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Biosecurity BriefingJune 20, 2008
Second NBSB Meeting Addresses Home Stockpiling and Personal Preparedness On June 18, 2008, the Department of Health and Human Services (HHS) held a meeting of the National Biodefense Science Board (NBSB) to discuss “preparedness and planning issues related to at-risk populations and pandemic influenza, consider issues related to medical response and preparedness for radiological and nuclear events, and receive an update from the Federal Biosurveillance Working Group.”1 This is the second meeting of the NBSB, which was created under the Pandemic and All Hazards Preparedness Act (P.L. 109-417) to “provide expert advice and guidance to the Secretary of the U.S. Department of Health and Human Services (HHS) on scientific, technical, and other matters of special interest to HHS regarding activities to prevent, prepare for, and respond to adverse health effects of public health emergencies resulting from chemical, biological, nuclear, and radiological events, whether naturally occurring, accidental, or deliberate.” The inaugural meeting of the Board was held December 17-18, 2007.1 According to a Federation of American Scientists (FAS) Strategic Security Blog posting on June 19, the NBSB meeting discussions focused on the issue of “home stockpiling,” including whether “it is safe, effective, and worthwhile.” The newly appointed Director of HHS’ Biomedical Advanced Research and Development Authority (BARDA) Dr. Robin Robinson led the day’s discussions on medical countermeasures, and solicited input from the Board “on what should be the right balance of government and personal strategies for preparedness.”2 The NBSB also received briefings from a number of experts on a range of issues. Captain Daniel Sosin from the Centers for Disease Control and Prevention (CDC) briefed the Board on CDC’s Draft National Biosurveillance Strategic Plan; Susan Cooper from the Tennessee Department of Health addressed the issue of vulnerable populations in a public health emergency; C. Norman Coleman from the Radiation Research Program at HHS and Richard J. Hatchett from the Radiation Countermeasures Research and Preparedness program at the National Institute of Allergy and Infectious Diseases (NIAID) discussed the Radiation Management System and radiation countermeasures development; and Amy Patterson, Executive Director of the National Science Advisory Board for Biosecurity (NSABB) provided an overview of the work of NSABB to the Board.2 As next steps, the NBSB decided to take a closer look at the issue of personal preparedness and home stockpiling. The Board will also be administering a new working group on Disaster Mental Health. The next meeting of the NBSB will be held in November 2008.2 Crystal Franco References
On June 12, 2008, the New England Journal of Medicine published results from a randomized clinical trial of a whole virus H5N1 avian influenza vaccine that was produced in cell-culture. The authors report that two doses of unadjuvanted vaccine produced evidence of a positive immune response for three clades of the H5N1 virus, with side-effects comparable to both split-antigen H5N1 vaccines and other whole-virus H5N1 vaccines with adjuvant that are grown in eggs.1 The authors conducted the “randomized, dose-escalation phase 1 and 2” study at three sites in Austria (n=1) and Singapore (n=2).1 Between June and September 2006, 275 healthy male and female patients (ages 18 to 45) received one of six possible vaccine formulations: 3.75 µg of antigen with adjuvant (n=45 patients); 7.5 µg with adjuvant (n=45); 7.5 µg without adjuvant (n=45); 15 µg with adjuvant (n=46); 15 µg without adjuvant (n=45); 30 µg with adjuvant (n=49). The vaccine was based on the clade 1 H5N1 virus (A/Vietnam/1203/2004). Patients in each study group received a second dose of vaccine 21 days after their first dose. There was no placebo group. The investigators report that the highest antibody response was noted in the group that received the vaccine with 7.5 µg of antigen and no adjuvant. The authors estimated seroconversion to be 69% among patients in that study group. Adjuvants “did not improve the antibody response.” Among all patients receiving vaccine, reports of side effects were generally mild (mild pain at injection site and headache were most common) and comparable to those reported for other H5N1 vaccines (including subvirion vaccines and whole virus vaccines grown in eggs). The authors also found that the “whole-virus clade 1-based vaccine” induced “a substantial…response against clade 2 and clade 3 strains” of the H5N1 virus.1 The study notes that the development of whole virus vaccines may offer advantages in a pandemic setting, as there is some evidence that they produce a positive immune response at smaller doses than vaccines that are created from only the surface antigens of the influenza virus. Moreover, vaccines that are grown in cell culture provide a “robust manufacturing platform that eliminates dependence on embryonated chicken eggs, which would be an advantage in the event of limited availability of such eggs during a pandemic caused by a highly pathogenic avian virus.”1 Baxter Bioscience developed the study vaccine.1 As reported in a previous Biosecurity Briefing, the Republic of Indonesia, which signed a memorandum of understanding with Baxter last year, recently accused the drug manufacturer of “moving too slowly in developing a bird flu vaccine using the [country’s] virus strain.”2 Jennifer Nuzzo References
On June 17, 2008, CIDRAP News reported that the Australian Therapeutic Goods Administration (similar to the U.S. Food and Drug Administration) approved Panvax®, an H5N1 avian influenza vaccine developed by CSL Limited.1 According to a June 17 CSL press release, the vaccine “can be used only when an influenza pandemic has been officially declared by the Australian Government in consultation with the World Health Organization.”2 The Australian government contributed more than $7 million to the development of the Panvax® vaccine and has stockpiled an additional 1.2 million doses of a “foreign-made vaccine.”1 According to CIDRAP News, Panvax® is a split-virus vaccine that requires two doses for efficacy, and the vaccine performed well in safety and immunogenicity clinical trials. Panvax® is produced in eggs and includes an adjuvant to enhance the effect of the vaccine. It is estimated that mass production of a “precisely matched” version of the egg-based vaccine “will take 4 to 6 months after the identification of a pandemic flu strain.”1 In a related CIDRAP News report on June 16, sanofi pasteur has pledged to “give 60 million doses of H5N1 influenza vaccine over 3 years to the World Health Organization (WHO) for a planned stockpile to help poor countries in the event of an influenza pandemic.”3 This comes a year after GlaxoSmithKline (GSK) promised 50 million doses of its H5N1 vaccine (which was approved in May by the European Union for marketing) for the WHO stockpile. Like the GSK vaccine, the sanofi vaccine requires two doses. The combined total of the two donations would be enough for the WHO to vaccinate approximately 55 million people. The WHO stockpile was initiated in 2007 in response to concerns posed by “Indonesia and other developing countries about lack of access to commercial H5N1 vaccines.”3 In other news, the U.S. Department of Health and Human Services (HHS) announced that the Centers for Disease Control and Prevention (CDC) “has awarded $12.9 million for the development of low-cost influenza tests that can detect and differentiate seasonal human influenza viruses from avian influenza within three hours.”4 The HHS release indicates that new, rapid diagnostics will “be performed in a hospital or a commercial laboratory and would expedite the diagnosis of a large number of patients” for both pandemic and seasonal influenza.4 Current technologies can take up to 24 hours for accurate identification of H5N1. HHS Secretary Michael Leavitt commented that “early detection will aid in improving patient survival, overall health outcomes, and use of containment measures” during an influenza pandemic.4 Contracts for development of influenza diagnostic tests were awarded to Nanogen, Inc., and Meso Scale Diagnostics, LLC. Each company received an initial $6.5 million. However, the contracts allow funding for up to $10.4 million for Nanogen and $12.1 million for Meso Scale Diagnostics over three years. CDC and the Biomedical Advanced Research and Development Authority (BARDA) awarded the contracts jointly. Kunal Rambhia References
On June 11th, 2008, an Institute of Medicine (IOM) committee released a report entitled Initial Guidance for an Update of the National Vaccine Plan: A Letter Report to the National Vaccine Program Office.1 The IOM committee was charged by the National Vaccine Program Office (NVPO) of the U.S. Department of Health and Human Services (HHS) with reviewing the current federal vaccine plan and providing guidance on a forthcoming update. First implemented by the federal government in 1994, the current National Vaccine Plan (NVP) calls for vaccine development and immunization efforts to reduce morbidity and mortality caused by infectious diseases. The four goals of the plan are to:
The first section of the report is a review of progress achieved in these areas during the last fourteen years. The analysis identifies changes to the healthcare delivery system, medical technology, and the global environment as factors that have produced changes sufficient to merit an update of the NVP.1 The remainder of the document outlines the committee’s guidance on how an update of the NVP would address its current limitations. Recommendations include:
The Committee also “noted some important omissions in the 1994 plan and identified several emerging areas and changes in context that will require attention in a major national document on the future of vaccine development and immunization.” The following are specific additions that the Committee suggests the federal government should consider in updating the NVP:
The IOM report notes that the committee’s continuing work, which includes review of the evidence and input received from national stakeholders, “will form the basis for more detailed recommendations on priorities in the update to National Vaccine Plan.” Matthew Watson References
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