Multiple mutations in Indonesian bird flu strain
Jul 13, 8:17 AM ET
LONDON (Reuters) - Multiple mutations have been found in the H5N1 bird flu virus that killed seven family members in Indonesia although scientists are unsure of their significance, a leading science journal said on Thursday.
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"The functional significance of the mutations isn't clear -- most of them seem unimportant," the journal Nature said in a report in the latest issue on Thursday.
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Virologists contacted by Nature said part of the reason the significance of the mutations is unclear is because withholding the information has hampered the study of the virus.
http://news.yahoo.com/s/nm/20060713/wl_nm/birdflu_mutations_dc_1
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Top animal health official reassigned over bird flu in
Indonesia
Thu Jul 13, 1:27 PM ET
JAKARTA (AFP) - Indonesia's top animal health official has been reassigned over his agency's poor performance in tackling the deadly bird flu virus.
http://www.yahoo.com
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On May 3, 2006, The Bush Administration Announced The Implementation Plan For The National Strategy For Pandemic Influenza.
On December 30, 2005, the President signed the Department of Defense, Emergency Supplemental Appropriations to Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act, 2006. The Act includes $3.8 billion for pandemic influenza preparedness, the first installment of the President's request to launch these critical activities
http://www.whitehouse.gov/infocus/pandemicflu/
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[Federal Register: February 3, 2006 (Volume 71, Number 23)]
[Notices]
[Page 5909-5965]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03fe06-135]
[[Page 5909]]
SUMMARY: This notice revises program apportionment or allocation
amounts published in the December 20, 2005, FTA notice entitled ``FTA
Fiscal Year 2006 Apportionments and Allocations.'' The revisions are
required because Public Law 109-148, the Department of Defense,
Emergency Supplemental Appropriations to Address Hurricanes in the Gulf
of Mexico,
and Pandemic Influenza Act, 2006,
mandates an across-the-board rescission of one percent
of every program, project, and activity
in fiscal year 2006. In addition, this notice identifies other changes
or corrections to the December 20, 2005, notice. The notice also
identifies the States selected for participation in a Section 5310
Pilot Program.
http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/06-961.htm
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Pandemic Influenza Act, 2006
Fact Sheet: Advancing the Nation's Preparedness for Pandemic Influenza
http://hongkong.usconsulate.gov/avian/avian_2006050303.htm
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Flu Vaccine Problems Possible This Fall
The Centers for Disease Control and Prevention has "heightened concern" that the nation will not receive all the seasonal influenza shots it needs this fall after the Food and Drug Administration's stern warning over contamination issues against Sanofi Pasteur, the country's largest flu vaccine maker.
Sanofi, which is producing 50 million doses of injectable influenza vaccine at its Swiftwater, Pa., manufacturing plant, was slapped by FDA last week for what the regulatory agency called "a number of significant objectionable conditions" at the plant. Among them were findings that 11 lots of Fluzone concentrate used to make the seasonal flu doses were contaminated with an unnamed microbe, out of 250 to 300 lots needed to make the promised vaccine.
"We are concerned," said Dr. Lance Rodewald, director of the CDC's immunization services division. "We are always concerned. Now, concern is heightened."
Since problems have hit the nation's seasonal flu vaccine program in four of the last six years, Rodewald said CDC is watching Sanofi "very closely," not just because the firm is America's largest producer, but because it also produces vaccine for children under age 4, one of the groups at highest risk for seasonal influenza.
The FDA would not identify the contaminant but agreed with Sanofi that the problem appeared unlikely to prevent Sanofi Pasteur from making its 50 million doses. That amount is about 40 percent of the 120 million total flu shots expected for the United States this year.
"With regard to the upcoming influenza season, we are confident that we will meet our manufacturing goal of approximately 50 million doses of influenza vaccine for the U.S. market," said Sanofi spokesman Len Lavenda. "... The amount of material impacted is minimal relative to our overall manufacturing capacity, and none of this material has been or will be used in the manufacture of this year's vaccine."
Sanofi's problems were reminiscent of the 2004 contamination issues at a Chiron Corp., flu vaccine plant in Liverpool, England, which cost the United States 48 million of the 100 million doses it expected that year. The unexpected shortfall stunned public health officials and physicians across the country, created sharp demand for vaccine and caused the CDC to reorder its priorities for who should get vaccinated.
Dr. Walter Orenstein, associate director of the Emory Vaccine Center, questioned whether the FDA knows the source of Sanofi's contamination because he found the warning letter "too vague."
"The big concern to me is whether Sanofi and FDA have an idea of what is causing the contamination," he said. "I don't know if they have suspicions, or if they have no idea."
Dr. David Elder, the FDA's director of enforcement, said the warning letter was intended to alert Sanofi that it needed "prompt corrections."
Dr. Karen Midthun, deputy director of the FDA's Center for Biologics Evaluation and Research, said, "Sanofi hasn't fixed everything" but is expected to do so. "We remain concerned with the overall quality issues . . . we cannot know for sure if the problem has been corrected,"
http://www.wtopnews.com/?nid=106&sid=844742
Ping to # 67.