As vaccine makers seek full FDA approval, how will it impact hesitancy?
MADISON, Wis. (WMTV) - Moderna has joined Pfizer in beginning the process of applying for full approval from the Food and Drug Administration for its COVID-19 vaccine.
The vaccines are currently only approved under Emergency Use Authorization (EUA). Tuesday, Moderna announced it has filed for full approval.
Dr. Bill Hartman is the principal investigator for UW-Health’s vaccine trials. He says full approval requires the vaccine makers to provide much more data than what was considered for the EUA.
“When you go for full approval by the FDA, you have to be able to establish the safety and efficacy data very strongly. There can be no doubt,” said Dr. Hartman.
He says the hope is that once that full approval is granted, it gives those who are currently unvaccinated the peace of mind they need to get the shot.
“A common theme that does comes up with people who are hesitant is these were approved under emergency use so in their minds it’s a science experiment but it’s not a science experiment at this point,” said Hartman,
He says millions have successfully taken the shot around the world and that the data shows the vaccines work.
“We see the downtrend in cases, there’s fewer hospitalizations in Wisconsin than anytime during the pandemic...we really need to get everybody who can be vaccinated vaccinated so we can stop the spread of any variants that are out there,” said Dr. Hartman.
Right now Moderna plans to submit trial data to the FDA on a rolling basis. To apply for full approval, the company needs to do a six month follow-up.
“Hopefully by having full authorization people will have confidence in the process they had to go through to get to full authorization and the confidence helps them put away their hesitant fears and they can go ahead and get the vaccine,” said Hartman.
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