Fizer asked the U.S. government to allow the use of its COVID-19 vaccination in children ages 5 to 11 — and if regulators agree, shots could start within a matter of weeks.
Many parents and pediatricians are clamoring for protection for children younger than 12 who d survive the lower cutoff of the vaccine made by Pfizer and its German partner BioNTech. Not only can children get seriously ill, but often keeping them in school can be a challenge with the coronavirus still outbreaking in poorly vaccinated communities.
Pfizer announced in a Twitter comment that it had filed its application with the Food and Drug Administration.
Now FDA will have to decide whether there is enough evidence that the shots are safe and will work for younger children like they do for teenagers and adults. An independent panel will privately debate the evidence Tuesday, Oct. 26.
One big difference: Pfizer says its research shows that the younger children should get a third of the dose now given to everybody else. After their first dose, 5 - to 11-year-olds developed virus-fighting antibody levels just as strong as teenagers and young adults get from regular 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 extra-contagious delta variant has swept through the country
It makes me very happy to help other kids get vaccines, said Sebastian Prybol, 8, of Raleigh, North Carolina. He is enrolled in Duke University's Pfizer s study and doesn t yet know if he received the vaccine or dummy shots.
It is absolutely safe to them, says Britni Prybol s mother Sebastian. If FDA clears the vaccine, she said she would be overjoyed.
Pfizer studied the lower dose in 268 volunteers aged 5 to 11 and has said there are no serious side effects. The study isn t large enough to detect any extremely normal side effects, such as the heart inflammation that can occur occasionally after the second dose of the second-best 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 young, and the CDC will make a final decision.
To avoid Dosing mix-ups, Pfizer is planning to ship vials specially marked for pediatric use containing the lower dose.