The White House
President George W. Bush
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For Immediate Release
Department of Health and Human Services
October 19, 2004

Supply of Flu Vaccines, Medicines Will Keep People Safe

The Flu Vaccine Discussed with HHS Secretary Tommy Thompson

HHS Says Supply of Flu Vaccines, Medicines Will Help Keep People Safe During Coming Flu Season

Department Stockpiles Medicine, Coordinates Flu Response, Invests in New Technology

HHS Secretary Tommy G. Thompson said today that about 60 million doses of influenza vaccine combined with an ample supply of antiviral medicines -- potentially enough for more than 40 million people during the flu season -- puts America in a strong position to keep people safe during the upcoming flu season.

Secretary Thompson said the nation's cache of vaccine and medicines includes an additional 2.6 million doses of influenza vaccine that Aventis said today it will make available in January. The Centers for Disease Control and Prevention (CDC) also issued today interim guidance on the use of antiviral medicines for preventing and treating the flu. In addition, the formalization of a federal government task force will help ensure an ongoing coordinated effort to manage the supply of medicine and prevent price gouging.

"In addition to the 60 million doses of influenza vaccine, we have healthy supplies of antiviral medicines to help keep you safe from the flu," Secretary Thompson said. "While we don't have as much flu vaccine as we planned for, the combination of existing vaccine and antiviral medicines gives us the ability to stave off any harsh effects of the flu."

Secretary Thompson said the combined supply of influenza vaccine and antiviral medications precludes the need for seniors and others to stand in long lines waiting for vaccine. In addition, about 24 million doses of this influenza vaccine supply has yet to be distributed and will be steered toward the people and places who need it the most. He advised seniors seeking vaccine to be patient and persistent, keeping in contact with their doctors and public health departments.

"We are still in the early stages of the flu season, and millions more doses of the vaccine will be shipped in coming weeks, so there is still time to get vaccinated," Secretary Thompson said. "We understand the public's concerns about the loss of the Chiron flu vaccine, but they should know we have a healthy supply of vaccines and medicines to cope with flu season."

The Secretary noted that the government is exploring every option to replace some of the lost vaccine from other sources, and noted that the Bush administration has made unprecedented investments to protect against the flu. The President's investment in flu-related activities increased 720 percent since he took office -- from $39.3 million in 2001 to $283.1 million proposed for FY 05.

Vaccine For Most Vulnerable: The Secretary said the supply of 60 million doses of influenza vaccine includes about 58 million doses of Aventis vaccine and 2 million doses of FluMist nasal spray, and there is some potential more doses may be secured from other sources.

Secretary Thompson stressed that the influenza vaccine needs to go to those who are most vulnerable, including seniors 65 and older, young children age 6 months to 23 months, and pregnant women. He urged people not in the priority categories to forgo getting the flu vaccine because it takes a shot away from someone who needs it more.

"We need to get the influenza vaccine to those who need it most," Secretary Thompson said. "I want to thank those Americans who are helping out in the best traditions of this nation by forgoing their vaccines and leaving it for people who need it most."

Antiviral Medicines: The federal government has purchased and stockpiled antiviral medicines to treat more than 7 million people. Supplies of antiviral medicines also exist in the private sector and manufacturers indicate that they have the ability to significantly ramp up production. All told, between existing stockpiles, private sector supplies and production capabilities, the Food and Drug Administration (FDA) estimates there could be enough medicine to treat nearly 40 million people through the heart of flu season.

For the first time, the federal government created a stockpile of antiviral medicines under President Bush's leadership, specifically as a contingency if there were not enough flu vaccine. It includes enough doses of Rimantadine for 4.25 million adults and 750,000 children, and by December it will include enough Tamiflu for 2.3 million people. Two other antiviral products on the marketplace to help prevent and treat the flu are Amantadine and Zanamivir.

CDC today issued new interim guidelines on the use of these antiviral medicines in the prevention and treatment of flu for this coming season. They are available at .

"We stockpiled antivirals and vaccines, as well as created plans for prioritizing who gets the vaccine, in preparation for the possibility of a vaccine shortage," Secretary Thompson said. "These medicines will help us address the flu, particularly for those most vulnerable."

Federal Task Force: The Secretary also announced the formalization of a federal task force that will coordinate our nation's efforts to ensure that the flu vaccine and treatment medication goes to those who need it most and without any price gouging. Secretary Thompson said marshalling all the resources of the federal government -- including the health agencies, Department of Justice, Federal Trade Commission, Homeland Security and Veterans Affairs -- will help ensure that all aspects of flu season are being addressed for the American public.

The Flu Action Task Force will also continue ongoing partnerships with the private sector in addressing challenges of the flu season, including the public health community, physicians, law enforcement and prosecutors, trade associations and advocacy groups.

"From the time we learned about our loss of the Chiron vaccine, a strong partnership between federal agencies, the private sector and the public health and law enforcement communities has helped us rapidly and effectively address the challenges before us," Secretary Thompson said. "It's important that we keep these partnerships strong during flu season, this year and beyond."

Transforming the Flu Vaccine Marketplace for 21st Century

President Bush has invested more in research, development and acquisition of flu vaccines and medicines than any President in our nation's history in an effort to revitalize a deteriorated flu vaccine marketplace and better protect the American people.

The problem

In 1994, there were five injectable influenza vaccine manufacturers: Wyeth, Evans (now part of Chiron), Connaught (now part of Aventis), Parke Davis and Lederle; today there are two - Aventis and Chiron.

The high risks of complex vaccine production, unpredictable consumer demand and low profit margins, coupled with the lack of liability protection from costly lawsuits, drove many manufacturers out of the flu vaccine business during the 1990s.

Getting manufacturers back into the marketplace is further complicated by the length of time for a new manufacturing facility to come on-line - five years or more. The FDA has high standards for flu vaccine production, including good manufacturing processes, which ensure the safety and efficacy of vaccines. These high standards helped keep 46 million doses of contaminated vaccine produced by Chiron from making it into the arms of Americans this year.

A record of solutions

Immediately upon coming to HHS, Secretary Thompson under the leadership of President Bush began transforming the flu marketplace by investing in new technologies, securing more vaccines and medicines, and preparing stronger response plans. Actions the Administration has taken include:

Unprecedented Investments: The largest investments ever made by the federal government in protecting against the flu have been made under President Bush's leadership. This includes increases for CDC Flu Funding: $17.2 million to $41.6 million (242 percent increase); National Institutes of Health Research and Development: $20.6 million to $65.9 million (320 percent); FDA Research and Licensing: $1.5 million to $2.6 million (173 percent increase); Creation of Strategic Reserves/Stockpiles: $0 to $80 million. These investments are further detailed below.

New Technologies: In each of the last two budgets, HHS has asked for $100 million to shift vaccine development from the cumbersome egg-based production to new cell-culture technologies, as well as to provide for year-round availability of eggs to provide for a secure supply and surge capacity. HHS received $50 million in the fiscal year 2004 budget, and Secretary Thompson urges Congress to fully fund the $100 million request for 2005.

These new technologies will help produce flu vaccine more efficiently and provide more adaptability to unexpected problems or losses in production.

Creating the Nation's First Stockpiles of Medicines: This Administration is the first to create stockpiles of both influenza vaccine and antiviral medications. The department invested $40 million in 2004, and seeks another $40 million in 2005, to stockpile influenza vaccine through the Vaccines for Children Program. It invested $87.1 million to stockpile 2.3 million doses of Tamiflu. And it invested $34 million on Rimantadine capsules to treat 4.25 million adults and Rimantadine syrup to treat 750,000 kids.

These stockpiles give the government new ability to protect the most vulnerable, and respond effectively when there is a shortage of vaccine.

Pandemic Flu Plan: In August, Secretary Thompson unveiled the department's draft Pandemic Influenza Response and Preparedness Plan. This plan outlines a coordinated national strategy to prepare for and respond to a flu pandemic. One of the first internal committees the Secretary created when he came to HHS was on the pandemic flu.

Improving Access by Covering Costs: The Centers for Medicare & Medicaid Services (CMS) has more than doubled the payment rates for the vaccine and its administration since 2000. In 2004, CMS is paying $18.30 for the vaccine and administration -- up from $8.92 in 2000. This is helping to make sure the vaccine is affordable for patients to get and cost-effective for providers to administer.

"The marketplace is full of disincentives for manufacturers to produce the vaccine," Secretary Thompson said. "We're making progress in reversing this environment. We need to build upon our efforts to transform the marketplace so manufacturers get into the flu vaccine business without the fear of being driven out by lost costs from production and high costs from lawsuits."


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