After Shortage, Vaccine for Flu Goes Unused

[Guest guest]

Hopefully that 115 million doses will keep getting smaller and smaller and smaller and smaller.

After Shortage, Vaccine for Flu Goes Unused

http://www.nytimes.com/2006/12/16/health/16flu.html?_r=1 & oref=slogin"Still need a flu shot? Stefanak has so many left over he is giving them away by the carload". "I sent out a blast fax to 700 physicians in the Youngstown area offering to give it away if they just come pick it up," said Mr. Stefanak, the health commissioner of Mahoning County, Ohio, which includes Youngstown. So far, he said, there have been few takers."I'm concerned that we'll throw away 20 million doses," said Dr. L. J. Tan, the co-chairman of the National Influenza Vaccine Summit, a group of 140 companies, nonprofit groups and public agencies. "If we keep on doing that, I can guarantee that the following seasons we won't have 115 million doses anymore." So let's see, 20 million doses equals 10 million milliliters or 100,000 liters. At 50,000 micrograms Hg per liter, that's a hell of alot of hazardous waste to dispose of. MW

[Guest guest]

After Shortage, Vaccine for Flu Goes Unused

By ANDREW POLLACK

Still need a flu shot? Stefanak has so many left over he is

giving them away by the carload.

" I sent out a blast fax to 700 physicians in the Youngstown area

offering to give it away if they just come pick it up, " said Mr.

Stefanak, the health commissioner of Mahoning County, Ohio, which

includes Youngstown. So far, he said, there have been few takers.

Two years ago, the nation was plagued by a severe shortage of flu

shots, with huge lines at clinics and many people going without. This

year it looks as if there may be a glut.

Yet, somewhat perversely, because of distribution delays earlier in

the season, this year's abundant supply has not meant that everyone

who wanted a flu shot has received one.

The situation underscores the fragile nature of the nation's supply

system for flu vaccine, a risky and volatile business, in which the

federal government has a limited role.

While experts say an excess is better than a shortage, too large a

surplus could hamper the government's goal of steadily increasing the

production and use of flu vaccines. Because makers, distributors,

doctors and health departments lose money from vaccine they cannot

sell to patients, they may be discouraged from making or ordering as

much in coming years — potentially leading to future shortages.

And there is little opportunity to stockpile for lean years, because

flu vaccine is good for only a single season. The composition must be

changed each year to match the strains of influenza virus in circulation.

Some manufacturers dropped out of the flu vaccine business in the

past, in part because they could not sell all they made. That set the

stage for the shortage in 2004, when there were only two major

suppliers and one of them, Chiron, had to suspend production because

of sanitary problems.

This time around, experts say millions of doses might go unused, in

part because production is at an all-time high.

The four vaccine suppliers are expected to make as many as 110 million

to 115 million doses, with more than 100 million having already been

delivered. The most vaccine ever distributed in any previous year was

83 million doses.

In Ohio, for instance, about 100,000 of the roughly 250,000 doses the

state health department acquired for distribution to local health

offices remain unused, Mr. Stefanak said. His own department, as of

early this week, still had 2,700 of the 5,500 doses it received from

the state.

If drumming up demand for so much vaccine was going to be a challenge

in any event, the task was made harder by manufacturing and

distribution snags that caused shortages in some places in September,

October and early November — the months when most people are

accustomed to getting vaccinated.

When millions of doses did finally get delivered in late November or

earlier this month, it was too much, too late, many health officials

say. Holiday distractions make it difficult to get people to come for

immunization in December.

Also, the flu season has been relatively mild so far this year, making

a flu shot seem less urgent.

" There's so many people out there that need it, and we know didn't get

it yet, " said Dr. Henry H. Bernstein, a pediatrician at Dartmouth

Medical School and member of the infectious diseases committee of the

American Academy of Pediatrics.

Under current medical guidelines, a yearly vaccination is recommended

for 218 million of the nation's population of 300 million, a number

that has been steadily increasing. But many people in the recommended

groups decline to get vaccinated, in part because they do not consider

the flu a serious enough disease, health officials say.

To avoid a glut health officials have embarked on a campaign to change

the public assumption that flu shots must be received before

Thanksgiving to do any good.

The Centers for Disease Control and Prevention proclaimed Nov. 27 to

Dec. 3, the week after Thanksgiving, the first ever National Influenza

Vaccination Week, telling people that vaccination in December or

January is still worthwhile because the flu itself often does not peak

until February.

" Catch the holiday spirit, not the flu, " Dr. L. Gerberding, the

director of the agency, says in a radio public service announcement

still being broadcast.

And why stop at January? The American Academy of Pediatrics is

considering a recommendation that its members offer flu shots as late

as May 1 each year, said Dr. ph A. Bocchini, chief of pediatric

infectious diseases at Louisiana State University and a member of

academy's infectious diseases committee.

Children younger than 9 getting vaccinated for the first time, he

said, need two shots separated by at least a month, something hard to

fit into the traditional vaccination season.

But changing an entrenched mind-set can be difficult. That is why even

though many more people could still end up getting vaccinated this

season — especially if a severe outbreak of flu occurs soon — some

industry and public health officials are already assuming there will

be leftovers.

The day after the national vaccination week ended, Henry Schein Inc.,

a major vaccine distributor, said its profits would suffer because it

would sell only 9 million doses, 4.5 million fewer than expected.

Paladino, executive vice president, said that by the time the

company received several million doses, its customers no longer wanted

them.

Schein got those flu shots from a GlaxoKline subsidiary in Canada

that was entering the United States market for the first time. It did

not receive Food and Drug Administration approval to sell its vaccine

until early October.

Another reason for the early season delay was that one of the virus

strains in this year's vaccine grew more slowly than expected in the

millions of chicken eggs used to multiply the viruses. Because of

that, Sanofi-Aventis, the largest supplier of the vaccine, did not

begin shipping its first lots until Aug. 23, about three weeks later

than usual, Tomsky, a spokeswoman, said.

The government has been trying to coax more vaccine supply into the

market, in part by speeding approvals, to lessen the risk of a

shortage like the one in 2004. Having greater manufacturing capacity

also would make it easier to produce enough vaccine if a pandemic

should arise.

The authorities also say more people should be immunized to reduce the

estimated 36,000 deaths and 200,000 hospitalizations a year from

influenza.

This year for the first time, for example, vaccination was recommended

for children from age two until their fifth birthday, having been

previously recommended only for children 6 to 23 months old.

This year there are three manufacturers of flu shots: Sanofi-Aventis,

which has shipped 50 million doses so far; Novartis, which acquired

Chiron and has shipped at least 31 million doses; and GlaxoKline,

which has shipped 24 million. MedImmune, which makes a nasal spray

vaccine, has sold 2.5 million doses so far.

The companies say a single year of surplus will not deter them from

long-term commitments to increase output, but some experts are

worried. " I'm concerned that we'll throw away 20 million doses, " said

Dr. L. J. Tan, the co-chairman of the National Influenza Vaccine

Summit, a group of 140 companies, nonprofit groups and public

agencies. " If we keep on doing that, I can guarantee that the

following seasons we won't have 115 million doses anymore. "

The makers say that a single year of surplus is not likely to deter

them from long-term commitments to increase output.

Manufacturers lose money if they cannot sell all they make. But once

they sell it, they generally do not accept returns. So some health

care providers say they may order less next year if they are left with

unused vaccine this year.

" We will reduce our order by 1,000 doses next year, " said Terry L.

Brandenburg, health commissioner of West Allis, Wis., which ordered

3,500 doses this year but could not schedule vaccination clinics

because it did not know when its vaccine would arrive.

Some doctors are also questioning whether they should continue to

offer vaccines, for which they pay $10 or more per dose. Besides the

financial risk, they say many of their patients are now getting

vaccinated at grocery stores, pharmacies or the workplace.

" It's really hard for your primary care doc who might need 1,000 doses

to put out $10,000, " said Dr. Harry Oken, an internist in Columbia, Md.

He said his practice ordered about 1,500 doses but had received only

about 50 by early November. When more became available at the end of

November, the practice took only 400, assuming that many of its

patients might have already gone elsewhere.

With problems seeming to occur nearly every flu season, calls are

rising for reform of a distribution system that is left to numerous

private distributors. Senators Hillary Rodham Clinton, Democrat of New

York, and Pat , Republican of Kansas, have introduced

legislation that would set up a centralized tracking system for flu

vaccines.

Dr. Jeanne Santoli, deputy director of the immunization services

division of the Centers for Disease Control and Prevention, said that

as the amount of vaccine being made each year continued to increase,

it would inevitably make vaccination season extend further into the

winter.

" We want to change the approach we have to influenza vaccination in a

fundamental way, " Dr. Santoli said. " That's not something we can

accomplish in the first year. "

http://www.nytimes.com/2006/12/16/health/16flu.html