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FDA Finds Five Million
New Doses of Flu Vaccine
Oct. 28, 2004 – The Food
and Drug Administration has identified about 5 million new doses of
influenza vaccine from foreign manufacturers; HHS has been able to
recoup an additional 300,000 doses of the injectable vaccine originally
bought for federal employees and the military; and a major pneumonia
vaccine manufacturer plans to triple its production.
These new doses would add
to the 61 million doses of vaccine already available, including 58
million doses of vaccine from Aventis and 3 million of FluMist nasal
spray from MedImmune. Additionally, the nation has a supply of antiviral
medicines, potentially enough for more than 40 million people that can
be used to prevent or treat the flu.
HHS Secretary Tommy G.
Thompson said these medicines would add to the nation's growing supply
of vaccines and medicines to protect Americans during the coming flu
season. With the news of additional supply, the Secretary stressed again
that millions of influenza vaccine doses are still to be distributed to
states this flu season. Specifically, about 17 million of the Aventis
vaccine is still to come (about 3 million doses a week are being
distributed), as well as 2 million doses of FluMist.
Secretary Thompson said
FDA inspectors would be traveling to two foreign manufacturing
facilities -- GlaxoSmithKline's facility in Germany and IDBiomedical's
facility in Canada -- to inspect their manufacturing plants and
products. The inspection teams will confirm the availability of the 5
million doses, assure that the vaccine can be used safely, and then make
arrangements to acquire them. The department is still exploring the
potential of additional doses of vaccine from other foreign sources as
well.
The vaccine from foreign
manufacturers would be distributed according to greatest need at the
time of acquisition this flu season. These doses would most likely have
to be distributed as an investigational new drug (IND), requiring
recipients to sign a consent form and follow-up with a health care
worker.
Additionally, the
department has recouped about 300,000 doses of influenza vaccine that
had been purchased by the federal government for federal employees and
the military this flu season.
This includes 200,000
doses of vaccine purchased originally for the military, which will now
use FluMist thus freeing up the injectable vaccine for the priority
populations who cannot take FluMist. This shift will not affect the
timing or supply of vaccine for members of the military who are eligible
to receive the flu vaccine. Additionally, HHS has recouped nearly
100,000 doses from the Federal Occupational Health service. All of these
doses will now be redirected to states based on need for their priority
populations.
Secretary Thompson also
announced that Merck & Co. is tripling its production of pneumococcal
vaccine used to prevent one of the major complications of the flu,
pneumonia. The company, which typically sells 6 million to 7 million
doses of Pneumovax 23, will increase its production to between 17 and 18
million for this flu season. The vaccine is for adults and children ages
2 years and older who are at increased risk for pneumonia.
Pneumovax is not a
substitute for the influenza vaccine, but can help shield people against
flu complications. A single dose can protect against 23 different types
of Streptococcus pneumoniae bacteria that are responsible for causing
more than 90 percent of pneumonia cases. Many people who fall into the
priority groups for the influenza vaccine should also get the pneumonia
vaccine, including seniors.
"We're continuing to
build our arsenal of vaccines and medicines to confront the coming flu
season," Secretary Thompson said. "We are encouraged about the potential
for some 5 million doses of vaccine from foreign manufacturers and we're
sending our inspectors to those facilities. We're redirecting vaccine
originally purchased by the government for federal employees and the
military to priority populations throughout the country.
"We're growing stronger
each week in our supply of vaccines and medicines, which makes us
optimistic about our ability to protect the American public as we go
into flu season," he added.
Secretary Thompson said
the Centers for Disease Control and Prevention (CDC) is making flu
vaccine data available for state health commissioners on a secure Web
site to help them track supplies coming to their states. He noted that
the data is proprietary information that Aventis asked be protected
through the secure Web site. The Web site is the result of efforts by
the CDC and Aventis to redirect undistributed vaccine to places of
greatest need.
The CDC also has asked
states to submit their high-risk needs that are not being met as soon as
possible, so that this information can be used to distribute remaining
doses to where they are most needed.
Furthermore, the
Secretary wants states to be clear that vaccines and medicines will be
covered through Medicaid and Medicare for the populations those programs
serve. This includes children in Medicaid and seniors in Medicare. In
fact, Medicare will reimburse seniors who received their vaccine from a
provider who is not enrolled in Medicare, and it will cover the costs of
antiviral medicines that can prevent or treat the flu.
Secretary Thompson
thanked the American public for its cooperation in making sure the flu
vaccine goes to those in priority groups. He reminded the public that
the priority groups for influenza vaccination are all children aged 6
months to 23 months; adults aged 65 and older; persons aged 2 to 64 with
underlying chronic conditions; all women who will be pregnant during
influenza season; residents of nursing homes and long-term care
facilities; children aged 6 months-18 years on chronic aspirin therapy.
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