Avian flu vaccine approved by FDA

Posted by: Arney

Avian flu vaccine approved by FDA - 04/18/07 09:48 PM

A vaccine for the H5N1 strain of influenza has finally gotten approval from the Food and Drug Administration. The vaccine requires two doses, about a month apart. This vaccine will not be available for sale, but the US gov't will purchase it to add to the U.S. Strategic National Stockpile maintained by the CDC.

Note that this is *not* the magic bullet that will save us from the next pandemic. First, the next pandemic could involve a completely different disease or a different strain of influenza that this vaccine doesn't protect against. However, H5N1 is the most likely candidate at present to become the next pandemic. Secondly, the vaccine is "only" effective for about half the people who receive it. The other half may have partial immunity to no immunity. The point of this vaccine is to slow down any H5N1 epidemic by immunizing at least a good chunk of the population. That will give scientists time to develop and manufacture a vaccine for the specific strain that is circulating.

Anyway, good news, I think. I'm not aware of any serious side effects during the clinical trials, although that only involved 103 participants, so it's possible that a rare but serious side effect could still appear in widespread use, like during an actual epidemic/pandemic.

Oh, that reminds me. A couple weeks ago, there were reports out of Japan that the run-of-the-mill influenza B was developing resistantance to anti-viral meds, like Tamiflu. Hypothetically, someone infected with H5N1 and the common influenza B could transfer the drug resistance to H5N1, creating a new, drug-resistant strain.


Posted by: Jess

Re: Avian flu vaccine approved by FDA - 04/20/07 10:15 PM

Great. I can add that to the laundry list of shots the military makes me get, to include anthrax and small pox--I am going to become indestructible. When the apocalypse hits I am going to be the only one left alive. Along with cockroaches and Cher.
Posted by: wildman800

Re: Avian flu vaccine approved by FDA - 04/20/07 11:21 PM

I'm glad I retired when I did! At least I can look forward to sleeping until the end of eternity, someday.
Posted by: norad45

Re: Avian flu vaccine approved by FDA - 04/21/07 12:47 AM

Originally Posted By: Jess
I am going to become indestructible. When the apocalypse hits I am going to be the only one left alive. Along with cockroaches and Cher.


Good grief that was funny. Thanks for making Chianti come out of my nose! grin grin grin
Posted by: MDinana

Re: Avian flu vaccine approved by FDA - 04/21/07 02:03 AM

Is it just me, or is bird flu (queue the spooky music) getting a lot more press than it should? Yeah, I know the comparisons to Spanish flu of 1918. But any pandemic that's vicious and fast spreading tends to burn out rather quickly - those suceptible die, those that aren't, survive. Either that, or everyone freaks out, buttons up inside their house, and it fizzles out.

Maybe it's just that this strain is more "democratic" in those that it debilitates?
Posted by: infrared

Re: Avian flu vaccine approved by FDA - 04/21/07 08:51 PM

I think,aside from the deaths a pandemic would bring itself,a major concern should be that with the current size of the world's human population and the ability for any disease to spread rapidly across the globe,the very real and possibly more dangerous effects of rotting corpses that can't be buried fast enough will cause secondary epidemics that would strain any society and it's economy.
So in my opinion,H5N1 isn't getting enough attention and with it the aftermath of potential millions of bodies needing to be disposed of rather fast and efficiently.
Posted by: ironraven

Re: Avian flu vaccine approved by FDA - 04/22/07 08:31 PM

They didn't have a problem with disposing of the bodies during the Black Death- pile them up and light them, communal pyres.

Posted by: Susan

Re: Avian flu vaccine approved by FDA - 04/22/07 09:03 PM

So far, since this Bird Flu surfaced and anyone started counting, a grand total of somewhere near 200 deaths have occurred since 2004. In the whole world.

That is not an epidemic, that is random. All the deaths that I've read about happened after heavy contact with infected birds, and most of the infected birds were in high-density populations.

A lot of people were sure it would follow the migration patterns of birds. It didn't --- it followed the roads along which dripping trucks of birds carcasses traveled.

The last time there was a Flu Scare was in the 1970s, they rushed a flu vaccine through the system to avoid a major pandemic. A grand total of ONE person died from Swine Flu, 25 died from the vaccine, and at least 500 came down with Guillain-Barré syndrome from the vaccine.

If H5N1 DID happen to mutate into a human-to-human disease, the mutation itself would probably make the current vaccine useless, wouldn't it?

And I don't really understand why they think this particular flu would be the one to go pandemic. A pandemic could come from many other, and possibly more likely, sources, such as pigs, which seem to share a lot of diseases with us.

I'll pass. It's time to go out and see how my chickapoos are doing!

Sue
Posted by: benjammin

Re: Avian flu vaccine approved by FDA - 04/22/07 10:21 PM

I'd say what makes the threat so alarming isn't it's current configuration, where it does not readily infect humans. I would say it's propensity for mutating, the contagion rate of this type of influenza, and the effects it has on it's human hosts that make it such a big scare.

That this strain would tend to adversely effect younger, healthier people by triggering a cascade of overwhelming immune response that seriously compromises the lungs, and that this virus doesn't just attack the respiratory system but readily infects other organs, including the brain, liver and heart, and damages them severely, make this a particularly noxious bug. Human influenzas are extremely contagious, and the way they attack the body by forcing healthy cells to manufacture more of the virus until the cell dies is pretty efficient. The virus itself doesn't do any work, it fools the cell into doing it all.

If you look at the 1918 outbreak, something that isn't so popular are the after effects, a particularly nasty encephalitic infection that came on about 3 or 4 years later in people who were infected but survived the respiratory attack, only to succomb to a vegetative consumption in the 20's as the virus slowly ate their brain.

Anti-virals like Tamiflu only postphone the pandemic, they don't immunize you against infection, they just temporarily block or inhibit the virus from taking over your cells. It is only effective in your system for a little while, and the timing of the dosage is critical to effectiveness as well. Once you've dosed and it wears off, you are just as susceptible to infection as you were beforehand. It will take 6 to 8 months for a vaccine to be produced once the virus mutates; the current vaccine will likely not be effective against a mutated human host strain. Think what happens to our civilization if people refuse to function to keep it going for 6 to 8 months. Yeah, I kinda like the idea of being thrown back in time for a bit too, kinda like the end of that Kurt Russell movies Escape to LA, but realistically we produce one heckuva waste stream these days, and if the sewage treatment plants stop functioning and the garbage doesn't get collected, well, things get very simple very quick. We run the risk of other more recognizably nasty diseases becoming a big factor now as well. How many of us have a big check valve at the main drain from our households, so that when the sewage system backs up it doesn't just start flooding into our homes, which I've seen happen more than once.

Now, I ain't trying to play chicken little here. I got more pressing issues to worry about right now just like the next guy, and my finances are just as finite and I am required to prioritize my needs, and I am not going to go hog wild right now preparing for a perceived threat beyond my general preparation for surviving in this day and age. Realistically if the flu did go off now, I would be hard pressed to avoid being one of it's statistics. I do think, though, that knowing what I am up against helps me to be prepared for it a little better. Our first tool of defense is always knowledge.

Were I to get stuck out in the open where I had to go be amongst the public during such an event, I would be looking to grab a few good tyvek suits, a full face motorcycle helmet, and a few goodies from the local hardware and electronics stores. Those ought to be reasonable, maybe the tyvek might be a bit of a challenge, so it pays to locate a supply nearby now and keep it in mind if the time comes.

That's about the extent of it I reckon.
Posted by: Arney

Re: Avian flu vaccine approved by FDA - 04/23/07 01:45 AM

Originally Posted By: Susan
If H5N1 DID happen to mutate into a human-to-human disease, the mutation itself would probably make the current vaccine useless, wouldn't it?


This vaccine would likely provide some immunity to an H5N1-derived pandemic strain, although a radical mutation could render it ineffective. Like I said, scientists know that this vaccine won't match an H5N1 pandemic strain perfectly since the actual pandemic strain is just a hypothetical at the moment. I suppose most of us think in terms of individuals, and in that sense, a partially effective vaccine doesn't sound that great, but in terms of the public at large, even a partially effective vaccine could prove immensely useful and avoid a lot of deaths.

Originally Posted By: Susan
And I don't really understand why they think this particular flu would be the one to go pandemic. A pandemic could come from many other, and possibly more likely, sources, such as pigs, which seem to share a lot of diseases with us.


It's true that a completely different disease or influenza strain could turn out to be the next pandemic disease, but H5N1 is a front runner since it has proven to be able to infect humans and it is extremely lethal. That's gives it a leg up on pretty much every other emergent disease. All it needs is the ability to jump from human-to-human like your typical human influenza and then we'll all be in deep trouble.
Posted by: ironraven

Re: Avian flu vaccine approved by FDA - 04/23/07 02:08 AM

We do NOT know that it is extremely lethal. We know that among REPORTED cases it has a high mortality rate. What we do NOT know is how many people haven't been hospitalized, or even reported it to medical authorities.

And it would require a fairly radical mutation to make it readily transmittable among humans. You almost have to go out of your way to catch HN51 at this time- the humans who have caught it have mostly had wounds or sores that were exposed while handling the carcasses of dead or dieing birds, or did not wear even the simplest mask while doing so. Those who wore protective equipment and showered thoroughly and decontaminated or destroyed their clothing afterwards have had almost none, zero, no infections. When you have had human-human transition, it is by communication of bodily fluids are being in very close proximity, such as a loved one acting as a caregiver. It's almost as hard to catch HN51 as most STDs.

I was on the state's Y2K team, and people on the state's Bird Flu working group know me personally and run things past me because they know about my "morbid little hobby". In both cases, the human factor is going to grossly outweigh the actual problem's direct effects.
Posted by: Arney

Re: Avian flu vaccine approved by FDA - 04/23/07 05:13 AM

Originally Posted By: ironraven
We do NOT know that it is extremely lethal. We know that among REPORTED cases it has a high mortality rate. What we do NOT know is how many people haven't been hospitalized, or even reported it to medical authorities.


Well, no one has done blood tests of every single human on the planet if that's what you're getting at, but in the limited communitywide blood testing done so far in areas with H5N1 outbreaks like in Hong Kong and Vietnam, there is no evidence of widespread but unnoticed H5N1 infection. Basically, if the H5N1 virus can get a toehold in your body, you're going to get extremely ill.

Roughly half of the laboratory-confirmed cases of H5N1 infection have ended in death. By any medical standard, that's an extremely lethal disease. Very few infectious diseases kill that many people even if you limit your denominator to just those sick enough to seek medical care. For comparison, Spanish Flu "only" killed a couple percent of those who fell ill.

Genetic reassortment between H5N1 and a regular human influenza virus could theoretically give it the ability to easily pass from human-to-human and result in a full-blown pandemic strain literally overnight. That's the nightmare scenario that medical experts worry the most about because there won't be any warning signs before there's an explosion of new cases. H5N1 does not have to slowly mutate and evolve human-to-human transmissiblity on its own over time, although it could do that, too.
Posted by: benjammin

Re: Avian flu vaccine approved by FDA - 04/23/07 05:50 AM

Right, if the H5N1 finds a host already infected with a readily transmittable human form influenza, and the two viruses comingle in host cells, the chance of a mutant factor developing that has both the lethal aspects of H5N1 and the infectious aspects of the human influenza will be quite high, in one host!!! The H5N1 only needs to modify it's receptor protein to something that human cells membranes have a greater affinity to and the show will begin. It is not a long shot radical mutation, but a very plausible and historically supported event that happens almost annually with current strains.

As far as lethality goes, H5N1, like most other influenza viruses, causes the body to generate cytochyme as an immune response to defend the system. However, in H5N1 currently, the virus overstimulates this response, and a cytochyme storm within the body occurs, which becomes a pathological event that compromises lung tissue. That's why an H5N1 infection is more devastating on young healthy people who's immune systems are working at peak efficiency. The body ends up working against itself. Combine this with the viruses ability to migrate to other organs and cause damage, and that makes this one bug that can do a lot of damage fast, and spread easily.

It would be good if we had the time to see the WHO come up with a broad spectrum vaccine, trying to counter the most likely recombinant variations that could occur. Unfortunately every year we are given vaccines that may or may not precisely target the one virus that will migrate the most. In a way, this little threat is doing us some good, forcing us to focus our efforts on developing more effective treatment processes. Necessity is the mother of invention.
Posted by: infrared

Re: Avian flu vaccine approved by FDA - 04/23/07 04:20 PM

A lot less people back then and a much more widely spread population than today. Don't think any government around today has the ability to handle disaster on a large scale.Plus when/if there is something that widespread going on food supplies and other utilities will suffer only adding to the problem of starvation and disease-people won't be happy when the pooper is in the backyard next to the dogs can
Posted by: stealthedc

Re: Avian flu vaccine approved by FDA - 04/23/07 06:49 PM

Originally Posted By: benjammin


Were I to get stuck out in the open where I had to go be amongst the public during such an event, I would be looking to grab a few good tyvek suits, a full face motorcycle helmet, and a few goodies from the local hardware and electronics stores. Those ought to be reasonable, maybe the tyvek might be a bit of a challenge, so it pays to locate a supply nearby now and keep it in mind if the time comes.

That's about the extent of it I reckon.


could you elaborate on the few goodies from the hardware and electronics stores for inquiring minds. thx...
Posted by: MDinana

Re: Avian flu vaccine approved by FDA - 04/23/07 07:58 PM

Originally Posted By: benjammin

As far as lethality goes, H5N1, like most other influenza viruses, causes the body to generate cytochyme as an immune response to defend the system.


Benjamin, I couldn't find "cytochyme" on google. Do you mean cytokine? Or cytochrome?
Posted by: benjammin

Re: Avian flu vaccine approved by FDA - 04/23/07 10:10 PM

It is cytokine. I was pretty knackered yesterday and I think my posts reflect the rummies a bit.
Posted by: benjammin

Re: Avian flu vaccine approved by FDA - 04/23/07 10:18 PM

Yep, a DC PC cooling fan, like, a small hepa rated vacuum cleaner filter , a project box, the electronics to build a small dc regulator circuit, a sealed LA cell, probably 12v, and some wire etc. I would punch a hole in the back of the helmet, rig up the fan and the hepa system, and run a positive pressure system into the helmet. Keeps the head cool and provides virus free fresh air. You can get a full face PP filter setup, but who has a spare $500 sitting around? Mine cost me about $100. If the virus can't get in, then you don't get infected.

This would also help with hayfever (hint: original motivation for the application).

You have to get a fan that has enough cfm to overcome your respiratory volume, otherwise you will draw negative pressure on the inhale to hard and unfiltered air will come in the bottom of the helmet.

Or you could just wear a disposable particle mask and a set of goggles, but that doesn't look as cool.
Posted by: Arney

Re: Avian flu vaccine approved by FDA - 04/24/07 02:09 PM

Originally Posted By: MDinana
Benjamin, I couldn't find "cytochyme" on google. Do you mean cytokine? Or cytochrome?


If you're interested in doing some more reading, try looking up the phrase "cytokine storm" on Google. That should give you some interesting reading on the rev'd up immune response that Benjammin was mentioning.