males. New England Journal of Medicine. Feb 3 2011

[9] HPV Vaccine Works for Boys: Study Shows First Clear Benefits. Science News. Feb 4 2011

[10] Jane J. Kim, Sue J. Goldie. Cost-effectiveness analysis of including boys in a human papillomavirus (HPV) vaccination program in the United States. British Medical Journal, online October 9, 2009