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生物技术公司和辉瑞(Pfizer)公司的基于mRNA的候选疫苗BNT162b2已经被证明在预防Covid-19感染方面有超过90%的有效性(普通流感疫苗也只有70%左右),这项研究始于7月底,对全球43500多名参与者进行了三期研究。
Jefferies的一份研究报告称: 该疫苗候选品的保护率高于预期的70%,也高于美国食品和药物管理局要求的50%。BioNTech联合创始人兼首席执行官Ugur Sahin说:随着试验的继续,BioNTech和辉瑞将继续收集进一步的数据,以进行最终分析。
这些公司估计,在本月的第三周,有关候选疫苗的足够的安全性数据将能够满足FDA对紧急用途潜在授权的要求。他们预计今年全球供应量将达到5000万剂,明年将生产13亿剂。
而在德国合作伙伴BioNTech取得临床成功后,复星制药(Fosun Pharma)股价也得到了飙升。目前,复星正在与监管机构沟通,并努力在获得监管机构批准的情况下,尽快开始衔接临床试验,并在中国大陆推出Covid-19疫苗。
BioNTech and Pfizer’s mRNA-based vaccine candidate BNT162b2 has proven to be more than 90 per cent effective in preventing Covid-19 infections. BioNTech and Pfizer’s mRNA-based vaccine candidate BNT162b2 has proven to be more than 90 per cent effective in preventing Covid-19 infections, based on a global phase-three study on more than 43,500 participants that began in late July, they said in a statement late on Monday.
The vaccine candidate’s protection rate is higher than expectations of 70 per cent and the 50 per cent required by the US Food and Drug Administration, according to a Jefferies research note. BioNTech and Pfizer will continue to collect further data as the trial continues, for a final analysis planned when an accumulative total of 164 confirmed Covid-19 cases has accrued among the participants, said BioNTech co-founder and CEO Ugur Sahin.
The firms estimate that sufficient safety data on the vaccine candidate will be available by the third week of this month to meet the requirements of the FDA for potential authorisation for emergency use. They expect to be able to supply up to 50 million doses this year globally, and manufacture up to 1.3 billion doses next year.
The shares of Shanghai Fosun Pharmaceutical (Group) surged by as much as 20.8 per cent on Tuesday after the success of German partner BioNTech’s Covid-19 vaccine during clinical trials. Currently, Fosun Phama is communicating with regulators, and is striving to be able to start bridging clinical trials and to launch BNT162b2 in mainland China as soon as possible, subject to regulatory approvals. source
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