FDA advisory panel member discusses next phases of Pfizer vaccine

Published: Sep. 20, 2021 at 10:54 PM CDT
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MONTGOMERY, Ala. (WSFA) - Food and Drug Administration advisory panel member Dr. James Hildreth says there wasn’t enough data to make a confident decision to grant full authorization for Pfizer vaccine booster shots.

“There are only 300 or so participants in the study and only about a dozen of those participants are over the age of 65,” Hildreth said.

He says the decision was also based on concerns that some younger men developed a heart issue after receiving the vaccine.

So for now, boosters will only be given to those 65 and older or those who run a high risk of severe disease.

Hildreth says he believes boosters will eventually be approved for everyone, but it will take more time.

Meanwhile, Pfizer now says it has data showing its vaccine is effective for children ages 5 to11 something Hildreth calls good news.

Pfizer will now present the data to an FDA advisory panel that will make a final recommendation to the FDA.

Hildreth says he thinks it will be approved.

“The fact that the Pfizer vaccine is fully approved now by the FDA will make it a lot easier to get full approval for the vaccine for children as well,” Hildreth said.

He says parents should expect the vaccine to be ready for children before Thanksgiving.

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