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Why haven't COVID-19 vaccines gotten full approval yet?

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Posted at 10:24 PM, Jul 26, 2021

LAS VEGAS (KTNV) — The COVID-19 vaccines have been widely available for months, but none of them have actually gotten full approval from the Food and Drug Administration. It also comes as the government is encouraging people to get the vaccine right now.

The rapid development of COVID-19 vaccines has been regarded by health officials as a significant step in ending the pandemic. However, none have been fully approved yet and the current health emergency has pushed them to market quickly.

“When there’s an emergency happening or a crisis like this, there’s a process to get vaccines and other medications to market faster so that we can save lives.”

All the available vaccines are being given thanks to an emergency use authorization. Dr. Brian Labus, a UNLV health professor, says it’s a temporary form of approval that allows people to get shots while the agency continues to study their effectiveness and safety. He says full approval would require six more months of data.

“They have to collect more data and that, in turn, takes a longer amount of time to ensure that we meet all those requirements to have a safe and effective vaccine,” he said.

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Dr. Labus says this doesn’t mean the vaccines aren’t already safe and effective under the emergency authorization.

“The vaccines that are out there under emergency approval have been tested. Have been shown to be safe and effective. Just the time period which we’ve studied them is shorter than we’re going to do with that full approval,” he said.

He says the FDA is taking its time to fully approve the vaccine so it won’t undermine public confidence in its process even in a pandemic.

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“None of us working in public health or working as drug manufacturers want to endanger people. The whole point of this is to save lives and keep people out of the hospital and keep them from getting COVID-19,” he said.

The difference between emergency authorization and full approval matters. Full approval would give school districts and other organizations legal backing to require the vaccine. Dr. Labus believes schools may be the first to have a vaccine mandate if that happens.

“That’s because we already have laws in the books that require a number of other vaccines to attend school. This would be adding one additional vaccine to the list of things already required,” he said.

The makers of the Pfizer and Moderna vaccines have applied for full approval earlier this summer and could get full approval by January.