Forum: Vaccine II

A very sharp discussion, continued from here

Anon_451 – at 00:03

Leo7 – at 23:57

My Grandfather told me that If you want to teach a mule anything you hit them between the eyes with a 2×4 and when you have there attention then you can teach.

However the 2×4 that we need will come in the form of a rapid outbreak and it will be too late then.

Thinlina at 19:37:

It’s also pretty much a slam dunk that when a vaccine does prevent infection — or at least doesn’t cause any adverse effects — that doesn’t always get reported either. This sort of problem with biased collection of data is one of the reasons for all the emphasis on double-blind, placebo-controlled studies. The idea is to make it hard for someone with a pre-formed conclusion or a vested interest to support the position they favor by “cherry picking” the data. You give the same vaccine to a whole bunch of people, and keep track of who got sick, and who had side-effects; the kicker being that until the results are recorded, no one — not the patient, not the doctor, not the researcher — knows who got the real thing and who got the placebo.

Racter:

What you say is true, but there is not long term monitoring in the controlled setting for vaccines. There haven’t been phone contacts or physical exams 5, 10, 15 years down the road because who wants to look for the unlucky? After the double-blind, placebo controlled studies in small numbers at most a couple thousand in one study like chicken pox, the vaccine spreads into the general population (millions and then billions when it goes international) where reporting by individual doctors on adverse reactions is the only indicator of a problem, because parents don’t know what to do but take them back to the doctor. Do you think public health departments do any followups or report adverse events?

 And Racter-see your last sentence-after seven years of clinical research I can tell you that you have to train your mind to stay objective when patients have compliants or adverse events.  The blind is rarely broken except in dire emergencies but you would have to be deaf, blind, and dumb not to form nearly correct impressions when they break out in hives, have swelling at injections sites, visit ED’s or suffer critical warnings in lab results.  I just didn’t voice what I thought, because I was trained not to inadvertently break the blind in a patients mind or change my clinical performance.  All that said, vaccines do and have saved lives, i just think some companies got carried away.  Did we really need a chicken pox vaccine just so mom or dad didn’t have to take off from work or junior miss a week of school?   

Leo7:

If every patient who ever recieved a vaccine had been monitored for the rest of their lives, there would still be those who would complain that “we don’t have all the facts” — and they’d be right. We’ll never have all the facts. When attempting to apply finite resources to complex real-world problems, having all the facts is beyond being a rare luxury; it’s non-existant. Lots of different types of entities, public agencies included, conduct clinical trials. At some point, a decision has to be made as to where benefits begin to outweigh risks.

One thing that bothers me is that I keep seeing the notion: “we don’t know that there aren’t a lot more problems that we aren’t seeing” presented as if it were equivalent to: “we know that there are a lot more problems than we’re seeing”.

Chicken pox may be more serious than you think. If hives and swelling bother you, consider the fact that varicella can infect the cornea, resulting in permanent blindness, or spread to the lungs, causing death.

According to the CDC:

“Before the introduction of the varicella vaccine in 1995, approximately 4 million cases of the disease were reported annually, including 4,000 to 9,000 hospitalizations and 100 deaths. Varicella is the greatest vaccine-preventable killer of children in the United States.”

“At some point, a decision has to be made as to where benefits begin to outweigh risks.”

What are the risks? The real risks. We don’t really know. Why? Because if you told the public, millions more may choose not to be vaccinated or vaccinate their children. That would disrupt your “herd immunity” philosophy. Racter, lets be honest, you probably believe some of the data concerning vaccines and their negative effects has been suppressed. However, this deception is acceptable to folks like you because of the “big picture”. I don’t believe it’s honorable to sacrifice children/adults in the name of anything, even herd immunity. I believe not acknowledging and communicating the real risks of vaccines is an act of cowardice, not good medical practice. I encourage those reading this thread to explore the dangers of vaccines. Use the all mighty google. Leo7, great comments. I guess Racter is not interested in long term side-effects.

Racter. I have suffered from vaccine several vaccine reactions and I have seen the effects of vaccines failures or worse in animals more than once…but no one believes more in vaccines than me…I was born in the middle of a Polio outbreak in my town before the vaccine was developed by Dr. Saulk (sp?)

However, I would like you to read as much information as you can get your hands on…with respect to the efficacy of influenza vaccines and particularly seasonal influenza vaccine. I wish I could give you my three references but of course I don’t save references and when I read them I did not even know a website like this existed…I thought I was completely on my own in the fight to raise awareness of H5N1.

Two references were long-term American studies reported in the winter of 2005 and the other was a study reported this spring from Ontario Canada.

There are vaccine reactions as I know only too well but the benefits of rabies vaccine far outweighs the risks even if I got into trouble as a guineau pig…a nieve and stupid guinea pig!!

Lets discuss the real crux of the issue…efficacy. They are jumping through hoops removing liabilities and throwing money at a solution that my dog knows won’t work…

…the influenza virus is to unstable and mutable to produce an effective immune response to soon enough. It is just the way it is.

I know of some very effective solutions that will save millions of lives…just not the lives of the 2% that get the serious form of the disease who can’t be saved anyway…given my experience with similar diseases in animals.

We must concentrate on lives lost due to secondary infections, lives lost to lack of insulin etc. and lives lost to secondary infections, dehydration etc…

…and we have to accept lives lost due to the cytokine storm because we are going to lose them one way or another anyway

Sorry, should have read…We must concentrate on lives lost due to infrastructure loss, lives lost due to lack of insulin etc. and lives lost to secondary infections, dehydration etc.

If pharmaceutical companies can provide me with an measured an effective vaccine that protects say 70% of those recieving it…then of course a .001% adverse reaction rate is acceptable…

…but I know you as a smart, funny and highly articulate person…study the abysmal results that they have produced with all of their vaccine attempts…

…the existing problems with seasonal influenza vaccines are multiplied by hundreds or thousands of times for H5N1…it is a freak.

We must read the writing on the wall and move off the two obvious losers antivirals and vaccines because they are going to soak up all of the attention and funds…because researchers like fiddling with stuff like this and not the boring stuff like…how to increase antibiotic production by ten thousand times in two months…same for another absolute essential powdered oral electrolytes.

We have wasted too much time and lost too much time already with the ‘magic pills’ unless I can be reassured with scientific data that this pandemic is not coming for twenty-years…then it really doesn’t matter what they do in the short term!!

Tom DVM – at 09:18

“because researchers like fiddling with stuff like this and not the boring stuff”

“We have wasted too much time and lost too much time already with the ‘magic pills’ unless I can be reassured with scientific data that this pandemic is not coming for twenty-years…then it really doesn’t matter what they do in the short term!!”

Could not have said it better my self. Just like a cop that likes the high speed chase or the break down the door drug bust, instead of the boring walking a beat to prevent petty crime. The car chases and drug busts make the news, while the petty crimes rage out of control.

Leo7 – at 01:49 You just wrote the same I thought. These little couple-of-months studies are basicly nothing especially when speaking of growing children. Clinical feedback and training doctors and nurses to even recognize the situation is necessary. We are talking about decades here - not months. Thanks anyway for the smallpox and polio vaccine etc. I’m not trying to say the vaccines are all bad.

I’d like to read your comments of this: http://scienceblogs.com/effectmeasure/2006/07/the_vaccine_news_how_good_1.php

Tom:

I guess that depends on who you talk to.

I don’t have any very good way to do that. All I can do is study the studies, and I’ve done plenty of that.

Sure, just as soon as I finish sucking the marrow from the bones of the child I had for breakfast.

I don’t agree. We never know ALL the facts, but we do know SOME facts. We can see the antibodies. We know that antibodies still offer at least some protection even when the virus has changed some. The problem lies with the fact that numerous strains circulate at the same time, and we have no sure-fire way to predict which will get traction during the next season. If you shoot a gun at somebody and miss, it doesn’t mean the bullet was ineffective, exactly.

Racter. From my viewpoint, I must respectfully disagree with you.

They have produced a titre (antibody response) in less than ten percent of the participants and the fact that there are antibodies does not mean the antibodies produced will have any effect on the virus.

Even if the antibodies are protective there is no garauntee that the weak immune response will produce enough to snuff out the virus upon challenge.

There is no garauntee that by protecting against a right cross the virus doesn’t spin and hit you with an immunogenically unique left-hook.

I am not sure which studies you are reading that leave much room for optimism…I honestly haven’t seen any.

We should remember that going through the process of making a vaccine does not ensure that the end result will be of any uselfulness whatsoever…and there are otheres, more qualified than me, saying the same thing.

If it is to be of little use than it must be garaunteed that it will be of little harm as well.

Tom,

I would like to refer to the table from Fedson that I posted on part 1 of this thread, showing that in order for a larger number of people to be protected, we will have to lower the antigen dose and thereby the efficacy.

In an ideal world, one would want to produce a vaccine with maximum efficacy and minimum adverse reaction for an individual. But in a pandemic, when billions of people will have zero access to vaccine, and millions will die, the arithmetic will have to be a bit more ruthless: by how much can we lower the efficacy of each dose to have the maximum number of people protected, bearing in mind that those protected may not include our loved ones?

We must solve that problem for the collective before we can even have the moral right to ask what is the vaccine going to do for me as an individual. We may have no choice but to accept the reality of a vaccine with low efficacy and possibly higher risk of adverse reaction (since higher safety standards always mean delay in regulatory approval and production) for the greater good.

We cannot survive in isolation, we sink or swim with the rest of the world.

Getting that balance right is going to take a lot of science, scrutiny, and compromise.

Therefore discussions on pandemic vaccines should be entirely separate from discussions on seasonal or regular vaccines, IMHO.

annon 22. Do we have to accept a vaccine with ‘zero’ efficacy?

…and if we are going to remove all liability and bring these vaccines on the market with no testing of benefit or harm…what insurance do we have of benefit or harm.

…and do we put all of our limited resources for a pandemic that could occur this year in a vaccine program that for the foreseeable future, more than a decade, couldn’t produce enough vaccine for three hundred million people and that is for seasonal influenza vaccines…and they have not been able to get this virus to produce even close to that type of immune response.

I know what infrastructure investments, antibiotic…electroytes etc, and investments in heart drugs and insulin will produce in benefit…it is accurately measurable.

Is the benefit from antivirals measurable at this point? and if it is how many doses are going to be avaliable.

I will stop beating the dead horse but we have to take a broader spectrum approach to this thing…and not put all of our eggs in two baskets that have very well demonstrated already their limitations.

We have to accept that we are going to lose a lot of people…and not lose the ones we could and should save.

The link is here a regulatory dilemma

Tom,

First of all, I accept and agree with all your points about electrolytes and non-vaccine strategies.

Secondly, we DO need to talk about vaccines. If every discussion about anything brings everything else into it, it will be very hard to have any creative results. So let’s just for now stay with pandemic vaccine efficacy and risk, what is acceptable and what is not.

Thirdly, I don’t think anyone is proposing zero efficacy.

So talking about how to make or judge a pandemic vaccine does NOT mean proposing that we put all our resources into vaccines.

If every post about vaccines or antivirals etc have to include all other possibilities under the sun, the threads will be so long and we will all be old before we have any resolutions.

:-)

Tom,

“if we are going to remove all liability and bring these vaccines on the market with no testing of benefit or harm…what insurance do we have of benefit or harm.”

removing liability is not the same thing as bringing the vaccines to market with no testing. I think you understand that.

annon 22. It seems that removing liability occurs because insufficient time is avaliable to do the required testing…same goes for testing of efficacy.

How are they going to prove that the miniscule antibody response is protective…field challenge with the virus? I don’t think so.

We could easily have a completely useless vaccine foisted upon us with significant side-effects.

They have enough problems producing useful pharmaceuticals under existing protocols let alone shortening them.

As they say in the country…’a pig in a poke’.

how nice would it be, if we could watch the importance of such news on some betting market.

Tom DVM – at 13:09 “annon 22. It seems that removing liability occurs because insufficient time is avaliable to do the required testing…same goes for testing of efficacy.”

The FDA is still following the same standards as the normal seasonal vaccine, so no, vaccine companies still need to spend the time to do the testing, up to the FDA standard. The removal of liability comes after, that is, after the product has passed all the regulatory hurdles, not instead of.

But the FDA is being criticized precisely because of this inflexible attitude. There is a case for a lowering of standards for the (unpalatable but real) reasons that I just posted vis-a-vis Fedson. The European agency has adopted a different philosophy, that pandemic vaccines should have a different regulatory standard, and vaccines passed under that standard will be restricted to pandemic use or prevention only.

“How are they going to prove that the miniscule antibody response is protective…field challenge with the virus? I don’t think so.”

That, I admit, is a real problem, for which there is no absolute 100% solution. We can only work with best guesses. It will be very hard to accept for most people, but in the face of this extraordinary challenge to humanity, we may need to re-examine our demands, as I said earlier.

“We could easily have a completely useless vaccine foisted upon us with significant side-effects.”

Also, true. We can only do our best to scrutinize, challenge, and criticize. But at the end of the day, this is a no-win situation in a unprecedented catastrophe: we may just have to accept that beyond a certain point, those queries will bring no answers.

“They have enough problems producing useful pharmaceuticals under existing protocols let alone shortening them.”

Sometimes true, sometimes not.

Just because something is imperfect is not a good enough reason to not use it. We are talking about a potentially population-depletion event. We must use everything in our disposal, no matter how imperfect, no matter how distasteful.

The only thing WE here at the wiki can do is to inform as much as possible so people can make slightly more informed choices for themselves.

Trade Sports

annon 22 (12;59 13:01)

I agree with what you said…should be no surprise.

OK. Lets have the discussion about vaccines and antivirals and at some point lets discuss how many lives will be saved by the other mechanisms as well…

…but let’s have a debate with our eyes fully open and explain to those that do not understand the limitations of vaccines, antibody responses, testing measures, liabilities etc.

Let’s do our best to offset the spin from regulators, governments and pharmaceutical companies on these products. Someone has to do it.

If we all know the truth…then and only then can we come to informed conclusions and decisions based on those conclusions.

“but let’s have a debate with our eyes fully open and explain to those that do not understand the limitations of vaccines, antibody responses, testing measures, liabilities etc.”

Absolutely! That’s why we are here!

annon 22. I’ve got a hypothetical question for you.

When the pandemic starts, if China announces that it will have one billion vaccines in two weeks and they will be avaliable to the rest of the world at a price of x, would you allow yourself to be injected with the vaccine and secondly, would you allow your family members to recieve the same.

I am asking you the question only as a trusted colleague, physician, scientist and someone with an appetite for the truth of the matter always.

That’s why you will see me being the naysayer whenever vaccine companies put out press releases about the most wonderful thing that will save us all.

And you will also see me debating those who think vaccines are completely useless.

We need to play devil’s advocate for both sides. :-)

Tom DVM – at 13:29 “annon 22. I’ve got a hypothetical question for you.

When the pandemic starts, if China announces that it will have one billion vaccines in two weeks and they will be avaliable to the rest of the world at a price of x, would you allow yourself to be injected with the vaccine and secondly, would you allow your family members to recieve the same.

I am asking you the question only as a trusted colleague, physician, scientist and someone with an appetite for the truth of the matter always.”

Thank you for your kind words and your trust. And I must repay that trust by being completely honest and say that at this point, I find it very hard to decide.

The best guess I can make, and it’s a very crude one, will be that it will depend on the CFR for the age-group of my kids. That’s the bottomline.

But it’s a really hard question that I’ve thought about many times and I still can’t answer it.

Don’t forget you are talking to someone who’ve had to make life-and-death decisions for one child already, and lost that.

I wanted to erase that line cos now I’m in tears but I won’t so you can see it.

Thanks!!

Sorry.

Not your fault.

I need to go. Talk to you later. It’s not your fault, don’t feel bad.

Tom:

They? There’s a lot of “they” out there. The only studies I’ve seen with results like that involved elderly or immunocompromised patients, and even then it’s usually better than that.

I don’t think guaranteed is on the table with any of this. It’s about loading the dice.

Optimism is a bit subjective. I believe that seasonal flu vaccines are highly effective when the match is good, but I would hardly describe my outlook as “optimistic” as far as an H5N1 pandemic is concerned. This ACIP report says:

“The majority of vaccinated children and young adults develop high postvaccination hemagglutination inhibition antibody titers.”

And they back it up with these references:

La Montagne JR, Noble GR, Quinnan GV, et al. Summary of clinical trials of inactivated influenza vaccine--−1978. Rev Infect Dis 1983;5:723-−36.

Oxford JS, Schild GC, Potter CW, et al. The specificity of the anti-haemagglutinin antibody response induced in man by inactivated influenza vaccines and by natural infection. J Hyg (Lond) 1979;82:51-−61.

Neuzil KM, Dupont WD, Wright PF, et al. Efficacy of inactivated and cold-adapted vaccines against influenza A infection, 1985 to 1990: the pediatric experience. Pediatr Infect Dis J 2001;20:733-−40.

And this is from the La Montagne et al study:

“The results of these clinical trials indicated that two doses of H1N1 viral antigen were necessary to produce serum titers of hemagglutinin-inhibiting (HAI) antibody of greater than 1:40 in 80% or more of the test subjects younger than 25 years of age”

Also noteworthy:

“Only one vaccine was associated with a reaction index appreciably higher than that of placebo.”

and:

“No cases of vaccine-related neurological problems, including Guillain-Barre syndrome, were found during these trials.”

The GSK vaccine will be useless. It was made from a Pre Qinghai clade and will provide no immunity to what Joe calls Sichuan Sheet (Post Qinghai Lakes Bird Flu that attacks all manner of animals).

Racter – at 14:05 And how long follow-up did La Montagne et al. have? Did they consider encefaliti? And how did they decide what was vaccine related and what was not? Do you want us to extrapolate La Montagne study so that there are no vaccine-related CNS problems in any of the influenza vaccines? *oblique smile*

Somebody mentioned Measles/Mumps in Iowa and the ineffectiveness of the vaccines for same.

Folks, it was not measles or mumps according to doctors in several states. It is a new type of illness that mimmicks measles or mumps. It sometimes tests positive for Type A flu.

Looks like some sort of recombinant virus.

Allan, you are not being serious *unbelieving laugh*?

Or are you?

Quite serious. They made the vaccine from a pre-Qinghai strain, just like that guy Bush did last year. That was a 300 million waste of taxpayers dollars.

Stupidity to the max.

Well, wasn’t this kind of anticipated, anyway… Considering Bush admin style of decicion making…

That’s right, Thinlina, It is holy sheet time. I borrowed the “sheet” from Joe.

The GSK vaccine trial is likely to be one submitted for the European ‘Mock-up’ File application. That is, they make a vaccine with a pre-existing strain, run all the different tests and get the approvals etc, and then when a pandemic strain appears, they substitute with that strain. The approval process then becomes a lot faster. Last I heard, it may be as fast as 1–2 weeks.

I don’t think they are doing that for the US, although I’ll have to double check.

Here’s the link to EMEA Mock-Up Files Update showing the various vaccines going through trials. The GSK one mentioned is likely to be the last one on the first page with Novel adjuvant. Ph I and II started March 2006 but no EMEA file submitted yet by May 2006.

This is the link for EMEA Marketing Authorisations for Pandemic Influenza vaccinesin Europe, a very informative document. Recommended read.

So I was mistaken, the time for pandemic variation, ie approval for substitution of pandemic strain, can be as short as 3 days.

the Pan American Health Organization document Regulatory issues regarding the license of influenza vaccine highlights the difference between the FDA and the EMEA (European) approach:

FDA regulatory perspectives: FDA would regard pandemic vaccine in the same way that yearly strains variations are treated, provided the pandemic vaccine was manufactured by a company with a licensed product on the US market, with specific consideration to new manufacturing technologies or different formulations (such as use of adjuvants).

EMEA Regulatory perspectives: As pandemic vaccines will differ in their formulation (antigen contents, adjuvants, number of doses), use of data extrapolated from clinical testing of seasonal vaccines is notconsidered acceptable by EMEA. Clinical trials with a “mock-up vaccine”are therefore required to demonstrate safety and immunogenicity and to establish dose and dosing schedule

I’ve not found what this vaccine is exactly; one of the contracts awarded last year probably, but can’t quite pin it down. Aside from the obvious, any comments?

http://tinyurl.com/gxt6q HHS has enough H5N1 vaccine for 4 million people. Jul 5, 2006 (CIDRAP News) – In an update on pandemic influenza preparedness efforts, the federal government said last week it had stockpiled enough vaccine against H5N1 avian influenza virus to inoculate about 4 million people and enough antiviral medication to treat about 6.3 million.

Health and Human Services (HHS) Secretary Mike Leavitt said his department has stockpiled about 8 million doses of H5N1 vaccine. “Given a two-dose vaccination schedule, this would allow vaccination of 4 million people,” Leavitt wrote in a 12-page report.

glo, I think this is the formulation based on the seasonal vaccine by Sanofi-Pasteur, ie subunit inactivated, no adjuvant. Problem with that one is the efficacy is really low, even assuming it is the right strain.

They can’t grow Post Qinghai Lakes (Sichuan Sheet) in eggs as it kills the egg.

So how are they going to substitute the Sichuan Sheet virus for pre Qinghai H5N1 and produce millions of doses?

Somehow this statement of a miraculous cure does not sit well with me

If I could…If it were possible…If it was in my power…I would buy a dose of every single novel H5 vaccine to be manufactured. I would buy one for every one of my chicks and all those that keep their lives going and each and every other person I could. But my chicks would be at the top of my food chain! I would take all those doses and shelve them…I’d sit back and wait and see…What the risk of this dang virus would be…Then I would decide what or whether or not to use that vaccine. But I would absolutely, take everything I could get my hands on to buy that vaccine….Right now, even if it isn’t completely tested. I’ve already lost several child battles. I think maybe I’ve lost some battles with surviving chicldren. I DON”T want to lose some more! Yes! There may be side effects! H5 has a side effect too. Almost certain DEATH!

I have been sick, since receiving my second dose of H5 trial vaccine. I run a constant fever, still have Plurisy, and am waiting for a DNA test to see if I have Lupus. I can’t say the vaccine caused this…I don’t know! I know that, if H5 were knocking on my communities door…I would absloutely take the gamble and give my chicks the exact, same vaccine I have had, if there was hope it could save their lives…because even if it could be linked to auto-immune disporders, the death sentence is not that of H5. The risk is not the same.

That’s just me and mine and we all are different…I just can’t watch another one of mine take their last breath…Just can’t! We should at least have a choice to weigh. We are consenting adults and each of us should have the right,to make the decision that we determine is best for our loved ones.

Thinlina:

I don’t know.

You mean encephalitis? Yes. That’s included in “neurological problems”.

A strong statistical correlation can be shown between sales of ice cream and deaths by drowning. How does one decide whether they are causally related?

Of course not. That would be almost as idiotic as it would be to extrapolate from a single patient’s adverse reaction — tragic thought it may be — that everyone recieving the vax would have a similar experience. It is in fact precisely the point that vaccine recommendations are not based on extrapolating from such small sample sets, but rather represent the averaged results from a great many studies, some focused primarily on efficacy, some on safety.

Ok, say a vaccine is given. Who takes care of the individuals who have adverse reactions? We may see a whole lot of them. What do you say, Racter. Will you shrug your shoulders and ask for proof of a connection to the vaccine? Will doctors simply not report the reactions? Will there be funds set aside to care for them and their families? Or should we just let them take one for team, Racter. You know the “herd immunity” gang. What are we doing now for individuals who suffer reactions from recommended vaccines? If the government, medical community, etc, scare the public into receiving this vaccine, I hope they have the decency to care for the individuals who suffer side-effects. Currently, they ignore them.

If there is a pandemic in full swing, I don’t think the gov’t. or medical community would have to scare us into taking the vaccine…I would think watching our neighbor’s children leave their homes in body bags would have us running to be vaccinated…

I would think that those that have an adverse reaction to a pandemic flu vaccine, would have a lot more opportunities to be taken care of medically, then any of us will, if this pandemic breaks out…especailly if the vaccine prevents or drastically slows a pandemic virus down. Haven’t we been told over and over again, that 95% of us will never see any medical care, if there is a severe pandemic. I’ll take my chances with a vaccine, anyday, over this virus beast. There is no chance if we are infected by H5.

Roman:

Who takes care of the individuals who have adverse reactions to peanut butter? I mean, seriously, the only guaranteed safe vaccine is NO vaccine. Same thing with peanut butter. Where, in your opinion, is the point at which a benefit to an entire society should be sacrificed to avoid placing a few individuals at risk? Should we outlaw peanut butter altogether? (People are dying, remember). Suppose we had a sure preventative drug for cancer, the only drawback being that out of a million people who took it, some number would die a slow, painful death. What number would you consider acceptable? Fifty? Ten? Zero? (Keep in mind that out of that same million people, some number who didn’t take the drug would die a slow, painful death anyway, from cancer). Your answer is important.

I guess it depends on what you mean by “taking care of them”. If you mean providing necessary medical care, then I don’t see that being administered selectively based on cause. By longstanding tradition, medical care is usually dispensed based on ability to pay. If you mean awarding them huge settlements, then asking for proof of a connection to the vaccine doesn’t seem so unreasonable to me. Does it to you?

I hope you haven’t been watching over your shoulder for black helicopters ever since I mentioned that “herd immunity is a collective responsibility”. I don’t know what it’s like where you live, but nobody’s ever forced me to accept a vaccination at gunpoint so far.

You seem to be interested in making this an “us versus them” thing (“us sensitive, caring, open-minded types versus those callous, mercenary BigPharma androids and their minions”). Let me state for the record that I have no professional or financial stake in the vaccine issue. I’m not a BigPharma muckety-muck, or even a stockholder, and I’m not a bigwig in some governmental agency in charge of making decisions that affect millions of people. Like most of the folks here, I’m simply doing my best to gain a better understanding of complex issues and evaluate available information, primarily with the hope of making good decisions regarding the health and safety of my loved ones and myself.

If you were sincerely interested in furthering the discussion, you might do well to give the attempts at character assassination a rest (you’re not very good at it anyway), and instead get to work trying to come up with something more compelling than your own personal sense of outrage at “them” for failing to perfectly safety-proof your world.

I am normally a very private person. I don’t like to tell my personal stories to the world. But much as it pains me, I’m going to tell a small piece of it for those who care to reflect on this issue of hard choices.

No, horrible choices.

Several years ago, my 16-year old daughter came down with a particularly malignant form of leukemia. I read up the literature and found that those who relapsed while going through chemotherapy had 100% death rate, unless they underwent bone marrow transplant. For those who don’t know, a short explanation of bone marrow transplant is where they use extremely toxic chemotherapy drugs to kill all of your immune system, basically just this side short of killing you, and then put in another lot of immune cells from someone else to see if they will ‘take’ over and kill the rest of the cancer cells. In the process, first the chemo and then the donor cells will also kill a lot of your own cells and organs. The success rate depends on many things, among them whether there is a good match between the patient and the donor, and the malignancy of the original condition.

If normal chemotherapy is very toxic and has horrible side effects, the chemo used for BMT is many many times worse.

When my daughter relapsed very early into treatment, she and I had already read up on this and gone through several discussions.

Do you have any idea how hard it is to go through such discussions with your own child, particularly a very intelligent one? But it was HER life, not mine, and she had every right to be given the chance to make an informed decision.

When she relapsed, we (myself and my daughter) were told that the options were ‘palliative treatment’, meaning giving painkillers and stuff and go home and die, or, since there were no matched donors, to go for a haplo-identical transplant ie half-match with one of the parents, myself (since tests showed that my husband was not a suitable donor). Since her condition was rare, and such transplants were new and hazardous, there was no data to give the success rate. But the overall 5 year survival ie best case scenario, of the regular matched transplant in her situation was only 20–30%. With a haplo, it would be down to 15%, based only on guesses (Roman and Tom take note, NO DATA).

Remember this is only 5 year survival, which does not mean 5 years disease-free life, but battling all the life threatening complications and/or further relapses the whole way.

Suffice it to say that we went for the transplant route, she fought a brave, painful, and devastating, battle, and lost. She died of ARDS secondary to a lung infection.

I was there for every minute of it, sleeping in a cot in her room for those weeks and months.

Would it have been better if we took her home to die in comfort, surrounded by her family? Would she have had a better quality of that little bit of life left?

I don’t know. Probably. But, first of all, she didn’t want that. She was a fighter. She was also more scared of waiting to die than thinking there was a fighting chance.

I respected that.

Secondly, it was easier for me to keep her and everyone else’s spirits up that way. I could have influenced her choice, but I didn’t.

You can say I was selfish, I would admit that.

But going back to this discussion, when is it justifiable to use interventions that might have side effects? When is it justifiable to recommend something of which you as the professional have very little safety/success data?

After she died, the hospital consultant thanked us for being willing to undergo treatment. She said, “We need families like yours so we can learn. When we first started (doing transplants) ALL our patients died. They trusted us. We killed them. But we learnt.” Now their success rate is one of the best in Europe.

I will stop here and let everyone draw their own lessons. Each person will draw different lessons and come to different conclusions. I fully expect and respect that.

But don’t expect me to agree that one should not use drastic untested methods when faced with extraordinary circumstances.

Or, more importantly, that we should not offer such options for those who want them.

Racter, I think you are being stupid.

anon_22 – I found it in a “Biosecurity Briefing”. It’s a bit of wierd deal. It’s a contract awarded to Chiron in Oct 2005, to “provide a bulk stockpile of H5N1 influenza vaccine to HHS in 2006″, produced in Liverpool.

In Sept 05, a larger contract was awarded to Sanofi Pasteur “for the manufacture of a vaccine against H5N1 influenza.” [No additional info on this one.]

“These vaccines are to be integrated into the Strategic National Stockpile.”

Thinlina,

You need to quit being personal. Address the issue.

glo,

That would be it. Both those contracts were for the unadjuvanted inactivated split subunit vaccines. Very low efficacy unless you use large antigen dose, something like 90mcg. Which means, going back to Fedson’s arguments, that very few people will have access to it. In comparison, GSK is claiming they have good efficacy with 3.8mcg. But that’s with a novel adjuvant with unknown side effects.

If, God forbid, we have a pandemic, ALL options will be bad options and long shots.

anon_22 – at 02:18

I don’t think that any of us can truly appreciate your loss; but thank you for sharing that information and giving us a deeper insight into the choices that will have to be made in an increasingly confusing world.

Allan – at 17:28 “They can’t grow Post Qinghai Lakes (Sichuan Sheet) in eggs as it kills the egg.”

Not just that strain, but all H5N1 strains will kill the eggs.

“So how are they going to substitute the Sichuan Sheet virus for pre Qinghai H5N1 and produce millions of doses?”

They take the surface antigens ie HA and NA, get rid of the cleavage site on the HA, and recombine that in the laboratory with another human non-pathogenic influenza A virus. The WHO does that and then gives out the resulting seed strain to the vaccine manufacturers.

“Somehow this statement of a miraculous cure does not sit well with me.”

I don’t think GSK is claiming a miraculous cure.

And, you might want to do more investigation or ask more questions before drawing your conclusions.

anon_22, I crossed over your recent post and missed it. Thanks for sharing - that’s really hard. I appreciate it. All the more compelling for me, I have a 17 yo daughter. I get a visceral response, it makes my stomach hurt to think of it. She is my buddy. It would go the same way for us - the conversation, the decisions. There’s no question that we would do the same. Better a chance than no chance at all. I think the question of quality of life has no meaning in those circumstances and at that age. There is no ‘dignified death’ at 16. And if there was, it would be one of risk-taking and challenge. And yes, I am selfish.

I suffered the loss of a man that was my soulmate. There have been times that I had to work at staying breathing.

glo, I’m with you.

There have been times that I had to work at staying breathing.

Been there. You are not alone.

Well, the good news is that apparently most of us will not have to make tough decisions anyway. At least not right away. The bad news is that we won’t get to make tough decisions.

“HHS has enough H5N1 vaccine for 4 million people.” Efficacy issues aside, prioritization plans are health care workers and those involved in vaccine manufacture, estimated at 10 million doses. NIH says that the military gets 2.2 million of the first 8 million doses. In Alaska, top priority are pilots and essential personnel for the oilfield and pipeline. I haven’t seen it directly spoken to, but I feel strongly that border personnel will be prioritized as well.

http://tinyurl.com/k39tg - An old article, but a very good read and nothing much has changed.

What I was really looking for was the global vaccine status. I’m wondering if it wouldn’t be a better use of that stockpile, such as it is, to send it to Asia NOW, to supplement containment efforts. A casual thought - don’t scald me.

who will get the vaccine and who not ? Will it be freely available for money ? Will they use it as a weapon and give it preferrably to those parts of the population which they like ? (ethnic,age,political) Will it be available for increased prices in internet pharmacies ? in Canada ? On fisherboats in international waters ? Can I buy an option now, so I’ll get a dose ?

All those questions will need to be decided. They haven’t yet. And they will be the source of conflicts both inside and between nations.

(civil-) war for vaccine ?

those who pay most, will get it. As usual. Or you’ll have to throw down law and order.

anon_22 – at 02:18 — My heart and prayers go out to you and your daughter. My second husband was faced with a similar choice, with a successfuly resected small primary HCC/CC and 3 years’ remission. At the time of the peritoneal relapse, he was offered traditional chemo in Europe = 100% death - data available, or allogeneic peripheral blood stem cell transplantation to induce a graft-versus-tumor effect, in USA = approx 60% death - data not available. He chose traditional chemo. I respected his choice, though I know if it had been me, I’d have chosen the stem cells despite the lack of safety data. I went through the same road as you and I say like you: “But don’t expect me to agree that one should not use drastic untested methods when faced with extraordinary circumstances. Or, more importantly, that we should not offer such options for those who want them.”

Frenchie, my daughter also had PBSCT. I went through a course of GCSF injections and then plasmaphoresis for stem cell harvest. Technology continues to improve. 2 years after she died, there is a new drug which offers a slightly better chance.

The thing is that our modern day medical successes are all built on initial failures. One can only hope that those who come later will have a better chance.

Now I think about the availability of a H5N1 vaccine and who would want to chance it with the lack of safety data? My husband’s monozygotic twin has 85% chances of getting the same cancer as my husband. What would he choose if it happened to him, chemo or clinical trial? At this stage, he still refuses to even have check ups. And he’s seen his second half die. Even if I say if it were me I’d choose the clinical trial with no safety in the case of cancer, I am not sure that I would take the H5N1 vaccine. Would I take it before others in my family die to the flu, after another loved one dies to the flu? Would I decide to not take it all whatever the circumstances? Could I decide for someone else whether they should take such a vaccine? I have no answers with respect to H5N1 vaccine. I don’t know.

anon_22 — at 05:20 - Many thanks. I just hope progress will be such that if my husband’s twin falls to this cancer, the new treatments will be there for him, if he chooses them.

Frenchie,

I agree with you and said before that it will be a very hard choice for a lot of people. But

“Could I decide for someone else whether they should take such a vaccine?”

If that ‘someone else’ is every member of the public, then I am 100% certain that I cannot, should not decide for them.

That is, we should not take those options off the table even if we ourselves would not choose them personally.

Ah but the thing is, what if the decision has to be made for someone who is so impaired that the person cannot, for whatever reason, make an informed choice for his/her/self? What about my old lady, 88 years old? She is a member of the public, she is not my family, and she has no family or other friends. She has asked me to do certain things for when she falls ill, but I was never able to discuss bird flu with her. Will I have to decide for her? What will I decide?

Frenchie,

That is a hard one, I think we all agree.

My post was only answering some of the issues discussed much earlier on this thread, for those who object to vaccines with uncertain efficacy and uncertain adverse reactions, and those who appear to oppose using public funds to produce such vaccines.

anon_22, I sat by my mother as she slowly died from cancer. She received chemo long after it was doing any good. The doctor said it provided hope. My mother had “hope” in this treatment because it was what medical doctors recommended. To her, it was the only option. All the other alternative treatments were considered “exotic”. My mother asked about them. Her doctors discouraged any deviation from their treatment. She died. The cancer had found its way into her throat. She was fifty six. It was clear the doctors had no idea how to stop the spread of cancer. At the same time, they discourage any “holistic” treatment. Unfortunately, I think we (Americans) are locked into a medical model of health care. This model is protected by the legal system and special interest groups, AMA, etc. Funding for research and development finds its way to the groups that participate in this model. That makes it extremely hard for alternative health practitioners to improve their procedures and conduct large research studies. The result is, the medical model remains the “official” model. What a shame. Until other forms of treatment are allowed to develop, the public has to accept treatments that may be inferior and dangerous. However, because the treatments are part of the medical model, they are sold as the best chance you have to survive. Vaccines fall into this category. Let’s be clear on this point, if the government and medical community strongly recommends a BF vaccine. A vaccine that is being made in a hurry. Individuals who experience side-effects will have no legal recourse or be provided with care or financial help. Remember, some of these side-effects could be severe and life long. Death is also a possibility. When communicating the risk of side effects these organizations should be truthful. They simply don’t know. They have studies; however most of the data comes from research funded by Big Pharma. The same folks who make the vaccines. The public should also be encouraged to research the growing evidence of severe long term side effects from some current vaccines.

Also, it should be made very clear, that vaccine may not work.

I just got finished reading an article on the American Medical Association’s new Scope of Practice Partnership study. This study is an attempt by the medical community to reign in alternative care providers and place them under the control of an “official” physician. They claim this is an effort to protect the patient. Interestly, this study is being created during a continual exodus of patients from the traditional medical model. It seems the AMA can’t tolerate its members losing customers. They tried forty years ago to stop Chiropractic. They failed and were found guilty of engaging in a conspiracy to control and eliminate chiropractic by Judge Susan Getzendanner. No black helicopters, Racter. That is a fact. Limiting alternative treatments, then presenting “official” medical treatments as the best way to save us (vaccines, etc), is pathetic, false and inhumane.

A couple of decades ago, I was honored with a request to be Godfather to the most spectacularly beautiful little girl the world has ever seen. One look at her beaming face and her long curly hair was enough to instantly captivate anyone, and her parents were often advised to take her directly to the casting studios in Hollywood. When she was about four, she developed leukemia. Throughout the fight, she displayed a courage and a simple, pure wisdom that humbled us all. I still have a picture of her, bald as a doorknob, dancing with some of those streamer thingys. The sparkle in her eye is the thing you notice. I used to keep it in a spot where it would be one of the first things I’d see when I woke up. It reminded me that whatever happened that day, there was no challenge I could not face while that little girl fought so bravely. When, two weeks after his seventeenth birthday, my eldest son was killed in a car wreck, there were at least fleeting moments in which I was able to appreciate the mercy of instant death.

A couple of years ago, I saw that little girl at a wedding reception, as beautiful at eighteen as she was when she stole my heart at two. She’s been in full remission for many years, and her eyes still sparkle; in fact, more than ever, I’d swear, though I wouldn’t have thought it possible.

Doctors recommend certain treatments not only because they offer hope, but because sometimes they actually work.

Roman:

When it comes to production of flu vaccines, we really aren’t talking about “Big Pharma”; we’re talking about a tiny fraction of all the pharmaceutical companies out there. Currently, only four companies: Sanofi, MedImmune, Novartis, and GlaxoSmithKline are licensed to produce vaccines for the U.S. market. Been to the pharmacy lately? Some of us walk away carrying bottles of pills costing hundreds of dollars. Many return for more of these precious packages on a regular basis, and will continue to do so for the remainder of their lives. I’m surprised there aren’t more muggings. A flu jab typically costs around fifteen dollars, and they’re one to a customer. If that weren’t bad enough, the customers consistently stay away in droves, and the entire year’s output becomes worthless at the end of the season.

Tell me again why “Big Pharma” would place their reputations at risk by rigging clinical trials on one of the least profitable products they make?

Yep, it does, sometimes.

“Limiting alternative treatments, then presenting “official” medical treatments as the best way to save us (vaccines, etc), is pathetic, false and inhumane.”

Roman, this Forum and wiki is going to offer official medical treatments first and foremost, simply because it is more likely to be accompanied by outcomes-based research and data. It will also offer complementary treatments to the extent they are known.

Railing against either method is not welcome. I say that not because of you (nothing personal), but because more boards have been shut down over arguments of that sort than I can list. I don’t want that to happen here.

Is that clear?

Anon_22 I went thru the same thing with my sister when I was 17. I’m sorry.

I guess that’s why they fought to keep their treatments the only “official” ones. See how well that works.

“Railing against either method is not welcome” No one is railing. Exploring why some treatments are deemed official and worthy of funding and why other methods are not, is important. Obviously, the safety of the public is not the only factor involved. If this current medical model prevents the public from developing alternative and effective ways to survive the pandemic, it’s even more relevant. Perhaps the official treatments are flawed and will never provide protection. What does that leave us? Nothing. Because if the treatment doesn’t fit into the medical model, it can’t be considered. Anon_22 made the statement that a vaccine provided the best chance of survival. This thread explored many ways vaccines are flawed and not likely to work. However, it is considered our best chance? I believe the reason it holds this title can be found in my previous post. The public should be aware that other possibilities exist that may be more effective. TomDVM has made this point and given great examples in his posts.

I am clear.

“Perhaps the official treatments are flawed and will never provide protection. What does that leave us? Nothing.”

You make many if-then assumptions. A more likely perhaps is that the official treatments aren’t flawed and will provide some (but not perfect) protection. What does that leave us? Better off than before, but not completely protected.

Vaccines have issues with efficacy, production and distribution, same as antivirals. They hold the promise of prevention and protection better than anything else, but that promise is as yet to be fully achieved. For that reason, we have always advocated concentrating on the non-pharmaceutical approach as well, hence the existence of the wiki in the first place.

And for government agencies, we expect clarity and transparency so it’s clear what the expectations are. If something’s offered that’s not 100% effective, say so from the outset. Consumers are educable on issues like that.

Roman,

The problem with you is not that you don’t have a point, with concerns about side effects and efficacy. You do.

It is that you keep repeating them and thereby prevent other discussions. If mainstream medicine says vaccines are the best option, and other people think differently, we have already established that it is important to bear that in mind. By repeatedly going through the same point of challenging whether mainstream medicine is correct and whether pharmaceutical companies are lying, you are preventing other people who want to find out more about vaccines or discuss the finer details of pandemic vaccine production.

It is a selfish and self-indulgent act.

I am asking you here to cease and desist. You have made your point. It has been noted by everyone. Now move on.

The Inquistions guided most of the threatened populations to accept doctrine and conventional wisdom that they couldn’t possibly believe was correct.

The populace was left with no choice but to conform because the information was censored and was channelled only via official mouthpieces of the guiding organisations. The cost of searching for the truth could likely be discovery, torture and death because the search required going to secret places to discuss unofficial doctrines.

I have reduced my work on this wiki because I see the Inquisitors forming a barrier to discussion on issues that appear unpopular to the mainstream. I and many others consider the pursuit of valid information and knowledge important when the so-called evidence doesn’t undergird the mid- to long-term outcomes.

Flaws in the study construction and flaws in the motivation/compensation systems appear frequently in the so-called evidence. Look around your desks . . . haven’t you smirked or giggled from time to time about a study that clearly showed false outcomes / false causality, e.g. tobacco studies? Look around your families . . . do you see anyone who has been failed by complete reliance on the official channels? Worse yet, remember those who have been completely failed.

You, the up and coming Inquisitors, are asking the Romans and Nimans of the world, to stop the pursuit of science (knowledge) because you, the Inquisitors, will only allow input from official laboratories.

Has the WHO been forthcoming? Will they?

Are we certain that observation of all the facts, including long-term outcomes, is less than beneficial science?

Should we just stick to the beakers and flasks?

From each of you, I ask introspection, contemplation and a fresh direction.

No need to respond or debate.

I feel like wetDirt and the others who have stopped their work here after being pulled to a place that seemed beneficial, seemed open to communication and then became a series of closed monologues . . .

NS1,

Nobody is objecting to yours nor Roman’s points of view. What we are trying to do is retain some space for discussion for those who do NOT hold your points of view, or who are interested in actually finding out what mainstream science is saying before deciding whether mainstream science is incorrect or lying.

“A more likely perhaps is that the official treatments aren’t flawed and will provide some (but not perfect) protection.”

and the other possibilities will never be tried. So I guess we just have to settle for the imperfect “official” treatments. Addressing why they are called “official” is not important? We are clear.

“It is that you keep repeating them and thereby prevent other discussions.”

We had other discussions. You didn’t like it. Proclaiming vaccines the best hope humanity has to survive a pandemic does not leave much room for discussion. I hope the folks reading this thread realize that statement is an opinion and not shared by all. That includes individuals with a medical background. This is not a simple case of us (non-medical) vs. them (medical). You’re right. I’ve made myself clear. Good luck, public. Do some research and decide for yourself. I have.

Roman:

I couldn’t agree more. But what you’re doing is not “exploring”; it’s asserting. It’s not that you don’t have a point, it’s that you fail to make your case — worse than that; you don’t even try. Your mind is clearly made up — on the basis, you say, of research you’ve done. You, along with NS1, have been asked to present some of this evidence, and the sources from which you obtained it, but consistently choose instead to raise the emotional tone of the discussion. You seem more interested in a diatribe than a dialogue, as if you expect others to make their decisions based on the strength of your convictions.

NS1,

This thread was started to discuss a specific vaccine. It isn’t that general objections to vaccines are not allowed, but that after the first few posts, they do not give any further useful information to others. Repeating one point over and over does not make it more right than the first time it was made, it only makes it boring and confusing for others.

If you or anyone else has specific information against this particular vaccine, please post them.

In fact, I posted a major problem with this vaccine, that is the unknown ‘novel’ adjuvant with potentially serious side effects. I also posted the link to my previous posts on MF59 and suspected links to autoimmune problems.

I then went through the complexity and difference between deciding for an individual and deciding for a population. I also further acknowledged that this is not a clear-cut thing, I personally find it very hard to make a choice. I told my personal story of loss to illustrate the difficulties for those who actually have to deal with them, not just someone sitting in front of a PC.

If I believed mainstream medicine is the panacea for everything, I would not have written what I wrote.

You need to ask yourself whether all this counts as ‘inquisition’ and ‘censoring’, or whether it is your own bias that fails to let you see things properly.

Roman at 17:41:

You’ve been suspended, warned, yelled at and had it made very clear to you that a permanent suspension was on the table. And here you are arguing with a moderator who’s trying to, you know, moderate. The subject matter isn’t the problem as much as your insistence that, to borrow Racter’s words, the strength of your convictions alone should decide what everyone else talks about. I’ve blocked your IP address because nothing else works.

Well, there’s my evening free I guess.

And for NS1, who, after bringing us to the brink of Godwin’s law, prepares to take his ball and go stomping off the field (again):

Which of these two statements would you say has more truth value?

1) Ontogeny recapitulates phylogeny.

2) Ontogeny recapitulates phylogeny.

…what…? Embryonic development = evolutionary development. watterwetalkin’ about.

glo, the question isn’t about the actual truth value of the statement, but about whether its truth value increases with bolding. It might as well have been: “All prime numbers are divisible by two”.

NS1 – at 17:30

“I feel like wetDirt and the others who have stopped their work here after being pulled to a place that seemed beneficial, seemed open to communication and then became a series of closed monologues . “

Actually, the only work I see from you and wetDirt on this forum are related to promoting Niman recombinomics. No other threads are more ‘monologue’ and closed than Niman’s. If we ask any question, we would be shouted down by the Niman trio (the Inquisitors).

I am still interested in understanding conventional science and I don’t want you to shut it down by yelling Inquisition and Censorship. The same people who screamed censorship offer no specifics, only try to discredit others. Clearly projection.

If you have a specific point to challenge a vaccine, please post it, but don’t try to kill it to make room for non-conventional medicine.

If you have specific alternatives to vaccines, please start another thread.

Well said Anon-YYZ

This is what makes me nervous about vaccines: BARDA. I get a yearly flu shot, and all my routine immunizations (to start in nursing school (1969) we needed a slew of vaccinations, including a re-do of smallpox. The typhus shot made me as sick as a dog)

BARDA-aka the Biomedical Advanced Research and Development Agency (BARDA) was passed in 2005 (Senate bill 1873)-these are parts of the Bill that scare me to death-

“Allow the Department of Health and Human Services to sign exclusive sales contracts with particular manufacturers for a particular product.

Forbid government purchases of generic versions of such new drugs or vaccines as well as public sales of the products for use as countermeasures.

Exempt countermeasures from certain federal cost oversight requirements.

Provision of rebates or grants as incentives for domestic manufacturing of vaccines and medical countermeasures against bioterrorism and natural disease outbreaks.

Liability protections for drug makers that develop vaccines for biological weapons. The measure would make manufacturers, distibutors, health care providers, or administrators of security countermeasures immune from liability caused by a security countermeasure or any pandemic/epidemic product, by means of a limited antitrust exemption.”

source: http://tinyurl.com/ny4e3 (wikipedia)

It’s because of this legislation that shelters vaccine makers that I will extremely cautious about all vaccines I consider getting in the future- not just the H5N1 one.

Grace RN – at 21:47

I think the government should make it clearer to the public that there are risks with vaccines as they are constituted, to balance the publicity that vaccine manufacturers would get on product introduction, after (quietly?) getting liability protection.

I remember a few years back there were not enough seasonal flu vaccines because no one wanted to make them (money loser). There was a debate whether the public should invest in production (and research and development?) capacity. Does anyone know more about this?

IMHO, the government is too cosy with Big Pharma to make any public statements that could be construed as even a whisper against a vaccine. :(

Don’t get me wrong-vaccinations have saved millions of lives. I have seen healthy young people at death’s door from measles pneumonia. My husband’s uncle was crippled from polio.

I just think there had to be a better way to find a balance between getting safe vaccines produced in a timely manner and in adequate quantities than BARDA.

Grace RN – at 22:17

Let me try this:

As an individual:

1. Prep and shelter in place if you can, don’t rely on panflu vaccines 2. Vaccines only taken as last resort for those who must go to work and can’t SIP

As a public policy

1. Dont’ let regulatory steps be skipped without a lot of public scrutiny 2. If we run out of time, as a last resort, we may have no choice.

Please add/correct what I missed.

ANON-YYZ – at 22:37

Re: “1. Dont’ let regulatory steps be skipped without a lot of public scrutiny”

BARDA=“Biomedical Advanced Research and Development Agency (BARDA), that would act “as the single point of authority” to promote advanced research and development of drugs and vaccines in response to bioterrorism and natural disease outbreaks, while shielding the agency from public Freedom of Information Act (FOIA) requests. BARDA would be exempt from long-standing open records and meetings laws that apply to most government departments…”

source: http://tinyurl.com/ny4e3 (wikipedia)

It’s already been passed-we can’t get “in” to see what they’re doing…….. :(

Grace RN – at 22:41

Sorry to keep asking.

Can BARDA or its officials be held to account?

“The Vaccine Safety and Public Confidence Assurance Act of 2006 would create a new federal agency separate from the CDC. The bill seeks to remove what its backers contend is a dangerous conflict of interest in having the CDC promote widespread vaccination and at the same time watchdog safety issues that might decrease vaccination rates….

The bill was introduced by Reps. Dave Weldon (R-Fla.) and Carolyn Maloney (D-N.Y.). It would create a new Agency for Vaccine Safety Evaluation, which like CDC, would be a part of the Department of Health and Human”

Sounds like a retort to BARDA(which was passed in 2005.)

source: Atlanta Journal Constitution http://tinyurl.com/syusm

Grace RN – at 11:44

I like that.

Grace at 21:47

Agree with what you said here about BARDA which most folks have never heard of. Seperating CDC who promotes vaccines from also being the Watchdog is a good idea if and only if the new agency has clout. The problem is and has always been the newer vaccines want to ride on the success of the older ones which were established through the auspices of public health. Public health is now almost non existant and I don’t believe in immunity exemptions. Either they’ve done the safety testing and know they’re safe, or they haven’t and don’t want lawsuits. It can’t be both ways. A pandemic vaccine that hasn’t been tested should be throughly exposed as such and let the adults choose for themselves and their kids. I’m not aganinst them but I’m for full disclosure about what’s been done and what hasn’t been done. Informed choice…

Leo7,

“A pandemic vaccine that hasn’t been tested should be throughly exposed as such and let the adults choose for themselves and their kids.”

Well, it depends on what you mean by tested. Tests to pass the FDA regulatory standards will be mandatory. But, by definition, a pandemic vaccine will not have been ‘tested’ in the sense of ‘tried out in a real-life pandemic situation’ - that will be a luxury that we won’t have, by the very nature of a pandemic.

That’s why the whole thing is so controversial and difficult.

As I related earlier, the risk/benefits considerations for a pandemic vaccine will be substantially different from a seasonal vaccine.

The FDA, by refusing to acknowledge that, may risk landing the vast majority of the US population with no pandemic vaccine at all.

thread too slow, close and start new one here

Anon 22:

“The FDA, by refusing to acknowledge that, may risk landing the vast majority of the US population with no pandemic vaccine at all. “

Am in full agreement with you but especially on the last line. But, I am afraid that with all the various vaccines out and about in many countries—we may get something totally unexpected. I would hope we would be told this is the UK or Chinese vaccine and not lump all of them into the Pandemic flu vaccine category.