I asked my physician why the FDA did not approve the swine flu vaccine. He told me they did approve it. I checked. He was right. It was approved after they waived all of the qualification testing.
This is as hoaky as it gets. Next question: Why were the qual tests waived?
The testing will be done on the general population, that’s all.
The novel H1N1 vaccine is the same thing as the seasonal vaccine that has been tested and widely used for years. It's simply a monovalent version, while the seasonal is trivalent (targeting one virus vs. three).
The World Health Organization predicts which three flu strains will be most likely before a given flu season, and its recommendations are followed for the seasonal flu shot. Every year it selects an H1N1 strain, an H3N2 strain, and a B strain. The base of the flu vaccine is always the same, only the viral material targeted changes based on the WHO's recommendations. This year, WHO made its recommendations in February, then the swine flu outbreak occurred in April.
Since it was too late to alter the seasonal flu schedule, a "new" vaccine had to be developed for novel H1N1. But it's not really new at all: It's the same base as the seasonal flu shot, but with a different strain of H1N1 and no material from H3N2 or B. Had WHO waited a few months, or had the swine flu outbreak occurred earlier, novel H1N1 would have been included in the seasonal shot.
So there's really no reason for substantial tests. The base of the vaccine has been proven throughout the world for a number of years, and the same experience tells us that altering the targeted flu strain does not cause any unexpected changes. It simply changes which strain the vaccine protects against. (And I don't think seasonal vaccines are regularly tested, although I could be wrong.)