Let the testing begin

By Sheilah Downey (sheilahd@foodconsumer.org)

As swine flu deaths continue to climb in the United States, health officials announced today the launching of clinical vaccine trials for the H1N1 virus that has swept the globe.

California announced 23 new deaths from the swine flu over the past week, bringing that state's total to 55, and Florida reported 10 new deaths in the past week.

The National Institutes of Health announced that eight medical facilities throughout the country have been designated for clinical trials to gather critical data for two candidate H1N1 flu vaccines.

Scientists at the NIH said the data will be used to assess the new vaccines to see if they are safe and to see if they have the ability to induce protective immune responses.

"These data will be factored into the decision about how and if to implement a 2009 H1N1 flu immunization program this fall," said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases.

Fauci said the initial studies will involved healthy adults aged 18 to 64 and elderly people aged 65 and older. Different doses, given 21 days apart, will be given to groups to assess the amounts needed. A concurrent set of trials will look at the safety of the vaccines and immune response. If those trials indicate the vaccines are safe, similar trials will begin on children aged 6 months to 17 years.

The vaccines to be tested are from two manufacturers, Sanofi Pasteur and CSL Biotherapies.

The NIH stated that a panel of outside experts will review data from the trials to spot safety concerns. Data will also be used for recommendations for people in high risk groups, including pregnant women and those whose immune systems are compromised.

The network of medical facilities slated to begin the trials include Baylor College of Medicine in Houston, Children's Hospital Medical Center, Cincinnati, Emory University, Atlanta, Group Health Cooperative, Seattle,
St. Louis University, St. Louis, University of Iowa, Iowa City, University of Maryland School of Medicine, Baltimore and Vanderbilt University, Nashville.