April 12, 2021 -- Pfizer and BioNTech have asked the FDA to expand its authorization of their COVID-19 vaccine to include children as young as 12 years of age.
The companies said they plan to ask for similar rulings in other countries in coming days.
The request follows the March 31 announcement of a successful phase III study involving 2,260 adolescents aged 12 to 15. In the trial, there were 18 cases of COVID-19 among 1,129 teens in the placebo group and none among the 1.131 vaccinated study participants, showing the vaccine to be 100% effective in preventing illness in this age group.
The company said side effects from the shots were consistent with those seen in study participants aged 16 to 25. The vaccines also generated robust antibody responses 1 month after the second dose.
Currently, the companies have been granted emergency use authorization in to vaccinate people aged 16 and older.
Pfizer said that if the FDA grants the expansion, it hopes to begin vaccinating this age group before the start of the coming school year.
Other companies have also begun testing vaccines in this age group. Moderna announced that its study of children aged 12 to 18 years was fully enrolled in late February. Results from that study are due within a few weeks. Johnson & Johnson announced that it had begun tests of its vaccine in children and adolescents aged 12 to 17 in early April.