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辉瑞公司或已研发出新冠病毒候选疫苗

  • 责任编辑:siyu.zhang
  • 来源:互联网
  • 时间:2020-09-16 16:08:20

  新冠病毒的进展受到了全球人民的关注,近日辉瑞公司表示自己可能研制出了候选新冠病毒疫苗,具体情况一起看看吧。

  辉瑞公司(Pfizer)将试验范围扩大至4.4万人,称有可能研制出新冠病毒候选疫苗

  Karen Weintraub,《今日美国》,2020年9月15日美国东部时间晚上8:27

  辉瑞公司是新冠病毒疫苗研发的领先者之一,该公司表示,其候选疫苗看起来是安全的,预计下个月将有数据显示该疫苗对人类预防冠状病毒的效果如何。

  辉瑞公司首席执行官阿尔伯特·布尔拉周二说,他有意透露更多关于COVID-19候选疫苗的信息,而不是其他正在研发的疫苗,因为他希望整个过程公开透明。

  “透明度是必须的,特别是考虑到这种情况和疫苗的政治化,”他在与记者的问答中说。

  公司周六说,这是扩大试验从30000年到44000年人们包括青少年,年龄16 -以及患有疾病,如艾滋病、甲型肝炎,B或c .周二,Bourla说发生扩张,因为疫苗似乎是非常安全的,审判可以扩大没有延迟时间表完成。

  在周二发布的数据中,该公司显示,参与者——无论是年轻人还是老年人——只抱怨轻微的副作用,如头痛和手臂酸痛。数据包括大约6000人;一些人接种了活性疫苗,另一些人接种了安慰剂。该公司正在与德国疫苗开发商BioNTech合作开发名为BNT162的疫苗,但它不知道哪个参与者接种了哪个疫苗。

  辉瑞高管说,一个独立的数据安全委员会确实知道谁接种了活性疫苗,并一直在定期检查以确保没有健康问题。

  辉瑞高级副总裁兼疫苗研发负责人Kathrin Jansen说,试验期间可能出现了一些严重的健康问题,但安全小组已经“得出结论,这些问题都与疫苗无关”。

  她说,更大的数量还应使公司能够更密切地关注参与者的亚群,比如那些有潜在健康问题的人,比如那些感染了艾滋病病毒的人,以及那些在接种疫苗时感染了病毒的人。

  关于疫苗安全性和有效性的最终报告将于下个月提交监管机构进行审查。

  疫苗必须至少有50%的有效性——平均保护至少一半的服用者——才能获得联邦政府的批准并向公众开放。辉瑞目前在美国的三个工厂——密歇根州的卡拉马祖、密苏里州的圣路易斯和马萨诸塞州的安多佛——以及德国和比利时生产BNT162。

  目前还不清楚这种疫苗的保护作用能持续多久。该公司首席科学长迈克尔?多尔斯滕(Mikael Dolsten)博士说,公司正在为三种可能做准备:人们需要每年注射一次疫苗,就像流感一样;人们需要每隔几年注射一次疫苗,就像破伤风一样;

  “我们认为这种疫苗有可能提供合理和良好的保护,但是我们需要监测它,”Dolsten说。“我们有理由认为,我们可能在未来需要加强,因为这是一场真正的大流行,即使在全球接种疫苗之后,也会有很多病毒在传播。”

  Jansen说,尽管辉瑞公司仍然致力于并“对目前的候选疫苗非常满意”,但该公司已经开始研制第二代疫苗。

  她说,辉瑞希望对下一代疫苗进行两项重大改进:一是不再需要冷藏疫苗,二是改变技术,使疫苗只需要一剂,而不是两剂。

  BNT162使用一种名为信使RNA的技术,这种技术可以训练患者的细胞在导致covid19的冠状病毒表面制造一种蛋白质。一旦免疫系统学会识别这种蛋白质,当它再次看到病毒时就会攻击它。

  詹森说,在下一代疫苗中,她可以设想一种可以自我放大的信使RNA。“有了这样一种方法,你可能只需要一次注射,”这将提供“启动和促进效应”。

  疫苗目前需要冷冻在零下80度,也就是干冰的温度。辉瑞公司通过将BNT162装在保持超冷温度的冷却器中运输来实现这一目标。辉瑞生物制药集团(Pfizer Biopharmaceuticals Group)总裁黄燕(Angela Hwang)说,可以在冷却器中加入干冰,让疫苗冷冻15天,然后再冷藏5天,然后进行稀释和注射。

  黄禹锡说,由于该公司预计对疫苗的需求会很大,而且它现有的运输网络是高效的,因此她预计疫苗不会受到热损伤。她说:“没有一剂药会放很长时间。”

  但第二代疫苗不需要如此寒冷的条件将是一个改进,Dolsten说。

  在为期两天的投资者会议结束时,布拉对COVID-19疫苗和药物开发的政治化表示遗憾。

  但他说,他认为制药业正在“奋起应对”疫情,并希望这最终将提升制药业的公众形象。

  他说:“我不想仅仅因为我们将带来一种有效的疫苗或治疗方法就宣布我们取得了任何胜利,我们将回到我们应该回到的地方,但是我认为这将是非常好的一步。”“然后我们需要继续做正确的事情。”

  在问答结束时,他有一个结论:“科学将获胜,”他说。

  附上原文,以供参考,拒绝转载,侵权必删:

  Pfizer reports 'potential' with COVID-19 candidate vaccine after expanding trial to 44,000 people

  Karen Weintraub, USA TODAYPublished 8:27 p.m. ET Sept. 15, 2020

  Pfizer, one of the frontrunners in the quest for a COVID-19 vaccine, said its candidate vaccine is looking safe, and the company expects to have data next month on how well it is protecting people against the coronavirus.

  Pfizer CEO Albert Bourla said Tuesday that he is intentionally revealing more information about the COVID-19 candidate vaccine than he would about any other vaccine under development, because he wants the process to be open and transparent.

  "Transparency is a must, particularly given this situation and the politicization of the vaccine," he said in a Q&A with journalists.

  The company had said Saturday that it was expanding its trial from 30,000 to 44,000 people to include teenagers, ages 16-18, as well as people with diseases such as HIV, and hepatitis A, B, or C. Tuesday, Bourla said the expansion took place because the vaccine appeared to be extremely safe, and the trial could be expanded without delaying the timeline for completion.

  In data released Tuesday, the company showed that participants – both younger people and senior citizens – complained of only minor side effects, such as headaches and sore arms. The data included about 6,000 people; some who received the active vaccine and other the placebo. The company, which is developing its vaccine, called BNT162, in collaboration with German vaccine developer BioNTech, does not know which participant got which.

  An independent Data Safety Commission does know who got the active vaccine and has been checking regularly to make sure there are no health concerns, Pfizer executives said.

  There likely have been some serious health issues during the trial, but the safety panel has "concluded that none are vaccine related," said Kathrin Jansen, Pfizer senior vice president and head of vaccine research and development.

  The larger numbers should also allow the company to look more closely at subgroups of participants, such as those with underlying health conditions like HIV, and those who had the virus when they received the vaccine, she said.

  A final report on the safety and effectiveness of the vaccine should be ready for regulators to review next month.

  The vaccine must be at least 50% effective – protecting on average at least half the people who take it – for it to win federal approval and be given to the public. Pfizer is currently manufacturing BNT162 in three plants in the U.S. – in Kalamazoo, Michigan, St. Louis, Missouri, and Andover, Massachusetts – as well as in Germany and Belgium.

  It is not yet clear how long the vaccine's protection will last. The company is preparing for three possibilities: that people will need an annual shot as with the flu, that they will need a vaccine every few years, as with tetanus, or that it will be one-and-done, like the polio vaccine, said Dr. Mikael Dolsten, the company's chief scientific officer.

  "We think this vaccine has the potential to give reasonable and good protection, but we need to monitor [it]," Dolsten said. "It's reasonable also to assume that we need maybe in the future a boost, because this is a real pandemic and there's going to be a lot of virus circulating even after global [vaccination] campaigns."

  Jansen said that although Pfizer is still committed to and is "very happy with its current vaccine candidate," the company is already working on a second generation.

  Pfizer hopes to make two significant improvements with the next generation, she said: eliminating the need to keep the vaccine frozen, and altering the technology so only one dose will be needed, instead of two.

  BNT162 uses technology called messenger RNA, which trains the person's cells to make a protein on the surface of the coronavirus that causes COVID-19. Once the immune learns to recognize this protein, it will attack when it sees it again on the actual virus.

  In a next-generation vaccine, Jansen said, she could envision a messenger RNA that could amplify itself. "There may be an opportunity that with such an approach, you would be able to only need a single shot," that would provide both "the priming and the boosting effect."

  The vaccine currently needs to be kept frozen at minus-80-degrees, the temperature of dry ice. Pfizer is making that work by shipping BNT162 in coolers that maintain the ultra-cold temperature. The cooler can be fed with dry ice to keep the vaccine frozen for 15 days, and then it can be refrigerated for up to five more days before being diluted and injected, said Angela Hwang, president of the Pfizer Biopharmaceuticals Group.

  Because the company expects high demand for the vaccine, and because its existing shipping network is efficient, Hwang said she does not expect the vaccine to suffer heat damage. "No dose is going to be lying around for very long," she said.

  But a second generation vaccine that did not require such cold conditions would be an improvement, Dolsten said.

  Bourla, speaking at the end of a two-day conference for investors, bemoaned the politicization of COVID-19 vaccine and drug development.

  But he said he thinks the pharmaceutical industry is "rising to the occasion" of the pandemic, and hopes that will eventually boost the industry's public image.

  "I don't want to declare any victory, just because we're going to bring a vaccine or a treatment that works, that we're going to come back to where we deserve to be, but I think it will be a very good step," he said. "Then we need to continue doing the right thing."

  He had one concluding thought as he ended the Q&A: "Science will win," he said.

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

  Author:Karen Weintraub

  以上就是新冠病毒的最新情况介绍了,希望对大家了解辉瑞公司对新冠病毒疫苗的研制有所帮助。


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