NEWS SCAN: Clinton's warning on bioterrorism, biodefense bill progress, norovirus vaccine, antivirals and abnormal behavior

Dec 7, 2011

US calls for global cooperation to confront threat of bioterrorism
US Secretary of State Hillary Clinton appealed today for increased international efforts to confront what she called the growing threat of bioterrorism. Speaking in Geneva at the 5-year review conference of the Biological Weapons Convention (BWC), which bans such weapons, Clinton said the ability of terrorists to use bioweapons is growing, even as governments around the world have renounced them. As an example of recent warning signs, less than a year ago, al Qaida in the Arabian Peninsula urged "brothers with degrees in microbiology or chemistry to develop a weapon of mass destruction," she said in prepared remarks. Though Clinton said it is not possible to devise a verification mechanism to ensure that all countries are abiding by the BWC, she called for revision of the treaty's annual reporting systems to ensure that all governments report what they are doing to guard against the misuse of biological materials. She also called on countries to take steps to demonstrate transparency and promised that the US would hold an international forum to exchange views and discuss the evolution of its own biological research programs. In addition, Clinton urged countries to strengthen their ability to detect and respond to disease outbreaks and appealed for better global coordination. She also called for "thoughtful international dialogue about the ways to maximize the benefits of scientific research and minimize the risks."
Clinton's prepared speech
Dec 7 Reuters report on the speech
Dec 5 UN press release about related speech by Secretary-General Ban Ki-Moon
Dec 5 White House statement about the BWC meeting

US House passes biodefense reauthorization bill
The US House of Representatives yesterday passed a reauthorization of the 2006 Pandemic and All-Hazards Preparedness Act, designed to protect the country against infectious disease threats and acts of bioterrorism, Global Security Newswire said today. HR 2405 renews components of the 2006 act, which established the Biomedical Advanced Research and Development Authority (BARDA). It renews the Special Reserve Fund of Project Bioshield, which is responsible for maintaining medical supplies in the Strategic National Stockpile for combating anthrax, smallpox, flu, and other diseases. The bill authorizes $2.8 billion for that fund from 2014 through 2018. It is also designed to aid state and local public health preparedness, bolster bioterror-related efforts in the Centers for Disease Control and Prevention (CDC), and expand the duties of the Health and Human Services Department's assistant secretary for preparedness and response. "I hope and pray that we never need to use such defensive measures, but they are critical to ensuring that the public stands protected," said Rep Mike Rogers, R-Mich., one of the bill's sponsors, in a press release. The Senate's version of the bill was introduced Nov 10 and awaits committee action.
Dec 7 Global Security Newswire story
Dec 6 press release from Rep Mike Rogers
govtrack.us tracking page for HR 2405, with links to full text

Norovirus vaccine cuts risk of illness in half in early clinical trial
Researchers conducting the first clinical trial of a norovirus vaccine said it reduced the risk of illness in experimentally infected patients by 47%, according to their study today in the New England Journal of Medicine. The vaccine, made by LigoCyte, is a dry powder formulation that contains virus-like particles (VLPs) and is administered inside the nose. Today's report offers a more detailed account of the initial trial results, which the company first unveiled in October 2010. The phase 1/2 study involved 90 healthy adults who received either two doses or the vaccine or two doses of placebo, 3 weeks apart. Three weeks after the final doses, subjects who agreed to participate in the second phase of the study were admitted to a nursing unit and given a drink that contained the same type of norovirus contained in the vaccine. Patients were monitored for at least 4 days. The vaccine showed 47% (P = .006) efficacy against any norovirus illness and 26% (P = .046) efficacy against infection. In vaccine recipients who got sick, the severity was decreased and illness onset was delayed. The researchers emphasized several caveats about the study, including that the placebo did not contain the vaccine's two adjuvants, that they had problems with the dose-delivery device, and that the efficacy must be determined in younger and older populations. They noted that the vaccine's efficacy will need to be determined in a natural setting and that a multivalent vaccine will likely be needed to protect against GI and GII norovirus strains. The CDC estimates that noroviruses, frequently spread by food, cause about 21 million illnesses a year. LigoCyte is developing an intramuscular norovirus vaccine, and at least one other group is working on a norovirus vaccine that is produced with a vector-based technique.
Dec 7 N Engl J Med abstract
Oct 28, 2010, CIDRAP News story "First clinical trial results for norovirus vaccine outlined"
Mar 15 CIDRAP News Scan on vector-based vaccine

Japan logs more reports of abnormal behavior after antiviral use
After the Japanese government restricted the use of the antiviral drug oseltamivir (Tamiflu) in March 2007 in children aged 10 to 19 because of concerns over abnormal behavior associated with its use, reports of such behavior dropped in that age-group but more than doubled in younger children and increased dramatically in those taking zanamivir (Relenza), another antiviral, a new study found. In PLoS One yesterday, Japanese scientists detailed their analysis of 100,344 dispensation (sales) records from November 2006 through March 2009 for the two antivirals. They report that sales for oseltamivir in 2008 dropped to 20.4% of 2006 levels in the targeted age-group. Reports of abnormal behavior in 10- to 19-year-olds likewise dropped, from 24 in 2006 to 9 in 2008. However, oseltamivir-associated reports climbed from 12 to 28 in children under 10 during that same period. In addition, reports of abnormal behavior in children taking zanamivir rose in proportion to increased sales of that drug, from 11 to 114 cases. The authors conclude, "The observed increase in abnormal behavior reports in oseltamivir patients under age 10 and in zanamivir patients suggests that these patient groups may also be at risk, calling into question the validity of the current discrimination by age and agent."
Dec 6 PLoS One study

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