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FDA将完全批准新冠疫苗,会扭转现状吗?

FDA将完全批准新冠疫苗,会扭转现状吗?

Marco Quiroz-Gutierrez 2021-07-27
有证据表明,对新冠疫苗进行完全批准或将推动更多民众接种疫苗。

美国总统乔•拜登于7月21日表示,他认为美国食品与药品管理局(Food and Drug Administration,以下简称为FDA)最快将于今年秋季授予新冠疫苗完全批准。

在俄亥俄州的一处市政大厅,拜登表示,FDA将很快对新冠疫苗进行完全批准,而截至目前,相关疫苗获得的仅为紧急使用授权。

拜登说:“我们召集了许多科学家,其中20多位来自一线,经过对话之后,我预期在新学年开始的某个时候,8月底或者9、10月初,新冠疫苗将会获得完全批准。”

有证据表明,对新冠疫苗进行完全批准或将推动更多民众接种疫苗。凯泽家族基金会(Kaiser Family Foundation)于今年6月启动的疫苗监测报告发现,31%的未接种疫苗的成年人称,如果目前获得紧急使用批准的某款疫苗获得完全批准,那么他们将更有可能前去接种疫苗。

凯泽家族基金会的高级调查分析师卢娜•洛佩斯认为,对疫苗进行完全批准将对那些尚未接种疫苗同时表示“等等看”的民众产生最强影响。

洛佩斯说:“疫苗安全性、研发速度及新颖性都是他们非常关心的问题。获得FDA完全批准或将促使部分尚未接种且持‘观望’态度的民众前去接种疫苗。”

尽管有迹象表明,获得FDA完全批准或将推动部分民众前去接种新冠疫苗,但如洛佩斯所言,很多人实际并不清楚紧急授权与完全批准之间的区别。根据该基金会的报告,“三分之二的成年人(包括大多数尚未接种疫苗的成年人)要么认为美国现有疫苗已经获得FDA完全批准,要么不确定现有疫苗获得的是完全批准还是紧急使用授权。”

在2020年12月辉瑞(Pfizer)和BioNTech开发的新冠疫苗率先获得紧急使用授权之前,大多数美国民众可能并不了解紧急使用授权和完全批准之间的区别。此后, Moderna公司和强生公司(Johnson & Johnson)的新冠疫苗也都获得了紧急使用授权。

本世纪初,为保护军队免受“9•11”事件后的炭疽攻击,美国国会给予了FDA授予紧急授权的权力。猪流感(H1N1)、中东呼吸综合征(MERS)、寨卡病毒(Zika)和埃博拉病毒(Ebola)的实验疗法也曾经获得类似授权。

如果某些疾病病情严重且可能危及生命,但又尚无获得批准的治疗方案,那么FDA就可以通过授予紧急使用授权的方式批准有关方面使用未经批准的医疗产品来诊断、治疗和预防这些疾病。

但这并不意味着新冠疫苗并未经过严格测试。数以万计的受试者参与了按照FDA标准开展的严格临床试验,协助证明了疫苗的有效性。紧急使用授权只是加快了生产和行政审批流程。

辉瑞和Moderna分别已经于今年5月初和6月初递交了疫苗完全批准申请。强生公司尚未提出申请,但预计也将很快启动相关工作。相较紧急授权,在决定是否授予FDA完全批准时,监管机构将对更多数据进行更长时间的审查,同时还将审查生产和质量控制流程。

据《科学》杂志(Science Magazine)报道,7月16日,FDA已经接受了辉瑞的完全批准申请,并将其列为“优先审查项目”。如此一来,从理论上说,相较于通常所需的10个月的审批时间,该申请或将更快得到批准。目前,FDA尚未正式接受Moderna的申请。

目前,12岁以下儿童还不能接种疫苗。在同一场市政厅演讲中,拜登指出,他期望这些儿童也能够尽快获得在紧急状况下接种疫苗的资格。不过FDA已经表示,这种情况在冬季到来前不会发生。(财富中文网)

译者:梁宇

审校:夏林

美国总统乔•拜登于7月21日表示,他认为美国食品与药品管理局(Food and Drug Administration,以下简称为FDA)最快将于今年秋季授予新冠疫苗完全批准。

在俄亥俄州的一处市政大厅,拜登表示,FDA将很快对新冠疫苗进行完全批准,而截至目前,相关疫苗获得的仅为紧急使用授权。

拜登说:“我们召集了许多科学家,其中20多位来自一线,经过对话之后,我预期在新学年开始的某个时候,8月底或者9、10月初,新冠疫苗将会获得完全批准。”

有证据表明,对新冠疫苗进行完全批准或将推动更多民众接种疫苗。凯泽家族基金会(Kaiser Family Foundation)于今年6月启动的疫苗监测报告发现,31%的未接种疫苗的成年人称,如果目前获得紧急使用批准的某款疫苗获得完全批准,那么他们将更有可能前去接种疫苗。

凯泽家族基金会的高级调查分析师卢娜•洛佩斯认为,对疫苗进行完全批准将对那些尚未接种疫苗同时表示“等等看”的民众产生最强影响。

洛佩斯说:“疫苗安全性、研发速度及新颖性都是他们非常关心的问题。获得FDA完全批准或将促使部分尚未接种且持‘观望’态度的民众前去接种疫苗。”

尽管有迹象表明,获得FDA完全批准或将推动部分民众前去接种新冠疫苗,但如洛佩斯所言,很多人实际并不清楚紧急授权与完全批准之间的区别。根据该基金会的报告,“三分之二的成年人(包括大多数尚未接种疫苗的成年人)要么认为美国现有疫苗已经获得FDA完全批准,要么不确定现有疫苗获得的是完全批准还是紧急使用授权。”

在2020年12月辉瑞(Pfizer)和BioNTech开发的新冠疫苗率先获得紧急使用授权之前,大多数美国民众可能并不了解紧急使用授权和完全批准之间的区别。此后, Moderna公司和强生公司(Johnson & Johnson)的新冠疫苗也都获得了紧急使用授权。

本世纪初,为保护军队免受“9•11”事件后的炭疽攻击,美国国会给予了FDA授予紧急授权的权力。猪流感(H1N1)、中东呼吸综合征(MERS)、寨卡病毒(Zika)和埃博拉病毒(Ebola)的实验疗法也曾经获得类似授权。

如果某些疾病病情严重且可能危及生命,但又尚无获得批准的治疗方案,那么FDA就可以通过授予紧急使用授权的方式批准有关方面使用未经批准的医疗产品来诊断、治疗和预防这些疾病。

但这并不意味着新冠疫苗并未经过严格测试。数以万计的受试者参与了按照FDA标准开展的严格临床试验,协助证明了疫苗的有效性。紧急使用授权只是加快了生产和行政审批流程。

辉瑞和Moderna分别已经于今年5月初和6月初递交了疫苗完全批准申请。强生公司尚未提出申请,但预计也将很快启动相关工作。相较紧急授权,在决定是否授予FDA完全批准时,监管机构将对更多数据进行更长时间的审查,同时还将审查生产和质量控制流程。

据《科学》杂志(Science Magazine)报道,7月16日,FDA已经接受了辉瑞的完全批准申请,并将其列为“优先审查项目”。如此一来,从理论上说,相较于通常所需的10个月的审批时间,该申请或将更快得到批准。目前,FDA尚未正式接受Moderna的申请。

目前,12岁以下儿童还不能接种疫苗。在同一场市政厅演讲中,拜登指出,他期望这些儿童也能够尽快获得在紧急状况下接种疫苗的资格。不过FDA已经表示,这种情况在冬季到来前不会发生。(财富中文网)

译者:梁宇

审校:夏林

President Joe Biden said on July 21 he thinks the Food and Drug Administration will give full approval for vaccines as soon as this fall.

At a town hall in Ohio, Biden said the FDA would soon fully approve COVID-19 vaccines, which up to now have only been authorized for emergency use.

“My expectation talking to the group of scientists we put together, over 20 of them plus others in the field, is that sometime maybe in the beginning of the school year, at the end of August, beginning of September, October, they’ll get a final approval,” Biden said.

There is some evidence that full approval for Covid vaccines could push more people to get vaccinated. A vaccine monitoring report by the Kaiser Family Foundation from June found that 31% of unvaccinated adults said they would be more likely to get the vaccine if one of the shots that is currently authorized for emergency use received full approval.

Full approval would have the strongest effect on people that are unvaccinated and said they would "wait and see" before getting the vaccine, said Kaiser Family Foundation Senior Survey Analyst Lunna Lopes.

"One of the big concerns they have is the safety of vaccine, and how quickly it was developed, and just the newness of vaccine," Lopes said. "Full FDA approval could kind of nudge some of those people who are currently unvaccinated and in that 'wait and see' group towards getting the vaccine."

Despite indications that full FDA approval may push some people to get a Covid vaccine, Lopes said there is still confusion about the difference between emergency authorization and full FDA approval. According to the foundation's report, "two-thirds of adults (including a large majority of unvaccinated adults) either believe the vaccines currently available in the U.S. already have full approval from the FDA or are unsure whether they have full approval or are authorized for emergency use."

The difference between emergency use authorization and full approval is something most Americans were likely unfamiliar with until the first emergency use authorization for coronavirus was granted to the Pfizer-BioNTech COVID-19 vaccine in December 2020. Since then, both the Moderna and Johnson & Johnson (Janssen) vaccine have also received emergency approval.

The power to give emergency authorization was granted to the FDA by Congress in the early 2000s with one of the intention of protecting the military against anthrax attacks post-911. Similar authorizations have been issued to experimental therapies for swine flu (H1N1), Middle East Respiratory Syndrome (MERS), Zika, and Ebola.

Under emergency use authorization, the FDA can allow the use of unapproved medical products to diagnose, treat, and prevent serious and life-threatening diseases for which there are no approved alternatives.

Yet, this authorization doesn’t imply that vaccines aren’t rigorously tested. Tens of thousands of study participants have helped prove the effectiveness of vaccines in strict clinical trials that follow FDA standards. Emergency use authorization simply speeds up manufacturing and administrative processes.

Pfizer applied for full approval for its vaccine in early May and Moderna in early June. Johnson & Johnson has yet to apply, but is expected to do so soon. To determine FDA approval, the regulatory agency will review much more data over a longer period of time than it did for the emergency use authorizations. It will also review manufacturing and quality control.

On July 16, the FDA accepted Pfizer's application for full approval and labeled it “under priority review," according to Science Magazine. This means that the application will theoretically be approved faster than the typical 10 months it would usually take. The FDA has not formally accepted Moderna's application.

At the same town hall Wednesday, Biden said he expects children younger than 12, who can’t currently get the vaccine, to be eligible soon on an emergency basis, although the FDA has said it doesn't expect that to happen until the winter.

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