Latest reports from the Centers for Disease Control and Prevention (CDC) indicate that a total of 5,514 hospitalized cases of swine flu, or H1N1 influenza A, and 353 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 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/
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
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.
Updates—Vaccine Trials Begin Soon
Clinical trials of a vaccine against the H1N1 virus, developed by Sanofi Pasteur and CSL Biotherapies, are expected to begin within the next two weeks on approximately 2,800 volunteers. The vaccine will first be tested on adults. If it is found to be safe, it will then be tested on children, 6 months to 17 years old.
The vaccine will be given in one or two doses of either 15 micrograms or 30 micrograms, 21 days apart. Additional tests will be conducted to determine if it is safe to give the new vaccine with the seasonal flu vaccine. The H1N1 vaccine is made from inactivated virus proteins and cannot cause flu in test patients. If results reveal that the vaccine is effective and safe, it will be distributed in early Fall, before the flu season hits in the US. 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—healthcare workers, pregnant women, children 6 months to 4 years old and high-risk adults (those with such chronic health conditions as asthma, diabetes and heart disease).
The clinical trials will be conducted at the following sites: Baylor College of Medicine in Houston; Children’s Hospital Medical Center in Cincinnati; Emory University in Atlanta; Group Health Cooperative in Seattle; Saint Louis University, Missouri; University of Iowa; the University of Maryland School of Medicine; and Vanderbilt University in Nashville, TN.
NHF will try to keep the community informed of any new developments in the weeks ahead.