Pfizer has asked the FDA for emergency use authorization for its COVID-19 vaccine for kids as young as 5. A panel of FDA advisors is scheduled to meet on Oct. 26 to talk about Pfizer's application.
Pfizer began submitting data a couple of weeks ago. If this panel of advisors decides that data holds up, vaccinations for children ages 5 to 11 could be available within weeks, not months. The New York Times reports that 28 million kids would be eligible to get the shot.
This would be the first COVID-19 vaccine for younger kids.
Last month Pfizer released details of a trial showing its vaccine was safe, and that it generated a robust antibody response in subjects ages 5 to 11. Pfizer and its German partner BioNTech said their research shows the younger kids should get one-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 those that teens and young adults get from regular-strength shots.
The Pfizer vaccine is already fully approved for people age 16 and older. It has an emergency use authorization for kids ages 12 to 15.
Many parents and pediatricians are clamoring for protection for children under 12, the current age cutoff for COVID-19 vaccinations in the U.S. 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.
While kids are at lower risk of severe illness or death than older people, COVID-19 does sometimes kill children — at least 520 so far in the U.S., according to the American Academy of Pediatrics. And cases in youngsters have skyrocketed as the extra-contagious delta variant has swept through the country.
While some mothers and fathers will no doubt take a hard stand against vaccinating their children, many parents of elementary students are eagerly awaiting authorization of the shots after a stressful 18 months of remote learning, COVID-19 scares and infections, mask debates and school quarantines.
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They are looking forward to regular visits to grandparents again, worry-free playdates, vacations and the peace of mind of dropping children at school without the constant fear they will get sick. Principals are hoping the shots will allow schools to stay open and return to normal.
Pfizer studied the lower dose in 2,268 volunteers ages 5 to 11 and 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-size doses, there is 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.
To avoid mix-ups, Pfizer is planning to ship the lower-dose vials specially marked for use in children.
Moderna has requested FDA permission to use its vaccine in 12- to 17-year-olds and also is studying its shots in elementary school children. Both Pfizer and Moderna are studying even younger children as well, down to 6-month-olds. Results are expected later in the year.
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