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Colorado Doctor Explains What FDA Approval Of The Pfizer Vaccine Means

DENVER (CBS4) - A doctor at National Jewish Health said Monday the decision by the Food & Drug Administration to fully approve the Pfizer-BioNTech vaccine is a major step toward getting COVID-19 under control as the Delta variant continues to increase cases in the state. He explained there is now more than enough evidence to convince anyone still hesitant about the vaccine.

"It's an exciting day. It's got full FDA approval and that should provide additional assurance for anyone who needed it," said Dr. Steve Frankel, a professor of medicine and the executive vice president of clinical affairs at National Jewish Health. "It's safe, it's effective, and it's manufactured in a process you can have confidence in."

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Frankel hopes this reaches the 30% of Americans surveyed who said they would be more open to receiving the vaccine once it got FDA approval. He also wanted to acknowledge a lot of data was reviewed by the agency to give the vaccine emergency use authorization last December.

Months later in May, the vaccine was authorized for children 12 and older as emergency use. The decision on Monday gives full approval for people 16 and older.

"If you're unvaccinated, you absolutely should go out and get vaccinated," he told CBS4 on Monday. "This has met the highest possible standard."

Not only are there more than 200 million doses administered among 100 million Americans, but there are also hundreds of thousands of pages of data the agency reviewed as part of their decision. The FDA also had enough time to follow patients for six months to study the vaccine.

"We are currently in a pandemic of the unvaccinated so if you needed one more reason to go out and get vaccinated, this is it," he said. "A lot has happened and there has been a lot for the FDA to consider."

A chunk of hospitalizations are 97% unvaccinated patients, Frankel pointed out, another factor for those still unsure about the vaccine to take that step and protect themselves as well as their loved ones.

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"Our cases are way higher than they need to be, way higher than they should be, our hospitals are more full than they need to be or should be," he said. "They are putting themselves at risk, they're putting themselves at risk of getting sick, putting themselves at risk of dying."

The other two major vaccines, Moderna and Johnson & Johnson, have yet to receive full approval, but Frankel says they are on a similar path given the same science or available data for the other two vaccines, respectively. He said people should not rank the vaccines and continue to take the one available to them based on convenience.

"None of these have been compared head-to-head so you don't know which of these is better than the other," Frankel said. "We can help keep our kids safe, we can help keep our neighbors safe, we can help keep our communities safe."

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