The U.S. Food and Drug Administration is expected to
authorize Pfizer's COVID-19 vaccine for youngsters ages 12 to 15 by next week,
according to a federal official and a person familiar with the process, setting
up shots for many before the beginning of the next school year.
The announcement is set to come a month after the company
found that its shot, which is already authorized for those age 16 and older,
also provided protection for the younger group.
The federal official, speaking on the condition of anonymity
to preview the FDA's action, said the agency was expected to expand its
emergency use authorization for Pfizer's two-dose vaccine by early next week,
and perhaps even sooner. The person familiar with the process, who spoke on
condition of anonymity to discuss internal matters, confirmed the timeline and
added that it is expected that the FDA will approve Pfizer’s use by even
younger children sometime this fall.
The FDA action will be followed by a meeting of a federal
vaccine advisory committee to discuss whether to recommend the shot for 12- to
15-year-olds. Shots could begin after the Centers for Disease Control and
Prevention adopts the committee’s recommendation. Those steps could be
completed in a matter of days.
Pfizer in late March released preliminary results from a
vaccine study of 2,260 U.S. volunteers ages 12 to 15, showing there were no
cases of COVID-19 among fully vaccinated adolescents compared with 18 among
those given dummy shots.
Kids had side effects similar to young adults, the company
said. The main side effects are pain, fever, chills and fatigue, particularly
after the second dose. The study will continue to track participants for two
years for more information about long-term protection and safety.
Pfizer isn’t the only company seeking to lower the age limit
for its vaccine. Results also are expected by the middle of this year from a
U.S. study of Moderna’s vaccine in 12- to 17-year-olds.
Head of Pediatric Infectious Diseases at Stony Brook
Children’s Hospital Dr. Sharon Nachman appeared on News 12’s New Normal show,
saying that the FDA is being incredibly cautious in their vaccination efforts
on children.
“They are looking critically at all the data,” Nachman says.
“As well as the updated data from adults. This is exactly their job and they
are doing it right. They are cautious and looking at every piece of
information.”
But in a sign that the findings were promising, the FDA
already allowed both companies to begin U.S. studies in children 11 and
younger, working their way to as young as 6 months old.
While younger people are at dramatically lower risk of
serious side effects from COVID-19, they have made up a larger share of new
virus cases as a majority of U.S. adults have been at least partially
vaccinated and as higher-risk activities like indoor dining and contact sports
have resumed in most of the country. Officials hope that extending vaccinations
to teens will further accelerate the nation's reduced virus caseload and allow
schools to reopen with minimal disruptions this fall.