Moderna files paperwork for full FDA approval of COVID-19 vaccine

INDIANAPOLIS (WISH) — Moderna is following Pfizer in seeking full U.S. Food and Drug Administration approval for its mRNA coronavirus vaccine for people 18 and older.

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The shot has been under emergency use authorization since December. 

If the shot is granted approval, it would allow the vaccine to be delivered directly to healthcare providers without having to first go through the state. But, that’s not the only thing health experts hope — assuming all goes well — will happen. 

News 8 spoke with Dr. Amy Beth Kressel, an infectious disease specialist at Eskenazi Health, about what could ease the concerns of those still hesitant about vaccination. 

“I’ve taken care of a lot of patients in the hospital in the past month with COVID,” Kressel said. “All of whom did not complete their vaccinations. Either they did not complete their vaccinations or haven’t gotten their first shot and I’ve asked them why. I don’t really know why they are hesitant and I’m hoping FDA approval would sway people.”

Viruses are difficult to eradicate, she adds, and COVID-19 will be around at least for the near future. While we’re still in a public health emergency, the FDA can’t have an emergency use authorization of a vaccine forever. 

“At some point the FDA has to approve it or not. We now have over 100 million people in the United States who have gotten these vaccines and there have been very few adverse events. There is very little concerning safety data. If you compare these vaccines to others out there, they look great. From where I’m standing, it should be given approval. But we’ll have to wait and see what the FDA says,” Kressel said.


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