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Using emergency authorization for COVID-19 vaccine raises concern with some

Over the weekend, the FDA said it would be open to an emergency authorization to approve a vaccine before phase 3 trials were completed.

HOUSTON — There are multiple COVID-19 vaccines now in phase 3 human trials with researchers testing the vaccine to see if it is safe and effective.

Now the Federal Drug Administration says it could be open to approving a vaccine through emergency authorization before those trials are complete.

That has scientists and researchers sounding the alarm.

"We will make that decision only on the basis of science and data. We will not make that decision on the basis of politics," Dr. Stephen Hahn, commissioner of the FDA, said.

Hahn is trying to reassure the public his agency will not cut corners in approving a COVID-19 vaccine.

Over the weekend, he announced the FDA would be open to an emergency authorization to approve a vaccine before phase 3 trials were completed. That makes the possibility of a vaccine in 2020 more real.

Using emergency authorization is concerning to doctors like Dr. Peter Hotez.

He and his team at Baylor College of Medicine working on their own COVID-19 vaccine. He said the current vaccine vetting process in place is robust and reliable and adds that emergency authorization power has never been used to fast track a vaccine.

Hotez worries what impact that might have on the quality of a vaccine and public willingness to take it.

"It's a lower quality review, it’s a substandard review and I don’t think we need to do it,” Hotez said. "If we do it through emergency authorization, the American people won't accept it. They'll be very, very hesitant to accept COVID-19 vaccines.”

Hotez and other leading experts have expressed fears that political pressure may be influencing decisions about vaccines and other therapeutics.

The FDA had to cancel emergency authorization for hydroxychloroquine after risks were seen to outweigh any possible benefits.