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What's wrong with our flu vaccine supply? Official transcripts reveal ...

Article Excerpt
This year's flu season brought consumers a double dose of trouble. First, as is well-known to most, there was not enough vaccine made to be given to all who wanted it at the start of this year's apparently harsh flu season. By December 5, many health care providers were starting to turn shot seekers away, and the manufacturers said that all the vaccine they had made had already been shipped. Second, the vaccine made for the 2003-2004 flu season was not as close a match to the predominant flu virus currently circulating as the government's scientific advisors had wanted it to be meaning that the vaccine might offer less protection for this season than in seasons past.

These stories have been reported--and, indeed, spun--in a number of different ways. Most notably, the Centers for Disease Control has insisted that the silver lining of the vaccine shortage is that many more people sought the vaccine than had done so in previous years. Further, the mismatch between the vaccine and the virus has been characterized as a technical or scientific problem that could not be overcome in time to respond to late information about a new virus variant circulating.

A closer examination of what was actually said by the government's vaccine advisors paints a slightly different picture, however. In February and March of 2003, the Vaccine and Related Biological Products Advisory Committee met, as it does every year, to discuss what flu vaccine formulation to recommend to the Food and Drug Administration. The transcripts of those meetings reveal an advisory committee that was indeed facing some technical hurdles as it considered the possibility of switching to a new vaccine formulation. But the transcripts also show a committee repeatedly deliberating the option of pursuing multiple development strategies in order to reduce the risk that any one formulation would not work out. Instead they were told by industry and government representatives that multiple development strategies were not possible. Because of limited manufacturing capacity, the committee had to make "one best choice" of vaccine formulation. Eventually, the committee made the less risky choice of sticking with the tried-and-true formulation that had been used for several years, even though the committee believed it was not the best vaccine possible.

The story doesn't end there. While the manufacturers met their goal of making 83 million doses of the flu vaccine, they fell short of making a quantity sufficient to supply everyone who sought vaccination. Authorities are candid in their assessment that the extra demand for flu vaccine this season was induced by fears of an especially harsh flu season that seemed to be developing as a result of the early arrival and rapid spread of the new virus variant.

That development could have been anticipated. Any virus strain containing a significant genetic mutation, as this year's predominant flu bug does, will face much less natural immunity, allowing it to spread rapidly. Furthermore, authorities knew that this year's virus, though a new variant, is still of a type that occasionally arrives early. Both public health officials and the manufacturers knew the new variant was likely to be the predominant bug, but no planning for extra vaccine was made. The same transcripts that show much concern for respecting a manufacturing timeline, show no mention of anticipating a need for more vaccine. The manufacturers made 83 million doses this year, because that's what was used last year. As if a shortage wasn't enough for consumers to worry about, the FDA ended up having to investigate allegations of illegitimate sellers trying to fill the supply void with unsafe vaccine.

Why 'One Best'?

The source of these consumer problems is in significant part the inherent technical difficulty of producing a new vaccine strain. The VRBPAC transcripts show, however, that those technical difficulties can be aggravated by the fact that there...

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