par Lynn Shapiro
, Writer | August 27, 2009
FDA said it has issued an Emergency Use Authorization (EUA) that allows U.S. troops serving overseas to be tested for swine flu, using a yet-to-be approved DNA-based test made by the government.
An EUA authorizes the use of unapproved medicines or off-label uses of approved medicines during a public health emergency.
In this case, the EUA permits the U.S. Department of Defense to distribute the H1N1 test to laboratories that have the equipment and personnel to conduct the molecular test and interpret the results.
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"The test will aid in more rapid diagnosis of 2009 H1N1 influenza infections so that deployed troops can quickly begin appropriate medical treatment," said FDA commissioner, Margaret A. Hamburg, M.D.
CDC developed the assay, called the H1N1 Influenza Real-Time RT-PCR.
PCR uses recombinant technology to make multiple copies of DNA samples, so that a person's molecular profile--in this case the presence of swine flu--can easily be seen.
Vaccine Trials Are Underway
In other news, Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases for the NIH, said the agency is currently testing H1N1 vaccines made by two companies, Sanofi Pasteur and CSL Biotherapies.
Two trials will compare one versus two shots of each of the vaccines in healthy adults aged 18 years and older. A similar trial is ongoing for children aged 6 months to 17 years old. Dr. Fauci noted that the children's test was started on August 19 after researchers concluded the virus was safe for adults.
Single-dose data from the trial in adults are expected in mid-September, Dr. Fauci said. "If all goes well, second-dose data will be available somewhere around mid-October."
Pregnant Women Next
Trials expected to begin in September will test three vaccines in pregnant women. The trials will compare the safety and efficacy of using one versus two shots of medicine. About 120 women will be recruited for each of the three trials. The government has decided that pregnant women will be among the first to receive the swine vaccine, to prevent them from transmitting the virus to their fetuses.
Trials are also being planned for the use of adjuvants in "what we call a mix and match, where we take the antigen from one company and use the adjuvant from another company," Dr. Fauci said. "Those studies are scheduled to start somewhere in mid- to late September," he said. In total, he estimated that about 4,500 people will be tested.
Meanwhile, Jay Butler, M.D., director, H1N1 Vaccine Task Force for the CDC, provided an update of people infected in both the Northern and Southern hemispheres.