为加速我 国国内疫苗之研发及查验登记,我们参考欧盟 (EMEA)及美国FDA针对新型流感疫苗(pandemic influenza vaccine)快速查验登记之原则与精神 1-5 , 提出有关国内新型流感疫苗临床试验之浅见,并做 为日后疫苗研发以及快速核准上市的参考依据。
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To date, studies do not show harmful effects from the pandemic influenza vaccine with respect to pregnancy, fertility, or a developing embryo or fetus, birthing or post-natal development.
目前为止,研究并非发现甲流疫苗对孕妇、多次妊娠过的孕妇产生有害作用,也没有发现对胚胎发育、孕妇生产、产后的有害作用。
The snag is that the world's capacity to create a vaccine against pandemic influenza is based on the smaller amounts needed to fight seasonal flu.
现在最大的困难就是:全球需要大量生产疫苗抵抗大范围流感疫情,而当前的生产能力仅能生产很少量用以对付季节性流感。
It takes approximately five to six months for the first supplies of approved vaccine to become available once a new strain of influenza virus with pandemic potential is identified and isolated.
一旦鉴定并分离出具有大流行可能的流感病毒新毒株,大约需要5至6个月时间提供首批获批准的疫苗。
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