by Kaelan Deese
September 20, 2021
Pfizer-BioNTech announced on Monday that its two-dose COVID-19 vaccine was found to be safe and showed “robust” antibody response in children ages 5 to 11, according to a press readout.
Data was gathered throughout the test trials on more than 2,000 children. German partner BioNTech described the vaccine’s use in the age group as “safe, well-tolerated, and showed robust neutralizing antibody responses.”
COVID-19 vaccines are not yet authorized or approved for use in children under 12.
“I feel a great sense of urgency” in making the vaccine available to children under 12, said Bill Gruber, senior vice president of Pfizer. “There’s pent-up demand for parents to be able to have their children returned to a normal life.”
Pfizer tested a lower dose amount for the 5 to 11-year-old age group, a third of the regular amount that’s in each shot presently. Following a second dose, children ages 5 to 11 formed coronavirus antibody levels that are just as strong as teenagers or young adults, according to Gruber.
Gruber added that the companies are planning to apply to the Food and Drug Administration by the end of September for use in the 5 to 11 age group, shortly after applications for European and British regulators.
FDA chief Peter Marks said earlier this month that the agency would begin evaluating the data “hopefully in a matter of weeks” after Pfizer submits its study results.
Although children are at a significantly lower risk for severe COVID-19 infections, more than 5 million children in the United States have tested positive for COVID-19 since the outset of the pandemic last year, and at least 460 have died, according to the American Academy of Pediatrics.
Cuba began immunizing children as young as 2-years-old with homegrown vaccines, and Chinese regulators have approved two of its brands down to the age of 3.