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Timeline
of Major Events
October 5, 2004
Chiron Corporation notifies the
Centers for
Disease Control and Prevention
that none of the influenza vaccine they
had contracted with the government to
produce will be available for the
2004-2005 flu season. Chiron
Corporation, a British based company,
had their license suspended as a result
of contaminated vaccine production by
the Medicines and Healthcare Products
and Regulatory Agency, the governing
body in the United Kingdom similar to
our Food and Drug Administration (FDA)
in the United States. The United States
had contracted with both Chiron and
Aventis Pasteur to supply nearly 100
million does of the flu vaccine for the
2004-2005 flu season. Without Chiron
supplies, the US is left with only 54
million does of the vaccine. Thirty
million doses have already been shipped
to health care providers for
distribution. The remaining doses will
be shipped to providers and state health
departments for targeted distribution to
those on the priority list developed by
the CDC (see above).
Immediately
following this announcement from the
CDC, the NYS Department of Health began
working with the CDC to develop
recommendations for vaccination this
year. DOH was very involved with the
identification of the priority groups
identified above.
October 12,
2004
The Centers for
Disease Control and Prevention has
developed a plan with Aventis Pasteur to
distribute the remaining flu vaccine to
health care providers serving high-risk
patients. There are 22.4 million doses
of vaccine which have not been shipped
out to providers. Over the next 4-8
weeks, 14.2 million doses will be
distributed to high-priority providers
including long term care facilities,
hospitals, nursing homes, and private
providers who care for young children.
The remaining doses available from
Aventis will be delivered after this
first phase to identified high-need
areas. The CDC/Aventis plan is based on
the goal of targeting the available
vaccine to people who will get the most
benefit from it, in a way that is fair
and equitable to the greatest number of
people across the country.
October 15,
2004
The first wave of
remaining flu vaccine doses were shipped
from Aventis Pasteur. Two million doses
of vaccine were shipped to the
Department of Veterans Affairs for
distribution to VA Hospitals, Long Term
Care facilities and acute care
hospitals, State public health
officials, the Vaccines for Children
program, and to private providers who
care for young children.
October 18,
2004
US Health and
Human Services Secretary Tommy Thompson
tells the nation that the shortage of
flu vaccine is “not a health crisis” and
urges people to be patient as the
government works to reallocate the
limited number of vaccines so the most
vulnerable receive it. Thompson
reassures the country that the 24
million doses still held by Aventis
Pasteur will be distributed in the
coming weeks.
October 19,
2004
The CDC released
interim guidance on the use of antiviral
medicines for preventing and treating
the flu. Influenza antiviral
medications are an important adjunct to
influenza vaccine in the prevention and
treatment of influenza. In the setting
of the current vaccine shortage, CDC has
developed interim recommendations on the
use of antiviral medications for the
2004-05 influenza season. These interim
recommendations are provided, in
conjunction with previously issued
recommendations on use of vaccine, to
reduce the impact of influenza on
persons at high-risk for developing
severe complications secondary to
infection. HHS Secretary Thompson
reinforced his message that the flu
shortage is not a crisis and indicated
that with almost 60 million doses of
vaccine and more than adequate
medications to treat the flu, the nation
was in a strong position to keep people
safe during the upcoming flu season.
October 20,
2004
NYS Senate Health
Committee Chairman Kemp Hannon held a
public hearing to address the national
influenza vaccine shortage and further
ensure that available vaccine supplies
reach those individuals who are most
at-risk for flu related complications.
Speakers at the hearing include NYS
Department of Health
Commissioner Antonia C. Novello,
Healthcare Association of NYS President
Dan Sisto, Nassau County Department of
Health Commissioner David Ackman, as
well as many others. The hearing served
as an initial investigation into the
shortage, the effects of the shortage on
New Yorkers and on NYS health care
facilities.
At the hearing,
Dr. Novello declared the CDC vaccine
recommendations, established on October
5, 2004, the “standard of care” in New
York encouraging all health care
providers to strictly adhere to the
recommendations. The Commissioner also
stressed that violators of these
recommendations may be issued a citation
or be assessed a regulatory fine. The
effect of the standard of care is
outlined in the Department of Health’s
Influenza Vaccine Shortage Advisory:
Update #1.
October 22,
2004
In continuing the
distribution plan set by the CDC and
Aventis Pasteur in early October,
Aventis shipped out another 3.2 million
doses of the flu vaccine to health care
providers/facilities serving high-risk
patients. Each shipment of vaccine
includes a letter from the CDC
reemphasizing the priority groups and
urging providers to cooperate with local
and state public health officials to
ensure those who need the vaccines most
receive them. In addition, the CDC is
asking all providers who receive
vaccines to contact the CDC to confirm
receipt in an effort to identify gaps in
vaccine distribution.
October 25,
2004
The NYS
Department of Health issued
Influenza Vaccine Shortage Advisory
Update #2 to inform health
care providers and facilities of the new
antiviral guidelines adopted by the CDC
for the 2004-2005 flu season. The use
of antiviral drugs to treat the flu will
be an invaluable tool in containing the
flu this season and preventing epidemic
outbreaks in light of the vaccine
shortage.
October 27,
2004
The Department of
Health and Human Services has contacted
all state Attorney General’s to advise
them on a current flu vaccine price
gouging case in Florida, and to provide
support for those states uncovering
price gouging and seeking to file suits
in response. HHS is committed to
supporting states efforts in prosecuting
distributors if necessary. A friend of
the court brief issued by HHS in support
of the Florida case is available at
http://www.hhs.gov/flu.
October 28,
2004
The US Food and
Drug Administration (FDA) has located 5
million additional doses of influenza
vaccine from foreign manufacturers. The
new doses create 61 million doses
available nationally. Two members of
the FDA will travel to a GlaxoSmithKlein
facility in Germany and a IDBiomedical
facility in Canada to inspect the plants
and their products, and to confirm
whether or not the 5 million doses are
available and can be used safely in the
United States.
Because these
vaccines have not gone through the
rigorous approval process by the FDA in
the United States, the drugs would be
distributed as investigational new
drugs requiring that individuals
sign a consent form before the vaccine
is administered. In addition, patients
will have to follow up with their health
care provider.
October 29,
2004
The next wave of
vaccines have been shipped by Aventis
Pasteur. This week 4.2 million
influenza vaccine doses have been
shipped at the direction of the CDC by
Aventis Pasteur to health care providers
serving the identified high-priority
groups. As the plan continues to
unfold, Aventis expects to distribute
2.5-3 million doses each week through
early December to high-risk
facilities/providers. Another 2.6
million doses from Aventis will be ready
to distribute by early January.
In addition to
making flu vaccines available for those
most at risk, the
Department of Health and Human Services
has also purchased a stockpile of
antiviral drugs used to treat the flu.
The stockpile is equipped to treat an
additional 7 million people during the
2004-2005 flu season if the standard 40
million drugs nationwide are exhausted.
November 1,
2004
The NYS
Department of Health issued
Influenza Vaccine Shortage Advisory:
Update #3 to all health care
providers which discussed the use of
Live Attenuated Influenza Vaccine versus
the traditional “flu shot”. The
Advisory is intended to inform health
care providers on the appropriate
populations for each type of vaccine to
ensure the highest number of people are
vaccinated with the limited vaccine
supply.
November 3,
2004
NYS Department of
Health has
begun
distribution of its current supply of
flu vaccine to local
departments of health and to programs
serving children in the federal
children’s vaccine program. Local health
departments will receive a portion of
the initial 32,000 doses of vaccine to
distribute to those people who fall
within the identified vaccine priority
groups. In addition, 42,000 doses will
be distributed to health care providers
serving children in the Vaccines for
Children program. The redistribution of
the vaccines will continue throughout
November and December.
November 8,
2004
The NYS
Department of Health has released the
Influenza Vaccine Shortage Advisory:
Update #4 announcing the
availability of an additional 2 million
FluMist vaccines for the 2004-2005 flu
season. FluMist is a nasal spray
containing weakened live flu virus
intended for healthy people ages 5-49.
The first additional million doses is
about to be released by the FDA and
should be distributed in the next two
weeks. The final one-million doses will
be available at the end of 2004 or early
2005.
Related
Links:
US Centers for Disease Control and
Prevention
CDC Hotline:
1-800-CDC-INFO - a 24 hour, 7 day a week
information line for health care
providers and the public about influenza
and the influenza vaccine shortage
US Department of Health and Human
Services
NYS Department of Health
Weekly Influenza Activity Update in NYS
“Vaccines are not the only way to
Prevent the Flu” flyer
Medical Society of the State of New York
Greater New York
Hospital Association
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