Pfizer on Thursday asked the US government to allow the use of its COVID-19 vaccine in children ages 5 to 11 — and if regulators agree, shots could begin in a matter of weeks.
Many parents and pediatricians are battling to protect children under the age of 12, cutting the age for vaccines made by Pfizer and its German partner BioNTech today. Not only can youth sometimes become seriously ill, but keeping them in school can be a challenge, as the coronavirus is still rampant in poorly vaccinated communities.
Pfizer announced in a tweet that it has formally filed its application with the Food and Drug Administration.
Now the FDA must decide if there is enough evidence that the shots are safe and will work for young children just as they do for teens and adults. An independent expert panel will publicly debate the evidence on 26 October.
One big change: Pfizer says its research shows that young children should now get one-third of the dose given to everyone else. After their second dose, the levels of virus-fighting antibodies in children ages 5 to 11 are as strong as those found in teens and young adults with regular-strength shots.
While children have a lower risk of serious illness or death than older people, COVID-19 sometimes kills children and cases among young people have skyrocketed as the extra-infectious delta variant swept the country
“It makes me so happy that I’m helping other kids get vaccinated,” said 8-year-old Sebastian Priebol of Raleigh, North Carolina. He is enrolled in Pfizer’s study at Duke University and does not yet know whether he has received the vaccine or the dummy shot.
“We want to make sure it’s absolutely safe for them,” said Sebastian’s mother, Brittany Priebol. But she said she would be “very happy” if the FDA approves the vaccine.
Pfizer studied the lower dose in 2,268 volunteers aged 5 to 11 years and said there were no serious side effects. The study isn’t close enough to detect any extremely rare side effects, such as heart swelling that sometimes occurs after a second dose of the regular-strength vaccine, mostly in young men.
If the FDA authorizes the emergency use of a child-sized dose, there is another hurdle before vaccination can begin in this age group. Advisors from the Centers for Disease Control and Prevention will decide whether to recommend the shots for youth, and the CDC will make the final decision.
AP journalist Emma Tobin contributed to this report.
The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.
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