2010 Meeting Materials of the FDA Vaccines and Related Biological Products Advisory Committee: Transcripts of the February 2010 meeting now posted, includes discussion of strain selection for the Influenza Virus Vaccine for the 2010 – 2011 Season (July 21, 2010)

FDA News Release: FDA Clears First 2009 H1N1 Influenza Virus Test Previously Available Under Emergency Use Authorization. Clearance will allow continued use of Simplexa Influenza A H1N1 (2009) test (May 24, 2010)

Letter: Matsumoto C, et al. Risk for Transmission of Pandemic (H1N1) 2009 Virus by Blood Transfusion. Emerg Infect Dis. 2010 April 16(4).

Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus [PDF file] (FDA/CBER, Nov. 2009)

New Flu Victim: Blood Supply - Illness Keeps Donors Away, as Worries Surface About Whether Transfusions Spread Infection (Wall Street Journal, Nov. 10, 2009)

Obama declares H1N1 emergency (CNN, Oct. 26, 2009)

Dispatch: Reed C, et al. Estimates of the Prevalence of Pandemic (H1N1) 2009, United States, April–July 2009. Emerg Infect Dis. 2009 Dec. 15(12).

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release -updated weekly (FDA/CBER, Feb 24, 2010)

FDA/CBER Information: 2009 H1N1 Flu Virus. (Feb, 2010) Also see: Information about Newly Emerging 2009 H1N1 Influenza Virus and Blood Safety (FDA/CBER, June 2009)

Press Release: Gov. Schwarzenegger Issues Proclamation to Confront Swine Flu Outbreak (Office of the Governor, April 28, 2009)

Major Human Flu Events in History: Flu strains circulate for years before becoming a pandemic (USA Today, July 14, 2009)

Latest MMWR Articles:
• Update on Influenza A (H1N1) 2009 Monovalent Vaccines. October 9, 2009 / 58(39);1100-1101.
• Update: Influenza Activity -- United States, April-August 2009. September 10, 2009 / 58(Early Release);1-4.

AABB Association Bulletins (Membership required to access
• #09-07: Pandemic Influenza Update (Oct. 6, 2009)
• #09-03: Influenza A (H1N1) of Porcine Origin – Update (April 30, 2009)
• #09-02: Swine Influenza H1N1 Virus (April 27, 2009)

World Health Organization (WHO) EPR:
• H1N1 now in the post-pandemic period (Aug. 11, 2010)

CDC
• H1N1 (Swine) Flu Website (updated July 15, 2010)
• 2009 H1N1 Flu: International Situation Update (Aug. 9, 2010)
• Travel and 2009 H1N1 Vaccine (June 15, 2010)

Dispatch: Hourfar MK, et al. Blood Screening for Influenza. Emerg Infect Dis. 2007 Jul. 13(7);1081-3.

Research Article: Simmons CP, et al. Prophylactic and Therapeutic Efficacy of Human Monoclonal Antibodies against H5N1 Influenza. PLoS Med 4(5): e178.

Notice to Readers: Availability of FluWorkLoss 1.0 Software to Estimate Loss of Work Days During an Influenza Pandemic. MMWR Mar. 23, 2007; 56(11);256. Also see: Link to tool and Instruction Manual (Blood donor model example is at the end of the document).

Interim Pre-pandemic Planning Guidance: Community Strategy for Pandemic Influenza Mitigation in the United States - Early, Targeted, Layered Use of Nonpharmaceutical Interventions (US DHHS & CDC, February 2007)

World Health Organization (WHO) EPR:

• Global Alert and Response, including Cumulative Number of Confirmed Human Cases (July 22, 2010)
• Timeline of Major Events (June 29, 2010)
• Influenza Virus Tracking System

CDC webpages providing background information about avian influenza, including recent outbreaks, the viruses, and the risk to human health

CDC Traveler's Health Outbreak Notice Human Infection with Avian Influenza A (H5N1) Virus: Advice for Travelers (Nov. 4, 2008)

FDA News: FDA Approves Chagas Disease Screening Test for Blood, Tissue and Organ Donors.

Letter: Stimpert K, Montgomery SP. Physician Awareness of Chagas Disease, USA. Emerg Infec Dis. 16(5) May 2010.

Research: Reisenman CE, et al. Infection of Kissing Bugs with Trypanosoma cruzi, Tucson, Arizona, USA. Emerg Infect Dis. 2010 March 16(3).

Dispatch: Roellig DM, et al. Molecular Typing of Trypanosoma cruzi Isolates, United States. Emerg Infect Dis. 2008 Jul; 14(7).

AABB Chagas' Biovigilance Network

Dispatch: Dorn PL, et al. Autochthonous Transmission of Trypanosoma cruzi, Louisiana. Emerg Infec Dis. 13(4) April 2007.

Blood Donor Screening for Chagas Disease: United States, 2006-2007. MMWR February 23, 2007. 56(07);141-143.

Original Article: Young C, et al. Transfusion-acquired Trypanosoma cruzi infection. Transfusion 30 Jan 2007. 47(3);540-544.

Also see"e-Network Forum
(or use search tool)

West Nile Virus Activity - United States, 2009. MMWR. July 2, 2010 / 59(25);769-772.

West Nile Virus Transmission via Organ Transplantation and Blood Transfusion -- Louisiana, 2008. MMWR. Nov. 20, 2009 / 58(45);1263-1267.

Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion [PDF file ] (FDA/CBER, Nov. 6, 2009)

AABB West Nile Virus Biovigilance Network

West Nile Virus Update: United States, January 1- August 19, 2008. MMWR. Aug. 22, 2008 / 57(33);899-900

Latest West Nile Virus Activity in California (California WNV Website)

AABB Association Bulletin #08-03: West Nile Virus – Revised Recommendations for Triggering Individual Donation Nucleic Acid Testing and Use of Communication Plans (AABB membership required to access)

Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection (FDA/CBER, June 23, 2005)

Reporting West Nile Virus-Positive Blood Donors to Local Health Departments, 2005- letter and report form included in MS Word; also PDF version (CA DHS).

Research Article: Hamaguchi T, et al. Medical Procedures and Risk for Sporadic Creutzfeldt-Jakob Disease, Japan, 1999–2008. Emerg Infect Dis. February 2009; 15(2); 265-271.

First Edition Paper: Houston F, et al. Prion diseases are efficiently transmitted by blood transfusion in sheep. Blood. Prepublished online July 22, 2008; DOI 10.1182/blood-2008-04-152520.

New vCJD Case Raises Fear Of Mad Cow Disease Resurge In The UK (Medical News Today, Jan. 3, 2008)

Page Updated: Potential Risk of Variant Creutzfeldt-Jakob Disease (vCJD) From Plasma-Derived Products which includes Potential Variant Creutzfeldt-Jakob Disease (vCJD) Risk From US Licensed Plasma-Derived Factor VIII (PdFVIII, Antihemophilic Factor) Products (FDA/CBER, May 31, 2007)

Press Release: First Prion-Free Cows Reported in Nature Biotechnology (Hematech) Also see Scientists Announce Mad Cow Breakthrough: Genetic Engineering Creates Cattle Without Protein That Causes Disease (Washington Post, free registration required to access Jan. 1, 2007)

Research Article: Guerrra CA, et al. The International Limits and Population at Risk of Plasmodium vivax Transmission in 2009. PLoS Negl Trop Dis. 2010 Aug 3;4(8):e774.

Mali S, et al. Malaria Surveillance - United States, 2008. CDC MMWR. June 25, 2010 / 59(SS07);1-15.

Dispatch: Figtree M, et al. Plasmodium knowlesi in Human, Indonesian Borneo. Emerg Infect Dis. 2010 April. 16(4).

New malaria 'poses human threat'. An emerging new form of malaria poses a deadly threat to humans, research has shown (BBC News) Also see Article: Daneshvar C, et al. Clinical and Laboratory Features of Human Plasmodium knowlesi Infection. Clin Infect Dis. 2009 Sep 15;49(6):852-60.

Letter: Theunissen C, et al. Falciparum Malaria in Patient 9 Years after Leaving Malaria-Endemic Area. Emerg Infect Dis. 2009 Jan. 53(1).

Malaria: Malaria Blood Donor Screening & interactive Malaria-Risk Map Application: provides location-specific information on current CDC assessments of malaria-risk and recommendations for preventive malaria treatment (CDC)

Notice to Readers: Malaria Rapid Diagnostic Test. CDC MMWR, July 13, 2007 / 56(27);686.

CDC Announcement: Interactive CDC DengueMap Available Online. MMWR. August 13, 2010 / 59(31);993.

Travel-Associated Dengue Surveillance: United States, 2006-2008. MMWR. June 18, 2010 / 59(23);715-9.

Dengue Fever Among U.S. Travelers Returning from the Dominican Republic - Minnesota and Iowa, 2008. MMWR. June 4, 2010 / 59(21);654-6.

Outbreak Notice Update: Dengue, Tropical and Subtropical Regions (CDC Travelers' Health, June 2, 2010)

Locally Acquired Dengue - Key West, Florida, 2009-2010. MMWR 21 May 2010. 59(19);577-581.

Perspective: Wilder-Smith A, et al. Threat of Dengue to Blood Safety in Dengue-Endemic Countries. Emerg Infect Dis. 15(1). Jan 2009.

Dispatch: Szelei J, et al. Parvovirus 4–like Virus in Blood Products. Emerg Infect Dis. 2010 March 16(3).

Conference Report: Gubernot DM, et al. Transfusion-transmitted babesiosis in the United States: summary of a workshop. Transfusion. 10 Oct 2009. 49(12); 2759-71.

Transcripts from FDA Public Workshop: Emerging Arboviruses: Evaluating the Threat to Transfusion and Transplantation Safety, Dec 2009. Day 1 | Day 2

Research finds no proof that a virus is the cause of ME: UK scientists say they can find no proof that a particular virus is the cause of chronic fatigue syndrome (CFS) or ME, contrary to recent claims (BBC News)

Letter: Touinssi M, et al. Parvovirus 4 in Blood Donors, France. Emerg Infect Dis. 2010 Jan 16(1).

Letter: Pérez CL, et al. Human Herpesvirus 8 in Healthy Blood Donors, Argentina. Emerg Infect Dis. 2010 Jan 16(1).

Association Bulletin #09-06: Transfusion-Transmitted Babesia (AABB Membership required to access)

Dispatch: Stienlauf S, et al. Epidemiology of Human T-cell Lymphotropic Virus Type 1 Infection in Blood Donors, Israel. Emerg Infect Dis. 2009 July 15(7).

Ahead of Print Article: Miller MA, et al. WU polyomavirus in patients infected with HIV or hepatitis C virus, Connecticut, USA, 2007. Emerg Infect Dis. 2009 Jul; [Epub ahead of print].

Ahead of Print Article: Schwan TG, et al. Tick-borne Relapsing Fever and Borrelia hermsii, Los Angeles County, California, USA. Emerg Infect Dis. 2009 Jul; [Epub ahead of print].

Dispatch: Ngo V, Civen R. Babesiosis acquired through blood transfusion, California. Emerg Infect Dis. 15(5). May 2009.

Dispatch: Santos AP, et al. Hemoplasma Infection in HIV-positive Patient, Brazil. Emerg Infect Dis. 14(12) Dec. 2008.

Case Report: Anaplasma phagocytophilum Transmitted Through Blood Transfusion - Minnesota, 2007. MMWR. October 24, 2008 / 57(42);1145- 48.

Transcript of FDA Workshop to Consider Approaches to Reduce the Risk of Transfusion-Transmitted Babesiosis in the United States (FDA/CBER, Sept. 12, 2008)