FOR IMMEDIATE RELEASE: October 13, 2004
SCHUMER: FEDS TO BLAME FOR FLU VACCINE SHORTAGE; ANNOUNCES
PLAN TO SOLVE LOCAL CRISIS AND URGES U.S. TO IMPLEMENT IMMEDIATELY
Thousands in Central New York at risk as flu clinics throughout
the region have been canceled; New emergency plan would import an
adequate supply of the flu vaccine from Canada, Europe, and Japan
Schumer: Feds can't keep relying on a small number of Rx companies;
Lack of a backup plan put thousands of Central New Yorkers at risk
this season
Long term Schumer plan includes a gov’t guarantee to
drug companies that vaccines will be purchased; tax breaks for drug
companies who produce flu shots and expediting vaccine production
in effort to end reliance on a small # of drug companies
With two of the four hospitals in Onondaga County reporting severe
flu vaccine shortages, US Senator Charles Schumer today charged
the Federal government with being woefully unprepared to deal with
the situation and called for the immediate importation of emergency
supplies from Canada, Europe, and Japan. With just two drug makers
producing the flu vaccine for use in the US and no back up system
in place, Schumer faulted the federal government for leaving thousands
of high risk residents of Central New York in the cold this flu
season. To ensure the high risk are vaccinated this year, Schumer
called for importation of the vaccine from abroad. In addition,
Schumer unveiled a long term plan to end the federal government's
reliance on a few drug companies to produce enough vaccine, to guarantee
supply levels, and to boost research into expediting production
of flu vaccine.
"Last year’s flu outbreak should have been a wake up
call but instead warnings of repeat shortages fell on deaf ears
and now in one fell swoop this week at Chiron, we are once again
backed into a corner, unable to protect even our highest risk citizens
here in Syracuse," Schumer said. "Instead of taking steps
to prepare for such an outbreak, the federal government sat on its
hands for another year and let two drug companies have sole control
over how much vaccine to produce for the nation. We have to put
solutions for faster and wider production of the flu vaccine in
place for the future and we have to deal with the immediate crisis
by finding supplies from abroad."
The expected U.S. supply of flu vaccine was cut in half last Wednesday
to 54 million doses, when British government regulators shut down
production at supplier Chiron due to concerns about bacterial contamination.
Chiron was to supply just under half of the 100 million vaccine
doses planned for use in the U.S. this year. The remaining supplier
of the flu shot to the U.S. market is Aventis Pasteur, which will
send all 52 million vaccines it has produced. MedImmune, which produces
the vaccine in a nasal spray that cannot be used by many in the
high risk categories, is producing only two million doses of its
FluMist vaccine.
There are approximately 185 million Americans considered most at-risk
for the flu who should be given priority for immunization including
the elderly, care givers, and children under the age of two. Schumer
said that in Central New York the shortage could have a drastic
impact on how many of these high risk residents receive the vaccination.
It has been reported that the Onondaga County Health Department,
University Hospital and the Internist Associates of CNY, among others,
has ordered their vaccines from Chiron. St. Joseph’s Hospital
is also reporting a drastic shortage. According to the County Health
Department, only one nursing home in the Onondaga County out of
17 facilities and only 47% of the county’s 105 family practices
and internists has supplies of the vaccine. Most of the area’s
public clinics for flu shots have been canceled, including many
scheduled to be run at workplaces by Community General Hospital.
To ensure these high risk individuals get their vaccination, Schumer
announced that he is co-sponsoring a measure with Rhode Island Senator
Jack Reed and Massachusetts Senator Ted Kennedy that would allow
for the immediate importation of flu vaccines that have been approved
for use in Europe, Canada and Japan. The measure directs the Food
and Drug Administration (FDA) to perform an expedited review of
these vaccines for immediate distribution in the US.
Schumer said that the Federal government has a track record of
under-preparing for a flu outbreak. Last year’s outbreak hit
particularly strong and early in the season, causing a critical
vaccine shortage by December. The shortage was blamed in part because
drug companies, who were seeking to avoid any surplus of vaccinations,
only produced 83.9 million doses for the winter 2003-2004 season,
11.1 million fewer doses than they did the year before. When the
outbreak hit the US, however, it was too late in the production
process for the nation's two flu vaccine makers, who need four months
to make the doses.
Schumer said that not only is our reliance on a small number of
drug companies to produce the entire supply of vaccines problematic,
it is irresponsible and unnecessary. Currently vaccines are made
using a lengthy four month process involving chicken eggs, however
research suggests that using human or monkey tissue cells to develop
the vaccines could reduce turn around time to just nine weeks. This
means that in a shortage scenario such as the one currently facing
the US, drug companies could have provided some vaccination relief
by mid December, still early in the flu season. A few companies
have been running experiments on this type of vaccine and one company,
Baxter International, has received approval in the Netherlands to
produce the vaccine. Baxter, which is set to begin round three of
its US trials next fall, is not expected to have a flu shot ready
for use in the US until 2007.
Schumer said it was the federal government's job to work with the
drug companies to produce enough vaccine more efficiently so that
a surprise contamination at one company does not cripple its ability
to protect high risk Americans. He urged the Federal government
to take several steps to prevent future flu vaccine shortages:
• Faster Turn Around Time: Developing ways to expedite the
production of flu vaccine - Baxter International has developed a
new vaccine whose production time requires nine weeks and uses tissue
cultures instead of chicken eggs. The Baxter vaccine has not yet
received FDA approval but has gotten approval in the Netherlands.
Schumer called on the federal government to expedite the approval
process for Baxter’s vaccine and to provide additional funding
for research into even faster ways to produce vaccine and other,
low-cost, non-injectable ways of delivering it to people.
A Government Guaranteed Vaccine Market: Bringing more companies
into the flu vaccine market- Schumer today proposed that the federal
government guarantee the purchase of an adequate supply of the vaccine.
This will entice more companies to enter the market by alleviating
the risk of a mild flu season in which they are stuck with surplus
unsold vaccines. Drug companies now under produce in an effort to
minimize this risk, however, if the government guaranteed their
purchase, the US would achieve a greater supply of the vaccines.
Schumer is also co-sponsoring a measure with Senators Bayh and Craig
that would provide a 20% investment tax credit for companies to
construct new or renovate facilities for improved vaccine production.
• Education and awareness campaign - If there is a guaranteed
supply of vaccine, the CDC could step up outreach efforts and mount
an even more aggressive education campaign to make sure that those
most at risk for the flu get vaccinated.
"One of the reasons we have a federal government is to deal
with situations like this one, to deal with the unknown and the
unexpected," Schumer said. "The CDC and the federal government
have got to start learning their lessons and take steps to ensure
that we have a reserve on hand to contain that an outbreak, to research
ways to expedite production of flu vaccine, and to make sure those
at risk get vaccinated."
Schumer was joined by Onondaga County Health Commissioner Lloyd
Novack; President and CEO of the Syracuse Community Health Center
Dr. Ruben Cowart.
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