The FDA is likely to approve 2009 H1N1 swine flu vaccines before trial data can prove their safety and effectiveness against the virus.
Approving a vaccine without safety and immunogenicity data is not uncommon, FDA officials said during a daylong meeting of the Vaccines and Related Biological Products Advisory Committee.
The committee met to hear updates on H1N1 trials from the FDA, NIH, and the five companies that are applying for FDA approval of pandemic H1N1 vaccines.
In fact, the FDA approves seasonal influenza vaccines every year using its “strain change” process, in which it doesn’t require vaccine manufacturers to provide safety and efficacy data.
What is different about how the FDA is likely to handle approval for a vaccine for pandemic H1N1, however, is that the agency doesn’t normally approve vaccines while major clinical trials of safety and immunogenicity are ongoing.
Found by John Stec.
I’m going to arrange to be out of the country when it’s time to queue up for the shots.
Call me if the shots become mandatory. Till then, I don’t give a damn. Any drug can have side effects, and flu vaccines are notorious for them. From where I sit, a flu vaccine with potentially bad side effects getting approved doesn’t qualify as news.
You don’t like it, don’t get the shot.
@#2: Not mandatory for you but already mandatory for such populations as school children … For a general good we should be worried about forcing untested medication on children. For our own good we should be worried about anyone being forced to be vaccinated with the untested vaccine, as soon it could be us.
The annual virus vaccines use pieces of the protein coat of the virus to stimulate the immune system and, thus, don’t really change much and simply don’t require extensive testing.
Geeze, if you guys were in charge we’d still have a polio epidemic.
The crazy anti vaccine folks are clouding the issue. The questions is why such a push for a hastily produced, untested vaccine for a disease that has as yet been less virulent and dangerous than the regular flu that goes around every year?
I’m no conspiracy nut, but why all the panic? H5N1? (bird flu) panic away, that shits bad news. But this seems like a lot of noise.
http://www.kmbc.com/news/20156763/detail.html
Children’s Mercy Hospital To Test H1N1 Vaccine
KANSAS CITY, Mo. — Children’s Mercy Hospital is playing a crucial role in the testing of the vaccine to protect people, especially children, from the H1N1 flu virus. The flu strain has killed more than 700 people around the world.
If it’s for the greater good.. I’ll do it.
Am I allowed to show up totally wasted?
I have 3 kids 9,11,and 2. My wife and I will not allow anyone to give our kids this blasted swine flu shot. They have never gotten the regular flu shot, neither have I or my wife. I will not allow them to inject dangerous junk into the veins of me or my family. Even if it becomes mandatory. They can shove it.
It seems to me a bit silly to panic at this stage of the game. After all, we’ve been predicting, almost wanting and needing, some great catastrophe for some time now.
I for one say, “Bring it on, MoFo”. 😉
I’d rather deal with than cower in fear.
Man, you americans freak out over everything.
In Finland they decided to lower the threat level of this thing cos it’s nothing more than an overhyped flu. The only ones in danger are under 3 year olds. Most cases get by with just rest and maybe some medicine to bring down the fever, nothing else.
Flu shots are for dummies.
@#3: Some vaccines are mandated for school kids. Smallpox and the like. Flu vaccines tend not to be. What’s more, H1N1 can’t already be mandatory, because (while the FDA may be *likely* to approve it) it hasn’t been approved yet.
A problem with the anti-vaccine crowd is the mindset that all vaccines are the same somehow. They aren’t. Just because some vaccines are mandatory for kids doesn’t mean this one will be. Until it is, there’s no news here.
I’ve taken flu shots off & on for years, never had any problems. No one knows what this virus will do when winter flu season comes around, not any of you, me, or the people working on the vaccine. So far it’s been mild compared to other flu versions. Personally I will probably get the vaccination, never had any problems before and I’m not a lunatic believer in secret government mind control programs that are shuttled away in vaccines. And I do NOT want to hear any of you “truthers” bitching and moaning later on if any of your family members dies or becomes bedridden for the rest of their lives from complications from contracting the Swine Flu. A little common sense goes a long way, people, get some!
John, I hope that this flu season isn’t particularly nasty, because you are clearly encouraging people to not be vaccinated.
If you convince anyone with your idiocy, you’re putting the entire population at risk, since “herd immunity” requires that a large proportion of the population be immunized. The more non-vaccinated people, the more the disease will spread. The more the disease will spread, the more people will die.
I hope you’re ok with having deaths on your conscience.
Imagine if you had access to the internet during outbreaks of smallpox or polio.
What is this “hard immunity” crap and your wacked out claim that “the more non-vaccinated people, the more the disease will spread”?
The reality is more people die from the flu shot and medical treatments than the flu itself. In the 1970’s the doctors in Los Angeles went on strike due to skyrocketing malpractice insurance rates. Guess what? The death rate dropped like a rock. That’s because people stopped getting medical treatment.
People are brainwashed. Viruses are dead as a speck of dust. People are trained to run to the doctor, get their shots of bovine serum with added murcury, and poison pills to kill everything in the blood, as some sort of “healthy” thing to do, and then everyone blame “the virus” when someone drops dead from all the medically prescribed poisons. It’s a sad joke. Some people survive these medical terror regimes. Other’s aren’t so lucky. But please spare us this crap about how everyone’s going to die if they don’t get mercury and viruses shot directly into their blood, that’s cult brainwashing scare tactics not based on fact but only based on fear and manipulated data fed you by drug companies out to sell their wares.
Think about the insanity of it, you want to avoid catching the flu and so you go out and have the viruses claimed to cause it shot directly into the blood so you catch it so you don’t get it later. Oh yea man that makes sense, hand me another beer. Burp! Oh god I have to puke this beer is making me sick, I better get vaccinated with more beer.
Disease is not caught it is created.
There are many factors that go into why people create the flu in their bodies. Lack of vitamin C and/or other vitamins and minerals for a period of time, trace minerals you hardly know about, changes in the amount and quality of fiber which acts like a broom and magnet to rid the body of crap, not enough protein, not enough rest, stress, unhealthy bacteria feeding on rotting meat and given ample supplies of sugar so it can overwhelm the colon to create putrefication and huge emounts of toxins emitted by the bacteria, all of these and other things affect how a person creates the flu.
If you think you or I can catch the flu, prove it. Get it, then throw it to me. No, I said throw me the flu, not dead viruses. Throw me your flu. You and your doctors keep saying I can catch the flu. No, don’t throw me shots of mercury and dead viruses, I want you to throw me the flu. I’m waiting. Why aren’t you throwing me the flu? You keep insisting that I can catch your flu, but you keep throwing me dead viruses that don’t do shit, THEY ARE DEAD STUPID.
January 1, 2025 – I’m still waiting and I haven’t caught your flu you promised to throw. At this point, I have been waiting for years, I don’t want to play your stupid flu game anymore if you aren’t going to throw it to me. Here, you can have your dead viruses back. It’s no fun playing the flu with you if you are not going to throw it to me. Playing catch with viruses is no fun they are too small and slip through my hands and colon.
I’m convinced now John. You’re posters are in more need of antipsychotics than vaccinations. It you want to drive up hits, please return to photos of scantily clad young women. And for God’s sake take a break from Curry. I believe its affecting you.
Apparently the crazy anti flu people haver a time machine. Wow.
We are truly living in the future.
Correction – anti vaccine people.
I think its safe to say were all anti influenza.
This flu seems to be having the most adverse effects on young people. The current vaccine strains are growing in hens eggs more slowly than usual, so it will be slower to ramp up production.
Given these facts, and the results of epidemiological studies of recent flu outbreaks it seem reasonable to begin with vaccination of school children. With the sort of hysteria voiced above, this may not be politically possible. This is a shame since it might save lives.
As for the persons impugning members of the FDA above, I would like to assure the readers of these comments that the employees of the FDA (specifically CBER in this case) are very capable people working in the best interests of all of us.
Yep, it seems crazy people posting here are just babbling. Screw the testing, screw any testing. Just release the damn drug already and have them tested on kids first, because you know none of the supporters are lining up themselves.
I wonder why we didn’t think to do this with everything else…the nukes, space exploration, CPU, tasers, cosmetics and everything else. Wait a minuter, holy crap but we do test stuff! Damn it all to hell them, how about lets not be as careful and just release the damn thing. Sounds good! In fact, screw the entire QA industry!
#15 – I don’t like the fact that the WHO is tinkering with the virus to make it easier to achieve good yields of the vaccine. I don;t like that they are planning to use an attenuated virus instead of a dead virus or better yet, virus proteins to achieve immunity. And I especially don’t like that are almost preapproving the vaccines with almost no in vitro testing.
But, for god’s sake, please get off the thimerosol kick. There are only a couple of vaccines that use this mercury compound as a preservative: tetanus and, yes, some flu vaccines. Not all flu vaccines and I don’t know if the H1N1 vaccine will need that preservative or not.
It is important to know, thimerosol compounds are made up of ethylmercury which clears out of the body almost immediately. You’d have to be getting tetanus and flu shots every other day for a toxic level to build up.
Ain’t no way I’m taking the flu shot until I see what the experience is and whether it does resurge in the fall as a nastier beastie. Besides, I’m over 50 and so probably have some immunity already. You post-baby boomers can go pound mercury.
Actually, I encourage nearly everyone not to get the flu shot. Nearly everyone I don’t like that is. The beauty of this whole story is that the crazier the person, the less likely they are to get the shot and the more likely they are to die from the flu.
It has the potential to both reduce the surplus population (always a good thing) AND improve the gene pool all at the same time!!!!
Hip, Hip, Hurray!!!!!
The real problem is all the people driving down immunity by taking antibiotics for every little thing.