Trial data has yet to prove the safety and effectiveness of H1N1 (swine flu) vaccines. In fact, only one of the five companies seeking approval has even STARTED human trials.
But—surprise, surprise—that’s probably not going to stop the FDA from approving them.
Data will start coming in next month, and will continue through the early part of next year. But the World Health Organization wants to start vaccinating people in October, so they don’t have time for pesky details like whether or not the vaccines are safe.
In fact, the whole thing will take on a scary trial-and- error approach. FDA officials say they’ll update the immunization program as the trials shed more light— including whether or not two doses are better than one, or if a vaccine turns out to be ineffective.
In that case, emergency authorization for an oil-in-water adjuvant may be needed. The adjuvant sparks a stronger immune reaction, but causes more side effects.
What’s perhaps most alarming is that, according to FDA officials, approving a vaccine without safety data is actually not uncommon (though this situation is new and exciting in that they don’t usually approve them when major clinical trials of safety are ongoing)!
Seasonal flu vaccines are actually approved using the FDA’s "strain change" process, in which manufacturers actually don’t even have to provide information on whether the vaccines are safe—or if they even work!
That’s right—put it out there, see if it works and how many people are hurt in the process, and clean up the aftermath later.
Look. Swine flu could end up being a very real problem in the coming months. But we can’t let our panic get the best of us—shooting people up with unproven (and possibly unsafe) drugs could have disastrous consequences.
You know, I don’t know what it’s like to be a guinea pig. And I have absolutely no interest in finding out.
Ms. O’Brien has written for Nutrition & Healing, Healthier Talk and a variety of other natural and alternative health outlets. She believes in the power of natural medicine and her goal is to open people’s eyes to the benefits of alternative and integrative medicine.
Christine is passionate about helping people help themselves without having to turn to harsh drugs or invasive surgeries.
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