这儿有详细的解释。

来源: voiceofme 2020-12-27 19:50:19 [] [博客] [旧帖] [给我悄悄话] 本文已被阅读: 0 次 (7731 bytes)
本文内容已被 [ voiceofme ] 在 2020-12-27 20:10:17 编辑过。如有问题,请报告版主或论坛管理删除.

Are the COVID-19 vaccines rigorously tested?

Yes. Clinical trials are evaluating investigational COVID-19 vaccines in tens of thousands of study participants to generate the scientific data and other information needed by FDA to determine safety and effectiveness. These clinical trials are being conducted according to the rigorous standards set forth by the FDA.

。。

 In phase 3, the vaccine is generally administered to thousands of people in randomized, controlled studies involving broad demographic groups (i.e., the population intended for use of the vaccine) and generates critical information on effectiveness and additional important safety data. This phase provides additional information about the immune response in people who receive the vaccine compared to those who receive a control, such as a placebo.

 

 

FDA also expects manufacturers who receive an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue licensure (approval).

Post-authorization vaccine safety monitoring is a federal government responsibility shared primarily by FDA and the U.S. Centers for Disease Control and Prevention (CDC), along with other agencies involved in healthcare delivery. Post-authorization safety monitoring during the COVID-19 pandemic vaccination program will aim to continuously monitor the safety of COVID-19 vaccines to rapidly detect safety problems if they exist. There will be multiple, complementary systems in place with validated analytic methods that can rapidly detect signals for possible vaccine safety problems. The U.S. government has a well-established post-authorization/post-approval vaccine safety monitoring infrastructure that will be scaled up to meet the needs of a large-scale COVID-19 vaccination program

 

How is it that COVID-19 vaccines have been developed so quickly?

In public health emergencies, such as a pandemic, the development process may be atypical. For example, as demonstrated by the response to the COVID-19 pandemic, the U.S. government has coalesced government agencies, international counterparts, academia, nonprofit organizations and pharmaceutical companies to develop a coordinated strategy for prioritizing and speeding development of the most promising vaccines. In addition, the federal government has made investments in the necessary manufacturing capacity at its own risk, giving companies confidence that they can invest aggressively in development and allowing faster distribution of an eventual vaccine. However, efforts to speed vaccine development to address the ongoing COVID-19 pandemic have not sacrificed scientific standards, integrity of the vaccine review process, or safety.

https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained  

Emergency Use Authorization (EUA)

An Emergency Use Authorization (EUA) is one of several tools the FDA is using to help make certain medical products available quickly during the COVID-19 pandemic. In certain emergencies, the FDA can issue an EUA to provide access to medical products that may potentially be used when there are no adequate, approved, and available options.

The EUA process is different than an FDA approval or clearance. Under an EUA, in an emergency, the FDA makes a product available to the public based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance.

When evaluating an EUA, we carefully balance the potential risks and benefits of the products based on the data currently available. 

EUAs are effective until the emergency declaration ends. EUAs can also be revised or revoked by the FDA at any time as we continue to evaluate the available data and patient needs during the public health emergency.

https://www.fda.gov/consumers/consumer-updates/understanding-regulatory-terminology-potential-preventions-and-treatments-covid-19  

请您先登陆,再发跟帖!

发现Adblock插件

如要继续浏览
请支持本站 请务必在本站关闭/移除任何Adblock

关闭Adblock后 请点击

请参考如何关闭Adblock/Adblock plus

安装Adblock plus用户请点击浏览器图标
选择“Disable on www.wenxuecity.com”

安装Adblock用户请点击图标
选择“don't run on pages on this domain”