Pfizer Asks FDA For Emergency Use Authorization For COVID-19 Vaccine For Kids 5-11

(CBS/AP) - Pfizer asked the U.S. government Thursday to allow use of its COVID-19 vaccine in children ages 5 to 11 -- and if regulators agree, shots could begin within a matter of weeks.

Many parents and pediatricians are clamoring for protection for children younger than 12, today's age cutoff for the vaccine made by Pfizer and its German partner BioNTech. Not only can youngsters sometimes get seriously ill, but keeping them in school can be a challenge with the coronavirus still raging in poorly vaccinated communities.

Pfizer announced in a tweet that it had formally filed its application with the Food and Drug Administration.

Now the FDA will have to decide if there's enough evidence that the shots are safe and will work for younger children like they do for teens and adults. An independent expert panel will publicly debate the evidence on Oct. 26.

"This could take time. I know people were hoping kids could get shots in arms by Halloween, but it's more likely it will occur sometime between Halloween and Thanksgiving, assuming it all goes well," said WBZ-TV's Dr. Mallika Marshall.

One big change: Pfizer says its research shows the younger kids should get a third of the dose now given to everyone else. After their second dose, the 5- to 11-year-olds developed virus-fighting antibody levels just as strong as teens and young adults get from regular-strength shots.

While kids are at lower risk of severe illness or death than older people, COVID-19 does sometimes kill children and cases in youngsters have skyrocketed as the extra-contagious delta variant has swept through the country.

"It makes me very happy that I am helping other kids get the vaccine," said Sebastian Prybol, 8, of Raleigh, North Carolina. He is enrolled in Pfizer's study at Duke University and doesn't yet know if he received the vaccine or dummy shots.

"We do want to make sure that it is absolutely safe for them," said Sebastian's mother, Britni Prybol. But she said she will be "overjoyed" if the FDA clears the vaccine.

Pfizer studied the lower dose in 2,268 volunteers ages 5 to 11, and has said there were no serious side effects. The study isn't large enough to detect any extremely rare side effects, such as the heart inflammation that sometimes occurs after the second dose of the regular-strength vaccine, mostly in young men.

Dr. Richard Malley, a professor of pediatrics at Harvard Medical School who works with the Division of Infectious Diseases at Boston Children's Hospital, says several questions will still have to be answered in this state of the process. This includes Pfizer's plans on manufacturing the pediatric version and whether the sample size from the trials are sufficient to make a recommendation.

"The size of the study you would have to do to try to evaluate whether a small increase in, for example, heart inflammation is seen in five-to-11-year-olds, would be much larger than the study conducted by Pfizer," said Dr. Malley. "The study conducted by Pfizer was really essentially looking at what are the antibody responses in children. Is it well tolerated? Do you have any significant high-frequency side effect you would want to know about immediately. And the answers to those questions is no."

If the FDA authorizes emergency use of the kid-sized doses, there's another hurdle before vaccinations in this age group can begin. Advisers to the Centers for Disease Control and Prevention will decide whether to recommend the shots for youngsters, and the CDC will make a final decision.

Regardless, Dr. Shira Doron, an infectious disease expert at Tufts Medical Center, says the application for emergency use is another step in the right direction.

"A lot of things still have to go right still," said Dr. Doron. "This doesn't mean it's happening for sure, but obviously this is an important step."

(© Copyright 2021 CBS Broadcasting Inc. All Rights Reserved. The Associated Press's Larry Neergaard and Emma Tobin contributed to this report. The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education.)

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