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10/26/2009
WHY THE SHORTAGE OF SWINE FLU VACCINE?

I took some time this morning to do a little research on this issue, going back to last April when the first hint that Swine Flu would be a problem in the US was dropped.

In the ensuing months, the government conscientiously planned for an epidemic - a “worst case scenario” as laid out by HHS Secretary Kathleen Sebelius back in July. Funds totaling more than $700 million were made available from HHS to purchase vaccines from the 5 remaining vaccine makers (a whole separate story of government interference in the market that reduced the number of vaccine makers by 2/3 over the previous decade), as well as help states and local governments gear up for the crisis. In addition, more than $3 billion in preparedness funds will come from the stim bill, as well as monies redirected from WMD funds.

This was all done months ago and would appear to show the Obama administration out front of the problem.

At a planning meeting in July, the government set a goal of having 120 million doses of the vaccine by mid-October, with 200 million doses by the end of the year.

Then in August, it became apparent that there were snafus in making the antigens that protect us from the Flu. This put the whole process of approval by the FDA back a couple of months.

Hence, large scale manufacture of the vaccine was delayed. And as it has been reported, the government hasn’t even come close to the 120 million doses promised. In fact, there are about 30 million doses that will have been made available by the end of the week. And even if the companies making it are at peak production (they are not quite there yet evidently), the goal of 200 million doses will also prove to be elusive. The companies may very well have been able to manufacture something close to that number, but foreign orders will cut into the number of US doses available anyway.

Federal officials had projected that 40 million doses would be on hand by Oct. 15, but not even 13 million doses had arrived by Tuesday.

“They [federal health officials] made some earlier projections, but it looks like a number of those projections have been overly optimistic,” said Dr. Ciro Sumaya, a professor at the Texas A&M Health Science Center School of Rural Public Health, and a member of the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

On Tuesday, a top CDC official acknowledged that production of the vaccine was lagging, with a revised goal now of 50 million doses by mid-November and 150 million by year’s end.

So what happened. Whose fault is it?

In 2004, the shortage of Flu vaccine was George Bush’s fault. Just ask any Democrat:

As public health officials scramble to find more flu vaccine and experts debate how to increase the US supply, presidential candidate John Kerry hopes voters will come to one conclusion – the severe shortage the United States now faces is President George Bush’s fault.

Over the past several days, the vaccine shortage has been injected squarely into the presidential race, as Bush defends his administration and Kerry tries to hold him responsible for the loss of nearly 50 million doses of vaccine - half this season’s expected supply.

Kerry, the Democratic presidential nominee, released a radio advertisement yesterday stoking fears over the shortage as congressional Democrats blamed Bush for not addressing well-documented problems in the vaccine industry.

The British government closed down a vaccine maker because 50 million doses were contaminated - most of those earmarked for the US market.

And those “well documented problems” were the result of government policy going back to the Clinton administration, that allowed people to sue vaccine makers for adverse reactions to the vaccine - some of them ridiculous. This drove costs through the roof which convinced most vaccine makers to get out of the business altogether. You can argue about whether trial lawyers reaped the benefits of such a policy, but the result was the same; there are as many manufacturers of vaccine in the country as their are fingers on one of your hands.

But since the Democrats made blaming Bush a national pastime - even for stuff that was out of his control -shouldn’t we now turn the tables and blame Obama for this radical mismanagement in government planning? How could he be so far off in his estimate of doses that would be available? Was it incompetence? Stupidity? Wishful thinking?

Obviously, we can’t use the Bush standard of blame. Obama is smart. He’s competent. He sometimes speaks in complete sentences. He says “nuclear” and not “nuclar.” He wrote two books - yeah two.

Those are all good reasons to hold Obama harmless for the laughable-if-it-wasn’t-so-serious shortage of flu shots. Come to think of it, maybe the Democrats should have held Bush harmless for circumstances beyond his control too.

I can dream, can’t I?

Never mind. The real reason that there is a shortage of Swine Flu vaccine is very simple: it’s damned hard to make:

Experts such as Sumaya explained that glitches can — and apparently did — occur at several points in the complex process of developing a vaccine, especially for a virus that was first identified in April.

“It shows how there are many steps before you get a vaccine that’s available — the production, the testing, the packaging, the allocation and distribution. And there may be problems at every step, so as you go from one to the other to the other that slows things down,” he said Thursday.

Sumaya was attending a meeting of the CDC advisory committee in Atlanta, where the experts were collecting information on vaccine supply and demand, as well as getting up to speed on the latest H1N1 developments, how the virus is spreading across the country, how many people have been hospitalized and how many have died.

In explaining the vaccine delay, Sumaya said that, first, the H1N1 virus did not grow as quickly as expected during a half-century old — and often-criticized — egg-based production technique.

Second, he said, “because there was kind of a rush to get things done, there were some packaging areas that they [federal officials] had thought wouldn’t take long, yet they did.”

“Even in the distribution, to find certain target groups so it reaches them first, we have to have a sense of what is going on across the country, which is a dynamic situation,” he added.

Then there are the twin demands facing vaccine manufacturers to produce two different vaccines at the same time — one for swine flu and one for seasonal flu.

There’s a longer than anticipated time to grow the antigen, safely package it for distribution (that British contamination snafu in 2004 was the result of inadequate safeguards in packaging), and get it to areas of the country in some kind of rough prioritization.

No sense in blaming government. I think I showed pretty convincingly that the CDC and HHS have been on top of this problem from the get go. But their best laid plans came acropper when Mother Nature refused to cooperate in the growing of the virus in chicken eggs. That, and as always, there were apparently some questions about how safe the vaccine actually is. The anti-vaccination, psuedo-science crowd is making more and more headway despite the science showing that modern flu vaccines are safe and effective. Some people are going to die because they believed that crap. I hope the Luddites can sleep at night.

So even though it would be very nice to blame Obama for the lack of Swine Flu vaccines, we must content ourselves with the usual - making fun of his ears, calling him out for his inability to speak contemporaneously without a teleprompter, and criticizing him for getting up in the morning - all the important stuff.

And did you notice? He’s a black man.

By: Rick Moran at 9:26 am
18 Responses to “WHY THE SHORTAGE OF SWINE FLU VACCINE?”
  1. 1
    michael reynolds Said:
    10:44 am 

    You know I hate to disagree with you, Rick, but I do blame the administration to the extent that what vaccine has gone out has done so in a haphazard way.

    Both my kids got the vaccine last Saturday. So did my wife and I, which should not have been possible. We’d been searching it out for days and finally found some vaccine at a pediatric urgent care.

    There were no lines. The place was empty. Only my wife’s obsessive searching located this little batch of vaccine — none of the bigger companies had it. The nurse on duty was less well-informed than we were. I said, “Just the kids, we’re not priority. And we’re both over 50.” The nurse kept insisting — plenty more on the way, my doctor told me to give it to anyone, etc…

    So all 4 of us got the vaccine. In defense of our dubious moral decision, at that point we didn’t know there was to be a major shortfall, we just thought there was a small delay. And we’d heard about the Luddites and decided better to get it and provide some small fire break than not. And the nurse seemed to be confident that the protocol had been expanded to families with children.

    Why was the vaccine at an obscure clinic and not at CVS, Costco, Target, etc..? Why wasn’t the nurse properly briefed? Why is my county health department still useless? Why isn’t the vaccine being given in schools?

    It’s incompetence, some of it state and local, and even down to the level of the specific doctor, but some of it goes to HHS. Making plans is great: carrying them out is even better.

    Give the vaccine to WalMart, Costco, CVS and Target. I went down to Alabama right after Katrina: no one runs distribution as well as WalMart.

    Bound to be some misappropriation. We’re talking about a scale of almost unheard of distribution. And I would guess that HHS involvement stops with a state’s health department. Could they have mandated certain locations get more doses? Not sure of the procedural problems that would entail.

    The real problems are institutional - few vaccine manufacturers, antiquated way of making vaccines, and a virtually impossible goal of prioritizing by location. Maybe government should have been more anticipatory of these problems but hey! This is the US government wer’re talking about.

    ed.

  2. 2
    Richard bottoms Said:
    11:29 am 

    George Bush earned every bit of his derision. His slate had been wiped entirely clean on September 12th, 2001. By the time of the election the Iraq war was already a shambles and Bush’s malapropism had been on display for a full term.

    It was he alone who took an 80% approval rating and a free hand to do anything at all to fight terrorism to the beginnings of even Republicans getting the message of incompetence.

    Obama has been at the job a little over eight months in the middle of the worst economic crisis in history save for the Great Depression, not to mention two wars on the brink of failure.

    There is no comparison to the mighty Wurlitzer of paranoia and fear being cranked up by Faux and the GOP versus what Bush had to endure so early in his presidency.

    Even as he gets the blame for events put in motion before he even took the oath of office, he doesn’t seem to get any of the credit. I understood Obama had wrecked the stock market. Now the Dow is hovering around 10,000 again that line of attack seems to have disappeared.

    Obama isn’t perfect, but he isn’t, thank God, George Bush.

  3. 3
    Gayle Miller Said:
    11:49 am 

    Richard Bottoms: Obama isn’t George W. Bush and more’s the pity. The slagging at President Bush started on the day he took office and never abated until . . well actually “blame Bush” is the Leftwing mantra. Wonder how the problems engendered by the unprovoked attacks on this nation of 9/11 would have been handled had that lisping asshat Albert Gore, Jr. been elected in George W. Bush’s stead? I think I can guess.

    Our current president is an incompetent shell being run by George Soros and others of his ilk, with little to no regard for the U.S. Constitution. And don’t even DARE to bring up the Patriot Act - it was passed by the entire Congress of the United States and there is absolutely no evidence that any innocent person was harmed by it!

    And the distribution of the existing vaccine is abysmal. My county, for example, got MORE than it needed! Not that I’m complaining, mind you. I’ll have a shot at surviving.

  4. 4
    michael reynolds Said:
    12:10 pm 

    Gayle:

    You’re an idiot.

    Katrina, torture, Iraq, Afghanistan, nukes in North Korea, an Iranian nuke effort, massive deficits and the biggest economic collapse since the Great Depression.

    Yeah, it’s a good thing Gore didn’t win. He might have f–ked something up.

  5. 5
    Gayle Miller Said:
    2:40 pm 

    Oh horse manure Michael. First, I’m not an idiot; I guarantee I’m brighter than you on every level. Secondly - a president doesn’t create a hurricane and the local authorities were offered help and didn’t take it! Afghanistan was justified; Iraq likewise. Clinton set up the nukes in North Korea with his buying into their (hollow) promises and the same with Iran which is a problem for us because of that senile old fart James Earl Carter, Jr. The so-called biggest economic collapse since the great depression was engineered by George Soros in companionship with Barney Frank, Chris Dodd and a bunch of other Dems including our new Secretary of the Treasury, well-known tax scofflaw Tim Geitner! And that’s the fact, Jack!

    Gore is an idiot and so are you Michael Reynolds. Like that KoolAid you’re drinking.

  6. 6
    shau Said:
    2:47 pm 

    There is plenty of blame to go around on this one, and trotting out the old Bush vs. Obama comparo is a waste of time.

    The first culprit is a succession of administrations dating back decades that have allowed the America public health apparatus to go to hell.

    The second is that both the Bush and Obama administrations sent mixed signals in the face of possible pandemics.

    The third and the biggest culprit is a pharmaceutical industry that makes obscene profits (some of which they do pour back into R&D) allowing every American adult male’s penis to stand proudly at attention on cue but just can’t get the flu vaccine thing right.

    Oh, by the way, you ARE in idiot, Gayle.

  7. 7
    Eddie Said:
    4:07 pm 

    A great post, though I would wonder what happens if a lot of kids die and parents/educators sound notes about being betrayed by the failed promises of the Obama HHS.

    I wonder, how do we get more vaccine manufacturers? Is the litigation bar so high for insurance it strangles nascent producers in the crib or is it a mix of factors such as the equipment cost, regulations, etc?

    In 1992, there were 18 drug companies that manufactured flu vaccines. Now there are 5 and it’s totally due to the unreasonable verdicts handed down after Clinton removed most of the protections the companies had as far as liability was concerned. For every one real adverse reaction, it is believed that up to 10 more are bogus. But the trial lawyers and their class action suits would get hundreds of millions in verdicts, this making it unprofitable to make vaccines.

    The question of how much these companies should be held harmless for what used to be considered a public service (there was no profit with 18 companies making the stuff), has dropped away and now it’s open season on them. What Shaun calls “obscene” profits is a direct result of the market being denuded of competition by government action - a payoff to trial lawyers by a Democratic president.

    ed.

  8. 8
    busboy33 Said:
    4:31 pm 

    @GayleMiller:

    “the local authorities were offered help and didn’t take it!”

    Ms. Miller, while you always make me laugh (and this was a bellybuster), I do salute your dedication and faith. It is impressive. No matter what criticisms are leveled at you . . . nobody can ever claim you don’t give 110%.

    Sorry but you’re both right - and wrong. It’s a lot more complicated than simple statements that one or the other side was at fault:

    http://www.gpoaccess.gov/serialset/creports/pdf/hr109-377/execsummary.pdf

    “Failure” was the operative word all around. Trying to ascribe more blame to one side or the other is a fools game if you read this overview of the Select Committee’s findings. Believe me, both state/local and national govt come in for their fair share of withering criticism.

    If you absolutely have to have a main culprit, FEMA state and federal is it but trying measure such gross incompetence by a matter of degree is idiotic.

    ed.

  9. 9
    jon dough Said:
    5:05 pm 

    Leaving Reynolds’ and Gayle’s fisticuffs aside, this site:

    http://www.recombinomics.com/whats_new.html

    has been posting on H1N1 since January of this year and I believe, though the page of links ends with January, was posting on it earlier than that.

  10. 10
    John Galt Said:
    5:17 pm 

    This is a post on flu vaccines, but I feel I must address Katrina in my own way…

    In a world of finite resources, those resources cannot go everywhere. Anyone disagree? OK, after Katrina passed, New Orleans appeared unscathed. Good Ole Shep Smith was reporting from a pristine Bourbon Street afterall. Mississippi, however, was decimated. Now, if I have finite resources (National Guard, bottled water, food, etc) where do I send them in the immediate aftermath of the storm? New Orleans, which was unscathed??? Somehow I think what was left of the Gulf Coast of Mississippi might have been a little pissed at that. The levees broke after the storm had passed. The initial resources of the Federal Gov’t went first to where they were needed the most…Mississippi. It takes a little time to write the orders, assemble extra guardsmen and send them to New Orleans. It doesn’t help when the Governor of Louisiana doesn’t sign over the LA Guard to the national effort. Could things have been done better? Of course, but to paraphrase Rick, this is the government after all. This was an event of near biblical proportions that our nation has never seen before. Well, except maybe early in the century in Galveston, or maybe the Chicago fire, you know, disasters in which the cities recovered without federal help. I lived in New Orleans for 4 years. I love the town. Lotta fun there. But, it is a city built in a sinking bowl. Shit is going to happen there regardless of who has the reigns of power in Washington.

    As far as the flu vaccine situation. 100% agree with Rick. I only blame Obama in the way the Democrats blamed Bush…for political reasons instead of actual reasons. No matter how one might wish it, the Federal government can’t do shit about creating things.

  11. 11
    Connie Said:
    7:29 pm 

    It is apparent that you should have spent more than “some time this morning” researching. What an absolute load of filth this article contains. This obvious double standard is remarkably scary to me.

  12. 12
    Travis Monitor Said:
    7:33 pm 

    “Iraq, Afghanistan, nukes in North Korea, an Iranian nuke effort, massive deficits and the biggest economic collapse since the Great Depression.”

    Enough about Obama’s record … let’s talk about Swine Flu.

  13. 13
    Travis Monitor Said:
    7:38 pm 

    “Obama has been at the job a little over eight months in the middle of the worst economic crisis in history save for the Great Depression”

    … a crises aided and fomented by the economic mis-management of Democrats in Congress and Obama’s administraton. 4 million jobs lost since Obama was elected, and they wont return soon. Yeah, keep blaming the guy who’s out of office, that’s a real winner of an argument.

  14. 14
    Richard bottoms Said:
    8:05 pm 

    The argument that certainly isn;t winning is the country is better of with Republicans running the show.

    Just %20 of the populace are willing to branded Republicans.

    People know now from the GWB experience that when you care enough to send the most incompetent to Washington, look for the GOP label.

  15. 15
    Kevin Brown Said:
    8:19 pm 

    Dear Rick

    No large institution can plan for every contingency.
    Stuff happens. I am not going to blame Obama for this because he was clearly not involved in this at all. Because you see he has been overseeing other important aspects of the operation of our government over these last nine months. He has worked so hard and focused like a laser beam on the most pressing issues of the day.

    I do not understand your sarcasm Rick I mean President Obama I am sure cares a lot about this matter and I am sure he gave a speech on the very import of swine flu and ordered His Administration to cooperate and work together to ensure that everything went according to plan.

    I myself and rather pleased that he is taking his time on deciding on troops in Afganistan given the track record of his decsion making so far.

    But I am sure that the prior administration made things so dysfunctional at CDC and HHS that President Obama was unable to bring the staff into line in time. I know what it was why did I not think of this these snafus took place because President Obama lacked a Vaccine Czar and you know his original choice for HHS Secty did not pay his taxes and I am that this was a concoction of Karl Rove and GWB you know like a new roadside IED that was installed in DC on or about January 20 2009

  16. 16
    michael reynolds Said:
    10:52 pm 

    When I tell people I grew up in a military family they often ask if my dad was strict. No, he wasn’t. But because he was a skipper on various Army boats (Army yacht, ocean-going tug among others) my take-away was a somewhat nautical notion of responsibility.

    Basically, the Captain is in charge. If the First Officer runs the boat into a sandbar the Captain is still responsible. If the engineer burns out the engine the Captain is still responsible.

    So I tend to be intolerant of failure. You succeed or you fail, and the “why” of it is an interesting detail, but doesn’t change the basic fact: you did it, or you didn’t.

    Following that same line of reasoning I give a new Captain a grace period — especially if the previous Captain was a buffoon — but my patience is limited. Don’t come to me and say, “I want to be president, I want you to pay me 400k a year, pay for a private jet and a big white house, and enter me in the ranks alongside Washington and Lincoln,” but I don’t want to be responsible.

    I had no tolerance for Bush’s failures. Up to 911, okay, I don’t blame him for what carried over from the previous admin, but I hold him absolutely responsible for what followed. And I will hold Obama responsible for what comes.

    So yeah, I hold him responsible for the implementation of the flu response. His HHS, his responsibility. Don’t tell me why you failed, just tell me you succeeded.

  17. 17
    Connie Said:
    10:18 pm 

    Just 20% of the populace are willing to be branded “republican” because the other 50% would prefer to describe themselves as “conservative”.

  18. 18
    Person of Choler Said:
    2:06 pm 

    I fault the Obama administration for whooping up a possible threat and making big promises that they couldn’t keep to alleviate said threat. I keep hearing that Obama, himself a genius of astounding mental capacity, is surrounded by a group of stellar intellects as advisers. Why a couple of his brilliant scientists didn’t check out the mechanics of producing vaccine before promising to deliver a bunch of it is beyond me.

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