Pfizer Asks FDA to Allow COVID Shots for Children

Pfizer asked the US government on Thursday to authorize the use of its COVID-19 vaccine in children aged 5 to 11.

  • Pfizer announced it had formally filed its application with the Food and Drug Administration.
    Pfizer announced it had formally filed an application with the FDA

Pfizer called on the US government on Thursday to allow the use of its COVID-19 vaccine in children ages 5 to 11, and once approved, shots could be ready within a matter of weeks.

Many parents and pediatricians are thinking of how they will protect children under 12, the age cutoff for the vaccine made by Pfizer and its German partner BioNTech. 

The panic is not just because youngsters sometimes get seriously ill, but keeping them in school is yet another challenge as the coronavirus still ravages poorly vaccinated communities. 

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

The FDA must now decide whether there is sufficient evidence that the shots are safe and will work for younger children in the same way they do for teens and adults. On October 26, an independent expert panel will hold a public debate on the evidence.

Pfizer's research findings

On another note, Pfizer says its research revealed that younger kids should get a third of the dose now being given. After their second dose, children between 5 and 11 developed virus-fighting antibody levels that were just as strong as the teens and young adults get from regular-strength shots.

While children are at a lower risk of serious illness or death than adults, COVID-19 does occasionally kill children, and cases in children have surged as the extra-contagious delta form has swept the country.

Pfizer tested the lower dose on 2,268 volunteers aged 5 to 11 and found no major negative effects. The study is too small to detect any extremely rare side effects, such as heart inflammation, which occurs occasionally after the second dose of the regular-strength vaccine, mostly in young men.

If the FDA approves the use of child-sized doses in an emergency, there will be another obstacle before immunization in this age range may begin. The Centers for Disease Control and Prevention's advisors will decide whether to recommend the shots for children, and the CDC will make a final decision.