Swine Flu Shot May Require Emergency Use of Ingredients by Glaxo, Novartis

[Purveyor]

Source: Bloomberg

By Tom Randall and Gary Matsumoto

July 29 (Bloomberg) -- Swine flu vaccine makers may rely on a U.S. emergency declaration to use experimental additives made by GlaxoSmithKline Plc and Novartis AG to boost a limited supply of shots that will be available to fight the pandemic.

The ingredients, known as adjuvants, may be added for the first time to flu shots in the U.S. Health officials, meeting today at the U.S. Centers for Disease Control and Prevention in Atlanta, plan to discuss use of the additives, and may also recommend who should be first to receive the limited amount of vaccines drugmakers say they will begin delivering in October.

The U.S. Health and Human Services Department declared a public health emergency over swine flu in April, and the Food and Drug Administration has the power to allow the use of unapproved medical products during such a crisis. The U.S. has been slow to approve the use of adjuvants because of safety concerns, and for fear of giving Americans an excuse to avoid getting the shots, said John Treanor, a University of Rochester researcher.

“The question is, do you really feel comfortable throwing this new thing into the mix and do you really need to?” said Treanor, a professor of medicine, microbiology and immunology at the school in Rochester, New York. “I myself, if I had to do it, would really wrestle with that decision.”

The CDC agreed to pay London-based Glaxo and Novartis, based in Basel, Switzerland, more than $415 million for adjuvants that could be added to the swine flu vaccines, according to a July 13 statement.

Mice Studies...

Read more: http://www.bloomberg.com/apps/news?pid=20601087&sid=a_xObcaSxF2o

[hlthe2b]

1. Inevitable, but concerning

[midnight]

31. Why is it inevitable?

Because we know the pharmaceutical co. stock and bribes have purchase our elected officials?

[FarCenter]

2. Since the US doesn't produce much vaccine, we have to take what we can get

[jus_the_facts]

3. If they plan on FORCED vaccinations..I'd rather be shot in the face with a 9MM by the fascist fucks.

n/t

[nadinbrzezinski]

4. They don't. what part of limited supply are you missing?

They will have to TRIAGE to decide who gets it.

I am beting the military, health care, and people at very high risk... from the very limited supply

[du_grad]

18. I am one who processes the rapid flu testing

We in the microbiology lab are on the front lines, along with the ER nurses and docs who will be treating many of you who will get this in the fall. I would rather take a chance on a shot than a chance on dying of this, as the mutation risk is great. We have to squish the nasal swab into a buffer and put the resulting liquid in a cartridge. All of this creates aerosols. Granted, we do this under a safety hood, but there's still always a chance of exposure. Remember, viruses are extremely tiny and any aerosol includes millions of viruses in the air. This happens every time you cough or sneeze. The last flu outbreak a few years ago created seemingly nonstop rapid flu tests from the ER - many of them per shift.

We have not heard whether we will be included in the health care triage or not.

Talk is cheap. Which of you will be first to call your doc and head for the ER when you get sick??

[tavalon]

19. You damn well better be

We need to know quickly who has the H1N1 and who has the regular flu. It would be really, really stupid to wipe out our helpers in that task.

[BeHereNow]

9. Or battle the TRIFFIDS!

http://www.youtube.com/watch?v=Q8B_NcamuKQ

:rofl: :hide: :banghead:

BHN

[Ian David]

5. The fact is that they're using this in the wealthy nations first.

If it were REALLY dangerous, they'd be giving it away free to Africa.

[timeforpeace]

6. No way. It's better to be philosophically consistent than smart. No vaccine.

[tavalon]

20. Sarcasm?

[Devil_Fish]

7. lets put MTBE in the gas and see how that works.

this is why I don't trust U.S. in regards to Vac's. God I hope they don't make it mandatory. I would much rather take my chances with H1N1 then get a vac from this government.

There is no future, and no present, only the past happening over and over again.

[BeHereNow]

8. Well that seals the deal for me- No FUCKING way am I getting that vaccine-

ESPECIALLY since they have already set them selves up for immunity to
any ADR's that may result from it.

I'll take my chances, that you very much.
http://www.augustforecast.com/2009/07/28/swine-flu-pigs-to-fly-soon/

No one has actually bothered to read this link I keep posting on threads
concerning the swine "flu..." btw.

Want to be the first?

BHN

[Devil_Fish]

10. I read it. every one should. NT

[BeHereNow]

11. Congratulations! YOU are the first.

And welcome to DU!
BHN:toast: :hi:

[BeHereNow]

12. OOPS! Sorry, I didn't know you had been here for over a year-

I didn't post for a long time, so I missed you!
A belated WELCOME is due to you, from me.

BHN

[boppers]

13. Ignore facts! Look over here at a conspiracy theory!

H1N1: 50-100 million dead in 1918.

So far, we've had 179,000+ Infected and 1,346 dead. The piece is outdated, uneducated, conspiracy writing.

[BeHereNow]

15. Prove it- Your accusation of it being a CT.

Ignore the facts at your own peril.
The fact that immunity has already been put in place to protect the Pharma Cartel
against any lawsuits resulting from this "vaccine" is all I need to know.
BHN

[boppers]

25. "All [you] need to know"?

Well then, I guess that settles the matter for you.

People who actually work in medicine and epidemiology, thankfully, don't stop there.

[BeHereNow]

16. Out dated? DID YOU CHECK THE DATE?

I doubt you even read the link at this point.
BHN

[boppers]

23. Only 311 dead? No. Old, bad, data.

It's too early into the season to tell the final impact, Spanish Flu (also H1N1) took two years of nastiness, and took out a lot of people *because* there weren't global measures to screen folks at airports, quarantine schools (and cities), etc.

Here, something a little more credible than a blog:
http://ecdc.europa.eu/en/files/pdf/Health_topics/Situation_Report_090728_1700hrs.pdf

[tavalon]

30. How many died in the first wave of the H1N1 virus of 1918?

The huge numbers were for the second and third waves. Our second wave here in the US should really get going in about October, though the fact that it hasn't abated much through the summer gives me, and the WHO pause.

[PHIMG]

14. I will not take this vaccine.

This all sounds so fishy to me. Especially with DailyKos pimping the FluScare non-stop on the home page.

There is a bizarre group think taking hold on Flu Preparedness that I just don't understand.

[tavalon]

21. You would do well to learn what we already know

[PHIMG]

22. That the big bag swine flu is going to whip us all out?

What is that?

[tavalon]

24. No

Even if it remains at the same lethality (no guarantee on that, but we can hope) next to no one has immunity to this strain, therefore, instead of 8000 deaths as happens with the usual flu, this one will have a factor of 10 or more deaths and a factor of ten or more in just sick people. We are not trying to scare you, we are trying to get you to start thinking about this, because there are choices each of us have to make and it's better to have thought of those now when you can begin preparing instead of in the middle of November when your options may well be far more limited.

I'll give you a personal example. We have two 50 gallon drums that we've filled with potable water (likely overkill, but everyone forgets water) so if the utilities get fucked because there is no one manning the water stations, we have that covered. We have quite a bit of canned and dry foods (I hate canned foods but they last), enough to last through 6 weeks of interupted grocery store deliveries. We have enough n95 masks for the family and I have fit tested everyone and my husband knows that his precious beard will have to go if we start needing to use them. We have planned for our child to be out of school for as long as a month and can probably handle two months. I will change into scrubs outside my house and will take a shower outside the house prior to entering (I will be leaving my scrubs at the hospital after work, of course and will be wearing an n95 respirator at all times while there). If any of my family becomes ill with the flu, we will be quarantined and will not be going to the hospital because there will be no room at the hospital, not for my family and not for yours.

That's our plan. What is yours?

[BuddhaGirl]

32. sounds like Y2K

and then nothing happened. Everyone was whipped up into a frenzy over Y2K.

[tavalon]

34. That would be fantastic

but I don't think we're getting out of this one this time. And even if we do, we as a species are well overdue for a highly virulent, highly contagious pandemic flu so it will happen. Let's hope it doesn't happen this fall but prepare anyway.

[BuddhaGirl]

35. imho this is fear mongering, just like Y2K

and I am not buying into it. I just don't believe we are "overdue" for a so-called pandemic.

[tavalon]

36. Then you are choosing to be ignorant of the dangers

I think you are doing the wrong thing but I will be thrilled to have you tell me next summer that this wasn't what we thought it would be.

[BuddhaGirl]

42. I will be sure and tell you

when nothing happens :-)

[mzmolly]

17. So an "emergency" is the best time to "experiment"?

Good f-ing grief.

“Until GlaxoSmithKline and Novartis can show me it won’t harm a rat or guinea pig, I think it’s a bad idea to give it to humans,” Vicky Debold, a registered nurse with a Ph.D. in public health, who is a member of the FDA’s advisory committee for reviewing vaccines, said July 27 in an interview.

Thank goodness some are questioning this so called logic.

[tavalon]

26. They have to find an adjudivant that can help the vaccine be spread thinner

As is, it takes twice as much serum as the regular vaccine to achieve immunity so they need to make twice as much vaccine in less than half the time. That is why they are experimenting and yes, it is a really, really, bad time to be experimenting but we are metaphorically, up against a wall. It scares the fuck out of me, especially since my son was forever damaged by two adjudivants in his vaccines.

[mzmolly]

38. I think the rationale is a crock

sorry. Why not use an existing/tested adjuvant in this case? Granted adjuvants are questionable as it is, but at least we may know what we're dealing with.

I'm very sorry about your son tavalon. :(

[BuddhaGirl]

33. +1

n/t

[frustrated_lefty]

27. People seem to be missing the point...maybe...

Adjuvants boost the immune response, but some are viewed with skepticism. Immunology is not my strong point, so please forgive any technical inaccuracy. If I'm off on the specifics, the general principles remain true. Thimerosol is an adjuvant. It's also considered by some as a potential cause for autism in children. I'm not saying it is, nor am I saying it isn't. But, there's sufficient data to make it a valid concern. Some of the adjuvants used in the anthrax vaccine are thought to be possible contributing factors to "Gulf War Syndrome." It's an open question.

The CDC may have paid for the materials, but do we really want to pump these questionable materials into our bodies? Personally, I am wayyyy in favor of vaccines (in general), but I have concerns regarding the adjuvants. The thought of using relativly new adjuvants on a wide scale makes me nauseous.

[tavalon]

29. I'm a nurse and you explained it really well for a layperson. Kudos

I'm very nervous that they are trying out new adjuvents on an emergency basis - that is just asking for trouble. But the problem is, we have a looming disaster that could make adjuvents the least of our worries. Thimerosal did turn out to be dangerous for certain susceptible people and yeah, I think there is something to the anthrax/adjuvent issue.

So basically, I'm hating the position we're in and I'm hating that this may be done really badly but we are up against a wall, we really are. People have heard the government cry wolf too many times and are now poo pooing something that really is a big, scary, deal. It's really unfortunate.

[mzmolly]

40. I honestly wish the CDC would spend more money on educating

people about illness? Perhaps fund additional sick days? Encourage sick children/parents etc. to STAY HOME when they have flu symptoms vs. encourage everyone to 'go about their business' and take an experimental jab so we can.

If this is a disaster, Obama will be blamed. That worries me as well as the health consequences.

[mzmolly]

39. Well stated!

n/t

[Chemisse]

28. Pregnant women will be the first in line.

So what will these additives do to the fetuses?

This is a really bad idea.

[mzmolly]

41. Google "pregnancy flu and schizophrenia"

There are many reasons to be leery of putting pregnant women in line first.

[crim son]

37. Yet another reason to avoid getting this shot.

There have been too many false alarms over the last few years for me to want to risk my health or my children's health with a new vaccine containing unapproved medical products. At one point I thought we'd all be dead of bird flu, yet the human race survives. And before anybody jumps all over my ass on this one, let me tell you that I personally have been prescribed two drugs that were later pulled from the market due to dangerous side effects.

My father, a retired physician, tell me that when it's at all possible, wait at least five years after its introduction before using a new drug. It's a good policy except in extreme circumstances.

[InvisibleTouch]

43. Okay, I was vacillating on whether or not to get this flu shot...

...but this has made my decision for me. NO WAY. At least not until it's already been given for several months and we know something about its effects, or lack thereof. Until then, I'll take my chances.