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Biosecurity Briefing
May 16, 2008
FDA Approves Antimicrobial for Pediatric Inhalational Anthrax Exposure According to a Drug Industry Daily news report, the U.S. Food and Drug Administration (FDA) approved Levaquin® (levofloxacin) for use in pediatric patients who have been exposed to Bacillus anthracis.1 This is the first and only pediatric indication for Levaquin. Levaquin, which is a quinolone antimicrobial agent manufactured by Ortho-McNeil, is approved for this indication in children six months of age or older in 250 mg, 500 mg, and 750 mg strength tablets, 5 mg/mL injection, and 25 mg/mL oral solution.1,2 While it has not been tested in humans for the post-exposure prevention of inhalational anthrax, Levaquin was already approved by the FDA to treat adults “to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.”2 Brooke Courtney References
On May 9, 2008, the Occupational Safety and Health Administration (OSHA) of the U.S. Department of Labor released proposed guidance on workplace stockpiling of facemasks and respirators for pandemic influenza and is seeking public comment. OSHA recommends workplace stockpiling “because manufacturing capacity at the time of an outbreak would not meet the expected demand” and “employers will be able to better protect their employees as well as lessen the impact of a pandemic on their business, society, and the economy.”1 The guidance recommends that employers categorize employee positions into four risk types, “according to the likelihood of employees’ occupational exposure to pandemic influenza.”1 The categories are:
At each risk level, the guidance provides formulas for determining the number and type of respirators or facemasks needed and for calculating the total approximate cost of respirators and facemasks associated with a 120 day pandemic period. There is also a description of the types of respirators to use during a pandemic, including disposable, surgical, reusable elastomeric, and powered air purifying respirators. Additionally, the document provides benefits, drawbacks and price ranges for each type of respirator. According to OSHA, although inexpensive, surgical facemasks provide only a physical barrier against “large droplets of blood or body fluids.”1 In contrast, respirators “reduce an employee’s exposure to airborne contaminants;” however, they can cost between $0.50 and $1200 per unit, depending on the sophistication of the device.1 The OSHA guidance is being offered as an appendix to Guidance on Preparing Workplaces for an Influenza Pandemic (jointly issued by the Department of Labor and the Department of Health and Human Services) which was released in February 2007. The new guidance document will be open for public comment until July 8, 2008, and instructions for submitting comments can be found at: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=FEDERAL_REGISTER&p_id=20383. Kunal Rambhia Reference
On May 16, 2008, health officials from Indonesia announced that the republic would begin sharing information about H5N1 cases with a new global database known as the Global Initiative on Sharing Avian Influenza Data (GISAID). According to an Associated Press (AP) report, GISAID is a free online database that launched on May 15, 2008; it is not affiliated with the World Health Organization’s flu database.1 The new database “calls on users to reach an agreement with data providers before applying, for example, for patents needed for vaccines.” In addition, GISAID has created “an electronic tracking system that enables site users to see who has sent or received virus data—from government laboratories to pharmaceutical companies” in order to preserve transparency.1 The AP article notes that GISAID was developed after a group of more than 70 preeminent scientists published a letter in the journal Nature that calling for avian influenza information be shared “more quickly and openly.”1 Specifically, the scientists rejected the traditional practice in which individual organizations maintained private databases of viral genetic information. According to the article, the WHO’s H5N1 flu information was held in a database based out of Los Alamos, New Mexico, which was accessible to only 15 laboratories. In 2007, the WHO acknowledged an urgent need to address the international skepticism about process for sharing flu data. However, the AP article notes that the WHO does still believe that “some genetic data should be kept behind closed doors.” To that end, the WHO is seeking $10 million to implement “another database and tracking system.”1 The AP article notes that scientists, including members of WHO’s four influenza collaborating centers, have expressed skepticism regarding the WHO’s plans to develop a new database now that GISAID has been launched. These scientists have said that GISAID has been “tailor-made by and for influenza scientists” and they argue that “full transparency will not hinder efforts to carry out their vaccine strain selection process.”1 Jennifer Nuzzo Reference
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