Drugmakers tagged with vaccine delays

On the H1N1 pandemic vaccine, Big Pharma made a classic mistake. It over-promised and under-delivered. After pledging to deliver the pandemic shots at lightning speed, vaccine makers such as Novartis, GlaxoSmithKline, and Sanofi-Aventis ran into manufacturing trouble. The hang-ups have hamstrung production, delaying delivery by weeks or even months.

And because of the pandemic's high profile, those delays are making headlines--the kind of headlines that drugmakers usually try to avoid. The old trope about "no such thing as bad publicity" doesn't apply to vaccine shortages in the midst of fast-spreading flu.

The production difficulties arose early on, when drugmakers had trouble growing vaccine from the first H1N1 seed virus. The companies quickly claimed to have remedied that problem by using new seed strains, but lower-than-usual yields persisted. Novartis told the Wall Street Journal that the yield problems delayed its manufacturing. Plus, the U.S. wanted more single-dose syringes, which take more time to turn out than multidose vials. Now, the company says it won't fill the entire U.S. order till early next year.

Though other drugmakers haven't reported such lengthy delays, they've also been set back. Sanofi says it has boosted yields, but not quite to the level of seasonal flu. Its 75 million-dose U.S. order is due for completion by year's end. Meanwhile, FDA hasn't yet approved Glaxo's H1N1 shot, holding up U.S. shipments indefinitely. Even MedImmune, the AstraZeneca unit that has been able to quickly turn out virus for its nasal-spray vaccine, has been held up by a shortage of sprayer gadgets.

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