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This process will determine how quickly we get a coronavirus vaccine

September 13, 2020. Summarized by summa-bot.

With talk of the possible availability of a vaccine candidate heating up, you might have heard the term Emergency Use Authorization -- or EUA -- all over the news lately. But what is it exactly, and how does it apply to vaccines?

(CNN)With talk of the possible availability of a vaccine candidate heating up, you might have heard the term Emergency Use Authorization -- or EUA -- all over the news lately.

There is a lot of ongoing concern and debate about whether any vaccine candidate should be granted an EUA -- or outright approval -- without first completing Phase 3 clinical trials.

According to the FDA's website, during public health emergencies, the agency can use Emergency Use Authorizations "to help make medical products available as quickly as possible by allowing unapproved medical products to reach patients in need when there are no adequate, FDA-approved and available alternatives. "

So, in essence, what an EUA does is speed up the process of getting potentially helpful  medical products authorized for a specific use to the public during a health emergency, without the rigorous testing and subsequent scrutiny that's usually required to get FDA approval -- which traditionally takes years.

President Trump has said several times that he thinks a vaccine could be available by Election Day. Without a doubt, the pace of medical innovation has moved faster than ever before, and human vaccine trials began just 67 days after the virus was first identified.

Still, several government health officials have told CNN the idea that a vaccine could be available to the general public by November 3 is unlikely.

and just picking this date, before the election, sort of stokes those fears that the government isn't being duly diligent to make sure that any vaccine really is not just efficacious, but has few side effects," said Dr. Ali Khan, dean of the College of Public Health at the University of Nebraska Medical Center, and former director of the Office of Public Health Preparedness at the CDC.

In a study published in 2009, months after the US declared a public health emergency due to the H1N1 influenza and the World Health Organization declared it a pandemic, researchers explored the public's willingness to use a drug or a vaccine with an EUA (not full FDA approval) by surveying a representative sample of more than 1,500 US adults.

But there were also some other key factors that would convince respondents that a vaccine authorized under an EUA was safe to use.

As for an emergency use authorization, "I would not be comfortable with a vaccine unless it was shown in a clinical trial clearly to be safe and effective," Fauci said during an interview on NBC's "Today. " 

But if a vaccine is shown to be safe and effective in adequate and well-controlled clinical trials, it should not be withheld until all the stringent licensure requirements for FDA approval are met, because some of the requirements cannot be generated quickly.

"The EUA is the most appropriate regulatory mechanism for distributing vaccines that have been shown to be safe & effective in phase 3 RCTs (randomized controlled trials) but have not yet met all of the FDA's standards for licensure. " 

According to the FDA's guidance, any vaccine -- whether under emergency authorization or approved -- needs to either prevent disease or at least decrease severity by at least 50%.

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