|Published:||Jul 01, 2010 12:07 PM EDT|
|Updated:||Jul 01, 2010 9:10 AM EDT|
ATLANTA (AP) - About a quarter of the swine flu vaccine produced
for the U.S. public has expired - meaning that a whopping 40
million doses worth about $260 million is being written off as
"It's a lot, by historical standards," said Jerry Weir, who
oversees vaccine research and review for the U.S. Food and Drug
The outdated vaccine, some of which expired Wednesday, will be
incinerated. The amount, more than twice the usual leftovers,
likely sets a record. And that's not even all of it.
About 30 million more doses will expire later and may go unused,
according to one government estimate. If all that vaccine expires,
more than 43 percent of the supply for the U.S. public will have
gone to waste.
Federal officials defended the huge purchase as a necessary risk
in the face of a never-before-seen virus. Many health experts had
feared the new flu could be the deadly global epidemic they had
long warned about, but it ended up killing fewer people than
"Although there were many doses of vaccine that went unused, it
was much more appropriate to have been prepared for the worst case
scenario than to have had too few doses," said Bill Hall,
spokesman for U.S. Department of Health and Human Services.
Most leading health experts generally agree with that.
Millions of doses of flu vaccine generally go unused every year
and are marked for burning, but in recent years the leftovers
amounted to closer to 10 percent of the supply, rather than the 25
percent expiring now. Government flu experts couldn't recall
throwing away anything close to 40 million doses before.
The new H1N1 swine flu emerged in April last year, hitting
children and young adults particularly hard. It was difficult to
predict how deadly it might be or how easily it might spread.
Federal health officials pushed five vaccine manufacturers to
produce a vaccine as quickly as possible. What's more, they wanted
a lot of it - many experts thought most people would need two doses
for it to work.
The government placed three orders last year for a combined
total of nearly 200 million doses - an unprecedented amount and
almost double the amount of vaccine produced in recent years for
About 162 million doses were meant for the general public.
Another 36 million included doses for the military and other
But demand never took off, for several reasons:
-Tests of the vaccine soon showed only one dose was enough to
protect most people.
-Much of the vaccine was not ready until late 2009, after the
largest wave of swine flu illnesses passed.
-Swine flu turned out not to be as deadly as was first feared.
About 12,000 deaths have been attributed to it - or roughly a third
of the estimated annual deaths from seasonal flu.
So while people were waiting hours for swine flu vaccinations in
some cities in October and November, by January local health
departments were trying gimmicks to get anyone at all to come in
for a shot.
Government officials have known for months that they were
looking at a huge surplus. According to an Associated Press
calculation based on federal purchasing information, the dollar
value of the 40 million expired doses is about $261 million. The
government didn't release an official figure, but Hall said the AP
estimate was approximately correct.
In Europe, where nations also found themselves with millions of
unused doses, some commentators have attacked the World Health
Organization, which declared swine flu a global epidemic, or
pandemic. The critics have questioned the motivation of some WHO
advisers who had links to the pharmaceutical industry.
Some critics have simply lamented that a lot of anxiety was
raised and money wasted, not just during the swine flu scare but
also in government responses to bird flu and SARS, a respiratory
virus that swept parts of Asia in 2003.
"Each time the so-called experts told us that millions of
people would be killed worldwide by the respective viruses. We have
learned that the experts were utterly wrong," said Dr. Ulrich
Keil, a professor at Germany's prestigious University of Muenster
and a WHO adviser.
"This behavior is irresponsible because the angst campaigns ...
confuse the priority setting in public health," he said. The death
toll from influenza epidemics is much smaller than the number
killed annually by chronic illnesses like heart disease, cancer,
stroke and diabetes, he added, in an e-mail.
Unused flu vaccine is a common problem. The June 30 expiration
date is set by the FDA and has less to do with the vaccine's shelf
life than the desire to tweak the recipe each year to protect
against the three flu strains expected to cause the most illness.
"It's not necessarily because it's degraded or not potent,"
said Dr. Mark Mulligan, an Emory University vaccine researcher.
In the past year, about 114 million doses of seasonal flu
vaccine were distributed. The government thinks most of that was
used - demand was unusually high because of fears about swine flu.
In the flu vaccination campaign for this coming fall, swine flu
vaccine is being combined with two seasonal strains in single
doses. Manufacturers have told the government they expect to make
about 170 million doses.
An influential government advisory panel this year recommended
that virtually all Americans get flu shots each year. Still, that
doesn't mean it will all get used.
"No doubt there will be unused doses. This happens every
time," said Dr. John Treanor, an immunology specialist at the
University of Rochester Medical Center.