Millions of kid-size doses of Pfizer's COVID-19 vaccine could soon be available for children ages 5-11 throughout the United States.
Pfizer Inc. and BioNTech announced Friday that its phase 2 trial of the drug has shown a "favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen" of the kid-sized vaccine, with the doses administered 21 days apart.
Data will be submitted to the Food and Drug Administration and other regulatory agencies worldwide as soon as possible with a target of receiving approval for emergency use. Meanwhile, results from trials for children under 5 years old are expected later this year.
The FDA's independent advisory committee meeting is expected to discuss emergency use authorization for children aged 5-11 at a meeting on Oct. 26, before the CDC's committee meets on Nov. 2-3. If approved vaccines should be available in early November.
The vaccine doses used in the trial are smaller than doses provided to children ages 12-16, which Pfizer says has shown to be "well tolerated" among the 2,268 children involved in the trial.
Possible side effects from the vaccine include fatigue, headache, muscle pain, chills, fever and nausea. Pfizer says the side effects possible in children ages 5 to 11 are "generally comparable to those observed in participants 16 to 25 years of age."
The lower-dose vaccine, which is one-third the strength of the Pfizer dose provided to children ages 12 and up, was nearly 91% effective against symptomatic COVID cases, and none of the trial participants experienced severe illness.
The CDC reported earlier this week that even as the delta mutant surged between June and September, Pfizer vaccinations were 93% effective at preventing hospitalizations among 12- to 18-year-olds.
Much of the delta surge has been driven by childhood cases as schools resumed in September. While COVID has fortunately proven to be less deadly to children than to adults, health officials are eager to get as many vaccinated as possible to stop the virus' spread.