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.
#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.