FDA moves decision day for GSK pandemic vaccine, but why?

Research linking GlaxoSmithKline's ($GSK) swine flu vaccine to narcolepsy has precipitated calls for a rereview of a similar product before FDA makes an approval decision. Yet while everyone was focused on that possible snag, another issue has thwarted hopes of a speedy approval.

Approval has been delayed, but not for the reason you might expect. In its release detailing the delay, GSK makes no mention of the evidence linking its swine flu vaccine to narcolepsy. And Reuters quotes a GSK spokesperson as saying the delay is unrelated to the narcolepsy data. Instead, Glaxo attributed the setback to "an administrative matter." Further details of what went wrong are yet to emerge, but the U.K. drugmaker says the issue has been fixed recently, and it is working with FDA to "complete the review in a timely manner."

Whatever the reason, it moves the finish line for the pandemic flu vaccine, Q-Pan H5N1, a little further back. Q-Pan uses the same AS03 adjuvant as GSK's swine flu vaccine to intensify the immune response, and has consequently been caught up in the rising narcolepsy controversy. Researchers have yet to pin down why vaccine use seems to correlate with increased incidence of narcolepsy, but AS03 is being viewed as a possible cause. Some members of the FDA review panel that unanimously supported Q-Pan in November view the link as sufficiently compelling to justify reconsidering their decision.

Speaking to Pharmalot, an FDA spokesperson declined to speculate on a possible reconvening of the vaccine advisory panel. Senior media directors at GSK, meanwhile, were more open with information than seemingly intended. The Telegraph reports that some media contacts were cc-ed on a discussion about whether to include details of the FDA advisory panel vote in the regulatory update. "Without this information, a misconception could develop that we're trying to hide a more serious issue," a GSK communication chief reportedly wrote.

- here's the Reuters article
- check out Pharmalot's take
- read the Telegraph diary item

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