大多数美国人都可以使用新冠肺炎(新型冠状病毒肺炎)“曲速行动”的首席顾问蒙瑟夫·斯劳伊博士说,到今年春天早些时候,这种疫苗有可能在6月份之前为它们免疫。
“这还不确定,但这个计划——我很有信心——应该能在6月份之前让美国的每个人都接种疫苗,”斯劳伊周三早上告诉美国广播公司新闻部的鲍勃·伍德拉夫。
唐纳德·特朗普总统“扭曲速度行动”是一项在不牺牲安全性的情况下加速疫苗推广的努力。该项目已向众多制药公司投入数十亿美元,希望开发出一种或多种安全有效的新冠肺炎疫苗。这笔钱旨在帮助加快开发、试验和制造,同时消除公司的财务风险,以防疫苗失效。
尽管疫苗开发速度很快,但斯劳伊说,他没有从白宫那里收到任何不适当的压力,要求他在他认为安全的情况下加快这一进程。
“我绝对没有压力,真的,没有压力,”斯劳伊说,并补充说,如果是这样的话,他会辞职。“我(一直)说过,如果我受到不必要的压力,我会说出来,然后辞职。”
斯劳伊说,制药公司莫德纳和辉瑞可能是第一个与候选疫苗向食品和药物管理局申请紧急使用授权,最早可能在11月或12月。斯劳伊说,如果一种疫苗在年底前获得批准,大约有2000万到4000万剂疫苗将被储存起来,准备分配给有限的人口。
“然后我们可以开始免疫高危人群,一线工作人员健康“年底前,护理人员,”斯劳伊告诉美国广播公司新闻现在,并不是每个人都能在12月份接种疫苗,但这些公司将继续生产疫苗——到1月份,我们计划生产大约6000万到8000万剂这两种疫苗。"
斯劳伊说,阿斯利康的临床试验将“很快”在美国恢复
与此同时,阿斯利康疫苗的临床试验被美国食品和药物管理局和制药巨头暂停强生公司的候选疫苗被放在一个自愿暂停调查为什么某些志愿者在试验中患上了无法解释的疾病。阿斯利康已经恢复了在欧洲和世界其他地方的试验。
dado Ruvic/路透社
在这张摄于2020年4月10日的照片中,一个医用注射器被插入一个标有“新冠肺炎疫苗”的小瓶中。
但是停止这两项晚期临床试验可能会引起一些疫苗怀疑,尽管大多数科学家说这是这个过程正在起作用的迹象,并指出许多临床试验在继续之前会减慢对潜在问题的研究。
斯劳伊担心疫苗态度也可能受到最近政治的影响。
“我认为,不幸的是,这是围绕它的政治,”斯劳伊说。“我认为,如果这些同样的事件发生在两年前,远离选举时间,我肯定同样的审查会发生,但它会有不同的语气。”
9月,在停止这些临床试验之前,一项盖洛普民意调查显示,如果疫苗现在是免费的,只有大约一半的美国人会接种疫苗。
曲速行动的目标是为美国人民提供多种疫苗选择。已经有八个在人体试验中。因此,斯劳伊鼓励更多的人自愿参加正在进行的和未来的新冠肺炎疫苗试验。
他参观了乔治·华盛顿大学的疫苗研究中心现代疫苗试验-周三上午的新闻发布会,现在正在敦促人们报名。
斯劳伊说,在完成第三阶段研究所需的3万名志愿者中,莫德纳已经获得了近2.9万名志愿者。像目前正在测试的许多疫苗一样,莫德纳疫苗需要每隔几周注射两次。
一旦一个独立的监测委员会表示这些晚期试验的数据准备好进行评估,FDA可能需要大约三周时间才能做出授权决定。
Trump's Operation Warp Speed adviser says all Americans could be immunized with COVID vaccine by June
Most Americans may have access to aCOVID-19vaccine by early this spring, one which could potentially immunize them by June, according to Operation Warp Speed's chief adviser, Dr. Moncef Slaoui.
"It's not a certainty, but the plan -- and I feel pretty confident -- should make it such that by June, everybody could have been immunized in the U.S.," Slaoui told ABC News' Bob Woodruff Wednesday morning.
President Donald Trump's Operation Warp Speed is an effort created to accelerate a vaccine rollout without sacrificing safety. The program has pumped billions of dollars into numerous pharmaceutical companies in hopes of developing one or more safe and effective COVID-19vaccines. The money is intended to help ramp up development, trials and manufacturing while removing financial risk from the companies, in case the vaccines don’t work out.
Despite the rapid pace of vaccine development, Slaoui said he has not received any improper pressure from the White House to expedite the process beyond what he considers safe.
"I've had absolutely no pressure, really, no pressure," Slaoui said, adding that he would have quit if that were the case. "And I have [always] said, if I get undue pressure, I will say it and I will resign."
Slaoui said the pharmaceutical companies Moderna and Pfizer are likely to be the first withvaccine candidatesto apply for emergency use authorization by the Food and Drug Administration, possibly as soon as November or December. If a vaccine is authorized before the end of the year, Slaoui said approximately 20 to 40 million doses of it will be stockpiled and ready for distribution for a limited population.
"Then we can start immunizing the highest risk people, front-line workers, thehealthcare workers, before the end of the year," Slaoui told ABC News. "Now, not every one in that population can be immunized in December, but the companies will continue to manufacture and produce vaccine doses -- and in January, we plan to have about 60 to 80 million doses of those two vaccines."
Slaoui said AstraZeneca's clinical trial is due to resume in the U.S. "imminently."
This comes as clinical trials for both AstraZeneca's vaccine were put on regulatory hold by the FDA and pharmaceutical giantJohnson & Johnson's vaccine candidatewere put on a voluntary pause to investigate why certainvolunteers developed unexplained illnesses during the trial. AstraZeneca has already resumed its trials in Europe and elsewhere in the world.
A medical syringe is inserted into a small bottle labeled "Vaccine COVID-19" in this illustration taken April 10, 2020.
But halting the two late-stage clinical trials may have caused some vaccine skepticism, despite most scientists saying it's a sign the process is working, and pointing out that many clinical trials are slowed to investigate potential problems before moving on.
Slaoui worries vaccine attitudes may also be influenced by recent politics.
"I think, unfortunately, it's the politics around it," Slaoui said. "And I think if these same events were happening two years ago, far away from an election time, I'm sure the same scrutiny would happen, but it would have a different tone to it."
In September, prior to halting these clinical trials, a Gallup Poll indicated that only about half of Americans would take a vaccine if it were free and available now.
The goal of Operation Warp Speed is to have multiple vaccine options available for the American people. Already eight are in human trials. So, Slaoui is encouraging more people to volunteer for ongoing and future COVID-19 vaccine trials.
He visited George Washington University's Vaccine Research Center -- one of the sites of an ongoingModerna vaccine trial-- for a press conference Wednesday morning, and is now
Slaoui said Moderna has obtained nearly 29,000 volunteers of the 30,000 required to complete their phase 3 study. Like many of the vaccines currently being tested, Moderna's requires two shots administered a few weeks apart.
Once an independent monitoring board says the data from these late-stage trials is ready to be evaluated, it may take the FDA about three weeks to make its authorization decision.