FDA grants Pfizer emergency use for COVID-19 vaccine for children aged 12 to 15
The Food and Drug Administration has expanded the emergency use authorization for the Pfizer COVID-19 vaccine to children aged 12 to 15, meaning access for millions more adolescents. The Pfizer vaccine is so far still the only one approved for use in 16-to-18 year olds.
The emergency use authorization had been expected. An analysis that included 1,005 vaccine participants in this age group found the vaccine was 100% effective in preventing COVID-19.
In a press conference Monday night, FDA acting commissioner Janet Woodcock said that the vaccine would be distributed to adolescents in the same regimen and dose as adults.
"This vaccine is just the exact same dose and regimen as what has been given out already, so all those places, those pharmacies, those vaccine centers, all those sites can simply extend down to the younger age group," Woodcock said.
"The FDA's expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic," said acting FDA commissioner Janet Woodcock, M.D. "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. 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."
The emergency use authorization could particularly benefit students and families when it comes to schools, making it easier for students to return to regular schooling in person by fall if they aren't now.
Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, called expanding the vaccine to this age group a "critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic."
Marks said Monday night that there would be additional issues for younger age groups they wanted to discuss.
"As we get down to younger children, age 11 and below, different doses of the vaccine will need to be used," Marks said. "And there are also different benefit risk considerations because we know that younger children have been susceptible to this interesting multi inflammatory syndrome with COVID-19, and we have to make sure that we're not going to see anything untoward in the youngest children."
Pfizer has also asked the FDA for full approval of its vaccine, which means it would no longer be distributed under an emergency use authorization.
Alex Tin contributed reporting.