这项临床试验将帮助研究人员评估这些候选药物是否安全，会否产生最强（可以抵御病毒）的免疫反应和剂量是多少。辉瑞计划推进最有希望的候选人。
辉瑞疫苗负责人凯瑟琳说，德国的候选疫苗测试从上个月开始。美国对360人研究可能最早在下个月获得结果，但是该疫苗仍需要在更多的患者中进行进一步的测试。詹森博士说，辉瑞公司将跟踪研究进展，以选择最有希望的疫苗候选者。她说：“要专注于有益的地方，然后继续前进。”这是一种很快的消除方法。如果测试有效，那么疫苗可以最早在秋天准做好紧急应用准备。辉瑞公司首席执行官阿尔伯特·布尔拉（Albert Bourla）上周对《华尔街日报》表示，尽管该公司将继续进行临床试验 。美国政府有权在紧急情况下，在测试完成之前，允许疫苗或药物的有限使用。
几种潜在的冠状病毒疫苗已进入人体测试，包括来自Moderna Inc.和牛津大学的候选药物。与典型的疫苗研发时间表相比，疫苗的工作进展迅速，尽管一些专家对此表示担忧。测试将足够严格，足以充分评估疫苗是否可以安全地保护人们免受伤害感染病毒。费城儿童医院疫苗教育中心主任保罗·奥菲特（Paul Offit）开发了一种针对小儿常见疾病的疫苗，称为轮状病毒，可引起腹泻和呕吐说。“问题是，您要跳过哪些步骤？”
马里兰大学医学院的医学教授KirstenLyke表示，对于这种病毒的免疫力如何发展尚无定论。没有这些知识，研究人员就只能依靠对先前冠状病毒和中和病毒的抗体的了解。
辉瑞表示，辉瑞和BioNTech疫苗最初将在18至55岁的成年人中进行研究，最终将招募年龄较大的志愿者，在接受首剂后，患者将在三周后接受第二剂。詹森博士说，辉瑞公司稍后将测试其他剂量，包括单剂热。每五个研究对象中有四个将获得该疫苗，使用一种称为信使RNA的基于基因的技术。 Messenger RNA或mRNA从DNA传递指令到人体细胞，以制造某些蛋白质。一种从未被批准用于预防任何传染病的mRNA疫苗。
纽约大学朗格健康中心疫苗中心主任Mark Mulligan表示，他不希望挑战患者。“坦率地说，人们已经感染了这种病毒，他们他说：“我们想尽一切力量进行反击。公众认识到，要开始恢复正常，我们必须保护人们，为此对疫苗抱有最大希望。”
研究人员已开始为美国健康志愿者提供由辉瑞公司（Pfizer Inc.）和合作伙伴BioNTech SE开发的实验性冠状病毒疫苗，该最新研究探索了对呼吸道疾病的潜在防御能力。
曼哈顿纽约大学格罗斯曼医学院和巴尔的摩马里兰大学医学院的研究人员周二表示，他们开始向BY JARED S. HOPKINS注射药物
The clinical trial will help the researchers evaluate whether the candidates are safe, which produces the strongest immune response that could fend off the coronavirus and what the dose should be. Pfizer plans to advance the candidate that proves most promising. Testing of the vaccine candidates in Germany began last month.Results from the 360-personstudy in the U.S. could come as early as next month, but the vaccine will still need to undergo additional testing in-more patients, said Kathrine, Pfizer’s head of vaccine research and development.Pfizer will track the progress of the study to pick the most promising vaccine candidate, Dr. Jansen said. The plains to “weed out, weed out,weed out, focus on what’s good and move on,” she said.“It’s a quick elimination.”A vaccine could be ready for emergency use as early as the fall if testing indicates it works safely, Pfizer Chief Executive Albert Bourla told The Wall Street Journal last week, though the company would keep studying it in clinical trials.The U.S. government has the authority to grant limited use of a vaccine or drug during a health emergency, before testing is complete.
Several potential coronavirus vaccines have entered human testing, including candidates from Moderna Inc. And the University of Oxford.The vaccine efforts have advanced quickly compared with typical vaccine R&D timeline,though some experts have expressed concern over whether
testing will be rigorous enough to adequately assess if the shots can safely protect people from
contracting the coronavirus.“The question is, what steps are you skipping?” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, who developed a vaccine for a common disease in young children called rota virus that causes diarrhea and vomiting.Adding to the challenges of deciphering whether a coronavirus vaccine works, researchers say, is uncertainty about how immunity develops against the virus.Without that knowledge, researchers are relying on their understanding of previous corona viruses and antibodies that neutralize viruses, said KirstenLyke, a professor of medicine at the University of Maryland School of Medicine, who is helping lead the Pfizer trial.The Pfizer and BioNTech vaccine will initially be studied in adults 18 to 55 years old, and eventually will enroll older volunteers, Pfizer said.After receiving the first dose, patients will receive a second dose three weeks later.Pfizer will test other doses later on, including a singles hot, Dr. Jansen said.Four out of every five study subjects will get the vaccine,while the remaining subjects will take a placebo.The vaccine uses a genebased technology known as messenger RNA. Messenger RNA, or mRNA,carries instructions from DNA to the body’s cells to make certain proteins. An mRNA vaccine has never been approved to prevent any infectious disease.Mark Mulligan, director of the Vaccine Center at NYU Langone Health, said he doesn’t expect challenges enrolling patients.“People, frankly, are sick of this virus and they want to do whatever they can to fightback,”he said.“The public recognizes that in order to start returning to normalcy,we’ve got to get people protected, and vaccines hold the greatest hope for that.”
Researchers have begun giving healthy volunteers in the U.S. an experimental coronavirus vaccine developed by Pfizer Inc. and partner BioNTech SE, the latest study exploring a potential defense against the respiratory disease.
Researchers at the New York University Grossman School of Medicine in Manhattan and the University of Maryland School of Medicine in Baltimore said Tuesday they began injecting people with BY JARED S. HOPKINS