Interim Assessement Report
The EMA review was started by the Agency’s Committee for Medicinal Products for Human Use (CHMP) to support decision-making by health authorities. This first interim report includes information on seven experimental medicines intended for the treatment of people infecte...d with the Ebola virus:
BCX4430 (Biocryst);
Brincidofovir (Chimerix);
Favipiravir (Fujifilm Corporation/Toyama);
TKM-100802 (Tekmira);
AVI-7537 (Sarepta);
ZMapp (Leafbio Inc.);
Anti-Ebola F(ab’)2 (Fab’entech).
The amount of information available for the seven treatments is highly variable. For some compounds there is no data from use in human subjects available. A small number of treatments have been administered to patients in the current Ebola outbreak as compassionate use. Finally, there are also medicines included in this review that have already been studied in humans, albeit for the treatment of other viral diseases.
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The immediate objective of the country visit to Cameroon was to ensure that the country is as operationally ready as possible to effectively and safely detect, investigate and report potential Ebola virus disease cases and to mount an effective response that will prevent a larger outbreak. After te...chnical working group meetings, field visits, a “table-top” exercise and a hospital-based simulation exercises were undertaken.
Key strengths and weaknesses were identified, and the following areas for improvement were proposed to the Ministry of Health: coordination, surveillance, contact tracing, infection prevention and control, rapid response teams, case management, social mobilization, laboratory, points of entry, budget, logistics.
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The main objective of this mission was to assess the level of preparedness of Guinea-Bissau in respect of the WHO consolidated checklist. The checklist helps countries to assess and test their level of readiness it is being used to identify concrete action to be taken and where countries will requir...e support from partners. It lists 10 key components and tasks for both countries and the international community that should be completed within 30, 60 and 90 days from the date of issue of the list, with minimal requirements for equipment, material and human resources.
The components include: overall coordination; rapid response teams; public awareness and community engagement; infection prevention and control; epidemiological and laboratory surveillance; contact tracing; points of entry; laboratory; social mobilization and risk communication; budget.
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