Duke researcher calls FDA’s potential approval of vaccine before phase 3 trials “very dangerous”

Coronavirus

RALEIGH, N.C. (WNCN)- Duke researchers are working quickly to manufacture an MRNA vaccine for COVID-19. While they along with other vaccine developers are in a race against the clock, one researcher said we need to be careful with how quickly we fast track projects.

“This process is on a faster track than anything I’ve seen in my whole career for developing a lot of different strategies for different pathogens,” said Dr. Thomas Denny, a chief operating officer at the Duke Human Vaccine Institute.

This vaccine would be used to offer short term protection from the virus rather than a long-term protection like a measles vaccine.

“This would be a way of giving as short-term protection to people. Perhaps first responders, people who are more vulnerable,” said. Dr. Denny.

Skipping large human trials

In this race for a vaccine Dr. Denny says speed and effectiveness are a delicate balance.

“Between making sure you have enough data to know it’s safe and it’s effective at preventing versus rushing, doing it prematurely and finding out that you did harm to people that you were trying to help,” said Dr. Denny.

He’s weary of the FDA’s consideration of an emergency approval of a vaccine before phase 3 human trials.

Phase 3 typically expands trials to a larger population, sometimes more vulnerable or older, to determine effectiveness.

“I think it’s a very dangerous precedent,” said Dr. Denny.

Andy Slavitt, Former Acting Administrator for the Centers for Medicare and Medicaid Services told CNN, “So, he’s not talking about data. He’s basically laying the groundwork for him to be able to say that he believes that the benefit outweighs the harm, which is not a scientific standard we should use for this vaccine that we’re going to put into tens of millions of people.”

However, CNN reported the FDA commissioner Dr. Stephen Hahn, told the Financial Times, “We have a convergence of the COVID-19 pandemic with the political season, and we’re just going to have to get through that and stick to our core principles. This is going to be a science, medicine, data decision. This is not going to be a political decision.”

Determining if the benefit outweighs the risk could be difficult to determine this early on in our understanding of the virus.

“Things are moving at rapid speed. Understand it, be able to ask about it, be informed,” said. Dr. Denny.

Timelines still unknown

Dr. Denny estimated the university would be in it’s first phase of human trials by early 2021. Depending on how well that process goes, he said that phase could last two or three months.

He said that would put the university at Phase 3 by Summer 2021. However the time for a mass production of their vaccine was still unknown.

While the White House has expressed optimism in a vaccine by the end of 2020, many vaccine developers remain optimistic about a vaccine making it out to the public relatively quickly but a concrete timeline is still up in the air for many- dependent on the results of human trials.

Vaccine skeptics

Results from a survey by Ipsos for the World Economic Forum showed only two thirds of Americans said they would get a vaccine. The survey found the most common concern among Americans was the possibility of side effects.

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