Until the new supply of flu vaccine, flu shots to be dumped
Millions of doses of flu vaccine will expire at midnight June 30, unsold during this year's mild flu season and written off as trash. Still perfectly good, and possibly useful for a few more years, the vaccine will wind up being destroyed
This annual ritual is supposed to ensure that Americans get the most up-to-date vaccine, but the leftovers -- more than 10 million of a record 110 million doses produced -- will be destroyed before a new supply is guaranteed.
An Associated Press examination of this longstanding practice raises questions about its consequences. For years, policy-makers have talked about letting doctors keep unused vaccine until new doses are in hand, donating leftover supplies to poor countries, or pushing back the expiration date. Wasted vaccine means lost money for drug companies and one stopped making flu shots because of it -- setting the stage for a flu shot shortage in 2004..
Having n# Oneo vaccine in the summer deprives travelers of the chance to get a shot before they visit places where flu is in season. It also prevents summer vaccinations for children, who need two doses the first time around.
"All of those issues have come up in the past," but there is a strong reluctance to change policy, said Dr. William Schaffner of Vanderbilt University, a government vaccine adviser. "These ideas clearly have merit and at the very least ought to be discussed."
Each package in the latest recall bears the establishment number "Est. 2424" inside the USDA mark of inspection. Product details
The June 30 expiration date is set by the federal Food and Drug Administration and has less to do with the vaccine's shelf life than with the desire to tweak the recipe each year to include the three strains causing the most cases.
However, vaccine degrades very slowly and not into anything harmful, said Dr. Peter Patriarca, a scientist who formerly worked for vaccine maker MedImmune Inc. and once headed the FDA's vaccine division. Patriarca says most vaccines would be stable for another year or two years, some as long as three or four
The June 30 date is mostly to ensure that all old vaccine is gone before new doses come out.
"There is some benefit to a system where unused vaccine is discarded even if it hasn't really lost that much potency," said Dr. John Treanor, a vaccine expert at the University of Rochester in New York.
One more argument for the current system: Straying from a set expiration date for an entire season's vaccine would probably cause a huge headache for those trying to manage vaccine supplies, and for manufacturers trying to calculate the following season's demand, added Dr. Carolyn Bridges of the federal Centers for Disease Control and Prevention.
Stockpiling leftover vaccine until new vaccine is available "doesn't sound like an unreasonable thing to be doing," said another vaccine scientist, Dr. Robert Belshe at St. Louis University. After all, usually only one of the three vaccine strains changes -- often, only slightly. Twice in the last decade, the recipe didn't change at all, said Alexander Klimov, a CDC flu strain expert.
As long as public demand falls short of supply and manufacturers can make enough fresh vaccine, "there doesn't appear to be any reason to hang on to it," said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases
Even better, Fauci said, would be a universal, permanent flu vaccine effective for all strains of the virus, something his office has been researching
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