PITTSBURGH (KDKA) — In a rush to beat COVID-19, a vaccine could be made available through the Food and Drug Administration’s Emergency Use Authorization (EUA).
“EUA is when the FDA, in a crisis, will review the data that’s been provided to them,” AHN Director of Microbiology, Kelly Stefano, PhD, said.
Different from full FDA approval, this authorization speeds up getting tests and drugs to market for a specific use for a limited time.
Typically, a series of bigger and bigger studies of safety and effectiveness lead to FDA approval.
“It can take many years for all of that to happen,” says Stefano. “Because of the pandemic, [regulatory agencies] have somewhat accelerated that path.”
The U.S. government has invested $10 billion in eight different vaccines under development, buying millions of doses, ready to go if the FDA gives the green light, possibly by the end of the year.
“I just wonder if we could really get that many people and the data and the outcome to really evaluate it,” Stefano says.
Moving too quickly could have drawbacks.
For instance, people may be hesitant to get immunized if they perceive the development process was too hurried.
“You really run the risk of the population not trusting that a vaccine is safe or effective,” she said. “We really need people to step up and want to receive the vaccine to stop spreading this.”
There could be unforeseen side effects.
“We do report those back to the FDA and they take that into consideration as to whether that vaccine or that treatment should remain on the market,” Stefano said.
A vaccine with only weak effectiveness could be a problem, too.
“[People who are vaccinated] might have a false sense of, ‘I’ve been vaccinated, I can’t get COVID; therefore, I can do what I want,’” she said.
Transparency will be important to show the public why a vaccine is being put forth. The end of the year may be too soon to get there.
“Is 2021 a reasonable time? Sure, if we have the resources, and we dedicate our time,” says Stefano. “I think all of us are excited for a vaccine, but we don’t want to rush it.”
A concern, she says, many in the medical community share.
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