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第416期
(2020/12/10出刊)
英國搶頭香 批准施打輝瑞新冠疫苗

 On December 2nd, the UK became the first country to approve Pfizer-BioNTech Covid-19 vaccine, leaping ahead of the US and the EU. Vaccinations will start for high-risk groups using 800,000 shots from Pfizer’s manufacturing center in Belgium. The treatment requires two shots, which means about 400,000 Britons will receive the treatment this year. Pfizer has agreed to supply Britain with 40 million shots of vaccine through 2021. The vaccine was developed and introduced in just 10 months, a process which normally takes 10 years.
 The US Food and Drug Administration (FDA) met on December 10th to consider Pfizer’s emergency use request. The agency will meet again on December 17th to look at American drug-maker Moderna’s emergency use request for its vaccine. The US is expected to receive 40 million shots of vaccine from Pfizer and Moderna by the end of this year, enough to vaccinate 20 million people. Health care workers and nursing home residents would be at the front of the line when the first coronavirus vaccine shots become available.
 The European Medicines Agency said it has received emergency use requests from both Pfizer and Moderna. The agency will meet on December 29th and is expected to make the same conclusion with the UK.

 英國十二月二日搶頭香,趕在美國與歐盟之前,成為全球第一個批准使用美國輝瑞與德國BioNTech 合作研發之新冠疫苗的國家。英國將使用輝瑞在比利時生產中心製造的八十萬劑疫苗,優先為高危險族群施打。輝瑞疫苗的療程需要施打兩劑,因此,英國今年將有四十萬人得以接種。輝瑞同意在二○二一年,提供英國四千萬劑疫苗。該疫苗從研發到上市只花了十個月,通常這個過程需要十年之久。
 美國食品藥物管理局在十二月十日開會,評估輝瑞的緊急授權使用申請;十二月十七日會再度開會,評估美國藥廠莫德納研發的疫苗的緊急授權使用申請。這兩家公司預計在今年底前可提供美國四千萬劑疫苗,足以供兩千萬人施打。醫護人員與接受長照的人將是優先接種的對象。
 歐盟藥物管理局表示,已收到輝瑞與莫德納的緊急使用授權申請,將於十二月二十九日開會評估,預料會和英國一樣核准這兩款疫苗。