“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” Acting FDA Commissioner Janet Woodcock, said in a statement. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”
In results from trials conducted among the younger group the vaccine showed 100% efficacy and robust antibody response, Pfizer previously said. Side effects were similar to those experienced by adults.
BioNTech SE and Pfizer previously said they hoped the vaccine would be available to children in this age group before the start of the school year next fall.
The companies recently announced they are seeking full regulatory approval of their vaccine.
According to CDC data, there were about 1.5 million COVID-19 cases reported in individuals aged 11 to 17 as of the end of April, though the infections in this age group have tended to be milder.
As previously reported by Fox News, the FDA is expected to hold a meeting next month where it will discuss vaccines in children.
Pfizer received authorization for use in individuals aged 16 and over late last year.
So far nearly 140 million doses of the Pfizer vaccine have been administered in the U.S., according to the CDC.