“As we speak’s motion permits for a youthful inhabitants to be protected against COVID-19, bringing us nearer to returning to a way of normalcy and to ending the pandemic,” Performing FDA Commissioner Janet Woodcock, mentioned in a press release. “Mother and father and guardians can relaxation assured that the company undertook a rigorous and thorough assessment of all out there knowledge, as now we have with all of our COVID-19 vaccine emergency use authorizations.”
In outcomes from trials carried out among the many youthful group the vaccine confirmed 100% efficacy and strong antibody response, Pfizer beforehand mentioned. Negative effects had been much like these skilled by adults.
BioNTech SE and Pfizer beforehand mentioned they hoped the vaccine could be out there to kids on this age group earlier than the beginning of the college yr subsequent fall.
The businesses just lately introduced they are looking for full regulatory approval of their vaccine.
In line with CDC knowledge, there have been about 1.5 million COVID-19 circumstances reported in people aged 11 to 17 as of the tip of April, although the infections on this age group have tended to be milder.
As beforehand reported by Fox Information, the FDA is predicted to carry a gathering subsequent month the place it is going to focus on vaccines in kids.
Pfizer acquired authorization to be used in people aged 16 and over late final yr.
To date practically 140 million doses of the Pfizer vaccine have been administered within the U.S., in response to the CDC.