Pfizer Seeks Approval To Give COVID-19 Vaccine To School Children Ages 5 To 11
SAN FRANCISCO (CBS SF/AP) -- For the thousands of San Francisco Bay Area residents struggling with the nightmare of COVID-19 testing for their children, help may soon be on the way after Pfizer announced Friday morning it has asked the FDA for emergency approval to administer its COVID-19 vaccine to children ages 5 to 11.
If the federal regulators agree, shots could begin within a matter of weeks.
The news opens the door for a state-wide mandate requiring COVID vaccinations for all K-12 students by later this year or early in 2021. Gov. Gavin Newsom announced the planned mandate -- the first of its kind in the nation -- last week.
"What you have seen across the country is that leaders assert the need and desire for the social and emotional benefits of in-person instruction, yet they're not following the science," Newsom said. "Schools have actually closed more frequently in those states that have not been more disciplined in advancing a more scientific and data-driven approach to taming this disease and doing the best to get this pandemic behind us."
Many parents and pediatricians have also been 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.
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.
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.
© Copyright 2021 CBS Broadcasting Inc. All Rights Reserved. The Associated Press contributed to this report.
