25 July, 2009

American Vaccine.


American Vaccine.

أمريكا تبدأ تجارب سريرية على لقاح لأنفلونزا الخنازير


تعتزم الولايات المتحدة بدء تجارب سريرية لقاحين يرجح استخدامهما لعلاج مرض أنفلونزا الخنازير الذي أسفر عن مقتل 700 شخص في جميع أنحاء العالم، وفقاً لما أعلنه معهد الصحة الوطني، «وكالة تابعة لوزارة الصحة والخدمات البشرية الأمريكية».وستشترك ثمانية مستشفيات جامعية في التجارب، والتي ستكثف في إطار سباق الولايات المتحدة لابتكار لقاح يكون جاهزاً قبل تفش جديد محتمل لفيروس إيه (إتش 1 إن 1) المسبب لمرض أنفلونزا الخنازير المحتملة في فصل الخريف، عندما يطل موسم الأنفلونزا برأسه على شمال نصف الكرة الأرضية الغربي.وذكر المعهد أن من المتوقع أن تبدأ التجارب «في المستقبل القريب جداً»، دون أن يقدم تاريخا محددا لذلك، ومن المرجح أن تبدأ تلك التجارب في منتصف آب المقبل.وبعد عزل فيروس أنفلونزا الخنازير، الذي ظهر في المكسيك، وانتشر بسرعة في مختلف أنحاء العالم، وزعت المراكز الأمريكية لمكافحة الأمراض والوقاية منها بزور الفيروس على الشركات المصنعة لتطوير لقاح يطرح للاختبار.وسوف تبحث الدراسات الأولية فيما إذا كانت جرعة أو جرعتين «حجم الجرعة 15 ميكروغرام» من لقاح الفيروس ضرورية لحث جهاز المناعة على العمل لدى متطوعين بالغين «18 إلى 64 سنة» وكبار سن «65 سنة فما فوق».وسيتم إعطاء الجرعات على مدى 21 يوماً حسب وكالة الأنباء الألمانية (د ب أ)، حيث سيتم اختبار لقاحين أنتجتهما شركات «سانوفي باستور» و«سى إس إل»، كما ذكرت المراكز الأمريكية بأنه في حال ظهور بوادر سلامة اللقاحات فسيبدأ تجربتها على الأطفال «6 أشهر إلى 17 عاماً

Swine Flu Vaccine Close To Reality According to Experts

Officials of the Federal government believe that the swine flu vaccine that would protect all Americans from future H1N1 outbreaks would be available by January or late November at the earliest.
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wever, countries outside the United States and other nations that manufacture vaccines would take several years to generate sufficient vaccines to meet global demands.
Although manufacturing of the vaccine is faster than it was a few years back, it may still not be enough to prevent death and illness if the dreaded virus begins to spread and becomes virulent, experts predict.
In the United States, the main obstacle despite long years of effort remains to be the 50-year old technology they use in manufacturing flu vaccines. The Federal government had invested time and billions of dollars shifting to a quicker and more reliable method.
One such procedure involves cultivating the vaccine viruses in vats of cells instead of hen's eggs. There are several small companies that are developing new methods that would pave the way for the creation of large volumes of vaccines in a span of weeks.
Dr. Greg Poland, who is the head of the vaccine research program at the Mayo Clinic, admits that the cell-based cultivation technology is not yet available while the never technologies have not yet been proven to satisfy most experts.
In addition, government officials have also not yet decided on whether or not H1N1 is a potential risk that demands production of vaccine. However, they are implementing the initial steps. Andrin Oswald, Chief Executive of the Vaccine Division of Novartis, revealed that one possible problem would be the manufacture of vaccines for swine influenza could hamper the production of seasonal flu vaccines for the coming winter. The most likely thing to do is to compromise, according to Oswald.
However, Robin Robinson, who manages the Emergency Preparation Research Program of the Department of Health and Human Services, believes that majority of manufacturing efforts of vaccine makers would have been completed by June.
According to Dr. Robinson, if the manufacture of the H1N1 vaccine would commence after that, the first 50 million to 80 million would be ready by September.
Dr. Robinson continued by saying that the entire 600 million doses, which are sufficient to give the required two shots for every American would be available by January. Adding the immune stimulant adjuvant to the vaccine could greatly reduce the required dosage, paving the way for the availability of the doses by the latter part of November.
The vaccine industry in the country is now very much capable of responding to the outbreak than it was five years back, when there were only two vaccine manufacturers and encountered a severe shortage. At present, there are five manufacturers supplying vaccines to the domestic market. The vaccine industry, which is used to be the backwater of the pharmaceutical industry, is generating new investments, as a result of government subsidies and higher cost for vaccines.
Despite of this, a World Health Organization and International Federation of Pharmaceutical Manufacturers and Associations revealed that it would still require four more years of manufacturing to meet global demands for a vaccine that would provide protection against bird flu strain that has been the major concern of health officials over the last few years.
Finally, the Federal government is encouraging manufacturers to shift their production in the United States, since all except Sanofi Aventis is now importing swine flu vaccines.
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