HHS Update on Avian Flu Preparations

HHS Secretary Michael Leavitt released an update today on U.S. preparations for a potential pandemic. The PDF is available here. After a sobering (but accurate) introduction assessing the current status of the virus and its westward spread, vaccines receive significant attention in the report.

One interesting piece of information appears in the pie chart on page 2 showing funding allocations. It notes that HHS was appropriated $3.3 billion for pandemic flu activities during the current fiscal year. Of that amount, nearly $1.8 billion (54%) has been allocated to vaccines. That’s more than the amount given to antivirals, state and local preparedness, medical supplies, surveillance, lab capacity, risk communications, and international activities combined. Look for comments in the next few days from constituencies in the medical community expressing concern over this distribution of resources, particularly among state and local public health officials.

Of the 12-page document, nearly 3.5 are devoted to vaccines. It appears to be a thorough, honest assessment of where we are regarding vaccine development and the many unknowns moving forward (which we’ve discussed previously here and here).

One statement in the report, while not new, should remind us of the many ethical issues regarding vaccine safety, manufacturer liability and the limits thereof, and the potential consequences of large-scale immunization efforts that could surface in a worst-case scenario…

“If a pandemic occurs prior to licensure of a vaccine, the FDA can use its Emergency Use Authorization authority to permit the use of unapproved products (or to permit unapproved uses for previously approved products) if there’s a reasonable belief the products may be effective and if the benefits would outweigh risks.”

More to come, no doubt.