FDA Approves Vaccine for 2009-2010 Seasonal Influenza

The U.S. Food and Drug Administration today announced that it has approved a vaccine for 2009-2010 seasonal influenza in the United States.

The seasonal influenza vaccine will not protect against the 2009 H1N1 influenza virus that resulted in the declaration of a pandemic by the World Health Organization (WHO) on June 11, 2009. The FDA continues to work with manufacturers, international partners and other government agencies to facilitate the availability of a safe and effective vaccine against the 2009 H1N1 influenza virus.

Although this year’s seasonal vaccine is directed against other strains of influenza expected to be circulating and will not provide protection against the 2009 H1N1 influenza virus, it is still important for those Americans for whom it is recommended to receive the seasonal influenza vaccine. No vaccine is 100 percent effective against preventing disease, but vaccination is the best protection against influenza and can prevent many illnesses and deaths.

“The approval of this year’s seasonal influenza vaccine is an example of the FDA’s important responsibility to assure timely availability of vaccine to help protect the health of the American public,” said Margaret A. Hamburg, M.D., commissioner of food and drugs. “A new seasonal influenza vaccine each year is a critical tool in protecting public health.”

The six vaccine brand names and manufacturers are: Afluria, CSL Limited; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; Fluvirin, Novartis Vaccines and Diagnostics Limited; Fluzone, Sanofi Pasteur Inc.; and FluMist, MedImmune Vaccines Inc.

Each year, experts from the FDA, WHO, U.S. Centers for Disease Control and Prevention (CDC), and other institutions study virus samples and patterns collected from around the world in an effort to identify strains that may cause the most illness in the upcoming season.

Based on those forecasts and on the recommendations of the FDA’s Vaccine and Related Products Advisory Committee, the FDA determines the three strains that manufacturers should include in their vaccines for the U.S. population. The closer the match between the circulating strains and the strains in the vaccine, the better the protection against the disease.

The vaccine for the 2009-2010 seasonal influenza contains:

* an A/Brisbane/59/2007 (H1N1)-like virus
* an A/Brisbane/10/2007 (H3N2)-like virus
* a B/Brisbane/60/2008-like virus

There is always a possibility of a less than optimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness. Even if the vaccine and the circulating strains are not an exact match, the vaccine may reduce the severity of the illness or may help prevent influenza-related complications.

According to the CDC, between 5 percent and 20 percent of the U.S. population develops influenza each year. More than 200,000 are hospitalized from its complications and about 36,000 people die. Older people, young children, and people with chronic medical conditions are at higher risk for influenza-related complications. Vaccination of these groups is critical.

Additionally, influenza immunization of health care personnel is important in protecting them and others from influenza.

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Obama Administration Calls on Nation to Begin Planning and Preparing for Fall Flu Season & the New H1N1 Virus

The Obama Administration sent a strong message to the nation today that it is time to start planning and preparing for the fall flu season and the ongoing H1N1 flu outbreak and that the federal government is prepared to commit resources, training, and new tools to help state and
local governments and America's families get ready.

White House Homeland Security Advisor John Brennan, Secretary of Health and Human Services Kathleen Sebelius, Secretary of Homeland Security Janet Napolitano, Secretary of Education Arne Duncan joined with delegations from 54 states, tribes and territories today at the H1N1 Influenza Preparedness Summit at the National Institutes of Health in Bethesda, Md., to kick-off the government's nation-wide fall flu preparedness efforts.

"The President and the administration are actively engaged in mitigating the effects of the H1N1 flu virus and developing a national response framework and action plan that builds on the efforts and lessons learned from this spring's initial onset to prepare for the possibility of a
more serious fall outbreak of the virus," said White House Homeland Security Advisor Brennan in his address to summit participants.

"Over the course of coming weeks and months, we will move aggressively to prepare the nation for the possibility of a more severe outbreak of the H1N1 virus," said HHS Secretary Sebelius. "We ask the American people to become actively engaged with their own preparation and
prevention. It's a responsibility we all share."

"The federal government is working together with its federal, state, local and tribal partners to develop a nation-wide plan to combat the H1N1 flu that incorporates the lessons we learned this spring," said Homeland Security Secretary Napolitano. "The H1N1 Summit will allow us to continue this aggressive preparation for all possible H1N1 virus outbreak scenarios to ensure that we are doing everything possible to keep our country safe and healthy."

"Effectively dealing with a potential H1N1 outbreak requires all of us -- parents, educators, health providers, and local, state and federal governments -- working together on our emergency management plan," said Education Secretary Duncan. "Today's Flu Summit is an important step in that direction. Our primary goals at the Department of Education are the health and well being of students, faculty and staff, and ensuring that, in the event of any school closures, the learning process will continue."

Maryland Governor Martin O'Malley moderated a Governors panel with participation via videolink from Governor Jim Douglas of Vermont, Governor Jim Doyle of Wisconsin, Governor Mark Parkinson of Kansas, Governor John Baldacci of Maine and Governor Jodi Rell of Connecticut.

"When responding to a national pandemic or a national recession, the basic principles of smart government remain the same -- to increase efficiency, openness, and transparency in everything we do. Today's summit illustrates our collective commitment to that goal," said Maryland Governor Martin O'Malley. "The experience in the spring taught us that while earlier pandemic flu planning efforts were effective, there are also areas for improvement. Effective response requires accurate and timely information that is as close to real time as possible. We share the commitment of the Obama Administration to constantly monitor, evaluate and improve these processes as we continue to lead the world in emergency preparedness."

Throughout the one-day summit, Administration officials laid out specific ways that states and local governments could start their planning and preparation efforts and announced new programs and resources to help state and local governments, the medical community and every day America prepare for H1N1 and the fall flu season.

First, HHS will make available preparedness grants worth a total of $350 million. These grants were funded by Congress in the latest supplemental appropriations bill and they will give state and local public health offices and health care systems valuable resources to step up their
preparedness efforts.

Second, the federal government will centralize communications about H1N1 and seasonal flu on the federal government's new Web site www.flu.gov. This one-stop comprehensive site brings together flu-related information from across HHS and other federal agencies. The expanded site builds on the pandemic planning information long presented on www.pandemicflu.gov, and incorporates information about the novel H1N1 flu as well as the seasonal flu.

Finally, HHS is launching a new PSA campaign contest to encourage more Americans to get involved in the nation's flu preparedness efforts by making a 15-second or 30-second PSA. Officials at the summit stressed the idea of "shared responsibility" when it comes to combating the flu and the goal of the new HHS PSA campaign contest is to tap into the nation's creativity to help educate Americans about how to plan for and prevent the spread of H1NI influenza. HHS will evaluate submissions and will present the best PSAs back to the public so everyone can vote on their favorite submission. The winning PSA will receive $2,500 in cash and will appear on national television. Contest details as well more information about the larger effort to plan and prepare for the flu season are available at www.flu.gov.

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