FDA offers delayed approval for Glaxo vax

GlaxoSmithKline finally won an approval for its H1N1 vaccine from the FDA, but don't look for any big shipments to the U.S. The regulatory approval clears the way for Glaxo to deliver only 7.6 million doses of the swine flu shot in December. But as Glaxo CEO Andrew Witty told reporters recently, that amounts to only a bit role in the chaotic vaccine drama being played out here.

Glaxo won an approval for an unadjuvanted vaccine. Its main H1N1 vaccine is the adjuvanted Pandemrix, which includes an additive intended to boost the effectiveness of vaccines that is not allowed in the U.S. Getting an approval for an unadjuvanted vaccine caused an eight-week delay in the regulatory response, pushing back any shipment until after swine flu is expected to peak in the U.S.

Glaxo is shipping 440 million doses of Pandemrix around the world and announced that 50 million doses will be donated to the World Health Organization. The health group says that Glaxo, Sanofi-Aventis, MedImmune and CSL have offered a total of 156 million doses for use in poor countries.

- read the story from the Los Angeles Times
- here's the Reuters story
- check out the report from the AP