楼主:
Aqqqa (Aqqqa)
2021-08-11 10:15:17※ 引述《deathdecay (VOID)》之铭言:
: 经济日报
: 编译洪启原/综合外电
: Novavax执行长尔克(Stanley Erck)说:“要让所有的制造、分析、疫苗效力及纯度检
: 验都保持一致、合格且合规,这是耗时的过程。”
: 尔克表示,预计第4季呈交两剂式疫苗的EUA资料给美国食品药物管理局(FDA)。Novavax
: 先前已把这个时程延从第2季延至第3季。
主要是美国政府下令停止在美国制造Novavax, 除非品管都一致, 且通过FDA认证
https://reurl.cc/2rR3vO
节录自Science
Novavax, the small, Maryland-based company that has been struggling for
months to bring its promising protein-based COVID-19 vaccine to market,
announced a setback yesterday in its quest for an emergency use authorization
(EUA) in the United States, sending its share prices tumbling today. The U.S.
government has ordered Novavax to stop making vaccine in the United States
and said it will offer the company no more manufacturing funding until it
passes muster with the Food and Drug Administration’s (FDA’s) strict
manufacturing requirements, such as ensuring each lot of vaccine has the same
potency.
美国很多家新闻媒体都有写
因为各批次品质不稳定
所以退回EUA申请 且严格要求品质的稳定
我们高端虽是系出同门
但一定青出于蓝
所以火速通过EUA