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【drug-news】FDA官员支持首个美国禽流感疫苗
FDA panel endorses first U.S. avian flu vaccine
By Donald G. McNeil Jr. Published: February 28, 2007
The first vaccine against avian flu for the United States has been endorsed by a Food and Drug Administration advisory panel, but merely as a stopgap measure until better vaccines are developed.
The experimental vaccine, made by Sanofi-Pasteur, protected only 45 percent of the 91 people on whom it was tested in a hasty clinical trial. Reaching even that level of protection required 12 times the dose of antigen delivered by a typical flu shot, and required that the treatment be given in two shots several weeks apart. Also, it is based on a virus strain that was circulating in Vietnam three years ago.
Dr. Robert Couch, an advisory panel member from Baylor College of Medicine in Houston, said members knew of better vaccines still in development "but this is the only vaccine we had in front of us."
The panel voted unanimously Tuesday that the vaccine was effective enough to be used.
The FDA usually accepts the recommendations from its expert panels.
Because it would be unethical to infect clinical trial subjects deliberately with a flu that can kill, it is not possible to say accurately how many people the vaccine can save from death or hospitalization, so "45 percent protection" is a bit of a misnomer, the spokesman, Len Lavenda, said.
The closest scientists can get is to draw blood from subjects a month after vaccination and see how many have developed as many antibodies to the target virus as are provoked by a seasonal flu shot to its targets.
The government has plans to stockpile enough H5N1 vaccine to protect 20 million doctors, nurses, paramedics, laboratory technicians and other emergency workers if a pandemic breaks out.
Sanofi does not plan to sell this vaccine to the public; it is developing newer ones, including one based on a later strain from Indonesia, Lavenda said. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 FDA panel endorses first U.S. avian flu vaccine
By Donald G. McNeil Jr. Published: February 28, 2007
FDA委员会认可首个禽流感疫苗
The first vaccine against avian flu for the United States has been endorsed by a Food and Drug Administration advisory panel, but merely as a stopgap measure until better vaccines are developed.
美国首个禽流感疫苗已经获得美国食品药品管理局（FDA）顾问委员会认可，但这只是作为一个权宜之计，FDA期望更好的疫苗出现。
The experimental vaccine, made by Sanofi-Pasteur, protected only 45 percent of the 91 people on whom it was tested in a hasty clinical trial. Reaching even that level of protection required 12 times the dose of antigen delivered by a typical flu shot, and required that the treatment be given in two shots several weeks apart. Also, it is based on a virus strain that was circulating in Vietnam three years ago.
该疫苗由赛诺菲巴斯德公司生产，在一个仓促的临床试验中，该疫苗只能保护45%的受试者（共91人）。而且，要达到这一水平的保护作用，还需要一个典型的流感疫苗的抗原剂量的12倍剂量，注射还分两次进行，第二次注射与首次注射间隔好几个星期。还有，这一疫苗是基于三年前在越南流行的病毒株而研制的。
Dr. Robert Couch, an advisory panel member from Baylor College of Medicine in Houston, said members knew of better vaccines still in development "but this is the only vaccine we had in front of us."
顾问委员会成员、来自休斯顿Baylor医学院的Robert Couch博士说：“虽然委员会成员都知道有更好的疫苗在研发之中，但是当前，我们只有这一种疫苗了。”
The panel voted unanimously Tuesday that the vaccine was effective enough to be used.
委员会于本周二进行了投票，一致通过认为该疫苗是有效可行的。
The FDA usually accepts the recommendations from its expert panels.
通常，FDA都会接受它的专家委员会的提议。
Because it would be unethical to infect clinical trial subjects deliberately with a flu that can kill, it is not possible to say accurately how many people the vaccine can save from death or hospitalization, so "45 percent protection" is a bit of a misnomer, the spokesman, Len Lavenda, said.
用一种可以致命的病毒去感染临床受试者是不道德的，因此不可能准确的说出到底有多少人会由于得到这个疫苗的保护而免于住院或者逃离死亡。因此，发言人Len Lavenda说，“45%”是有点用词不当的。
The closest scientists can get is to draw blood from subjects a month after vaccination and see how many have developed as many antibodies to the target virus as are provoked by a seasonal flu shot to its targets.
科学家能够得到的最接近的数据来自受试者的血液。在疫苗注射后的一个月，从受试者抽取血液检查到底有多少人产生了足够的抗体，而且，针对目标病毒的抗体数量跟普通的流感疫苗的抗体数量相当。
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作者:admin@医学,生命科学 2011-03-01 05:12
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