No surprises here, but President Obama is being advised that quicker identification of pandemic viruses and a shift from egg-based to cell-culture production top the list of short-term measures to speed influenza vaccine production. The President's Council of Advisors on Science and Technology also named better seed strains, speedier methods of sterility testing, more reliable potency test reagents, and larger, updated fill/finish facilities.
The recommendations follow last year's delays in production of a pandemic vaccine. They were submitted by the council, for the most part, as short- and long-term measures. One item in a non-time-frame category: guidance from the FDA on what it takes to have a new flu vaccine approved.
Commissioner Margaret Hamburg can add that to her growing to-do list from her bosses. Near the top of that list are explanations to Congress regarding FDA actions surrounding Johnson & Johnson's Tylenol manufacturing violations, and for the unresolved elements of the heparin contamination of several years ago.
Longer-term recommendations of the President's council include study of obstacles and incentives for cell-culture production facilities; developing three recombinant flu vaccines; and development of a universal flu vaccine.
Another item on the long-term list: Implementing a new federal structure to oversee vaccine-production strategies. Let's hope this item gets bumped to the short-term list. As reported last week, the Department of Defense already has underway some of the initiatives (rapid viral vaccine production and a 12-week process for production of swine flu vaccine) recommended by the President's advisors.
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