Breaking down the difference between full FDA approval, emergency use authorization for vaccines

COVID-19 vaccine hesitancy is a primary concern for health officials

Breaking down the difference between full FDA approval, emergency use authorization for vaccines

SAN ANTONIO – The hesitancy of getting a COVID-19 vaccine is one of the top concerns for state and federal health officials.

Some people say emergency use authorization isn’t enough for them, and they’d rather wait for full approval by the FDA. However, doctors are still urging everyone to get a COVID-19 vaccine as soon as possible to help mitigate the spread of the delta variant.

Currently, 50% of Americans are fully vaccinated with the COVID-19 vaccine.

When emergency use is granted for these vaccines, it allows the FDA to make a product available to the public based on the best available evidence instead of waiting for all the evidence needed for full FDA approval.

None of the COVID-19 vaccines in the U.S. have been given full FDA approval as of yet.

Dr. Cory Hallam, Ph.D., a professor of innovation management at Texas Biomedical Research Institute, said due to the dire situation of the COVID-19 pandemic, time was ticking and there wasn’t time to wait for full FDA approval when the vaccines were released.

“Essentially, they’re recognizing that we’re in dire need of some response, whether therapeutic or vaccine perspective, because the threat to the nation, the threat to the world is so large. And so it doesn’t mean you’re going to circumvent that process. They will still go through that full FDA approval process over time as more and more data comes in. But essentially, we rely on the fact that they brought together the best scientists, the best minds to look at the data that’s available, track it clinically. And as they’re doing the distribution, continue the tracking, even as you would do in a normal approval process,” said Dr. Hallam.

Hallam said in a non-pandemic, the vaccine approval process where no previous science has been done could take 15 years.

For the vaccines we’re using against COVID-19, he said decades of science and research have already been done on mRNA technology. This led to vaccine companies really only ramping up clinical trials and working on multiple phases of the process at the same time.

“They put a lot of activities in parallel that used to happen sequentially. And so, you would be running some challenge studies at the same time that you would be running first in human phase one to safety dose studies.” said Dr. Hallam “You’re not skipping anything. You’re essentially doing that in parallel. And as the data became available, the FDA was able to look at that.”

Hallam said the vaccines that are given full FDA approval will essentially be the same as those that are being used now under emergency use authorization.

“We would expect that the FDA approval will go through for exactly what was submitted for the emergency use authorization.”

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About the Authors:

John Paul Barajas is a reporter at KSAT 12. Previously, he worked at KRGV 5 in the Rio Grande Valley. He has a degree from the University of Houston. In his free time, he likes to get a workout in, spend time on the water and check out good eats and drinks.