HHS Takes Additional Steps Toward Development of Vaccine for the Novel Influenza A (H1N1)

[Possibilities]

http://www.hhs.gov/news/press/2009pres/05/20090522b.html

FOR IMMEDIATE RELEASE
Friday, May 22, 2009


Contact: HHS Press Office
(202) 690-6343
HHS Takes Additional Steps Toward Development of Vaccine for the Novel Influenza A (H1N1)

HHS Secretary Kathleen Sebelius announced today that the department will take important steps necessary to prepare for potential commercial-scale production of a candidate vaccine for the novel Influenza A ( H1N1). The Secretary is directing approximately $1 billion in existing funds that will be used for clinical studies that will take place over the summer and for commercial-scale production of two potential vaccine ingredients for the pre-pandemic influenza stockpile.

?Preparation and planning are critical to keep Americans safe in the face of a potential pandemic,? Secretary Sebelius said. ?Our goal throughout this new H1N1 outbreak has been to stay one step ahead of the virus. An important part of this effort has been our work to develop a potential vaccine because vaccines can help prevent and control influenza virus outbreaks. The actions we are taking today will help us be prepared if a vaccine is needed.?

The funds will be used to place new orders on existing contracts with companies that hold U.S. licenses for flu vaccines. With these orders, they will produce a bulk supply of vaccine antigen and adjuvant. Antigen is the active ingredient in a vaccine that causes the human body?s immune system to develop antibodies that help fight an invading virus. Depending on the results of clinical studies, adjuvants could be added to a vaccine to improve the immune system?s response and potentially reduce the amount of antigen necessary for the body to recognize and fight a virus.

Having both antigen and adjuvant on hand provides maximum flexibility in a future immunization program, if a program is recommended. For example, if needed these ingredients could be used in vaccine to help protect health providers and other members of the critical workforce, as recommended by the National Strategy for Pandemic Influenza.

With these funds manufacturers will also prepare pilot lots of potential vaccine for use in clinical studies to determine the proper dose for a vaccine, determine if adjuvants are appropriate and ensure a vaccine is safe and effective. The U.S. government will share as much information as possible from the results of these clinical studies with the World Health Organization and the global community so that other countries can benefit from the U.S. efforts to determine dosage, safety and effectiveness.

The Biomedical Advanced Research and Development Authority (BARDA) in the HHS Office of the Assistant Secretary for Preparedness and Response established the existing contracts with these companies in 2004 as part of the National Strategy for Pandemic Influenza.

To learn more about the National Strategy for Pandemic Influenza, visit http://www.pandemicflu.gov/plan/fede...-influenza.pdf. More about BARDA is available at http://www.hhs.gov/aspr/barda/index.html. For the latest on the H1N1 flu virus, see http://www.cdc.gov/h1n1flu/.

[Shiloh]

Medical Conditions That Can Make Flu Cases Worse

Source: http://ny1.com/Default.aspx?ArID=99689



Updated 05/26/2009 04:01 PM
Certain Medical Conditions Can Make Flu Cases Worse

By: NY1 News

Department of Health officials say that all four people who have died in the city's H1N1 flu outbreak had "underlying medical conditions."

City officials have not released the specific causes of death for the four cases, and insufficient data are available to determine who is at higher risk for complications of H1N1 influenza virus infection.

However, the same age and risk groups who are at higher risk for seasonal influenza complications should also be considered at higher risk for swine-origin influenza complications. Some pre-existing medical conditions that could worsen seasonal influenza include asthma, obesity, diabetes, lung disease and heart disease.

Populations At Higher Risk Of Flu Complications

According to the Centers for Disease Control and Prevention, groups at higher risk for seasonal influenza complications include:

? Children less than 5 years old.
? Persons aged 65 years or older.
? Children and adolescents under the age of 18 who are receiving long-term aspirin therapy and who might be at risk for experiencing Reye syndrome after influenza virus infection.
? Pregnant women.
? Adults and children who have chronic pulmonary, cardiovascular, hepatic, hematological, neurologic, neuromuscular, or metabolic disorders.
? Adults and children who have immunosuppression (including immunosuppression caused by medications or by HIV).
? Residents of nursing homes and other chronic-care facilities.

High-Risk Children's Medical Conditions

Department of Education officials say that sick children with flu-like symptoms should be kept out of school until 24 hours after their symptoms resolve.

The great majority of children recover from influenza quickly without treatment, but those with chronic underlying health conditions should call a doctor about receiving antiviral treatment.

Children at higher risk of severe flu complications include:

? Infants younger than six months.
? All children with immune suppression.
? Pregnant adolescents.
? Children with chronic kidney disease, heart disease, sickle cell disease.
? Children with HIV/AIDS.
? Diabetic children.
? Children with asthma or other problems of the lungs
? Children on long-term aspirin therapy for chronic disorders.
? Children with any condition that affects respiratory function including neurological conditions such as intellectual and developmental disability, cerebral palsy, spinal cord injuries, seizure disorders, metabolic conditions or other neuromuscular disorders.

Seek Hospital Treatment For Certain Symptoms

According to the DOH, people with worsening flu symptoms should visit a doctor or a hospital right away. Those who are not sure where to get car can call 311 for information.

Care is always available for those who need it, and no one will check patients' immigration status.

Some signs to get medical treatment can include:

Adults
? Trouble breathing or shortness of breath.
? Pain or pressure in the chest or stomach.
? Sudden dizziness.
? Confusion.
? Severe vomiting that won?t stop.

Children

? Fast breathing or trouble breathing.
? Bluish skin color.
? Fever with a rash.
? Refusal to drink fluids.
? Vomiting or diarrhea that won?t stop.
? Not waking up or not interacting.
? Being too irritable to be held.
? Having flu symptoms return with fever and worse cough after starting to get better.

[Niko]

Re: HHS Takes Additional Steps Toward Development of Vaccine for the Novel Influenza A (H1N1)

US Vaccine Strategy timeline

h1n1vacstrat508.pdf