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VAX FAQs: How is full FDA authorization different from what COVID-19 vaccines have now?

Updated: May. 7, 2021 at 8:22 PM EDT
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COLUMBIA, S.C. (WIS) - Pfizer is working to have the word “emergency” no longer attached to its COVID-19 vaccine.

The drugmaker announced Friday it has begun applying to the FDA for full approval of its COVID-19 vaccine for people 16 years old and older.

If Pfizer’s rolling application is approved, the company will be the first coronavirus vaccine maker to have its vaccine receive this status.

However, public health experts don’t expect a change in authorization to impact the rollout of the vaccine for now.

Department of Health and Environmental Control Public Health Director Dr. Brannon Traxler told reporters Friday she hopes if the Pfizer vaccine is given full authorization it will help curb some vaccine hesitancy.

“We are still not very close to herd immunity,” she said. “We have more vaccines than willing arms at this time.”

According to the Kaiser Family Foundation, about one in six Americans say they’re waiting for more information before getting the shot or waiting for more people to be vaccinated.

So, how does the process work?

“Emergency use authorization requires an emergency, so when the emergency is over, you can’t get an emergency authorization,” said Dr. Helmut Albrecht, the Medical Director for the Prisma Health-University of South Carolina Center for Infectious Disease Research.

Albrecht said obtaining emergency authorization and full authorization is similar. But the main difference is companies have to submit six months of safety data on more than 50% of trial participants -- rather than two months.

He explained the other differences between the two may not apply in the case of COVID-19 vaccinations because it is being distributed by the government.

“There are theoretical differences with how this drug or this vaccine will be reimbursed by insurances, or how a company will be able to price a vaccine or drug,” he said.

The doctor also said the full authorization requires more paperwork and takes the FDA more time to review the data. Emergency use authorization usually happens in a couple of days, he said.

“It may change perception, but there really won’t be more safety data for the mRNA vaccines…there really isn’t anything new,” he said.

Albrecht and Traxler’s hope is that people will continue to get the vaccine while Pfizer seeks this authorization.

“We need to get more people vaccinated. The variants are the biggest threats to the vaccines admittedly, but the vaccines are the biggest threats to the variants,” he said.

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