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'Every person vaccinated is a good thing' | Mecklenburg County vaccine providers hoping FDA approval increases demand for shots

On Monday, the FDA granted full approval for the Pfizer vaccine for people 16 and older.

CHARLOTTE, N.C. — The Food and Drug Administration (FDA) granted full approval to Pfizer’s COVID-19 vaccine for people 16 and older. Clearing this hurdle makes it the first of the three shots on the market to be fully approved by the FDA.

This is a big step forward and comes as the delta variant spreads rapidly.

Local providers in the Charlotte area are hopeful this will encourage more people to get vaccinated. The process was unfamiliar to many people and some thought of the emergency use authorization as experimental, but that's not the case. This final stamp of approval reinforces the safety and efficacy of the Pfizer shots.

“It’s great news,” Dr. Katie Passaretti with Atrium Health said. “Hopefully this will help some people's comfort level and help increase our vaccination rates which continues to be essential for our communities right now.”

Like when the vaccines first came out, for now, this only applies to people 16 and older.

As the delta variant spreads, local providers have seen a slight bump in the number of people coming to get vaccinated, but they are still battling hesitancy.

According to a Kaiser Family study, three out of every 10 unvaccinated people said they were waiting for this full FDA approval.

“It hopefully will change the hearts and minds of folks to want to get vaccinated to feel safe and confident that this is a good product for them,” Alyssa Harris, the Rowan County Health Director said.

Providers are hopeful and ready for any increase in demand to get the shots.

“We have not stopped looking at our capacity and the capacity of all of our vaccine providers. We have conversations on a daily basis with vaccine providers and are proud to say vaccine is still widely available in our community,” Dr. Meg Sullivan, Medical Director for Mecklenburg County said.

The FDA working faster than usual to get to this point, but former FDA Commissioner Dr. Mark McClellan says the process didn't change and they didn't cut any corners.

“The FDA is applying all of its gold standard regulatory approaches, review authorities, close audits, everything that it does in normal circumstances when we're not in a pandemic,” McClellan said.

Moving from emergency use authorization to full and final approval is a big step but the safety and efficacy of the shots had already been rigorously studied before the EUA was granted in December.

“We’re not really moving from an experimental phase into an approval phase so much as we're consolidating all of that information into a complete review,” McClellan said.

This comes at a pivotal moment, the delta variant causing a surge in cases and hospitalizations putting mainly the unvaccinated at risk.

“We’ve said it again and again. The vaccine is the most effective way to protect yourself and to protect others from COVID," Sullivan said. "I think the data is really there and that’s again what led to the full FDA approval."

Experts are hopeful it’s the confidence some will need to give a much-needed boost to vaccination rates.

“Every person vaccinated is a step in the right direction. So, no matter what some additional people will get vaccinated because of this news so every person vaccinated is a good thing,” Dr. Passaretti said.

Those aged 12 to 15 years old are still covered under emergency use authorization for the Pfizer vaccine. Moderna has also applied for full approval but Johnson & Johnson has not yet.

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