I wasn't going to post on the announcement yesterday by the US FDA that it had approved the Sanofi Pasteur H5N1 vaccine. We've discussed it before. It was pretty much a failure, requiring too much viral antigen, two doses, and resulting in putative protection of less than half of those who receive it. There is a stockpile (or will be) of about 3 million doses in the national stockpile, only enough for a tiny fraction of those who would need it, with doubtful value for many of them. It was approved because, like the crooked gambling wheel, it's the only game in town. Who would get it isn't clear. I don't expect to be on the preferred list (nor am I asking to be; I don't deserve it. I wonder how many others who don't deserve it would get it?). So what was there to write about?
Then I read this statement by U.S. Health and Human Services Sec. Michael Leavitt:
"The approval by the Food and Drug Administration (FDA) of the first U.S. H5N1 influenza vaccine for use in humans is a sign of progress in our ongoing efforts to protect the American people from a pandemic," the secretary said. "We have the opportunity to be the first generation that prepares for a pandemic, and we are working to that meet that challenge." (UPI)
A sign of progress? I guess I misread it. I thought it was a sign of desperation.
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Guess when you get thru getting that much stuff into an arm the pandemic level will be over.
Guess when you get thru getting that much stuff into an arm the pandemic level will be over.
Well, desperation *is* progress, kinda. At least they know enough to know they're desperate. Maybe someday this half-assed response will develop into something closer to a full-assed one. Maybe a cheek and a half or more.
We can only hope.
"Some people believe that everything will turn out for the best, they are therefore destined to be disappointed. I on the other hand prepare myself for the worst, should it not occur, I am delightfully surprised."
Benjamin Franklin I believe.
To those of us who've gotta inkling of what's going on vis a vis the various recombining regional H5 strains... All I can say is, "The Official Gov Authorities are funnier than Monty Python!" Frack knows, I need a good chuckle to ward off the deepening dread for my future -- will I actually be an old man in 2037, sitting in a public park reading a good book, or just a vague memory to those GenY/Z family members who survive the H5 pandemic!?!
Someone follow on for me and please tell me my perceptions are wrong.
1. It will take at least 6 months to make a specific antigen vaccine that will at least keep you alive if BF comes. That is what we are hearing.
2. At the six month time frame the BF wave one at least will have come and gone and taken depending on who you talk to either 5%, 8% or 30% of the population of the world. Thats 33.5 million, 53.6 million or 221.1 million
3. We cant get the samples from China, Indonesia, and others because they are fearful they wont get any vaccine if and when it is made.
4. Vaccine if and when its made will not be able to be made from chicken eggs, so where is said vaccine going to come from? Not the caterpillar thing I am sure.
5. Distribution of flu vaccine to the worlds populations if it were available along with the actual injections would take a time in motion of about 5 minutes per person. 5 minutes times 670000000 is 3.350 billion minutes or 55,833.333 hours, or 2,326,389 man days. This doesnt take into account the transportation, the set up, taking histories etc. It also is for a single shot vaccine which may not be possible.
I throw this out there for the simple reason that to even talk about a vaccine without a production of something that works in a hard and fast hurry is ludicrous. They are talking about this flu vaccine like its some sort of savior in a bottle. It barely qualifies as a vaccine by international standards and its only with the adjuvants that it does it.
So with the above in mind can anyone tell me that these assumptions are wrong in whole or part and what in Hell are they even talking about "promising" vaccines for this stuff. Its not even the version out there right now that will get us unless China and Indon are REALLY hiding something from us.
Correction to the above it should read 536 million, and then 2,010,000,000 rather than millions. The rest is right. Thanks John. Its one in the morning.... some slack plz.
MRK, you're not usually one to underestimate the threat, are you? In your point 2 you are off by an order of magnitude I believe. Current world population is about 6.5 billion so that's 335 million, 536 million and a whopping 2.2 billion dead folks if current CFR doesn't drop DRAMATICALLY.
Regardless, your point re vaccine delivery to world population is well taken.
Sorry MRK, didn't see your correction, blame it on interntional time zones.
Scary though, isn't it?
I wonder if they all play by the same playbook. I don't know how many times I've heard GW make the excuse, "it's hard work doing " and Sec. Levitt saying, "We have the opportunity to be the first generation that prepares for a pandemic, and we are working to that meet that challenge."
working, working hard, hard work, hard working. All work and no play makes Sec. Levitt a dull boy. I got an idea for the dynamic duo. Work smart, not hard.
MRK: Yes, 2 Trillion minutes is awfully lot. I'm curious about the 1-6+Billion needles. Are there really that many available. Even if we discount the air injected for the indusctrial nations. Does a stockpile of needles for every man, woman and child actually exist?
It appears that we are all on the same page. The 1918 pandemic appeared with a bang and disappeared a year or two later. The pandemic came as fast as it left. I wonder if it will do the same?
well, revere, to be fair, we can't get inside the guy's head to know exactly what he meant. Progress - perhaps if you couldn't figure out whether there was any point in getting that vaccine before, now you have, that's progress! Not that he is sharing with us what the point IS. My guess is of course 'better than nothing', or, more cynically, cos it's time for some announcement of good news?
And, you know what? You've got to learn to read carefully! The guy is saying "We have the opportunity to be the first generation that prepares for a pandemic" NOT "We have an opportunity to save lives during a pandemic", but an OPPORTUNITY to BE THE FIRST GENERATION, as in "don't let the kids get the prize"????
I don't know, English was not my first language....
Yes, "Vaccine Dreams" is a good title for this article.
So why is the "dream" story out there? I am concerned it is a panic control item. The average person will not think about the article---they will just say to themselves:
"The bird flu vaccine is ready. I don't have to do anything to prepare----"THEY" will take care of me and my family."
We ARE the first generation to try to lessen the impact of a pandemic.
From what I have seen over the last few years, and in my personal opinion, THERE IS NO SOLUTION TO A SEVERE PANDEMIC!!! We still have YEARS to go before we will have the capacity to vaccinate the US alone. Sanofi Pasteur, for instance, has a plant in America---but it is owned by a French company. If a pandemic blows---do you think they are going to sell any vaccine to the US---or will they keep it for France?
One of our last (THE LAST????) influenza vaccine companies that are US-owned is considering a buy-out right now---MEDIMMUNE. Will we have a vaccine manufacturer that is US-owned left if Medimmune is bought by a foreign company?
and EVEN IN A HUNDRED YEARS----there will not be a fair and equitable solution to a pandemic event.
FAIRNESS does not exist on Earth. It never has. Save the
outrage energy for getting your family ready---because "THEY" really cannot help you. It is really beyond their capacity right now.
I checked---I am so sorry to bring this very bad news to Americans......
Influenza Vaccine manufacturing plants located in the US according to WHO website (painfully out of date, by the way!):
USA Medimmune-Avirion http://www.aviron.com
USA Sanofi Pasteur http://www.sanofipasteur.com
USA Wyeth Lederle http://www.wyeth.com/
http://www.who.int/csr/disease/influenza/manulist/en/index.html
Here is the bad news.
Wyeth is no longer in the influenza vaccine business. GlaxoSmithKline---(GSK)bought Wyeth's old plant to make cell culture based vaccines---but it is nowhere near ready.
GlaxoSmithKline is owned by a UK company.
As I said above, Sanofi Pasteur is owned by a French company.
AND OUR LAST US-OWNED vaccine company will be owned by the highest bidder soon???? Medimmune:
http://phx.corporate-ir.net/phoenix.zhtml?c=83037&p=irol-investornewsAr…
Chiron had a plant in California---but the Swiss company-- Novartis----bought them out.
So even if a vaccine were possible for the US---who will make it FOR US?????
We have left ourselves extremely vulnerable through GREED and STUPIDITY.
Susan-You know, I didnt even think about the syringes and needles beyond the physical aspect of it. I dont think they could use the mass injection guns because air pressure is used and it might blow atomized blood into the air. We guys from the military shot lines noted that beyond the shots given in basic training with the guns, everything else has always been via injection....Good point.
Of course we could always let the Libyan government run things, you know used needles and all..
Besides the amount of vaccine you would need to get of the new Sanofi stuff you almost need an IV rather than a shot. Anyone got the contract on IV bags around here???
Excerpted from the FDA website and press release on this vaccine....
"The vaccine was generally well tolerated, with the most common side
effects reported as pain at the injection site, headache, general ill
feeling and muscle pain. The study showed that 45 percent of
individuals who received the 90 microgram, two-dose regimen developed
antibodies at a level that is expected to reduce the risk of getting
influenza. Although the level of antibodies seen in the remaining
individuals did not reach that level, current scientific information
on other influenza vaccines suggests that less than optimal antibody
levels may still have the potential to help reduce disease severity
and influenza-related hospitalizations and deaths. Additional
information on this H5N1 influenza vaccine is being collected on
safety and effectiveness in other age groups and will be available to
the FDA in the near future."
"One multi-center, randomized, double-blinded, placebo-controlled,
dose-ranging study in healthy adults, 18 to 64 years of age,
investigated the safety and immunogenicity of the vaccine. A total of
103 healthy adults received a 90 microgram dose of the vaccine by
injection, followed by another 90 microgram dose 28 days later. In
addition, there were approximately another 300 healthy adults who
received the vaccine at doses lower than 90 micrograms and a total of
48 who received placebo by injection. Of the various doses tested,
the study showed that the 90 microgram dose had the better immune
response, meaning that at this particular dose, the vaccine induced
the most antibodies in the blood against the H5N1 influenza virus
strain. The 90 microgram two-dose regimen produced levels of
antibodies expected to reduce the risk of getting H5N1 influenza in
45 percent of those who received it. Although the remaining
individuals did not develop this level of antibody, current
scientific information on other influenza vaccines suggests that less
than optimal antibody levels may still have the potential to help
reduce disease severity and influenza-related hospitalizations and deaths."
Revere, it sounds to me like they tried to put a beard on an ugly goat here. Its better than nothing? Maybe not. They indicate "one study" which IMO is just that "ONE", produced some titer levels that were considered to be effective in the "ONE" study. Okay, call me crazy but where are the other studies and it didnt say directly that these people were given H5N1 to see if they would croak or not. It says that it MAY reduce the severity and blah-blah.
This kind of drivel came out when Clinton was Prez and GB1too. So what gives. It sounds to me like they took the best study and published that and bought 3 million doses of something that might slow it down just a little. Is that what I am reading here? Did they give someone the H5N1 or not?
Randy: The study referred to (I posted on it, I think) measured neutralizing antibodies in those getting the vaccine. That's the best they can do at this point. We can't give them H5N1 and see if they are protected for ethical reasons. It is likely the level of protection is higher than they estimate, in fact. So I don't think the release is misleading. It just isn't very promising. It's all they've got at the moment and they've got 3 million of them.
The Indonesians want vaccine for samples. I think we should ship this stuff to them and let them field test it by throwing the blanket on Java and Jakarta now before it goes any farther. They get the juice, we get the field test and the samples. Quid pro quo.
SEASONAL flu vaccine manufacturers:
Sanofi Pasteur---based in FRANCE
Novartis AG---based in SWITZERLAND
GlaxoSmithKline---based in the UK
Medimmune---based in the US---to be sold next week. I guess it doesn't really matter much who buys Medimmune.
They account for only 7 million doses out of 127 million.
http://www.vaccinerx.com/news/influenza/u.s.-flu-vaccine-dose-update-20…
U.S. Flu Vaccine Dose Update
Written by Scott Cosby
The United States is expected to have at least 127 million flu vaccine doses on hand for this year's influenza season.
Sanofi Pasteur of the vaccine unit for Sanofi-Aventis, mentions it would provide 50 million doses.
Novartis AG estimates 40 million doses, GlaxoSmithKline Plc stated it would provide 30 million to 35 million doses, and MedImmune would provide 7 million doses.
An Australian vaccine maker, CSL Ltd., mentions it could provide some vaccine as well, depending on approval from the United States.
Good news and bad news:
Good news----
Solvay Pharmaceuticals is going to build a flu vaccine plant somewhere in the Southeastern US.
http://www.al.com/news/mobileregister/index.ssf?/base/news/117654224581…
Bad news----
Solvay is headquartered in Brussels, Belgium.
Marietta, GA is only a branch office.
http://www.solvay-investors.com/
Medimmune has been sold to a British company:
http://www.msnbc.msn.com/id/18269955/
When this deal is done--there will not be any influenza vaccine plants owned by an American company in America.