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Doctors at UVA discuss off label use of Pfizer vaccine

Published: Sep. 13, 2021 at 1:21 PM EDT
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CHARLOTTESVILLE, Va. (WVIR) - The Pfizer vaccine has been officially approved by the FDA for several weeks now, ushering a wave of vaccine mandates across the country. However, the Pfizer vaccine is only fully approved for people at least 16 years old.

Doctors at UVA Health, like Dr. Debbie-Anne Shirley, say some people may be looking to use a loophole to get those who are ineligible for a shot because of their age, vaccinated.

“I think a lot of families are asking, ‘Can I get the vaccine off-label now that Pfizer has full approval?’” Shirley said.

When a vaccine has full approval, Shirley said it allows healthcare providers to have some leeway in how it’s used. That means it could be used “off label,” or for unapproved uses, like giving a Pfizer vaccine to someone who is not yet of age.

However, she said clinics that provide the COVID-19 vaccine are doing so under the guidance of the CDC, which has not yet recommended use of vaccine for younger age groups.

“It is really a clinicians decision to follow those recommendations, but I anticipate that most clinicians are going to want and desire proper guidance on exactly how to use the therapeutic and that is true not only for vaccines but many other medicines that we use in our daily practice,” said Dr. Costi Sifri, an epidemiologist with UVA Health.

Both Sifri and Shirley say it all comes down to dosage.

“We want to be safe about it for kids, if the trials are using different doses or things like that, we don’t want to just assume and give them an adult dose when that’s not the right thing to do,” Shirley said.

“Children are not just little adults. The dosage of the therapy is going to be different, the doses that are being trialed right now are going to be different than what is used in adults,” Sifri said.

Vaccine trials are now including more children. Dr. Sifri said he expects the vaccine to be highly effective in young children, as it has proven to be in other age groups.

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