新闻：美国疫苗在望

中文报道：https://finance.sina.com.cn/wm/2020-11-10/doc-iiznezxs1006660.shtml

"11月9日，美国制药巨头辉瑞公司（Pfizer）在官网发布消息称，其与德国生物新技术公司（BioNTech）合作研发的mRNA新冠候选疫苗BNT162b2在没有感染新冠病毒的参与者身上，已经证明了超过90%的有效性，效果好于预期，并且远高于美国食品药品监督管理局（FDA）所要求的50%。

对此，辉瑞公司9日回复澎湃新闻的采访时称，该公司计划在11月的第三周向美FDA提交紧急使用授权，此外预计在2020年将生产5000万剂疫苗，到2021年将生产多达13亿剂疫苗。"

https://www.sohu.com/a/430818396_115362

“上述疫苗在8月初开始了三期临床试验，是在43538名参与者中进行的，目前仅有94例被感染。这4万多人中，约42%的人是不同种族。临床试验数据显示，接种了疫苗的人和接受了安慰剂的人对照表明，在第二剂疫苗接种后7天，疫苗的有效率达到90%以上，这意味着在初次接种疫苗后的28天即可免疫新冠病毒。目前，这款疫苗没有明显的安全问题。在接下来的几周里，该疫苗的三期临床数据，包括有效性和安全性数据将完全公布。”

 

英文: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against

Monday, November 09, 2020 - 06:45am 

• Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
• Analysis evaluated 94 confirmed cases of COVID-19 in trial participants 
• Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected 
• Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November 
• Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints

 

 

https://www.cnn.com/world/live-news/coronavirus-pandemic-11-10-20-intl/index.htm

State health officials in the US have told CNN that they are feeling “overwhelmed” and “daunted” at the prospect of distributing Pfizer's Covid-19 vaccine, should it become widely available soon. 

On Monday, Pfizer announced that early data from its Phase 3 trial showed its vaccine was more than 90% effective. The drug giant could apply for authorization from the US Food and Drug Administration (FDA) as early as this month. 

The vaccine's handling requirements are stringent — it has to be stored at about minus-75 degrees Celsius (minus-103 Fahrenheit), more than 50 degrees Celsius lower than any other vaccine currently on the market in the US.