Biosecurity Briefing: Drug Industry Daily news reports the FDA approved Levaquin (levofloxacin) for use in pediatric patients who have been exposed to Bacillus anthracis. This is the first and only pediatric indication for Levaquin.
Fri, 16 May 2008 19:23:46 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/countrmeasr_dev/2008/2008-05-16-fdaapprovantimicrobialpedathrax.html
Biosecurity Briefing: CQ Politics reported that the HHS released a request for proposals (RFP) for development of a new anthrax vaccine. The RFP requires 25 million doses of a vaccine that can be administered in only three doses.
Mon, 10 Mar 2008 14:57:04 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/countrmeasr_dev/2008/2008-03-07-hhsrfpanthraxvac.html
Biosecurity Briefing: The Human Genome Sciences, Inc., (HGSI) announced results from two animal studies of its treatment drug, ABthrax (raxibacumab) that "...demonstrate a survival benefit in two animal species..."
Fri, 21 Dec 2007 19:29:24 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/agents_diseases/content/anthrax/2007-12-21-studyabthraxprotectsmonkeysrabbits.html
Biosecurity Briefing: The Dept of HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) posted a draft request for proposal for Anthrax recombinant Protective Antigen (rPA) vaccine for the Strategic National Stockpile.
Mon, 03 Dec 2007 17:28:48 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/countrmeasr_dev/content/2007/2007-11-30-hhsissuesdraftrfprpaanthraxvac.html
Biosecurity Briefing: The Senate Com. on Homeland Security and Governmental Affairs held a hearing titled Six Years After Anthrax: Are We Better Prepared to Respond to Bioterrorism? The hearing addressed a GAO report on mgng anthrax vac.
Fri, 26 Oct 2007 21:22:02 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/govt_response/content/2007-10-26-senategaorptexamineanthraxprep.html
Biosecurity Briefing: The House Committee on Homeland Security expressed disappointment regarding the pace with which the agency has moved toward the development and procurement of a recombinant protective antigen anthrax vaccine.
Biosecurity Briefing: According to a study in Infection and Immunity, anthrax vaccine with a new adjuvant administered nasally provided guinea pigs greater protection against lethal doses of anthrax than the standard vaccine administered by injection.
Fri, 24 Aug 2007 21:03:00 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/countrmeasr_dev/content/2007/2007-08-24-studyshowsnewadjuvantprotectagainstanthrax.html
Biosecurity Briefing: Reuters reported Israel has developed its own version of a U.S. anthrax vaccine. In a top secret program administered from 1998 to 2006, the Defense Ministry developed the vaccine and tested it on 700 Israeli solders.
Fri, 18 May 2007 20:24:50 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/agents_diseases/content/anthrax/2007-05-18-israeldevelopedanthraxvac.html
Biosecurity Briefing: Reuters reported that British vaccine developer Acambis won a $425 million, 10-year contract to supply the U.S. govt with 9 million doses of the ACAM2000 smallpox vac. each year for delivery to the Strategic National Stockpile.
Biosecurity Briefing: 62 "probable" cases of monkeypox reported in humans in the Republic of Congo since Jan 07. SIGA Technologies, Inc. announced its smallpox drug, ST-246, demonstrated 100% protection against death in primates w/monkeypox.
Mon, Oct 01 2007 14:12:55 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/international_biosecurity/content/2007-09-28-monkeypoxcongodrugreducemortality.html
Biosecurity Briefing: The FDA announced the approval of ACAM2000(TM), a cell-based smallpox vaccine and the first smallpox vaccine to be approved by the FDA since 1931.
Biosecurity Briefing: The July 15, 2007, issue of the Journal of Infectious Diseases (JID) includes a study that investigates human antibody responses to membrane proteins of the vaccinia virus (VV), the virus used in vaccines against smallpox.
Mon, Jun 18 2007 13:40:16 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/countrmeasr_dev/content/2007/2007-06-15-studyhumanantibodysmallpxvax.html
Biosecurity Briefing: HHS announced the award of a $500 million contract to Bavarian Nordic for the manufacture and development of 20 million doses of next generation modified Ankara (MVA) smallpox vaccine to be added to the Strategic National Stockpile.
Fri, Jun 08 2007 20:54:59 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/countrmeasr_dev/content/2007/2007-06-08-hhspurchasesnextgensmallpoxvax.html
Biosecurity Briefing: The UK-based pharmaceutical company Acambis announced that its ACAM2000 smallpox vaccine received unanimous approval a U.S. Food and Drug Administration (FDA) advisory committee.
Fri, May 18 2007 20:51:14 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/agents_diseases/content/smallpox/2007-05-18-fdacomrecommendapprovalacam2000.html
Biosecurity Briefing: CIDRAP reported that the HHS purchased $192.5 million worth of clade 2.2 H5N1 vaccine from sanofi pasteur. The purchase will provide 6.4 to 38.5 million doses of the vaccine to the Strategic National Stockpile (SNS).
Mon, 05 May 2008 16:20:01 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/govt_response/2008-05-02-hhsspends192mh5n1vaccine.html
Biosecurity Briefing: Reuters reported that Iomai, a small Gaithersburg, MD, biotechnology company, received "U.S. [Department of Health and Human Services] approval..." to begin phase II clinical trials testing "a bird flu skin patch on more people."
Biosecurity Briefing: The European Medicines Agency, equivalent of U.S. FDA, announced that it recommends "the authorization of...[Europe's] first 'pre-pandemic vaccine' for humans against influenza caused by the H5N1 virus."
Mon, 10 Mar 2008 16:20:39 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/international_biosecurity/2008-03-07-1stprepanfluvaceulicense.html
Biosecurity Briefing: CDC reports seasonal flu more severe than last 2 years and a mismatch between this year's vac and two of predominant strains of flu. Europe reports unexpected emergence of H1N1 virus with a decreased sensitivity to oseltamivir.
Tue, 19 Feb 2008 15:31:18 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/avian_pandemic_flu/2008/2008-02-15-fluvacmismatchresisteurope.html
Biosecurity Briefing: On January 29, 2008, the International Vaccine Institute (IVI) reported the results of a study that examines a new way of delivering influenza vaccines: sublingually, or under the tongue.
Fri, 01 Feb 2008 20:40:49 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/countrmeasr_dev/2008/2008-02-01-newundertonguefluvacstudy.html
Biosecurity Briefing: The European Centre for Disease Prevention and Control reported that "some of the A (H1N1) viruses in circulation this winter are resistant to the antiviral drug oseltamivir (also know by the brand name Tamiflu)."
Fri, 01 Feb 2008 20:39:52 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/international_biosecurity/2008-02-01-tamifluresistancefound.html
Biosecurity Briefing: PATH, an international, non-profit organization, announced a $39 million award from the Bill & Melinda Gates foundation to launch the rapid development of flu vaccines and "innovative vaccine technologies" for developing nations.
Tue, 22 Jan 2008 13:35:13 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/avian_pandemic_flu/2008/2008-01-18-gatesawardsmillionsfluvac.html
Biosecurity Briefing: BBAcambis has reported positive results from phase I clinical trials of its new flu vaccine. The FDA announced that "a test that simultaneously detects and identifies 12 specific respiratory viruses" has been cleared for marketing.
Fri, 11 Jan 2008 19:57:39 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/avian_pandemic_flu/2008/2008-01-11-fluvactrials.html
Biosecurity Briefing: CIDRAP at the Univ. of Minnesota reported that the FDA's Pediatric Advisory Committee voted to recommend stronger language on warning labels of two antiviral flu medications, oseltamivir (brand name Tamiflu) and zanamivir.
Mon, 03 Dec 2007 17:51:12 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/avian_pandemic_flu/content/2007/2007-11-30-fdavotesstrongerwarnfludrugs.html
Biosecurity Briefing: On October 23, 2007, the U.S. government released "Draft Guidance on Allocating and Targeting Pandemic Influenza Vaccine" to provide states and communities with guidance on who should be vaccinated.
Fri, 26 Oct 2007 21:31:14 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/avian_pandemic_flu/content/2007/2007-10-26-fedgovdraftguidpanvacpubcomments.html
Biosecurity Briefing: Sanofi pasteur announced new data indicating that its "new investigational H5N1 vaccine...achieved a high immune response at the lowest dose of H5N1 antigen reported to date."
Biosecurity Briefing: A study in BMC Public Health reviews the progress that European Union member states and the non-EU countries of the Global Health Security Action Group have made toward establishing pandemic vaccine priority groups.
Biosecurity Briefing: The Journal Emerging Infectious Diseases (EID) released a study online, ahead of print for its September 2007 issue, on findings of reduced H5N1 influenza virus sensitivity to the antiviral drug oseltamivir.
Fri, 10 Aug 2007 17:51:44 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/avian_pandemic_flu/content/2007/2007-08-10-studyh5n1showingincreasedresistance.html
Biosecurity Briefing: An article from Proceedings of the National Academy of Sciences (PNAS) provides evidence against a commonly asserted hypothesis: that inhibition of host immune response may protect against lethal infection with influenza.
Biosecurity Briefing: On Tuesday, July 17, 2007, the White House Homeland Security Council released its one-year review of the National Strategy for Pandemic Flu Implementation Plan (originally released May 2006).
Biosecurity Briefing: HHS Secretary Mike Leavitt announced that the agency has established a public health advisory board to provide guidance on chemical, biological, radiological and nuclear (CBRN) threats. He also announced contracts for flu vaccine.
Fri, 22 Jun 2007 20:36:01 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/govt_response/content/2007-06-22-hhscbrnadvisorybrdvaxcontracts.html
Biosecurity Briefing: According to a June 13, 2007 Reuters report, pharmaceutical company GlaxoSmithKline (GSK) plans to donate 50 million doses of its pre-pandemic H5N1 vaccine to a global stockpile specifically for the world's poorest countries.
Mon, 18 Jun 2007 14:06:10 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/avian_pandemic_flu/content/2007/2007-06-15-gskmaydonatateh5n1vax.html
Biosecurity Briefing: On April 14, 2008, the U.S. Department of Health and Human Services (HHS) issued a press release naming Robin Robinson, Ph.D. as the first director of the Biomedical Advanced Research Development Authority (BARDA).
Biosecurity Briefing: The Proceedings of the National Academy of Sciences (PNAS) published a study describing the generation of a new research strain of Ebola virus which would be "safe" to handle "outside of a biosafety level-4 facility."
Mon, 28 Jan 2008 14:56:30 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/agents_diseases/vhf/2008-01-25-ebolasafelaboratories.html
Biosecurity Briefing: HHS Secretary Michael Leavitt officially announced the 13 voting members of the National Biodefense Science Board (NBSB). It met for the first time from December 17-18 in Washington, DC.
Fri, 21 Dec 2007 19:16:48 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/govt_response/content/2007-12-21-natlbiodefensescienceboard.html
Biosecurity Briefing: A recent report issued by the FDA Science Board's Subcommittee on Science and Technology has concluded that FDA can no longer fulfill its mission without substantial and sustained additional appropriations.
Fri, 07 Dec 2007 14:01:00 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/govt_response/content/2007-12-07-comrprtsfdainsufficientresources.html
Biosecurity Briefing: A policy review published in Emerging Infectious Diseases examines the utility of the Emergency Use Authorization as a tool for approving public health countermeasures in the event of a national public health emergency.
Biosecurity Briefing: A paper published PLoS Medicine suggests that infection rates during a flu pandemic could be reduced if more people were vaccinated with lower doses of vaccine rather than if a lesser number of people are vaccinated with full doses.