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“What Would One Want From A National Vaccine Plan?"

SausageBy Kelli Ann Davis

“What Would One Want From A National Vaccine Plan? A Predictable Regulatory Environment” – Philip Dormitzer, Novartis

Predictable: v. to state, tell about, or make known in advance, especially on the basis of special knowledge.

On December 1st, the Institutes of Medicine’s (IOM) Committee on Review of Priorities in the National Vaccine Plan held its Second National Stakeholder’s Meeting in Irvine, California; this pivotal IOM Committee has been given "carte blanche" marching orders from the National Vaccine Program Office (NVPO) for developing the National Vaccine Plan. (More detailed information at the end of this post.)

Among the invited attendees were pharmaceutical representatives Philip Dormitzer (Novartis), Edward S. Mocarski, Jr. (MedImmune), and Stanley Plotkin (Sanofi Pasteur).  Due to an audio telecast, many of us were able to hear various strategies promoted by these vaccine manufacturers which (more often than not) went virtually unchallenged by government officials; here are some highlights from the meeting:

Strategy 1: Push for Predictability

Dormitzer: When discussing vaccines for the market he states, “We don’t need incentive because it’s already there.”  He’d rather have a “predictable regulatory environment” which “while ensuring public safety one has confidence that the vaccine makes it through.”  And “communication with the public” is his key to making that happen.  But since “we’re not the best advocates because we have a financial incentive” he suggests “government agencies are the advocates” to get the job done.

Strategy 2: Push for Recommendations

This theme came up multiple times throughout the day.

Plotkin: “The second point I want to hammer is the importance of recommendations.”  He mentions a prior 2000 IOM Committee (included in his second slide presentation) and states, “The most important external or nonscientific event is the recommendation of the previous IOM panel.  Recommendation from committees like this really do get read.”  He then goes into some detail about CMV and says, “Until the recommendation came out companies were uninterested because they didn’t think it was important” and as such a “limited number of companies were interested.”  But “once the IOM recommendation came out things changed and numerous companies are now interested in CMV/experimental vaccines.”

Later in the afternoon during his second slide presentation, he expands on this subject further.  “Lime disease vaccine” is an example “where public health failed. One reason it failed was the lukewarm recommendation from ACIP.”  He expounds a bit and then drives home his points: “Public health recommendations are key and they have to be considered” and “Recommendations have to be formulated so the vaccine is used.” For the second time that day, he mentions the importance of the previous IOM recommendation by saying, “the 2000 IOM report was issued” and “experimental vaccines are being produced because of this report.”

Strategy 3: Target an “Orphan Group” and Use Recommendations to Bolster Your Market
When a vaccine is likely to be targeted to a limited number of individuals in the US, it is called an “orphan vaccine”.   Generally, the costs of producing orphan vaccines surpass the potential sales. Therefore, few organizations are willing to develop vaccines for rare diseases when they do not expect to recover the development costs.

During Panel One, discussions focus on pregnancy, vaccines and recommendations.
Mocarski: There is a “need to vaccinate young woman/pregnant woman” but unfortunately, “ACOG (American College of Obstetricians and Gynecologists) hasn’t bought into this idea.”
Alas, a few moments later he is reassured by Kathryn Edwards (Vanderbilt University) who replies, “ACOG is interested” and she then goes on to state how parents will blame the vaccines if their children “don’t grow up and go to Harvard -- that it’s somehow attributed to want they got during pregnancy.”

Plotkin: “Pregnant women are an orphan group” and expounds by discussing the “legal issue and public perception issue” and goes on to state, “there has to be a way of including pregnancy into the compensation system.”  He provides some background history and declares, “From my experience” the issue “causes lawyers to raise up and say ‘no way.”’  But, he’s not deterred.  He continues, “Government can change it by saying ‘we need vaccines for women.’”  But, seems ACOG may still be an issue since he goes on to say, “obstetricians are worried about the idea.”  He reasons that “passive protection would protect infants” and then goes back to suggesting “NVAC and the IOM need to say ‘this is important and we should be doing this.’”

Strategy 4: Push for Legal Protections

During Panel One, Robin Robinson  (DHHS) started discussing influenza in regards to requirements and shared how they “did something different.”  They asked the “specific question: could we use the adjuvant from one company to another because that’s not how it’s licensed.  After a year, the CDC/NIH/FDA/DOJ/FTC were involved because of the anti trust issue here” and by using these agencies they were able to “waive that.”  The motivation was if the “pandemic occurred tomorrow what would we do?”  “The issue that was most formable was publication.”  He went on to describe how the “companies didn’t want to go that way” and so eventually the work was “published with commentary by HHS.”  He discussed “going forward” along with “real partnership” and defined that as “if you participate you get to see data and if you don’t participate you don’t see data.”
Plotkin picked up on the discussion by stating they need to be “innovative in the use of adjuvants.”  He discussed “legal issues” and “intellectual property” followed by “anti-trust issues” and used “bio-defense” as an example on why they “tried to organize companies” but the “lawyers said we can’t do that” and so the “legal issues need to be addressed” in order to “stimulate process innovation” because there are “financial and regulatory implications.”  He indicated that once an “established vaccine was being made there’s not much incentive to change it.”
Next he discussed liability protection which I wrote about (HERE).

One glimmer of hope from the day long proceedings happened when Ray Strikas (NVPO) went up to the mike and challenged Harry Greenberg (Stanford) by stating, “I disagree with Dr. Greenberg.  Benefits and risks are important in regards to the public.”

Earlier, Greenberg gushed, “I love vaccines and anyone would have to be an idiot not to recognize what vaccines have done” followed closely by ”safety and public health perceptions create problems” and “without government intervention a vaccine won’t go forward like it needs to go.”

He responded to the criticism from Strikas by noting that “there is nothing in the document about the benefits and risks” and “I don’t think it goes there.” 
Boy, do we have a lot of work to do in changing the course of these discussions.   

About the National Vaccine Plan:

The NVPO, part of Department of Health and Human Services (DHHS), is coordinating the update to the 1994 National Vaccine Plan and DHHS agencies and other departments are contributing to the plan with advice from the National Vaccine Advisory Committee (NVAC). 

There are many important stakeholders whose input is needed.  IOM has been asked to get input from scientific, medical, public health, and private sector experts (meetings are open to the public).  NVPO will conduct a separate and extensive process to obtain input from the general public. 

The purpose of Stakeholder Meetings will be to: explore topics related to the five major goals of the draft National Vaccine Plan and; react to draft objectives being developed by DHHS agencies.

Overview of the Study Process: Charge to the IOM Committee

1. Review the 1994 National Vaccine Plan and then provide guidance on the development of the update to the plan:

• On March 3, 2008, the IOM’s Meeting 1: Review of Priorities in the National Vaccine Plan took place in Washington, D.C.  At this meeting, I learned the National Vaccine Advisory Committee’s (NVAC) Vaccine Safety Working Group (VSWG) was busy working on a “vaccine safety white paper” and after my public comment (HERE). I was able to connect with Ray Strikas of the NVPO.  (On April 11, 2008, the “white paper” was discussed in-depth at the NVAC VSWG meeting in Washington, D.C. (HERE).   

2. The committee will hold five information-gathering meetings with stakeholders to explore areas of the developing plan and prepare a report about priorities in updated National Vaccine Plan:

• On July 24, 2008, the First National Stakeholder’s Meeting was held in Chicago, Illinois.
• On December 1, 2008, the Second Stakeholder’s Meeting was held in Irvine, California.

Kelli Ann Davis is the D.C. Political Liaison for Generation Rescue.


Dawn Loughborough

Does anyone remember the civil rights movement? This one should be called the health rights movement. We have a lot of work ahead to keep any rights over what goes into our bodies and our children's bodies. When's the next rally in D.C.? We have to keep the conversation alive with our representatives and the public. I so want to get involved.


Kelli Ann Davis,

I agree with your last post 100%. To me the battle is against the mandates and efforts to vaccinate 100% of the population against every germ they can. Obviously the big companies are pushing for the mandates and that, well, maybe is evil. But the CDC is the real problem here, at least in my mind.

My experience is in biotech, which is often like comparing the family farmer to Monsanto, but I can say that the safety has been the absolute number one focus everywhere I've been. But it is hard. Frankly, we're not smart enough to be doing this. We can't understand everything and everybody's immune system. That's why it is the mandates that bother me. The lack of informed consent and freedom of choice.

I think in protecting the mandates they CDC is forced to cover up the safety issues, including thimeresol. I think it would have taken one word from the CDC for the drug manufacturers to do it. The CDC told them not to. Should they have done it anyway, YES and may they burn for not. But still it could have been done with one word from the CDC.


I think the AAP and CDC declared (without our knowing or consent) a war on infectious disease. As in any war, all is fair. There are casualties in this war, just like any war. And just like in any war they use propaganda to cover up or justify the loses and atrocities. Wrong assumptions are made that cost or destroy lives, but in war all is forgiven (for the greater good).

Unfortunately, we the people are getting no say in this war and there is no consideration among the press as to whether this is a war that should be waged or to what scale we should wage it. The lies and cover-ups of the true nature of war are more evil to me than bomb manufacturers and soldiers who believe they are doing right by their country.

In the end I fear our victories over the microbes will be pyrrhic in nature and we run the potential risk of losing the war in swift and dramatic fasion.

That is if global warming, pollution or nuclear accidents/war don't get us first.

I'm generally not this pessimistic

Kelli Ann Davis

"Would they sit cruelly in a meeting and devise ways to get our precious children to eat more of it, despite the growing rise of obesity and juvenile diabeties?"

Except for one glaring difference: Consumers in grocery stores have OPTIONS; first, on whether they buy the product in the first place and second, even if they decide to buy a product there are usually many items to choose from and thus, they are more likely to get a safer product.

Bottom Line: No one is “mandating” parents to feed Little Debbies to their children.


You're right, Jack; it's complicated. Evil exists, overt or banal, but also passivity and evasion of blame.

"The Corporation" used the DSM-IV to classify the Big Business mentality as psychopathic. But within corporate walls, individual people use groupthink as a shield for their own bad choices.

Advertising agencies focus on pushing product. Their employees operate within insular overlapping circles of peer influences and market forces. Like vaccine manufacturers they, too, look at consumers as target clusters. They rationalize promotion of questionable consumer goods by telling themselves that if they didn't do it, someone else would.

The dark humor of the movie "Thank You For Smoking" broadly illustrates the kind of mental machinations some breadwinners assume in their quest to make a buck.

Cold-hearted administrators set policy, and loyal footsoldiers carry out the orders unquestioningly. So why are we so surprised that vaccine-injured children are treated like road kill?


I think it is easy to paint one group of people as evil in any battle. Maybe many are, but maybe it is more complicated.

Walking through the grocery store (the only one within 30 miles that carries Ian's) I couldn't help but wonder about the Little Debbie's Christmas Tree Snack Cakes. Is the grocery store manager more or less evil than the pediatrician? They're both selling poisons but have been told by the people they trust (US Gov't) that they are safe. What about the ad wizards that thought of ways to peddle that crap? Would they sit cruelly in a meeting and devise ways to get our precious children to eat more of it, despite the growing rise of obesity and juvenile diabeties?

Mark Blaxill

Business is most freqently a positive force in society, but there are times when the drive for profit needs to be constrained. And when regulators fail to do their job, businesses can become an evil force, in much the way that Hannah Arendt describes in Eichmann in Jerusalem. Eichmann was a logistics manager. He made sure the trains ran on time, not too much more than that. But he also knew what was on the trains and where they were going. That made him evil.


Kelli Ann-- though your coverage of this and commentary are gripping, the mundane way that some at that meeting went about their business was jaw dropping under the circumstances. The following paraphrase from Hannah Arendt, the author of "Eichmann in Jerusalem: A Report on the Banality of Evil," says more than I could:

Evil is never "radical", is only extreme, and... it possesses neither depth nor any demonic dimension... It is "thought-defying"...because thought tries to reach some depth, to go to the roots, and the moment it concerns itself with evil, it is frustrated because there is nothing. That is its "banality."

Hannah Arendt, 1964


I really really hate to keep sounding like I'm defending them, but I know their lingo a bit and some things may sound worse to us than how they were meant.

If you want vaccines approved to do the good they can do (that point is debatable) you then you have to have Point 1. You have to have a predictable regulatory environment. By that they don't meant everything approved. By that they mean that if it takes 8 years to develop a new vaccine (which would be good) you HAVE to know that the rules are the same in the 8th year as they were in the first. Or have a good collaborative effort with FDA to know what the rules will be so that you can prepare for them and move you compliance efforts in that direction. That's how that term is used in the industry.

This highlights a big problem in a different way though. If we are constantly holding people to the standard of today, every drug would be considered dangerous and obselete. That's why approved drugs stay on the market and are not improved. To make a new one would face such a higher standard than the old.


I was just reading up on Dr. Mouldon's explanations for why vaccinations cause micro-vascular stroke and one of the things that happen with vaccines is that they cause an over-reaction of our immune system which leads to micro-vascular stroke.


Can anyone explain to me why it is important to reduce the immune response, taken from the notes?

Ben's Dad

one more thing -

Right now I have one request on my mind. Lets say for the sake of argument that the 'vaccine at all costs' advocates are half right. Lets walk through a discussion where they are right about vaccines being completely safe for everyone regardless of mitochondrial dysfunction, that vaccines for sexually transmitted diseases should be mandated for everyone regardless of age, behavior, or religion, that they should be given as soon after birth as possible for everyone so that the body can put its energy into immunity rather then on development of vital systems, that in this one exception injected mercury is completely innoxoius, and that you can give as many as you want at one time in order to save money people are willing to spend. Just for arguments sake lets walk past that for a minute.

I BEG THE PROFESSIONAL COMMUNITY to consider the harm they may cause by denying the existence of an autism epidemic for the sake of defending vaccines. If you are 100% right about the vaccines, but 100% wrong in denying an epidemic, them you are tragically derailing the justification to aggressively find answers elsewhere. The sooner that other thing is found; the sooner vaccination rates will improve. Please do not be defensive in the question of whether or not an autism epidemic exits, because you may be shooting yourself in the foot.

So, what if you are right about vaccines, but wrong about the epidemic? That would be an equally tragic mistake to make.

Please look aggressively at the recent epilepsy study involving valproate, where pregnant mothers had a 7 times greater risk of having a child with autism then mothers on other epilepsy medication. A study where the larger group of pregnant mothers on other epilepsy medications had a lower incidence of children with autism then the cohort group that was not on epilepsy treatments. Please look aggressively at things similar to valproic acid, such as the valceric acid that valproic acid was developed as an analog of – an ingredient commonly used in flavorings, cosmetics, pesticides, acme medication, and even naturally items such as vinegar. Maybe this is one of the kryptonites we have been looking for. If you can get out of the way of the autism epidemic question and the genetics only angle and help show progress in other areas, you will sell more truly safe vaccines and we will have a healthier population all around.

Ben's Dad

Point 1 seems to ask – ‘Will you sell for use? We want to know that you will push our products and say they are safe and necessary, no matter how defective and unnecessary they are.’

Are these folks at all concerned at the suggestion that preventable diseases are ignored by the free market? It must be terrible to have something that nobody can figure out a way to make money off of…

On the OBGYN issue - “buying into an idea” is phrase that makes a clear statement of politics over science. You don’t need to buy into science.

Ms Edwards – Maybe if so many OBGYN’s weren’t devoting so many resources into the highly profitable, largely unsuccessful, and well insured practices of mixing up Harvard grade eggs in a petri dish, they would be able to provide more reliable routine services.
I have never sent so much as a letter commenting on the mistakes that I witnessed that my wife and child were subjected to, but maybe I’ll get around to it if I keep hearing suggestions that injury is a fabrication of over competitive parents.

I would like to see the specific 2000 recommendation that was so inspiring. Was it a recommendation on immunity or, on priority, or on implied mandates? I think the observation of how important a recommendation from this panel is should translate into substantial responsibility by this panel to get it right. I miss the days when a recommendation implied choice.

I think there is a need for research data to go the way of open source code. If you are going to allow your work to be cited in a safety study or a governmental approval, then it needs to be published freely. All of these little journals nickel and diming (or $25 a pop) for access to research is really a drag on having informed, open and honest discussions.

As tempting it is I think it is as wrong to assume these people are evil as is for them to to be lazy about identifying subgroups. Vaccines save lives – I get that. It is important work We don’t know what causes autism. I get that too. But something is going wrong in our society, and the 30,054 new autism diagnosis’s a year are making a dent in the collective greater good argument.

Thanks for attending this for us and reporting back.

Kelli Ann Davis

Hey All,

A couple of follow up points:

Tanner’s Dad:

Agreed -- anyone who sits though one of these meetings is a “hero” and deserves a super-duper gold star for making it through, and in your case, give yourself two. During the first meeting in March, I practically fell asleep until the zinger “vaccine safety white paper” hit my ears. Suffice to say, *that* got my attention!

Bottom Line: Yes, the meetings can be quite boring at times but we’ve worked our butts off in putting on the pressure to *open* these meetings up to the greatest extent possible so all those little, gold nuggets zingers reach our collective ears!

Dan: Sausage making….that’s a new one and quite appropriate.

Noyfb: “Until safety is a top priority the public will not give their trust. trust is earned not an automatic gift.”

During the March IOM meeting (which I literally found out about 2 hours before it took place) I was the ONLY public person in the room. I was able to make a “last minute” public comment describing *exactly* your point – here’s the link


I recognize many of the comments made in your notes. Here’s something that I thought was *VERY* interesting but didn’t get to incorporate into my piece:

Near the end of the meeting, there were discussions on risk groups and the military. Clair Broome (Chairperson of the Committee) interjected a comment that I thought was *EXTREMELY* telling of the institutional mindset; she said, “Regarding a subset of vaccine targets that aren’t healthy”.... and went on to discuss the differences between high risk groups and how they need to approach vaccines differently for these groups and and then she uses the comparison “vaccines destined for high risk groups vs. destined for infants."

Did you catch that??

Bottom Line: The mistake she made is her ASSUMPTION that infants are automatically a HEALTHLY subgroup when in fact, we know little about a particular infant's “health” at such a young age.!!!!!


Sometimes we are called paranoid conspiracy theorists, but this meeting confirms that our perceptions are reasonable and valid.

As far as I have heard, the people in this meeting only expressed the view that vaccine safety and risk/benefit analysis are Public Relations issues. No discussion of how to make vaccines safer -- only discussion of how to sell vaccines to the public. And the government employees working hand-in-hand with pharma on this.

It's just sickening. No concern expressed for babies and children injured by vaccines. No plan to address problems at all, except by spin and liability protection.


Here are my notes.
I don't know if much can be gained by them.
I listened to a small portion of the meeting:

Stanley Plotkin*
Executive Advisor to CEO, Sanofi Pasteur
Emeritus Professor of Pediatrics, University of Pennsylvania

-need to come up w/ strategy to reduce immune response

-Therapeutic vaccines

-yellow fever- tropical disease

-HPV method to use for eboli and flu (H5 and 1)

-Intra-dermal vs. intra-muscular by micro needle

-Mucosal immunization w/ killed antigens

-Production ideas- make antigens in plants (tobacco)

-new adjuvant to Hep B reduced from 3 dose to 2 doses trials= FDA said stop because we already have a Hep B vaccine so since it can be supplied adequately they were not interested in reducing doses to 2 etc...

-Hep B for dialysis patient (someone later brings up risk/benefit ratio)

Edward S. Mocarski, Jr.*
Distinguished Fellow, MedImmune Vaccines
MedImmune, AstraZeneca
Professor Emeritus Stanford University
Robert W. Woodruff Professor in the Department of Microbiology and Immunology
Emory Vaccine Center, Emory University

-Virologists think differently than immunologists

-How do you Know what will work in humans?

-Need for Public health awareness not just through seeing the spread of disease (ie...a Mom is not going to be convinced to use a vaccine for prevention of a dis. she has never seen (advertising???))

-Need for good adjuvents as we don't know how they work (3 studies)

-balance prophylatic w/ therapeutic (for chronic disease like cancer)
HPV therapeutic to modify current vaccine



-Focus on regulatory issues for therapeutic vacc.s such as for chronic diseases

-atherosclerosis/stroke= therapeutic vacc.?

-we don't understand protective immunity

-CMV cyto-megalo-virus (a type of herpes virus)- seem very excited about

-Were extremely worried about Poultry retro-virus with FluMist, but were told safe.

-Want to Try out adjuvants on high risk groups instead of infants (adjuvants for broader implication)

-Risk/benefit- want to focus on BENEFIT. In military setting will accept more risk (biological attacks).

-diabetes/addiction etc.. not dealing with here

-For so many benefits you must accept risk. Make society understand what risk one must accept for benefits.

-Want to change how adverse reactions are handled in clinical trials.

-Increase Use of Vouchers for expedited review by small companies and for revenue.

lll Sorry about spelling and confusion lll


love the making sausage photo to accompany the commentary, very appropriate.

the USA today investigation on the front page today also will make people take notice of what kind of toxic environment we are dealing with!

this is not just about vaccine safety, but also don't forget the increased risk of Autism relative to position next to a mercury emitting smoke stack (Texas study). I wish the USA today also mentioned the risk of neurodev disability as well as inc cancer risk due to industrial pollution.


Not one word about safety. speaks volumes doesn't it? As for the so-called gentleman who mentioned predictability......WE have that too many given to a child with mito/metabolic issues causes Autism. If these bafoons really wanted public trust they would earn it by cleaning up vaccines,changing the scheduel,and devising additional screening for babies before vaccination. They would also be well served to demand all pediatricians take a vaccine safety course. They are having nurses vaccinate children prior to an exam, repeating vaccines given just 5 days ago when a child comes in ill[med errors]The dept of defense recommends no further vaccination until a neuro work up in individuals whom are experiencing difficulties. Pediatricians are not doing this. The dept of defense also recommends haulting vaccination and /or delaying it for the same individuals. Pediatricians are not doing that either. Until safety is a top priority the public will not give thier trust. trust is earned not an automatic gift.


These people are speaking as if they are not even referring to human beings.

Freaky scary!

dan olmsted

This indeed is how the sausage is made. It's government's job to protect the public from the competitive zeal of corporations. instead they're in cahoots. we see it in iraq (halliburton), we see it in the financial meltdown, we see it at the fda (lax, lax oversight, chronic underfunding by pharma-bought congress), and we see it in vaccines. lax oversight of vaccines is the most serious failure of all because while unregulated financial markets might end up causing people to lose their house, unregulated and corrupt vaccine and medicine oversight can cause you to lose your life -- or your child. thank kelli ann for showing us the real-time reality of sausage-making. -- dan

Tanners Dad

Thank you and you are a hero. I have only sat through two of these types of meetings. This being one of the two. They lull you to sleep and bang they hit you with a zinger.

Arrogance is the word that comes to mind...

Stanley Plotkin*
Executive Advisor to CEO, Sanofi Pasteur
Emeritus Professor of Pediatrics, University of Pennsylvania

Many “vaccine targets left” and we “haven’t exhausted need for new vaccines”…..

First 30 seconds of his talk.

I was also amazed by the lack of understanding of how vaccine adjuvants work and that they would say it out loud.

11:25 AM Central Time...

"We still don't understand how adjuvants work"

What the HE**!?

Be very very worried... We might be getting hundreds of vaccines one day.

Totally off subject I must be up too early this morning. I just realized that GOV could stand for Green Our Vaccines...


.gov do your job and Green Our Vaccines People Green Our World.

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