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FDA Approves Vaccines for H1N1 Virus
 

On September 16, 2009, the U.S. Food and Drug Administration (FDA) approved four vaccines to provide protection against the H1N1 virus, which causes a type of influenza commonly called swine flu. Three of the vaccines are given by injection into the arm; the other is given in a nasal mist. The vaccines are expected to be distributed nationally by mid- to late October.

“The vaccine will help protect individuals from serious illness and death from influenza,” said Margaret A. Hamburg, MD, FDA Commissioner.

Clinical trials at eight sites throughout the country revealed that adequate protection was provided after one injection. Recommendations for dosing amounts in children are expected soon, based on the trial data. Side effects of the injected vaccine are anticipated to be similar to those for seasonal flu vaccines—soreness at the injection site, mild fever, body aches and fatigue that lasts a few days. Reactions to the nasal spray included runny nose, congestion, sore throats in adults and fever in children ages two through six.

Tentative plans are to give priority to the cohorts of people who are most prone to this type of flu or who are exposed to it in their occupations—pregnant women, caregivers to children younger than 6 months old, healthcare workers and emergency medical services personnel, children 6 months through 18 years old, young adults 19 through 24 years old and high-risk adults (those with such chronic health conditions as asthma, diabetes and heart disease) ages 25 through 64 years old.

Flu Update

Latest reports from the Centers for Disease Control and Prevention (CDC) indicate that a total of 9,079 hospitalized cases of swine flu, or H1N1 influenza A, and 593 deaths in all 50 states, the District of Columbia, American Samoa, Guam, Puerto Rico and the U.S. Virgin Islands, have now been documented, causing heightened concern for many Americans. The novel virus differs from the seasonal flu virus in that most of the people who have gotten sick are young—5 to 24 years old. It is believed that people born before 1957 have immunity to this virus. In addition, the seasonal flu vaccine available in 2008 offers no immunity to this new virus. Most of the people who have been hospitalized had underlying conditions that increased their risk of developing complications, such as pneumonia.

For the bleeding disorders community, it is important to note that the virus does not pose a threat to the safety of plasma-derived clotting factor products. Influenza is a lipid-enveloped virus that is inactivated by a variety of steps in the manufacturing processes used for all licensed products. In addition, prospective plasma donors who show symptoms of flu during the screening process are deferred from donating. The fact that no case of influenza transmitted by transfusion has been reported in the scientific literature is a strong indicator of the safety of the current system.

CDC and HHS Web Info

The CDC has created a Web page with up-to-date information on the H1N1 virus, including prevention information and other guidance. The page can be found at: http://www.cdc.gov/h1n1flu/.

The U.S. Department of Health and Human Services has created the Web site: www.flu.gov, to provide information on H1N1, avian and pandemic flu.

Treatment Guidelines for Healthcare Professionals

The CDC is also providing guidance for healthcare professionals treating individuals who are confirmed to have contracted H1N1 or have been exposed to it. This information can be found at: http://www.cdc.gov/h1n1flu/recommendations.htm

HIV/AIDS and Swine Flu

Experts do not believe that people living with HIV or AIDS are at increased risk for contracting flu. However, individuals with low CD4 cell counts who do contract flu may be at greater risk for complications, including lower respiratory tract infections and pneumonia. Specific information on this subject geared to clinicians is available from the CDC at: http://www.cdc.gov/h1n1flu/guidance_HIV.htm

Plasma Supply

Although there are no current supply issues, if H1N1 continues to spread and large numbers of donors are deferred, it is possible that the supply of plasma and products could eventually be affected. NHF will work closely with industry and appropriate government agencies to monitor and address this situation if it becomes an issue.

Flu and You

Individuals who show flu symptoms are encouraged to contact their primary care or hemophilia treatment center physician.

NHF will try to keep the community informed of any new developments in the weeks ahead.

 

 

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