FDA working quickly to fully approve Pfizer COVID-19 vaccine

Coronavirus

INDIANAPOLIS — With a new surge of coronavirus, the U.S. Food and Drug Administration has accelerated its timetable for the full approval of the Pfizer COVID-19 vaccine.

While vaccines typically take decades to be developed, COVID-19 vaccines became available to the public in record time. But Dr. Anthony Fauci, the country’s leading infectious disease expert, says that doesn’t take away from the vaccine’s efficacy. 

“It was a major investment, both in the logistics, the resources and the clinical and basic research,” Dr. Fauci said.

The FDA has authorized three vaccines for emergency use in the U.S. Pfizer’s version could get full approval within the next few weeks. 

“The only thing they’re waiting for are, not issues relating to safety or long-term complications or anything like that, they’ve got all that data,” said Dr. Cole Beeler, medical director of infection prevention at IU Hospital.

He says FDA approval isn’t something to wait on if you’re on the fence about getting vaccinated.

“I think there are people out there who are going to be hesitant no matter what the FDA says,” Dr. Beeler said. “And I think we need to provide education to those people to try and convince them that the vaccine is in their best interest and in the best interest of the people around them.”

According to the FDA’s website, emergency use allows the FDA to make a product available based on the best available evidence. For full approval, the FDA would analyze the efficacy of the vaccine, including the safety and data collected in the real world, outside of a clinical trial. 

“They’re waiting on information about transporting the vaccine, storing it in freezers, things that really should not affect an individual’s decision whether or not to get the vaccine,” Dr. Beeler said.

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