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美国制药公司寻求FDA批准抗新冠病毒药丸

  • 责任编辑:siyu.zhang
  • 来源:互联网
  • 时间:2021-10-13 15:33:19

  制药商寻求FDA批准抗新冠病毒药丸;德克萨斯州州长格雷格·阿博特采取行动禁止新冠疫苗授权:最新的COVID-19更新

  塞丽娜·蒂博约翰·培根豪尔赫·l·奥尔蒂斯《今日美国》

  默克制药公司和Ridgeback生物治疗公司16日宣布,已向美国食品和药物管理局(fda)申请紧急使用molnupiravir的许可。molnupiravir是一种抗病毒药物,有望很快用药片治疗COVID-19。

  据这些公司介绍,口服抗病毒药物Molnupiravir被用于治疗有恶化为严重COVID-19或住院风险的轻至中度成人COVID-19病例。它是由亚特兰大埃默里大学的研究人员发明的,每天服用两次,每次4片,连续服用5天。

  一项临床试验的中期分析发现,抗病毒药物将住院或死亡的风险降低了约50%。

  自大流行早期以来,公共卫生官员一直希望能找到有效的抗病毒药物,帮助暴露在SARS-CoV-2病毒下的人预防严重感染。已有的几种药物在早期进行了抗病毒测试,但结果显示对患者没有益处。

  今年6月,拜登政府拨出32亿美元用于抗病毒药物的研发,称这些药物将是抗击病毒的关键部分。

  默克公司表示,如果这种药物获得紧急使用授权,它将向美国政府供应大约170万剂molnupiravir,供其分发。

  还有新闻:

  亚马逊(Amazon)周一改变了做法,在一篇博客文章中宣布,它将允许许多科技公司和企业员工无限期地继续远程工作,只要他们在必要时能够通勤到办公室。此前,在1月份办公室重新开放后,大多数员工每周至少要在办公室工作三天。

  葡萄牙成为世界上第一个为85%人口接种COVID-19疫苗的国家。

  据密歇根州立大学官员称,该校近90%的学生、教职员工已经接种了COVID-19疫苗。

  由于对冠状病毒的担忧,第125届波士顿马拉松赛从传统的4月开始,于周一举行,比往常规模更小、更低调,但终点很熟悉——男子和女子比赛都是肯尼亚人参加的。大约有2万名赛跑者,比往年少了1万人,而且一波一波地开始。沿途的人群被要求搁置为参赛者提供食物和饮料的传统。

  泰国总理巴育(Prayuth Chan-ocha)周一表示,从下个月开始,泰国将不再要求来自至少10个低风险国家(包括美国)的国际游客进行隔离,前提是他们已经完全接种了COVID-19疫苗。

  今天的数据:根据约翰霍普金斯大学的数据,美国已经记录了超过4440万例COVID-19确诊病例,超过713900例死亡。全球总数:超过2.382亿例病例和485万人死亡。根据美国疾病控制与预防中心的数据,超过1.87亿美国人(占总人口的56.4%)已全面接种疫苗。

  阅读内容:有一段时间,美国的疫苗推出令世界许多国家羡慕不已。从那时起,美国成为全球疫苗接种的落后者,其人口接种比例低于其他几十个国家。供应不是问题所在——复杂而混乱的需求不足才是问题所在。

  请不断刷新本页以获取最新消息。想要更多吗?注册《今日美国》的冠状病毒观察通讯,直接收到收件箱的更新,并加入我们的Facebook群组。

  德克萨斯州州长格雷格·阿博特下令禁止新冠疫苗的授权

  公开反对疫苗和口罩规定的德克萨斯州州长格雷格·阿博特(Greg Abbott)周一发布了一项行政命令,禁止该州对疫苗的要求,进一步加大了反对力度。

  该命令禁止任何实体强制州居民接种疫苗,“包括出于个人良知、基于宗教信仰或医疗原因(包括COVID-19之前的康复)反对接种疫苗的雇员或消费者”。

  阿博特还要求德克萨斯州立法机构将这一禁令列入议程,在第三届特别会议上审议,并使之成为法律。

  在该国许多地区,将接种疫苗作为就业条件已被证明有效地说服了那些不愿接种疫苗的人,但阿博特坚持认为,不应强制实施这一规定。

  他说:“COVID-19疫苗是安全、有效的,是我们对病毒的最佳防御,但应该是自愿的,而不是强制的。”

  世卫组织可能会建议老年人或免疫功能低下者增加剂量

  世界卫生组织(who)一直坚决反对对普通民众进行加强注射,认为这些剂量的COVID-19疫苗应该送到疫苗接种率低的国家。但这群人似乎愿意给最脆弱的人额外一击。

  为世界卫生组织提供建议的一个专家小组建议,老年人和免疫系统受损的人应定期服用额外剂量的维生素d,这与包括美国、英国和法国在内的许多富裕国家已经向其人口推荐的剂量一致。

  世界卫生组织疫苗主任凯特·奥布莱恩(Kate O 'Brien)博士说,目标是产生免疫反应,保护这些人免受严重疾病、住院和死亡的影响。她说,第三剂疫苗应该在第二剂疫苗之后的一到三个月注射,并强调这一建议不适用于健康的、对疫苗免疫反应正常的年轻人。

  威斯康星州的一位母亲在她的儿子被感染后起诉了学区

  威斯康星州一名妇女对沃基夏学区和学校董事会提起联邦诉讼,称她的儿子在接触了一名有COVID-19症状的同学后生病了,因为该学区缺乏缓解协议。律师弗雷德里克·梅尔姆斯代表香农·詹森和其他家长以及华克夏学区的K-12学生提起了诉讼。

  该诉讼称,委员会取消了2020-21学年大部分时间实施的口罩要求和其他许多COVID-19缓解措施。学校官员拒绝置评。

  ——亚历克·约翰逊,《密尔沃基哨兵报

  伊维菌素之战在纽约州展开

  纽约州处于一场关于使用抗寄生虫药物伊维菌素治疗COVID-19患者的全国性法律战的前线。法庭记录显示,至少有14起诉讼试图迫使纽约的医院给病情严重的COVID-19患者使用该药。在大多数情况下,在其他治疗失败后,许多病人的家人起诉医院试图使用伊维菌素来拯救他们的父母或配偶,他们中的许多人靠呼吸机维持生命。医院和医生对此表示反对,部分理由是,在药物的安全性和有效性问题上,法官否决了卫生官员的决定,可能会产生深远的伦理和医学后果。点击这里了解更多内容。

  达奇斯县的一名妇女指出,她63岁的丈夫是罕见的COVID-19疫苗突破性感染导致严重疾病的人之一。

  她说:“我丈夫做了联邦政府、纽约州政府和卫生部门要求他做的所有事情。”“他应该得到活下去的机会。”

  父母渴望给孩子接种疫苗;儿科医生要求耐心

  随着辉瑞生物技术公司(Pfizer-BioNTech)于上周四正式提交用于5至11岁儿童的新冠疫苗申请,2800多万名儿童可能在万圣节前后有资格接受疫苗接种,儿科医生和药剂师正准备迎接拥挤的局面。但专家们说,在食品和药物管理局(FDA)预期的批准后,家长们需要准备等待几天,同时系统会为这个年龄段的孩子准备新的低剂量配方。

  新泽西州纽瓦克大学医院的首席执行官Shereef Elnahal博士说:“很可能会有一段时间供不应求,这与我们去年12月看到的成人用药情况非常相似。”

  ——Elizabeth Weise,《今日美国

  在加州,学校对新冠病毒的规定不一致是常态

  虽然加州对所有学校都有一些全州范围内的要求,比如要求所有公立和私立学校的教师和学生在室内都要戴口罩,并从10月中旬开始对教师实施疫苗或测试规定,但许多其他细节都留给了当地学校官员。这包括谁、何时、何地和如何检测COVID-19,以及不断变化的隔离规则。

  洛杉矶、旧金山和奥克兰等一些大城市告诉学生在户外休息时要戴口罩,而其他许多地区则不这样做。一些学校有严格的强制性现场COVID-19检测项目,但许多学校没有。

  在整个州,希望看到更多考试的家长们都把洛杉矶联合学区——全国第二大学区——作为榜样。洛杉矶学区有一个雄心勃勃的计划,要求60万名学生和7.5万名员工每周进行现场测试。

  萨曼塔·本顿(Samantha Benton)是两个孩子的母亲,住在萨克拉门托(Sacramento),这里只提供自愿测试。她说:“像洛杉矶这么大的学区都能做到这一点,真是太疯狂了,而我们在这里只是在无所事事。”

  贡献:美联社

  附上原文,以供参考,拒绝转载,侵权必删:

  Drugmakers seek FDA clearance for antiviral pill; Texas Gov. Greg Abbott moves to ban vaccine mandates: Latest COVID-19 updates

  Celina TeborJohn BaconJorge L. Ortiz USA TODAY

  Pharmaceutical companies Merck & Co. and Ridgeback Biotherapeutics announced Monday they requested emergency use authorization to the Food and Drug Administration for molnupiravir, an antiviral drug that offers the promise that COVID-19 could soon be treated by a pill.

  Molnupiravir, an orally ingested antiviral pill, is used to treat mild to moderate adult cases of COVID-19 that are at risk of worsening to severe COVID-19 or hospitalization, according to the companies. It was created by researchers at Emory University in Atlanta and is given as four pills taken twice a day for five days.

  An interim analysis from a clinical trial found the antiviral medicine reduced the risk of hospitalization or death by approximately 50%.

  Since early in the pandemic, public health officials have hoped for effective antivirals that could help prevent severe infection in people exposed to the SARS-CoV-2 virus. Several existing drugs were tested against the virus early on but shown to have no benefit for patients.

  In June, the Biden administration allocated $3.2 billion toward the development of an antiviral, saying the drugs would be a crucial part of the fight against the virus.

  If the medicine receives emergency use authorization, Merck says it will supply about 1.7 million doses of molnupiravir to the U.S. government for distribution.

  Also in the news:

  Amazon reversed course Monday and announced in a blog post that it will allow many tech and corporate workers to continue working remotely indefinitely as long as they can commute to the office when necessary. Previously, most employees were expected to work in the office at least three days a week after offices reopened in January.

  Portugal became the world's first country to vaccinate 85% of its population against COVID-19.

  Nearly 90% of students, faculty and staff at Michigan State University have been vaccinated for COVID-19, according to university officials.

  The 125th Boston Marathon, moved from its traditional April date because of coronavirus concerns, was a bit smaller and more subdued than usual Monday but featured a familiar finish – with Kenyans claiming the men's and women's races. The field of about 20,000 runners was 10,000 less than previous years and started in waves. Crowds along the route were asked to shelve the tradition of offering food and drinks to the runners.

  Thailand will no longer require international visitors from at least 10 low-risk nations – including the U.S. – to quarantine beginning next month if they are fully vaccinated for COVID-19, Prime Minister Prayuth Chan-ocha said Monday.

  Today's numbers: The U.S. has recorded more than 44.4 million confirmed COVID-19 cases and more than 713,900 deaths, according to Johns Hopkins University data. Global totals: More than 238.2 million cases and 4.85 million deaths. More than 187 million Americans – 56.4% of the population – are fully vaccinated, according to the CDC.

  What we're reading: For a time, the U.S. vaccine rollout was the envy of much of the world. Since then, the United States has become a global vaccine laggard, the percentage of its population inoculated lower than dozens of other nations. Supply isn’t the problem — a complicated and confounding lack of demand is to blame.

  Keep refreshing this page for the latest news. Want more? Sign up for USA TODAY's Coronavirus Watch newsletter to receive updates directly to your inbox and join our Facebook group.

  Texas Gov. Greg Abbott orders ban on COVID-19 vaccine mandates

  Texas Gov. Greg Abbott, an avowed opponent of vaccine and mask mandates, doubled down Monday when he issued an executive order banning vaccine requirements in the state.

  The order forbids any entity to compel vaccination of state residents, "including an employee or consumer, who objects to such vaccination for any reason of personal conscience, based on a religious belief, or for medical reasons, including prior recovery from COVID-19.''

  Abbott also asked the Texas legislature to add the ban as an agenda item to be considered during its Third Special Session and make it a law.

  Making vaccination a condition of employment has proven effective at convincing those who are reluctant to get the shots in many parts of the country, but Abbott maintains they should not be mandatory.

  "The COVID-19 vaccine is safe, effective, and our best defense against the virus, but should remain voluntary and never forced," he said.

  WHO may recommend extra dose for those older or immunocompromised

  The World Health Organization has steadfastly opposed booster shots for the general population, arguing that those doses of COVID-19 vaccines should go to countries with low vaccination rates. But the group appears open to an extra shot for the most vulnerable.

  An expert group advising the WHO has recommended that older people and those with compromised immune systems get an extra dose as part of their regular schedule, in line with what many wealthy countries including the U.S., Britain and France have already recommended for their populations.

  The WHO’s vaccines director, Dr. Kate O’Brien, said the objective would be to produce an immune response to protect those people from severe disease, hospitalization and death. She said the third dose should be given between one to three months after the second and emphasized that the recommendation does not apply to healthy, younger adults who have a normal immune response to vaccination.

  Wisconsin mother sues school district after her son is infected

  A Wisconsin woman has filed a federal lawsuit against the Waukesha School District and school board saying her son got sickafter being exposed to a classmate who had COVID-19 symptoms because of the district's lack of mitigation protocols. Attorney Frederick Melms filed the lawsuit on behalf of Shannon Jensen and other parents and K-12 Waukesha School District students.

  The board removed a mask requirement and many other COVID-19 mitigation measures that were in place for most of the 2020-21 school year, according to the lawsuit. School officials declined to comment.

  – Alec Johnson, Milwaukee Journal Sentinel

  Ivermectin battle being waged in New York state

  New York state is on the front lines of a national legal battle over the use of an anti-parasitic drug, ivermectin, to treat COVID-19 patients. At least 14 lawsuits have sought to force New York hospitals to administer the drug to severely ill COVID-19 patients, court records show. In most cases, family members of patients, many of them kept alive by breathing machines, sued hospitals to try to use ivermectin to save their parent or spouse after other treatments failed. Hospitals and doctors are opposed, citing in part the potentially far-reaching ethical and medical ramifications of judges overruling health officials on the safety and effectiveness of drugs. Read more here.

  One Dutchess County woman noted her husband of 63 years was among the rare COVID-19 vaccine breakthrough infections that resulted in a serious illness.

  “My husband has done everything he was told to do by the federal and New York state governments and health departments,” she said. "He deserves an opportunity to live.”

  Parents eager to vaccinate their kids; pediatricians ask for patience

  With an official application submitted last Thursday for the Pfizer-BioNTech COVID-19 vaccine to be used on children ages 5 to 11, more than 28 million kids could become eligible to receive the shot around Halloween, and pediatricians and pharmacists are bracing for a crush. But parents need to be prepared to wait a few days after the FDA gives its expected go-ahead, experts say, while the system gears up to give the new lower-dosage formulation for that age group.

  “There is probably going to be a period of time where demand exceeds supply, very similar to what we saw in doses for adults back in December," said Dr. Shereef Elnahal, CEO of University Hospital in Newark, New Jersey.

  – Elizabeth Weise, USA TODAY

  In California, inconsistent school COVID rules are the norm

  While California has a few statewide requirements for all schools, such as requiring all public and private school teachers and students to wear face masks indoors, and a vaccinate-or-test rule for teachers starting in mid-October, many other details are left to local school officials. That includes who, when, where and how to test for COVID-19, and ever-shifting quarantine rules.

  Some large urban districts such as Los Angeles, San Francisco and Oakland tell students to mask up for outdoor recess, while many others do not. Some schools have rigorous on-site mandatory COVID-19 testing programs, but many don’t.

  Across the state, parents who want to see more testing are looking to the Los Angeles Unified School District – the nation’s second-largest – as a model. The L.A. school district has an ambitious program that mandates weekly on-site testing for all 600,000 students and 75,000 employees.

  “It’s crazy that a school district as huge as Los Angeles can pull it off, and we’re just twiddling our thumbs over here,” said Samantha Benton, a mother of two in Sacramento, where only voluntary testing is offered.

  Contributing: The Associated Press

  Source of articles:https://www.usatoday.com/

  Author:Celina TeborJohn BaconJorge L. Ortiz


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