辉瑞宣布其新冠疫苗有效率超过90%，这意味着什么？

美国辉瑞制药公司周一宣布，其研制的新冠病毒疫苗有效率超过90%，这一结果被认为是在抗击新冠大流行过程中的取得的一项重要成果。

这款新冠疫苗由辉瑞公司与德国生物科技公司BioNTech共同开发。虽然目前没有证据证实疫苗能提供多长时间的免疫力，但BioNTech公司CEO Ugur Sahin称，疫苗的保护期有望持续一年。

卫生专家们称，辉瑞疫苗显示出了正确的免疫反应，证实了新冠病毒可以通过疫苗接种阻断传播，这对于目前处在研发过程中的其他疫苗来说也是十分积极的消息。

Drug company Pfizer has said its experimental COVID-19 vaccine is more than 90 percent effective, an announcement that is being greeted as a major victory in the fight against the coronavirus pandemic. 

Pfizer and German partner BioNTech are the first drug makers to release successful data from a large-scale clinical trial of a vaccine, with their analysis showing a much better performance than most experts had hoped for from coronavirus vaccines. 

While questions remain about for how long the vaccine will provide protection, BioNTech CEO Ugur Sahin said he was optimistic its immunisation effect would last for a year.

With the companies set to seek authorization for the vaccine's emergency use this month, Albert Bourla, Pfizer's chairman and CEO, described it as "a great day for science and humanity."

"We are reaching this critical milestone in our vaccine development program at a time when the world needs it most, with infection rates setting new records, hospitals nearing overcapacity and economies struggling to reopen."

Health experts say Pfizer's results were positive for all vaccines currently in development, showing the inoculations were going after the right target and proof that the coronavirus can be halted through vaccination.

"It is a relief to see such positive results on this vaccine and it bodes well for COVID-19 vaccines in general," said Peter Horby, professor of emerging infectious diseases at the University of Oxford. "This news made me smile from ear to ear."

Distribution

在获得约4.4万人规模的临床试验的安全性数据后，辉瑞将向美FDA提交紧急使用授权，目前预计将在11月下旬进行。

美国政府已经与辉瑞和BioNTech公司签署了价值19.5亿美元的一亿剂疫苗订单。欧盟委员会主席冯德莱恩称，欧盟委员会将很快与辉瑞和和BioNTech签署购买三亿剂疫苗的合同。其他国家包括英国、加拿大和日本也有意向购买该疫苗。

这两家药企预计，如果获批成功，他们今年可以生产多达5,000万剂疫苗，足以给2,500万人接种，而在2021年疫苗产量将达到13亿剂。 

试验中期分析显示，疫苗有效率超过了90%，这远远超出了美国食品和药物管理局（FDA）所设置的50%有效率的门槛。

为了进一步确认疫苗有效程度，辉瑞公司表示将继续试验。该试验数据尚未经过同行评估，也还未发表在医学期刊上。

Pfizer is set to seek broad U.S. authorization for emergency use of the vaccine, but will first need two months of safety data from about half the study's 44,000 participants, which is expected late this month.

"I'm near ecstatic," Bill Gruber, one of Pfizer's top vaccine scientists, said in an interview. "This is a great day for public health and for the potential to get us all out of the circumstances we're now in."

Pfizer and BioNTech have a $1.95 billion contract with the U.S. government to deliver 100 million vaccine doses beginning this year and have also discussed supply agreements with the European Union, the UK, Canada and Japan.

The EU on Monday was set to sign a contract for 300 million doses of the vaccine, the head of the European Commission Ursula von der Leyen announced on Twitter on Monday.

The companies started manufacturing the vaccine before being sure of its effectiveness, in order to save time. They are now set to produce up to 50 million doses this year, enough to protect around 25 million people, alongside 1.3 billion doses in 2021.

The companies' interim analysis was conducted after 94 participants in the trial developed COVID-19, and examined how many of them had taken the vaccine versus a placebo. More than 90 percent effectiveness implies that no more than eight of the 94 people who caught the virus had been given the vaccine.

With the U.S. Food and Drug Administration only requiring 50 percent effectiveness for a coronavirus vaccine, the Pfizer shot has exceeded expectations. 

To confirm the efficacy rate, Pfizer said it would continue the trial until there were 164 COVID-19 cases among participants, expected to be completed before the end of November, but the data will first have to be peer-reviewed or published in a medical journal.

Market surge

受辉瑞版新冠疫苗试验结果激励，欧美股市大涨，标普500指数创下历史新高，旅游股持续拉涨。辉瑞公司和其他新冠疫苗研发已经进入临床III期试验的药企股票都有所上涨。

The prospect of a vaccine has boosted global stock markets, with the S&P 500 futures hitting a record high and travel and tourism shares trending upwards.

Conversely, shares in companies that have boomed during the pandemic dropped, including conferencing platform Zoom Video Communications, which was down 12 percent at one stage.

Pfizer shares were up around 7 percent in early trading in New York, while BioNTech's stock was up nearly 23 percent in Frankfurt. "Light at the end of the tunnel. Let's just hope the vaccine deniers won't get in the way, but 2021 just got a lot brighter," said Neil Wilson, chief market analyst at Markets.com.

Shares of other drug makers in the final stage of vaccine testing also rose, with Johnson & Johnson up 4 percent in pre-market trading and Moderna up 7.4 percent.

"The efficacy data are really impressive. This is better than most of us anticipated," said William Schaffner, an infectious diseases expert at Vanderbilt University School of Medicine, Nashville, U.S.. "The study isn't completed yet, but nonetheless the data look very solid."

The world reacts

美国现任总统唐纳德·特朗普发布推文称试验结果是“非常棒的消息”。乔·拜登也对辉瑞疫苗进展表示赞许，但仍呼吁美国民众配戴口罩，保持社交距离，因为距离疫苗普及可能还要好几个月时间。

英国首相鲍里斯·约翰逊则对依赖疫苗解决当前的疫情问题表示审慎乐观。

德国卫生部长延斯·斯帕恩认为，虽然辉瑞的消息让人振奋，但他预计疫苗须等到2021年第一季度才能真正投向市场。这一观点得到了世卫组织助理总干事布鲁斯·艾尔沃德的呼应，他预计疫苗将在明年三月推出，并可能从根本上改变疫情发展方向和态势。 

Current U.S. president Donald Trump welcomed the news of the test results and the market boost on Twitter: "Stock market up big, vaccine coming soon. Report 90% effective. Such great news!"

Projected president Joe Biden said the news was excellent, but stressed that other measures including face masks and social distancing would be needed well into next year.

In Europe, UK Prime Minister Boris Johnson said that, while Britain was ready to roll out a mass vaccination program, it was too early to rely on a vaccine as a solution to the coronavirus.

"We've talked for a long time, about the distant bugle of the scientific cavalry coming over the brow of the hill," Johnson told a media conference: "I can tell you tonight that today, that toot, that bugle, is louder, but it's still some way off. We absolutely cannot rely on this news, as a solution." 

Despite urging similar caution, England's deputy chief medical officer, Jonathan Van-Tam, added the UK "could begin to see some vaccine by Christmas."

Germany's health minister, Jens Spahn, while encouraged by the Pfizer announcement, said he did not expect a shot to be available before the first quarter of 2021.

This thinking was echoed by senior World Health Organization (WHO) official Bruce Aylward, who said a vaccine could be rolled out for the most vulnerable by March 2021, adding that such a development could "fundamentally change the direction and dynamic of this crisis."  

While about 200 COVID-19 vaccine candidates are in development globally, with dozens in human clinical trials, no shot has actually crossed the finish line and been approved, though the one from Pfizer-BioNTech appears to be on track.

Mirroring projections from the WHO, Germany's Chancellor Angela Merkel said on Sunday that only when 60 to 70 percent of the population had achieved immunity, either through vaccination or having caught the virus, could COVID-19 be deemed to have been "more or less overcome."

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目前全球共有200种候选疫苗处在研发过程当中，据世界卫生组织截至11月3日的统计，目前全球共有47款候选疫苗进入临床试验阶段，其中有10款已经开展了Ⅲ期临床试验。但仍然没有疫苗通过审批。在中国，目前已有4款新冠疫苗的研发进入Ⅲ期临床试验阶段，截至10月共计接种了约6万名受试者，未收到严重不良反应的报告。

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