If the best you can say about the human bird flu vaccine made by Big Pharma's Sanofi Aventis SA is that it is "better than nothing," are you even correct about that?
The Food and Drug Administration is considering a recommendation from an outside panel of expert advisers that it approve the Sanofi vaccine. Those experts endorsed the vaccine's safety and efficacy Feb. 27, but with a caveat: that it's only the first step in developing a way of successfully immunizing humans against the deadly H5N1 strain of bird flu.Sanofi said it recognizes the vaccine is only an interim solution, since evidence suggests it wouldn't protect most people against the flu strain. Still, the government is stockpiling the vaccine, regardless of whether the FDA approves it. Officials plan to use it to immunize emergency and health care workers in an outbreak.
Those officials hope the Sanofi vaccine eventually will be replaced by better vaccines, perhaps juiced up with immune boosters. Other companies, including Novartis AG and GlaxoSmithKline PLC, are developing bird flu vaccines. (AP)
The FDA sounds like Donald Rumsfeld, who told us "As you know, you go to war with the Army you have. They're not the Army you might want or wish to have at a later time." We know how that turned out. Yet the FDA is deciding to stockpile the vaccine they have, not the one they might want or wish to have at a later time:
"I hope we never have to use it," said Dr. Melinda Wharton, deputy director of the national immunization program at the Centers for Disease Control and Prevention and an FDA adviser. "But this is the vaccine we have now."
Another adviser, Dr. Jack Stapleton of the University of Iowa Hospital Clinic, called the Sanofi vaccine "better than nothing."
I would understand the reasoning better if there weren't already reports of better vaccines out there. It's not as if there is no cost to stockpiling the vaccine. I'm not talking money costs, I'm talking about using up productive capacity to make vaccines, in this case an inferior vaccine compared to what some companies like GlaxoSmithKline (see here and here) and CSL in Australia say they can make and have tested in trials. Novartis also has a product.
The pending FDA decision may have something to do with the Department of Health and Human Services already letting a contract to make several million doses of the Sanofi product. Wasting that money would be unfortunate, but if blindly fulfilling the contract means getting a product that is just "better than nothing" when we could instead use the time and restricted pathogen free egg supply to make a better one, then this doesn't make sense. Better dump the money down the hopper. It's not like they don't do that daily in Iraq.
Or maybe I've got it wrong. I look forward to being corrected. That would surely be better than nothing.
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revere,
The problem with the GSK and Novartis vaccines are they use proprietary adjuvants. Apart from alum which doesn't really work, the only adjuvant that is licensed, and only in Europe in one seasonal flu vaccine for the elderly, is MF59, with the Novartis vaccine. Additional research for other age groups will be 'happening shortly' according to Klaus Stohr who has just joined Novartis.
This is going to take a lot longer than press releases might cause us to believe, because the effectiveness and safety profile of adjuvanted H5N1 vaccines so far appears to vary significantly with the formulation of the vaccine itself. ie each vaccine, in varying dose ranges, has to be tested in the actual formulation with the adjuvant.
The other big problem (among many that I won't go into) is we don't even know what are the biological correlates of protection, ie whether the antibody tests used to fulfill licensing requirements actually corresponds to protection when exposed to the virus. I learnt just today that these magic numbers from FDA (same in Europe) evolved from one study from 1972 that said 50% of people were protected against seasonal flu if the HI titer was > 40. We know from animal models with H5N1 that there is sometimes at least some protection more than what is suggested purely by HI titers, so we don't actually know that a 'poorly immunogenic' H5N1 vaccine will not protect you. It might, or it might not.
So back to the 90ug vaccine. I agree with you that better than nothing is not good enough. However, the question that I have is what are we stockpiling this vaccine FOR? When are we actually going to use it? Is it to be used before a pandemic to prime a certain number of essential personnel? There is a case for that, but in that case the safety profile has to be set much higher than almost any ordinary vaccine, since you are vaccinating healthy individuals against a hypothetical threat, which was the exact same situation as the swine flu business!
In that sense, I would be very reluctant to use any oil-emulsion adjuvant for prepandemic vaccine. There might, however, be a case for stockpiling something less safe if it is only going to be used at the beginning of a pandemic. Since neither of these 2 decisions have been made yet, nor have we identified the criteria with which we should choose who to 'prime' with a very limited stockpile, there is therefore no guiding principle behind how to choose a vaccine to stockpile.
When there is no guiding principle, instead of someone standing up to be a leader and lead the debate on these and other issues, we have the classic bureaucrats' response of going for something that is 'better than nothing'.
Revere is old enough to remember the disasters leading up to the polio vaccine and how it was very apparent that the US was holding back on releasing data to the world about where Salk and Sabin were on their research. The same applied to the Belgians who were testing vaccines on human guine pigs in the Congo. In doing so there was a lot of conjecture that the primates that it was used on before that created the AIDS/HIV viruses. All in a buck and bullshit. If there is going to be a vaccine does it have to be a US vaccine. Even I have called this into question with my two Senators and while educated the initially didnt get it. Now they are on my daily update list of whats happening in the world with BF thru their area reps. Do they get it? Yep. Do I think that we are going to be using Australian vaccine? Nope.
Its just like the polio vaccine. Its worth pushing on a trillion dollars and they will give us basically shitty poultry vaccine and call it great progress. I am not going to take it for the first year, else I might lay an egg like they are.
I hope you two are using your clout offline to campaign on this issue.
I'd like to see an animal comparison of H1N1 vaccine efficacy vs. H5N1 compared to the Sanofi vaccine efficacy vs. a mis-match H5N1 strain. I suspect that they would each offer similar levels of protection.
If there is no difference in efficacy then we should just use the very familiar H1N1 proteins as our stopgap--that is, stockpile trivalent with H1N1 (versions including N1) instead of an equally (in-)effective H5N1 vaccine with all its uncertainties and drawbacks.
How would one go about pushing TPTB to donate massive quantities of trivalent seasonal flu vaccine to Jakarta for immediate use? If nothing else it would cut the noise from the bird flu signal, and at best it might reduce human cases (which as previously discussed might be so rare an event as to be an un-measurable benefit).
Dare I say it?
But it sounds like the adjuvant is an Effect Measure (modification).
Um, grist for the blog mill, this article gave me a "WTF?" moment.
http://news.yahoo.com/s/afp/20070305/hl_afp/healthfluhongkongusvaccine_…
Darin: You may say it, but to be correct you need to say the adjuvant is an effect modifier, not an effect measure.
Lisa: This think from Ho is all over the wires. Since none of the stories have any details, I've not posted on it. There is a lot of activity on the vaccine front and along with the genuine stuff comes the PR stuff. Sorting it all out is difficult and usually not possible with the info at hand. But whenever I see that something "works in mice" I tend to ignore it. Lots of things work in mice that don't work in humans and it also means it is a long way off, even if it does work. The new GSK hoopla is ferret work, too, which is a better model but still not humans. However it can be ramped up quickly if needed and I'd go in that direction rather than the Sanofi product which just doesn't cut it.
anon_22 raised some important regulatory issues about the GSK and Novartis products using adjuvants whose safety we are unsure of. In the event of a pandemic that would be a second issue, but as she points out, for prepandemic use it is a big issue. It could be sorted out relatively quickly if we needed to, however.
Those of brought up on Rothman were taught "effect measure modifier". I just say effect modifier as do my profs. It needed a little modification to get the pun in.
Lisa-There is apparently that discussion going on right now about the Aussies providing it to the Indons....stay tuned. I think they are doing it as much for placation and politics as anything else. Secondary channels say to me that its a win/win for all concerned. They get to field test their vaccine, the Indons get it for free or near free and then if it works we get to live another couple of days.