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SafeMinds on CDC Swine Flu Vaccine Meetings: Science Secondary to Policy Decisions

Knowledge is power Managing Editor's Note: We invite you to visit our sponsor SafeMinds to learn more about H1N1 and the vaccination program. Theresa Wrangham, President of SafeMinds, attended the CDC H1N1 public meeting in Colorado. Here's her report. CDC is offering to pay $50 for attendance at these meetings. Some of the dates are already closed.

By Theresa Wrangham

CDC Sponsors Public Engagement on Swine Flu Vaccine, Science Deemed Secondary to Policy Decisions and Questions Remain

As the Centers for Disease Control (CDC) holds the first round in a series of public engagement sessions designed to promote public discussion on how pandemic swine flu vaccine will be made available to the public, many questions remain unanswered in terms of the safety of the vaccine being developed.

Dr. Roger Bernier and Capt. Raymond Strikas were present at the Denver public engagement session held on August 8th, which I attended to get answers to questions that remain as a result of July meetings held by the FDA Vaccine and Related Biologic Products Advisory Committee (VRBPAC) and the Advisory Committee on Immunization Practices (ACIP).  Imagine my amazement as Dr. Bernier opened the meeting by stating that we “can’t pick the right answer based on science and data.” and I was pleasantly surprised that I was not alone in my questions around safety.  It seemed as though roughly half of those attending had many of the same questions I did – it did not bode well for CDC.  However, as the meeting progressed it was clear that the public engagement session was not going to be centered on answers to our questions; rather attendees were being asked to make policy decisions based on incomplete assumptions furnished to them by the CDC.  The purpose of the endeavor as far as I could ascertain was to take the pulse of the public in determining the level of response the public felt was necessary in pursuing a vaccination program for the new swine flu vaccine under development.

What were the assumptions and scenarios in the discussion guide…in a nutshell the scenarios were “Go Easy”  which was defined by providing a few extra sites for vaccination for expected low public demand for swine flu vaccine and providing time to gather data on severity and safety/effectiveness of the new vaccine; “Moderate” to promote vaccination to target groups identified by the last ACIP meeting with a media/communication effort to promote uptake – given low demand, while acknowledging that safety/effectiveness of the vaccine would be unknown; and “Full Throttle” meaning that significant monies on all levels would be expended to create as many vaccination sites as possible no matter the severity of the virus with extensive communication efforts to stimulate uptake. 

Assumptions on which to base program efforts were incomplete in that they did not clearly acknowledged severity of the swine flu as mild and stable.  The vaccines safety profile was based on the current seasonal flu shot without distinguishing that the antigen for the swine flu was new and education given to the public on what a Class C drug classification (has never been evaluated for carcinogenic or mutagenic potential and that animal studies have never been conducted to investigate possible fetal harm) meant as it applies to safety data on the seasonal and swine flu shot. 

Acknowledgments made and questions answered at the meeting were that there  would not be enough vaccine for everyone until February 2010, two doses of vaccine administered 21 days apart is needed for protection, “ample” thimerosal-free vaccine would be available; thimerosal content for thimerosal-containing swine flu vaccine would be the same as the seasonal flu vaccine (25 mcg/dose); the swine flu vaccine program would be voluntary unless state/local jurisdictions otherwise stated mandatory requirements; over a million military personnel would be used for clinical trials and some of that data would be available in mid-September; squalene adjuvants could only be used under Emergency Use Authorization; the federal government would provide the vaccine free of charge and any charge for vaccine would be associated with administration of the vaccine, and enhancements to existing mechanisms and infrastructure to track adverse events is underway.  

Attendees broke to mull over the scenarios and assumptions we were given in order to drive our policy decisions and when the session reconvened themes of consensus were apparent.  The top two concerns were safety and choice/informed consent.  The majority of attendees favored a moderate effort, but I have to wonder if this would remain true had participants been aware of previous statements on safety made at the FDA VRBPAC and ACIP meetings, which were not truly addressed during public engagement, as well as clear statements on the swine flu’s virulence to date.  However, what was very apparent from this process was that the public expected accurate information on which to base their choice and choice was a primary concern held by individuals regardless of vaccine beliefs. 

Safety and transparency again were concerns held by all individuals regardless of individual vaccine beliefs. At the end of the day what CDC should have come away with is that gone are the days of “trust me and roll up your sleeve”.  The rise in distrust and desire for choice, safety and transparency are values held by the general public.  In fact, enthusiastic cheers from the majority of attendees went up when one attendee stated that the “CDC and pharmaceutical companies must have some skin in the game” to gain the public’s trust and be accountable for liabilities and injuries resulting from vaccines. 
It will not surprise me if all ten public engagement meetings reveal the same themes. 

What would surprise me is if CDC really listens and pulls their head out of the sand and pursues a different tact in communications that is more honestly based on the actual risk/benefit of any vaccine inclusive of gaps and limitations of what is known and what remains unknown.  It would also be nice to think that gaps in vaccine safety research will be closed…one can dream.  However, Dr. Bernier’s statement that science has no place in the current swine flu vaccination effort is less than encouraging.  We are 10 years into the promise of thimerosal’s removal from vaccines – something that is possible but not made a reality; and 30 years into application of lessons learned from a swine flu pandemic that never materialized – many lessons from which have not been integrated into this current effort.

Questions that remain, or clarifications that are needed, continue and below is a brief list.  We hope that our community will turn out at the public engagement sessions yet to transpire and continue asking them.
• In Denver Capt. Strikas stated that squalene adjuvants could only be used under Emergency Use Authorization.  What studies are currently being conducted for the swine flu vaccine antigen to be used with squalene and thimerosal that demonstrate safety and efficacy and what are the gaps and limitations of this data?

• We keep hearing reassurance that the safety of H1N1 swine flu vaccine is assumed because it will be formulated in the same manner as seasonal flu vaccine. Yet the NVAC H1N1 subgroup draft recommendation specifically states, “The need to actively monitor vaccine recipients for vaccine adverse events is critical given that the vaccine candidates will all contain a new antigen and may be combined with adjuvants that are not part of licensed vaccines in the US.” Please explain the inconsistency between what the public is being told about safety vs. the concern cited by this HHS scientific advisory panel.

• How will warnings on possible side effects be identified to the public, and injuries compensated, with no safety data available prior to vaccination?

• During the Denver public engagement session Capt. Strikas stated that he believed that separate administration of the swine flu vaccine was not necessary, but that ACIP had not ruled on administration of this vaccine separately or simultaneously with other vaccines.  The National Vaccine Advisory Committee (NVAC) has already cited a lack of safety data on simultaneous administration of multiple vaccines for existing vaccines and ACIP does not meet again until October – how will administration of the swine flu vaccine in this sense be decided with roll-out to begin in October?

• In response to vaccine safety infrastructure deficits cited by NVAC H1N1 Subgroup, Capt. Strikas also stated in Denver that additional HMO databases and other measures were being added to existing monitoring and tracking infrastructure.  What other enhancements are underway and where is this information available to the public?

• Capt. Strikas stated he could not answer how long-term health outcomes would be tracked given that monitoring of adverse events will only be for 6 months and focus immune response.  How will this be accomplished and where is that information available to the public?
• Will preference be stated for thimerosal-free vaccine for special populations such as pregnant women, young children and premies, given that the thimerosal-containing vaccine will exceed IOM recognized EPA safety standards on mercury exposure from vaccines?

• Per the NVAC H1N1 Subgroup recommendations, will a transparent and independent panel of outside experts with no stake in vaccines be assembled to review accumulated data, assess risks and advise on implications of possible side effects of this vaccine be assembled?

The next round of public engagement sessions are being held August 15th.  Below are links to register for these meetings and registration is a requirement to attend.  Additional information including how to register for a meeting is available at http://keystone.org/H1N1/.  

Vincennes, Indiana, Saturday, August 15
Birmingham, Alabama, Saturday, August 15
Sacramento, California, Saturday, August 15
El Paso, Texas, Saturday, August 22
Spokane, Washington, Saturday, August, 29  

Additional meetings are being planned in the following cities. Please check back frequently for registration information.

Bucks County, Pennsylvania, Saturday, August 22
New York, New York, Saturday, August 22
Somerville, Massachusetts, Saturday, August 29

The public must keep pressing for answers to these important safety questions.  Please consider going to these meetings!  SafeMinds will continue to update our Swine Flu webpage with answers to questions as they become known, as well as those that remain unanswered. 

Theresa Wrangham is the mother of Rachel, a young adult with PDD/NOS, and Deanna and lives in Colorado with her husband, Scott.  Theresa was appointed to the Board of SafeMinds in 2007 and currently serves as their president.  She served as a past Board Member with the Autism Society of Colorado and co-founded the Autism Society of Boulder County (ASBC), serving five terms as president.  Theresa is also the Director of Educational Development and Conference Liaison for the US Autism & Asperger Association and serves on the advisory panel for the American Medical Autism Board. 



7 billion to the vaccine manufacturers,and at last count 173 billion to A.I.G. and affiliates, the war in the mid east, mass unemployment and more to come. A new health care system for our country that will be ran by the "lock step" "good ol boys" on the beltway in OUR nations capitol....the same one's who allowed the ADJUVANTS THIMEROSAL and SQUALENE to administered to "WE THE PEOPLE". In the future what will they allow or mandate that you or your loved one's to take? Combine all that with the media driven hype about the Ah1n1 and you get mass confusion, paranoia,and a society that's on the brink of breaking.Who to believe, what to believe, how much to believe? Most people do not have the time to sit down and research on their own the paramount problems that our country and our world are faced with.This great web site is a breath of fresh air for those of us who have the time to research these matters of importance...and provides us with a media to vent our views and our frustrations. Keep up the great work.....PHIL esq


Theresa and the folks at Safe Minds, Age of Autism and other fine organizations are extremely brave and well-educated on this issue. Please support them in anyway possible.

Becky Estepp

"In Denver Capt. Strikas stated that squalene adjuvants could only be used under Emergency Use Authorization."
This statement makes me VERY nervous because a Level 6 Pandemic allows the US to jump into the Emergency Use Authorization (EUA). So that statment was made to make the audience feel better, however, Capt. Strikas did not explain that we are already under EUA. Sigh.

Cherry Sperlin Misra

Today, I am exhausted. All this thinking about risks and benefits is tiring an old person like myself out. Should I accept the swine flu vaccine and risk Guillain Barre syndrome or MS and some other unknowns? Or shall I just wait for the mesothelioma cancer that I may get because I was a little girl in Seattle where they used a polio vaccine which carried a virus for that cancer. And if I take the swine flu vaccine am I going to get Alzheimers Disease from the mercury therein? I havent received any vaccine for over 20 years and I live in India where the media tells me that people are always dying in droves ! Obviously its a miracle that I am still healthy. Could someone lend me a really good computer and a statistician so that I can figure out what to do?

Ann Benson


Please read this. A Dr. says that he would never give his children vaccines and why.

Frank for Aidan

Please excuse my double negative. I meant to say that a forced vaccination program will not go well. If anyone has actual knowledge of the subject, please reply.

Frank for Aidan

A paragraph in the article states that "Acknowledgments made and questions answered at the meeting" included:

"...the swine flu vaccine program would be voluntary unless state/local jurisdictions otherwise stated mandatory requirements;..."

I assume the "mandatory" was meant for school attendence, or are there people who are actually contemplating forced vaccinations - akin to forced evacuations during a disaster? That is not something that will not go well.


.00001672 % of the worlds population has died from the Ah1n1. W.H.O. has declared a level 6 pandemic.The C.D.C. has to follow suit by declaring a level 6 pandemic. Under this level 6 pandemic it has been confirmed they will be using THIMERSOL and SQUALENE as the ADJUVANTS in the vaccinations you and your loved one's are mandated to take.Life long debilitating illnesses and even death have been proven to be caused by these ADJUVANTS. These ADJUVANTS have been federally banned....but can be used with impunity by these manufacturers during a declared pandemic. Over 7 billion of your tax payer's dollars have been allocated to these drug manufacturers. The Ah1n1 has been confirmed by private bio labs to be man made...1 part avian, 2 parts swine, 2 parts human RNA from separate parts of the world.Our C.D.C. wants to vaccinate pregnant women and our children first with these toxic cocktails...then it's our turn. Be afraid....be very afraid. Thank you for considering my in put.... PHIL

Deborah (www.debstake.wordpress.com

I read an article this morning called: Will Americans follow orders to take flu shots? Link is here---->http://www.wnd.com/index.php?fa=PAGE.view&pageId=106654. There was a quote made by the CDC in the article that says:
"the fear mongering regarding this flu is not warranted by forensic evidence that H1N1 is the potentially devastating plague the hyperbole purports it to be."

so now I have to ask; which is it going to be? Forced vaccination (which I will never allow) or is this going to die away like the Anthrax and smallpox vaccine scare a few years back?

danny day

With Autism their seems to be a growing awareness and it's great for parents and children. I've worked with the and they are delicate even concerning dangerous infections/diseases. They need our help and assistance and protection.

Nancy Wood

Check into what an Emergency Use Authorization involves. First and foremost, for a medication or medical device to be authorized for emergency use, or a mediciation that has not been subjected to the ordinary rounds of safety trials, a declared state of emergency (declared by secretary of HHS) must be declared. To my knowledge this has not occurred in reference to pandemic A H1N1-- so how can the vaccine be distributed via EUA? CDC offers a short online course on emergency use authorization on http://emergency.cdc.gov/training/eua/page21735.html

Kathy Blanco

IV Vit C for our family...and of course sticking to our biomeds...


What a convenient way to generate a "volunteer," "safety" trial of new vaccine ingredients in the general population (at least I think they're hoping to have sizeable groups of generally happy to volunteer individuals).

In a couple of years this adjuvant will probably be another variable in the recommended/mandated vaccine schedule, but probably not with full, publically available, documentation of all the adverse results from this trial.


Too much media generated hysteria...try not to get caught up.

Here are the actual numbers reported by the World Health Organization

As of July 31, 2009:

Total cases worldwide: 162,380
deaths worldwide: 1154

Source: WHO Weekly pandemic flu reports:


CNN Story: Hysteria over swine flu is the real danger, some say


In Massachusetts the MA DPH decided to deputize dentists and paramedics to help with the vaccination effort..much ado about nothing ...

In 2008, there were over 37,000 motor vehicle fatalities in the US, so there's a greater risk of dying in a car accident that the swine flu.


Do they use the single or multi-dose vials for their H1N1 trials ???


Oops, I mean Emergency Use Authorization.


By having a level 6 pandemic, doesn't that already fall under "emergency level authorization"?

Katie Wright

Great essay Theresa!

I was also concerned about the swine flu vaccines and very much wanted to attend the town hall meeting in my city. However, it is the one week a year we and 90% of the metro New York City population are on vacation.

WHY would such an important meeting be held- one time and one time only- in New York City the last week in August- assuring that almost no one will attend?

What kind of genius designed a schedule that would ensure the smallest % public participation possible in one of the most aggressively pro vacccine safe research cities?


On the news they reported that swine flu is no more dangerous that the common flu. According to the WHO reports there have been only 1154 deaths worldwide from Swine flu since July 31, 2009 and of those deaths, we don't know how many had underying health problems. In a world population of 6 billion that's a very small number. There are far more devastating diseases that the CDC should concern themselves with than this one.

In Theory TV

On August 12th I interviewed Jeffry Aufderheide of vacTRUTH.com about the meeting he attended in Denver, Colorado with the CDC involving Swine Flu (H1N1) vaccination program and the article he wrote about it.

Video interview:http://www.intheory.tv/2009/08/video-damn-the-torpedoes-cdc-continues-to-adopt-%E2%80%98full-throttle%E2%80%99-approach-to-mass-vaccinate-us-population-despite-public-meetings/

Article discussed: http://vactruth.com/2009/08/10/damn-the-torpedoes-cdc-continues-to-adopt-full-throttle-approach-to-mass-vaccinate-us-population-despite-public-meetings/

This interview was taken from the 8/13/09 In Theory TV broadcast.


Thank for your H1N1 information ,here this Disease is spread around the country(India).


Swine flu

Swine flu is very dangerous disease. Its almost fatal. But there are lot of people whose swine flu is being treated by Homeopathic treatments and it has been very effective since homeopathy has no side effects, but disadvantage of that is, its effects can be destroyed by the effects of smoking, pungent smells, coffee, camphor or petrol smell. So one have to take care of.

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