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FDA advisory committee to review data on Pfizer's COVID-19 vaccine for kids ages 5 to 11

Pfizer Vaccine
Posted at 9:21 PM, Oct 25, 2021
and last updated 2021-10-26 02:12:55-04

SAN DIEGO (KGTV) - On Tuesday, the Food and Drug Administration’s (FDA) vaccine advisory committee will meet to review data on the safety and efficacy of Pfizer’s COVID-19 vaccine in children ages 5 to 11.

In San Diego County, a large majority of the eligible population is fully vaccinated or has received one dose, and now the focus will also include children.

Pfizer’s vaccine is currently fully approved for teens 16 and older and has Emergency Use Authorization (EUA) for kids 12 to 15, meaning they too can get the shot. Tuesday’s meeting is the beginning of the process to decide if that EUA should also extend to include the 5 to 11-year-olds.

“We’ve had a couple of hundred kids hospitalized at Rady Children’s Hospital. 75 in the Intensive Care Unit with COVID, so this can be a serious infection,” said Dr. Mark Sawyer, a pediatric infectious disease specialist at both Rady Children’s Hospital and UC San Diego.

Sawyer is also part of the FDA Advisory Committee set to weigh-in on Tuesday.

“The question we’re being asked is, ‘does the totality of all the evidence support the release?’” he explained. “We will be going over all the data that the company submitted to the FDA, and also listening to the FDA’s interpretation of that data, and asking them some questions about how they went about their interpretation.”

He said the committee would also listen to public comments. He expects the meeting to last about 8 hours, wrapping up at about 5 PM ET.

After that, the committee will vote, and their recommendation will go to the FDA.

“The FDA doesn’t necessarily have to follow the committee’s advice,” he said. “They typically take a few days or even longer to digest what the committee says to them before they make their final decision, but in this case, I’m expecting a decision fairly quickly after the advisory committee meeting.”

If the FDA decides to move forward with authorizing the vaccine, they’ll wait for the Centers for Disease Control and Prevention (CDC) to weigh in next.

“Once the FDA has released a vaccine, physicians can use it, typically though under emergency use they wait for CDC’s guidance about exactly how to use it,” Sawyer explained.

The CDC’s advisory committee is set to meet on Nov. 2 and 3. Once authorization is released, Sawyer expects the shots to start immediately.

To watch the committee meeting live on Tuesday, click here.