2020-11-19 16:01

Pfizer's Covid-19 Vaccine Deliveries Could Start 'Before Christmas' But Only if 'All Goes Positively' V1N世界播



Pfizer Inc and BioNTech could secure emergency U.S. and European authorization for their COVID-19 vaccine next month after final trial results showed it had a 95% success rate and no serious side effects, the drugmakers said on Wednesday. V1N世界播

辉瑞公司(Pfizer Inc.)和生物技术公司(BioNTech)周三表示,在最终试验结果显示其新冠肺炎疫苗成功率为95%且没有严重副作用后,这两家公司下个月可能会获得美国和欧洲的紧急授权。V1N世界播

The vaccine's efficacy was found to be consistent across different ages and ethnicities - a promising sign given the disease has disproportionately hurt the elderly and certain groups including Black people. V1N世界播


The U.S. Food and Drug Administration could grant emergency-use by the middle of December, BioNTech Chief Executive Ugur Sahin told Reuters TV. Conditional approval in the European Union could be secured in the second half of December, he added. V1N世界播

BioNTech首席执行长沙欣(Ugur Sahin)对路透电视(Reuters TV)表示,美国食品和药物管理局(FDA)可能在12月中旬之前批准紧急使用。他补充说,可能会在12月下半月获得欧盟的有条件批准。V1N世界播

"If all goes well I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if all goes positively," he said. V1N世界播


The success rate of the vaccine developed by the U.S. drugmaker and German partner BioNTech was far higher than what regulators had said would have been acceptable. Experts said it was a significant achievement in the race to end the pandemic. V1N世界播


Of the 170 volunteers who contracted COVID-19 in Pfizer's trial involving over 43,000 people, 162 had received a placebo and not the vaccine, meaning the vaccine was 95% effective. Of the 10 people who had severe COVID-19, one had received the vaccine. V1N世界播


"A first in the history of mankind: less than a year from the sequence of the virus to the large-scale clinical trial of a vaccine, moreover based on a whole new technique," said Enrico Bucci, a biologist at Temple University in Philadelphia. "Today is a special day." V1N世界播

费城坦普尔大学(Temple University)的生物学家恩里科·布奇(Enrico Bucci)说:“这是人类历史上的第一次:从病毒序列到疫苗的大规模临床试验不到一年,而且是基于一项全新的技术。”“今天是个特别的日子。”V1N世界播

BioNTech's Sahin said U.S. emergency use authorization (EUA) would be applied for on Friday. V1N世界播


An FDA advisory committee tentatively plans to meet on Dec. 8-10 to discuss the vaccine, a source familiar with the situation said, though the dates could change. The FDA did not respond to requests for comment. V1N世界播




The final trial analysis comes a week after initial results showed the vaccine was more than 90% effective. Moderna Inc on Monday released preliminary data for its vaccine showing 94.5% effectiveness. V1N世界播


"We now have two safe and highly effective vaccines that could be authorized by the Food and Drug Administration and ready to distribute within weeks," U.S. Health and Human Services Secretary Alex Azar said. V1N世界播


The Moderna vaccine is likely to be authorized within seven to 10 days of Pfizer receiving its EUA, U.S. officials said, with states ready to begin distribution within 24 hours. V1N世界播


The better-than-expected results from the two vaccines, both developed with new messenger RNA (mRNA) technology, have raised hopes for an end to a pandemic that has killed more than 1.3 million people and wreaked havoc upon economies and daily life. V1N世界播


The news was especially welcome with the virus again running rampant around the world, setting records for new infections and hospitalizations almost daily. V1N世界播


The Pfizer-BioNTech shot was found to have 94% efficacy in people over age 65, a particularly high-risk group. V1N世界播


"This is the evidence we needed to ensure that the most vulnerable people are protected," said Andrew Hill, senior visiting research fellow at the University of Liverpool's department of pharmacology. V1N世界播

利物浦大学药理学系高级客座研究员安德鲁·希尔(Andrew Hill)说:“这是我们确保最脆弱人群得到保护所需要的证据。”V1N世界播

Global shares rose as the trial results countered concerns around the soaring infection rate. Pfizer shares were up 1.6% while BioNTech jumped 3.8% in the United States. Moderna shares fell 3.6%. V1N世界播


Investors have treated vaccine development as a race between companies, although there is likely to be global demand for as much vaccine as can be produced for the foreseeable future. V1N世界播




Pfizer said it expects to make as many as 50 million vaccine doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021. V1N世界播


While some groups such as healthcare workers will be prioritized in the United States and Britain for vaccinations, it will be months before large-scale rollouts begin in either country. V1N世界播


On Wednesday, Pfizer said it had offered to provide Brazil with millions of doses in the first half of 2021. It also has agreements with the European Union, Germany and Japan where distribution could begin next year. V1N世界播


Mike Ryan, the World Health Organization's top emergency expert, said it would be at least 4-6 months before significant levels of vaccination were taking place around the world. V1N世界播

世界卫生组织(World Health Organization)首席应急专家迈克·瑞安(Mike Ryan)表示,世界各地至少还需要4-6个月的时间才能进行大规模的疫苗接种。V1N世界播

Distribution of a Pfizer-BioNTech shot is complicated by the need to store it at ultra-cold temperatures of -70 degrees Celsius. It can, however, be kept in normal refrigeration for up to five days, or up to 15 days in a thermal shipping box. V1N世界播


Moderna's vaccine can be stored for up to six months at -20C though it is expected to be stable for 30 days at normal fridge temperatures of 2 to 8 degrees Celsius (36°-46°F). V1N世界播




Pfizer said vaccine was well-tolerated and that side effects were mostly mild to moderate, and cleared up quickly. The only severe adverse events experienced by volunteers were fatigue (3.8%) and headaches (2%) after the second dose. Older adults tended to report fewer and milder adverse events. V1N世界播


"These are extraordinary results, and the safety data look good," said David Spiegelhalter, a professor and expert in risk and evidence communication at the University of Cambridge. V1N世界播

剑桥大学(University Of Cambridge)风险与证据交流专家、教授大卫·斯皮格哈尔特(David Spiegelhalter)说:“这是非同寻常的结果,安全数据看起来不错。”V1N世界播

Of the dozens of drugmakers and research groups racing to develop COVID-19 vaccines, the next late-stage data will likely be from AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson said it is on track to deliver data this year. V1N世界播

在竞相开发新冠肺炎疫苗的数十家制药商和研究集团中,下一个后期数据可能来自阿斯利康(AstraZeneca Plc)与牛津大学(University Of Oxford)在11月或12月发布的数据。强生公司(Johnson&Johnson)表示,该公司今年有望提供数据。V1N世界播

Authorization of vaccines for children will take longer. Only Pfizer has started vaccinating volunteers under age 18 and as young as 12. Moderna and J&J have said they hope to start testing the vaccine in younger people soon. V1N世界播


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