https://facebook/groups/794657180557181/ According to the World Health Organization (WHO), millions of doses of Ebola vaccine should be ready and available next year. Efficacy trials for two different Ebola vaccines are slated to begin in December. As reported by The Verge:1 “The WHO says that there are no plans to begin a mass vaccination program until at least June 2015, and then only if the growth of the epidemic justifies it.” The vaccine industry has a number of hurdles to conquer before they will stand to make a fortune from an Ebola vaccine however. For starters, vaccine manufacturers are demanding indemnity against lawsuits that may arise from the use of a fast-tracked Ebola vaccine,2 similar to the indemnity claimed by the United Nations (UN), whose peacekeepers stand accused of causing the cholera outbreak in Haiti after the 2010 earthquake that devastated the small country. An estimated 700,000 Haitians have contracted cholera and 8,500 have died from it since the beginning of the outbreak. While the source of the outbreak could not be conclusively determined, a group of Haitians filed a lawsuit against the UN in 2013. A lawyer for the US Justice Department recently called for the case to be dismissed, saying the UN is “absolutely immune” to claims of wrongdoing.3 This is the kind of “immunity” vaccine makers want as well, but indemnity might not be quite as easy to get as initially thought in this case. articles.mercola/sites/articles/archive/2014/11/04/ebola-vaccines.aspx?e_cid=20141104Z1_DNL_art_1&utm_source=dnl&utm_medium=email&utm_content=art1&ut This report completely contradicts the outcome of a meeting held : WHO High-level meeting on Ebola vaccines access and financing 23 October 2014. More than 90 participants, including some of the world’s leading scientists, came, on short notice, from national and university research institutions, also in Africa, government health agencies, ministries of health and foreign affairs, national security councils, and several offices of Prime Ministers and Presidents. Also represented were national and regional drug regulatory authorities, the MSF (Doctors Without Borders) medical charity, funding agencies and foundations, the GAVI alliance for childhood immunization, and development banks, including the African Development Bank, the European Investment Bank, and the World Bank Group. Main conclusions reached The meeting concluded that all efforts to develop, test, and approve Ebola vaccines must be followed through to completion at the current accelerated pace, even if dramatic changes in the epidemic’s transmission dynamics meant that vaccines were no longer needed. “Pursue all vaccines until they fail” The principle of “pursuing all vaccines until they fail” was put forward as awise way to maintain momentum in responding to an emergency of this scale. Representatives from industry acknowledged the investment risks they are willingly undertaking despite knowledge that a vaccine might fail or not be needed in the end. Urgent measures to improve readiness for clinical trials and vaccines. The need for community engagement, mobilization, and preparedness to appreciate and accept the protective power of vaccines received considerable attention. All agreed: work with communities must start now. Urgent priorities included the streamlining and harmonization of regulatory requirements. Determination to finish the job Vaccine companies expressed awareness that a vaccine might not, in the end, be needed. At the same time, they affirmed their absolute determination to see current R&D efforts, clinical trials, and regulatory approval through to completion. First, a booster vaccine may prove essential. Second, as some – perhaps even all – vaccines may fail, the more products in the pipeline, the greater the safety margin. Third, even if the number of new cases were to drop significantly, a vaccine would still be needed to stamp out the disease completely, with full confidence. GSK identified sterile filling capacity as the most critical issue. As the vaccine used a genetically modified organism, sterile filling must be done in a biosafety level 2 facility. Only a few companies have this capacity: GSK, Merck, Sanofi, Novartis, IDT, and Emergent. A lifting of the biosafety level 2 requirement by regulatory agencies would relieve some of the constraints. Liability The meeting concluded that neither affected countries nor industry should be left alone to bear the burden should lawsuits arise following possible adverse reactions to an Ebola vaccine. To respond to this potential problem, a proposal was made to establish a “club” of donors, in collaboration with the World Bank. apps.who.int/iris/bitstream/10665/137184/1/WHO_EVD_Meet_EMP_14.2
Posted on: Wed, 05 Nov 2014 14:51:48 +0000
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