First Swine Flu Shots Will Not Be Safety Tested
On Friday, the National Biodefense Science Board met in emergency session to work on issues surrounding the H1N1 flu pandemic. They reviewed the report of their working group, "H1N1 COUNTERMEASURES STRATEGY AND DECISION-MAKING: A REPORT" [HERE], in order to provide input on it before it is sent to the Advisory Committee on Immunization Practices who makes final recommendations to Kathleen Sebelius on what the response to the outbreak should be.
They are working off of several key assumptions:
- Novel H1N1 viruses will continue to circulate.
- A second wave is likely to occur, as soon as fall 2009. Best estimates suggest that infection rates will be 2‐3 times higher than expected with seasonal influenza. The second wave could peak in October, but we must anticipate onset as early as September.
- Attack rates will continue to be highest in children and young adults.
- Hospitalizations and deaths will continue to be concentrated among children and younger adults with underlying medical conditions.
- Children will continue to act as an amplifier to community spread of the virus.
- Severity will continue to be similar to or somewhat greater than the current wave but the number of cases will be substantially larger.
- Catastrophic disruption of societal function, as anticipated in some planning scenarios for a severe pandemic, is unlikely.
- Waiting for a full characterization of the immunologic properties of candidate vaccines with extensive studies, and doing studies in series would result in the H1N1 vaccine not being available until late fall.
- Having vaccine only after the peak may be worse than having no vaccine at all: it incurs all of the risk and cost with no potential benefit. Licensed vaccines, or vaccines similar to licensed products, will be most acceptable at the beginning of the next epidemic wave.
- Safety of the vaccines, both real and perceived, will shape risk‐benefit calculations and acceptance. This will be true for both public health officials applying a collective perspective, and for individuals deciding whether to be vaccinated.
- Decisions about vaccine formulation must be made rapidly on the basis of available data. Strategies can and should be changed as more data become available, but we cannot wait beyond mid‐August if vaccine is to be in supply by mid‐September.
- The Biomedical Advanced Research & Development Authority (BARDA) strategic goal of being able to produce vaccine for all 300 million Americans within 6 months of declaration of a pandemic is an appropriate goal for capacity. However, it is not the same as the strategic goal for dealing with a specific pandemic.
Much of their probable agenda has already been publicly discussed, but here are a list of the board's current stance on vaccine issues. from page 5 of the report:
Goals and Principles:
- A critical goal is to have some monovalent novel H1N1 vaccine available by mid‐September 2009, should it be needed. This goal can take advantage of the decades of experience with other H1N1 subunit vaccines, typically at a 15‐mcg dose.
- Begin with the goal of targeting a small amount of the vaccine to a small group where it will do the most good. To the extent possible, this should be driven by sound epidemiologic data.
- This likely means focusing on infants, toddlers, school‐age children, pregnant women, and adults with risk factors applicable to novel H1N1 virus. Manufacturing of vaccine for additional cohorts of the US population and the world should proceed, but without interfering with the goals listed above.
- Safety monitoring must be in place before novel H1N1 vaccination begins, and have the sensitivity, power, and speed to detect signals and determine causal relations in a timely manner to aid policy and communication.
- HHS should remind States and local health departments that durable record‐keeping of who receives the vaccine (preferably in electronic format) is an essential component of local implementation plans.
- HHS should consider recommending school‐based immunization delivery for children for logistical simplicity.
- Decision‐making should remain flexible, based on clearly articulated principles and scientific evidence, and should be transparent.
Of the greatest concern to me was this portion of the paper:
- If the United States Government (USG) wants to have novel H1N1 vaccine available in September 2009, it should pursue a simplified testing program to achieve that goal. Additional studies may be appropriate for additional supplies in subsequent months, but time of availability seems to be the dominant criterion for vaccine decision making.
- Decades of experience with A/H1N1 influenza viruses provide a basis for selecting initial antigen quantities and dosing. If the US goal is vaccine availability on the shelf in September 2009, 15‐mcg unadjuvanted subunit vaccine and live attenuated intranasal vaccine for children may be a rational approach.
- If the second wave is delayed or production is slower than expected, mix‐and‐match studies of vaccine plus separate adjuvant may yield information that may stretch the available vaccine supply.
During the discussion, it was decided that the board would not only recommend having the first doses of the vaccine ready by September 15th, that they would shoot for September 1. However since the clinical trials of the vaccines will begin just this week, the studies will not be completed by the time manufacturing decisions must be made in order to meet the September deadline.
So it was decided to recommend that the first few tens of millions of doses be formulated and produced BEFORE the results of the clinical trials are in. After the trials are completed, they will then have the option to go back and make changes to the vaccine. It sounded like the second round of vaccine would be expected at the end of October, but they were not completely clear on that.
This means that members of the public who are vaccinated with the H1N1 flu shot in September and likely October will be receiving an untested vaccine. (Note that these will most likely be children, infants and pregnant women).
This seems contrary to the statement that Kathleen Sebelius made on the "Meet The Press" this week when she said:
"We're on track to have a vaccine ready by mid-October. We need to make sure it's safe, and so clinical trials will begin. And we need to make sure it's, it's effective against this new novel strain. So that's what's happening in the meantime. And if the scientists say it's a go, by mid-October we will have a vaccine available and start with the priority communities."
Scientists are already saying "go" and the people will have no such assurances that it will work, or be safe, when it is first administered.
The National Biodefense Science Board [HERE] will be meeting at least once a month for the next six months as this plan evolves. By law all meetings must be open to the public, and they are being teleconferenced. I encourage our community to be listening in and providing public comment and questions.
Ginger Taylor, M.S. is a former marriage and family therapist raising her seven year old son Chandler, who lapsed into autism following his 18 month vaccinations. She blogs at AdventuresInAutism.com
After reading the article about Autism Speaks' position on vaccines, and the 2% funding for the vaccine connection testing, I am once again reminded why AS is on the outskirts in the minds of many in the ASD community. True representation of children with autism involves LISTENING to the parents who KNOW that their children were injured by vaccines. Start there first. Science will follow.
But because they are another organization which condescends to parents (as if they know better than us)they are in the same league as the AMA, CDC, NIH and IOM. Even with Alison Singer gone, the culture at AS is still entrenched with the NAAR influence.
And they wonder why many in the ASD community do not support them.
Posted by: Mary Romaniec | August 02, 2009 at 04:54 PM
If I weren't a bit more spiritually evolved than I used to be, I might be glad for the over-reach of pharma and our government on this one. I just have a feeling it is going to turn into a spectacular debacle, and suddenly six months or a year from now the media is going to be running all kinds of stories with people pointing fingers at each other and insisting "NOBODY COULD HAVE PREDICTED!" that the vaccines would end up hurting so many people.
Posted by: Garbo | July 23, 2009 at 04:26 PM
I'd just like to warn those in the Seattle, WA area, that once again, they are targeted, this time to "test" the new swine flu vaccines. If you are a Group Health member, or your family members or neighbors are, please warn them.
Also notable and related: Legislator Eileen Cody, the Group Health Nurse from West Seattle is the House of Representatives Health Care chair. Cody has refused to bring numerous bills to the floor for a vote - and consistently blocks legislation that autism and environmental advocates work to get passed. Once they hit Cody's desk, she simply refuses to bring them to a vote. Many beleive she is receiving kick backs from industry because of the pattern of blocking bills.
Here's the article that includes list of places where Swine flu shots will be tested:
One more thing- Another reminder, in the original data sets that were used for the Verstratten study, which became the fiasco known as "Simpsonwood", Group Health Seattle was one of the 4 sites of immunization records used for the data. Cody was at Group Health at that time, (and in the legislature.)
Seattle families, forget the rain, 'cuz you've been hosed!
Posted by: Rainmom | July 22, 2009 at 07:57 PM
Sorsha ~ thanks for the article!
The WHO is following the CDC's communication advice to talk about death in the media to create demand for the product. See slides 27-29.
Posted by: Kevin Barry | July 22, 2009 at 01:34 PM
Kathleen Sebelius could demand that all members of Congress, the entire CDC, the entire FDA, and other proper executives be required to take & test the Swine Flu vaccine.... as is, right now.... this of course, would make for great television entertainment. Sort of a vaccine reality show...
This could help to boost confidence in the program.
Posted by: curtis | July 22, 2009 at 11:41 AM
This can be a pandemic because the WHO recently changed its definition of pandemic: http://www.spiegel.de/international/world/0,1518,637119,00.html
from the article: "Don't you think there's something noteworthy about the fact that the WHO has changed its definition of pandemic? The old definition was a new virus, which went around quickly, for which you didn't have immunity, and which created a high morbidity and mortality rate. Now the last two have been dropped, and that's how swine flu has been categorized as a pandemic."
Posted by: Sorsha | July 22, 2009 at 09:15 AM
the scenario you mention is highly, highly unlikely - HOWEVER, because of the swine flu's 'pandemic' status - it is a legal possibility. We have to stay vigilant as school opens and the first wave of vaccines hits the schools. At the very least, make sure you have the number for the school nurse and be ready to keep your children home during vaccine clinic days.
Posted by: Sorsha | July 22, 2009 at 09:05 AM
Apparently if you have the flu outside of flu season, you have "Swine flu" and become a statistic.
Posted by: Elizabeth | July 22, 2009 at 01:53 AM
Can they walk into the schools and vaccinate our kids without our knowledge or consent? This is my biggest fear.
Posted by: Marie | July 21, 2009 at 11:17 PM
We never should have allowed Sebelius to take this position.
Posted by: Jake Crosby | July 21, 2009 at 09:03 PM
Send this to FOX NEWS LIVE DESK, because everybody will believe what this doctor said. Why would they not believe him, since nobody challenged him other wise.
Thanks for the information
Posted by: Benedetta Stilwell | July 21, 2009 at 07:38 PM
U go , boy !!! Way to provide so facts and figures!!!
Posted by: Harry Tembenis | July 21, 2009 at 05:32 PM
6,772,357,798 people on Earth, 20:49 GMT (EST+5) Jul 20, 2009/ http://www.census.gov/main/www/popclock.html
429 deaths, from 94,512 cases, worldwide.
How is this a pandemic?
Posted by: Kevin Barry | July 21, 2009 at 05:00 PM
They may make some thimerosal-free so they can say they are available but it probably isn't possible to make 300 million individual vials in this short of time. They'll definately be multi-dose. I don't see how it can be otherwise.
Posted by: Jack R. | July 21, 2009 at 04:16 PM
I was told by the Maine Health Department that the swine flu shots they ordered would be in multi dose vials and would contain thimerosal.
Posted by: Ginger Taylor | July 21, 2009 at 03:02 PM
Doctor Alan Alverez on Fox news just now at 2:55 said," NUMBER ONE THING IT DON"T HAVE THE MERCURY!" Then went about those pregnant risk factors, and the few that will have problems are far outnumbered by the hundreds of thousands that end up in the hospital or die.
Fox News ask to email or probably twitter in right now and give your opinion. IT is the live desk
Posted by: Benedetta Stilwell | July 21, 2009 at 02:59 PM
They didn't discuss the details of when the studies would be completed, just that they would not be completed by the August 15th date for putting the manufacturing machine in gear. That only leaves two weeks before Sept 1 when they want to begin dispensing them.
I don't think think that they would be done by then, but again, they didn't say.
I can also say that there was NO discussion of NOT using the first batch if something was not right with the trials.
In fact they didn't even talk about safety concerns, they were only concerned whether or not the 15mcg dose would be enough to be effective.
Posted by: Ginger Taylor | July 21, 2009 at 02:59 PM
Not sure the headline here is quite right. As the text reads, it sounds like if the testing goes badly someone will have a tough decision to make: use an unsafe/ineffective vaccine (endangering X million/billion people) or toss all the already-manufactured first batch (at a cost of X million/billions of $). Who will that someone be, if it comes down to it? Who will advise them? Whose data will they use?
One more thing...National PTA is pushing a flu vaccination program, which sounds related to the school-based programs mentioned here. I emailed them and BEGGED them to at least please don't use any vaccines with thimerosal. It might help if more people made this point to them.
Posted by: Richard | July 21, 2009 at 02:36 PM
"•Safety of the vaccines, both real and perceived, will shape risk‐benefit calculations and acceptance."
NEVER THE "RISK" OF THE VACCINES. We might as well just cage our children because they are all guinea pigs.
They say we have to take our time on health care reform and not "rush it through" but we can rush this bullshit through?
I met a new mom who I talked to about vaccines for her baby. She and her "mom" friends are carefully choosing the number and timing of vaccinations and she knew nothing about the autism issue - they just think that the pediatricians are getting greedy and overzealous.
If this vaccine is mandated, I think that it will only serve to put many more of these moms into the "not my kids" category.
Posted by: Tim Kasemodel | July 21, 2009 at 01:35 PM
"The Biomedical Advanced Research & Development Authority (BARDA) strategic goal of being able to produce vaccine for all 300 million Americans within 6 months of declaration of a pandemic is an appropriate goal for capacity."
I can finally put the Gardisal campaign to good use... "ONE LESS..." swine flu vaccine for my kiddo, thank you!
Posted by: Tracy | July 21, 2009 at 01:31 PM
It's stories like these that get my "conspiracy nut" side to go nuts. (I try to refrain from having it take over). An untested Swine Flu vaccine for a flu which so far has not been any worse than any other 'regular' flu. There is something very sick about all of this....
Posted by: Sue M. | July 21, 2009 at 12:07 PM
You probably are more cynical. I think most of these people involved are really trying to do the right thing, even those in the vaccine business.
Unfortunately, I fear the combination of stupidity and arrogance even more than I fear evil.
Posted by: Jack R. | July 21, 2009 at 10:44 AM
Maybe Mr. Offitt will volunteer to be injected with the first 100,000 doses as , according to him ..." the body can handle that many vaccines..." ????
Posted by: Harry Tembenis | July 21, 2009 at 10:34 AM
Oh, and Jack - I am more cynical than you. I don't think they are running vaccine clinics at school for 'logistic simplicity'. I think they are targeting kids because they know the adult uptake on this will be VERY slow. They can't even get adults to take the worthless seasonal flu vaccine and this is a MUCH milder illness. The answer is always 'kids!' when big pharma can't find a market for its vaccines.
A little more than creepy though how smart the HHS is being. Mentally preparing parents NOW for the fact that kids will be used as guinea pigs in the Fall. The initial shock will have worn off entirely for some by then. Resistance will definitely be less by September.
Posted by: Sorsha | July 21, 2009 at 10:18 AM
Here is the actual press release on the study again, so you can print it and carry it around with you all fall and winter:
Posted by: Jack R. | July 21, 2009 at 10:07 AM
At least the document is still talking about choice. But you can assume that "high risk individuals" certainly includes asthma and we'll be told our kids with asthma will certainly be the ones to die.
And this despite this study:
Posted by: Jack R. | July 21, 2009 at 10:04 AM
I agree with Holly. I think even if they accept religious exemptions or accept that you've had it before so you have natural immunity, and your child avoids the shot, there is the potential for viral shedding, and we could end up making the pandemic leaps and bounds worse.
Posted by: AnneS | July 21, 2009 at 10:03 AM
they can do this because this 'flu' has pandemic status. there are all kinds of federal overrides that can come into play in 'pandemic' situations - things that override local health laws, like state issued religious exemptions, etc. the vax at school is a fearful thing. it could go mandatory at any time, even the day of the shots.
those of us with kids have got to pay close attention and be prepared to homeschool if needed.
the UK has just followed in our footsteps and given blanket immunity to pharma for these 'pandemic' vaccines. just think of the boon to big pharma here - governments are throwing money at them (the US has spent 8.5 billion already), they have immunity from lawsuits and now, don't even have to run safety trials. they are running the show here - no doubt about it.
Posted by: Sorsha | July 21, 2009 at 10:01 AM
The first to test should be the scientists that invent this. The next to test should be the high level managers and ceo-types at the pharma companies. The next to test should be all vaccine related government entities, such as CDC, ACIP, WHO, etc. And the next to test should be the president, his wife, and his daughters. After that, I will feel confident...maybe.
Posted by: AnneS | July 21, 2009 at 10:00 AM
Nothing like a little "pandemic" when the financial markets collapse this fall.
They are actually recommending two "regular" flu shots and two swine flu shots. I think this whole situation is making a lot of people start to look at "conspiracy" theories more seriously. Very bold move on the part of pharma, they must feel secure in their position of power.
Posted by: United States of Pharma | July 21, 2009 at 09:42 AM
My son will stay home with grandma on the days flu vaccine is given at school, that's for sure. Don't want any mix-ups.
Is this going to be 1976 over again?
Posted by: julie | July 21, 2009 at 09:18 AM
It's just so depressing. It looks like there are going to innoculate kids at school for "logistic simplicity" which means absolutely no assessment as to whether a kid is healthy or on antibiotics. Terrible.
I would think they'd still honor a religious exemption but who is to say when they line kids up in the hallway that they'll have that paperwork handy.
I think we'll have to at least skip school that week and see what happens, maybe they'll run out.
I really don't like this.
Posted by: Jack R. | July 21, 2009 at 09:14 AM
This is crazy! how can they allow the states via a mandate to forcebly inject an untested vaccine into someone... isn't that a violation of our civil rights? Don't our rights trump the state mandates? What happened to God bless America, Land of the free?
I'm also concerned for the NT kids who are getting this vaccine.. that could tip them over the edge into a disorder (ADHD, Bipolar, autism). Our "club" may be expanding.. sad to say.
Posted by: Sarah | July 21, 2009 at 09:13 AM
Manufactured immunity against a manufactured virus. Perfect.
Posted by: Sara | July 21, 2009 at 08:58 AM
This is insanely reckless.
I had the swine flu, so did my whole family. Two days of discomfort and we made a full recovery.
I would have the swine flu again, in a second, rather than yet another untested, unsafe vaccine. The saddest part is I have a choice, when this rushed to market dangerous vaccine is made compulsory for children, they won't.
Posted by: Katie Wright | July 21, 2009 at 08:28 AM
I'm concerned about the live vaccine that other kids will be getting either at their peds or in school. I don't want my kids around them. I'm wondering if I need to homeschool my girls in addition to my son.
Posted by: Holly M. | July 21, 2009 at 07:00 AM