A Biosecurity Survey in Kenya, November 2014 to February 2015.

A biosecurity survey was performed to gather information on the biosecurity level and laboratory capacity in Kenya for the purpose of providing information outlining relevant components for biosecurity legislation, biosecurity implementation, and enforcement of biosecurity measures in Kenya. This survey is, to the authors' knowledge, the first to be published from an African country. A total of 86 facilities with laboratories covering relevant categories, such as training laboratories, human diagnostic laboratories, veterinary diagnostic laboratories, and research laboratories, were selected to participate in the survey. Each facility was visited by a survey team and staff were asked to answer 29 groups of questions from a questionnaire. The survey showed that Kenyan laboratory facilities contain biological agents of biosecurity concern. The restrictions for these agents were found to be limited for several of the facilities, in that many laboratory facilities and storage units were open for access by either students or staff who had no need of access to the laboratory. The survey showed a great deal of confusion in the terms biosecurity and biosafety and a generally limited biosecurity awareness among laboratory personnel. The survey showed that the security of biological agents of biosecurity concern in many facilities does not meet the international requirements. The authors recommend developing a legal framework in Kenya for effective controls, including national biosecurity regulations, guidelines, and procedures, thereby reducing the risk that a Kenyan laboratory would be the source of a future biological attack.

Modernizing stockpiles of medical countermeasures against smallpox: Benefits, risks, and knowledge gaps.

OBJECTIVE: New smallpox medical countermeasures are entering the marketplace, offering the opportunity to modernize existing stockpiles. However, new smallpox countermeasures are developed under the animal rule, meaning that human efficacy data are lacking, and human safety data may be limited. Also, stockpile modernization would require prioritization of increasingly limited public funds. Approaches to address these issues are needed. METHODS: Smallpox vaccine data were gathered by literature search. The financial value of vaccination in the face of an outbreak was evaluated using a threatbased cost/benefit analysis model, involving i) estimation of the efficacy of new smallpox vaccines based on available clinical data on virus-neutralizing seroconversion in vaccinees, ii) estimation of the likelihood for a smallpox outbreak in Denmark, and iii) estimation of the expected life-saving effects of postevent vaccination. RESULTS: The authors estimated that i) the likelihood of a smallpox outbreak in Denmark is very low (one event in 200,000 years), ii) the expected efficacy of currently available and new vaccines is 95 and 75 percent, respectively, iii) the expected frequency of serious side effects from vaccination is between 100 and 10,000 fold lower for new than for existing vaccines, depending on modes of action. CONCLUSIONS: Despite the very low likelihood for a smallpox outbreak, the potentially large consequences combined with the protective effect of vaccination make maintenance of the smallpox vaccine stockpile justified and valuable. For vaccination in the face of a smallpox outbreak, a high efficacy rather than a lowered rate of adverse effects would maximize the number of lives saved.

[Biological warfare and terror: prevention and countermeasures]. / Biologisk krig og terror: forebyggelse og imødegåelse.

Biological weapons are the most commonly used weapons of mass destruction. Serious international concerns exist about their use by non-state actors, and such use is facilitated by developments in biotechnology. In Denmark, counter-proliferation is served by a new biosecurity act and the establishment of a new biosecurity authority. Aspects of biopreparedness have also been strengthened. International collaboration is necessary in order to enhance both the security measures aimed at avoiding the misuse of science but also to enhance societal resilience if potentially devastating biological attacks should occur.

Assessment tools in support of epidemiological investigation of airborne dispersion of pathogens.

Human health threats posed by airborne pathogens are difficult to handle for healthcare responders due to the fact that the contaminated area is not immediately recognizable. By means of wind dispersion modeling, it is possible to estimate the extent and geographical position of hazardous areas and health impact. Contemporary modeling tools can run on standard PCs, with short processing time and with easy-to-use interfaces. This enables health professionals without modeling experience to assess consequences of dispersion incidents, for example, from accidental releases from industries, shedding of pathogens from infectious animals or humans, as well as intentional releases caused by terrorist activity. Dispersion assessments can provide response managers with a chance to get on top of events. In the absence of modeling, reliable estimates of hazard areas may not be available until no earlier than the appearance of the first cases or after time-consuming sampling and laboratory analysis. In this article, the authors describe the concept of using wind dispersion assessments in epidemiological field investigations of naturally occurring disease outbreaks, as well as for bioterror scenarios. They describe the specifications of user friendly and real-time functional wind dispersion modeling systems that can serve as decision support tools during outbreak investigations and outline some of the currently available software packages.

Biosecurity in Scandinavia.

This article investigates the extent to which biosecurity measures are recognized and have been implemented in the Nordic countries, in the absence of formalized security standards and legislation. Two trials were undertaken: first, a broad combined biosafety and biosecurity questionnaire survey of the Nordic countries, and, second, a focused on-site audit of 22 facilities, with 94 laboratories, in Denmark. Both trials indicated that external security had been partially implemented but that little attention had been paid to internal security and the establishment of biosecurity. It was demonstrated that the backgrounds and identities of insiders were rarely checked and that they could have gained access to both pathogen inventory lists and freezers in many facilities. In 81% of pathogen-containing facilities, pathogens were not routinely and centrally accounted for. The authors recommend the establishment of a legal framework congruent with international standards and obligations; novel governmental national biosecurity authorities, requiring a fusion of both microbiological and technical expertise and legislative powers; and the formulation of a new code of conduct termed "Good Biosecurity Practice."

[Biological weapons and biological defence in Denmark]. / Den biologiske trussel og det biologiske beredskab i Danmark.

Biological weapons have been known for centuries, and since World War II, offensive programs have accelerated the development of these weapons considerably. The anthrax attacks in the fall 2001 and speculations regarding the research and development of Iraqi bioweapons have been causes for concern. The effect of biological weapons may be overwhelming, in particular when one is dealing with a contagious agent. The National Centre for Biological Defence provides a preparedness capability through evidence-based research and practical operational capabilities.

[Viral vectors for clinical gene therapy]. / Virale vektorer til klinisk genterapi.

The first positive clinical results of gene therapy trials have now become evident. The relatively few positive results and the numerous negative trials make it possible to identify both problems and potential for new development. The biggest problems have come from the viral vectors used for gene transfer. Most of the successful gene therapy trials have involved monogenetic diseases, where the relevant tissue has been isolated ex vivo, and where a retroviral vector has been inserted into the therapeutic gene in the nuclear DNA. Gene therapy seems to have a definite therapeutic potential in several rare, inherited diseases and also in certain acquired diseases, such as ischaemic heart disease.