Preliminary Testing of the H1N1 Influenza Vaccine, Emergency Provisions for Diagnostics

The H1N1 influenza pandemic began to rebuild momentum throughout the Northern Hemisphere in September, and it was being met by a series of developments, including:

● Officials at the U.S. Food and Drug Administration (FDA) in mid- September approved four vaccines to protect against the H1N1 influenza virus, including injectable products from CSL Limited, Novartis Vaccines and Diagnostics Limited, and Sanofi Pasteur plus a live-attenuated, flu-virus product from MedImmune LLC that is administered intranasally.

● Results from phase-I clinical trials involving adults indicate that the injectable 2009 H1N1 influenza vaccines are well tolerated and induce strong immune responses when administered as single 15-_g doses, according to Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (NIH).

● Results from phase-I clinical trials with the H1N1 vaccines involving children indicate that those who are 10 and older develop an apparently protective response following a single injection, whereas children between 6 months and 9 years will likely require two doses of vaccine.

● Late in August, FDA issued an Emergency Use Authorization allowing the RT-PCR 2009 H1N1 influenza virus test to be used for detecting the virus among U.S. troops serving overseas. ASM maintains a resource page on H1N1 flu that includes World Health Organization and Centers for Disease Control announcements and guidance documents. See the ASM website at http://www.asm.org/index.php?option_com_content&task_view&id_64294&Itemid_657.

Senate Bill Addresses Laboratory Biosecurity Issues

Senators Joseph Lieberman (I-CT) and Susan Collins (R-ME) of the Homeland Security and Government Affairs Committee introduced legislation on 8 September aimed at strengthening security at highcontainment biology laboratories. Provisions in the bill, the "Weapons of Mass Destruction Prevention and Preparedness Act of 2009," charge the Department of Homeland Security (DHS) with determining which pathogens have the greatest potential for being used in terror attacks and also with implementing security standards for labs that study those pathogens, including by setting and enforcing personnel reliability standards. In a related development, Congress extended the mandate of the Weapons of Mass Destruction Commission. Its report, "World at Risk," from December 2008 contains recommendations that helped to frame the Lieberman-Collins bill. Meanwhile, the Government Accountability Office (GAO) recommends in a September report (GAO- 09-574), "High-Containment Laboratories: National Strategy for Oversight Is Needed," that a new federal entity be established to oversee labs working on such pathogens.

Virus Implicated for Some Prostate Cancers

A virus that causes leukemia and sarcomas in mice is also present in malignant human prostate cancer cells, according to Ila Singha of the University of Utah in Salt Lake City, Robert Schlaberga of Columbia University Medical Center in New York, N.Y., and their collaborators. Specifically, the xenotropic murine leukemia virus (XMRV), which is a retrovirus, turned up "in 27% of prostate cancers we examined and was associated with more aggressive tumors," Singha says. "We still don't know that this virus causes cancer in people, but that is an important question we're going to investigate." The researchers also detectedXMRVproteins in malignant prostate cells, further suggesting that XMRV infection is linked to tumor formation. If so, these findings could lead to new diagnostic tests, vaccines, and therapies for treating this cancer, which is diagnosed in nearly 200,000 men in the United States each year. Details appeared on 7 September online in the Proceedings of the National Academy of Sciences.


In Microbiological Terms: No Guts, No Glory

Long underappreciated as a microbial habitat, the gastrointestinal (GI) tract is basking in the scientific limelight these days. Here are some recent examples:

● Engineering Escherichia coli bacteria to make GLP-1, a protein that stimulates cells in the pancreas to produce insulin, and then introducing the modified bacteria into the GI tracts of diabetic mice provides a way of treating that disease, according to biochemical engineer John March at Cornell University in Ithaca, N.Y., and his collaborators, who presented their findings during the August meeting of the American Chemical Society.

● In analyzing genes from the GI microflora of two healthy individuals, data based on DNA fragments encoding resistance genes "suggest that we have just begun to scratch the surface of the immense diversity of antibiotic resistance machinery in the human microbiome," report George Church of Harvard Medical School in Boston, Mass. and his collaborators, whose findings appear in the 28 August Science.

● Deer carrying the prion associated with chronic wasting disease excrete infectious prions in their feces long before they develop any symptoms of that disease, a finding that helps to explain how this disease spreads among deer, according to Stanley Prusiner of the University of California, San Francisco, and his collaborators, whose findings appear in the 10 September Nature.