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FDA Aims To Fully Approve COVID Vaccines 'As Quickly As Possible'

Nearly 200 million Americans have been vaccinated against COVID-19, but the FDA still hasn't given the shots full approval.
Posted at 12:20 PM, Jul 28, 2021

"We don't want to rush things. All that will do is reinforce to the unvaccinated that there isn't a solid process in place. We have to rely on science and the FDA, do the right thing, get it done, get as many people vaccinated as possible," said Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest.

Nearly 200 million Americans have received at least one COVID-19 jab. But the three vaccines circulating in the U.S. have not been fully approved by the U.S. Food and Drug Administration.  

Many Americans who haven’t gotten a shot say they’re hesitant to get a vaccine that’s so far only been given a lesser “emergency use” approval. 

Any time that there's a new product I'm always kind of hesitant," said 21-year-old Springfield, Missouri, resident Josiah Williams.

"I just kind of want to see. I know it's a new vaccine, so I'd rather wait to see what happens in the future with that," said 21-year-old Simon.

A recent Kaiser Family Foundation poll found 16% of unvaccinated adults surveyed said they thought the vaccine was too new, too unknown or not tested enough. 

The FDA hasn’t said when the vaccines will get their gold star. Typically, vaccine reviews can take six to 12 months. 

A spokesman for the FDA told Newsy, “The FDA recognizes that vaccines are key to ending the COVID-19 pandemic and is working as quickly as possible to review applications for full approval.” 

President Biden says he expects full approval to happen in the fall, but the White House maintains it has no influence over the agency’s timeline.   

"The FDA is the gold standard, in our view, and they move at the speed of science," White House press secretary Jen Psaki said Monday. 

The FDA says it’s conducting a priority review of the vaccine data on the Pfizer vaccine and has set a goal date of January 2022 for approval, but the FDA says it will likely come much sooner than that.  

Pitts, a former FDA associate commissioner, predicts all three vaccines will be approved by Labor Day. He says the holdup has been a review of potential side effects.   

"The FDA has to really understand why they happen, who they happen to, so that on the label of these products, they can tell physicians exactly what to expect," he said. 

Pitts says he’s skeptical full approval will lead to a wave of unvaccinated Americans getting the shot, but he says many businesses and schools are looking to the FDA to determine whether they should require vaccines. 

"Once the FDA does click that box and give the vaccine's full approval. I believe that more entities, business, private universities, et cetera, will, in fact, mandate vaccinations for the people that use their services, work in their companies, attend their schools," he said. 

Correction: A previous version of this story misstated the number of Americans who had received the COVID vaccine. This story has been updated.