The Food and Drug Administration’s action follows its
advisory panel’s unanimous recommendation for the shots from Moderna and
Pfizer. That means U.S. kids under 5 — roughly 18 million youngsters — are
eligible for the shots, about 1 1/2 years after the vaccines first became
available in the U.S. for adults, who have been hit the hardest during the
pandemic.
There’s one step left: The Centers for Disease Control and
Prevention recommends how to use vaccines. Its independent advisers began
debating the two-dose Moderna and the three-dose Pfizer vaccines on Friday and
will make its recommendation Saturday. A final signoff would come from CDC
Director Dr. Rochelle Walensky.
At a Senate hearing Thursday, Walensky said her staff was
working over the Juneteenth federal holiday weekend “because we understand the
urgency of this for American parents.”
She said pediatric deaths from COVID-19 have been higher
than what is generally seen from the flu each year.
“So I actually think we need to protect young children, as
well as protect everyone with the vaccine and especially protect elders,” she
said.
The FDA also authorized Moderna’s vaccine for school-aged
children and teens. Pfizer’s shots had been the only option for those ages.
For weeks, the Biden administration has been preparing to
roll out the vaccines for little kids, with states, tribes, community health
centers and pharmacies preordering millions of doses. FDA’s emergency use
authorization allows manufacturers to begin shipping vaccine across the
country. Vaccinations could begin early next week.
While young children generally don’t get as sick from
COVID-19 as older kids and adults, their hospitalizations surged during the
omicron wave and FDA’s advisers determined that benefits from vaccination
outweighed the minimal risks. Studies from Moderna and Pfizer showed side
effects, including fever and fatigue, were mostly minor.
“As we have seen with older age groups, we expect that the
vaccines for younger children will provide protection from the most severe outcomes
of COVID-19, such as hospitalization and death,” FDA Commissioner Robert Califf
said in a statement.
In testing, the littlest children developed high levels of
virus-fighting antibodies, comparable to what is seen in young adults, the FDA
said. Moderna’s vaccine was about 40% to 50% effective at preventing infections
but there were too few cases during Pfizer’s study to reliably determine
effectiveness, the agency said.
“Both of these vaccines have been authorized with science
and safety at the forefront of our minds,” said Dr. Peter Marks, FDA’s vaccine
chief.
The two brands use the same technology but there are
differences.
Pfizer’s vaccine for kids younger than 5 is one-tenth of the
adult dose. Three shots are needed: the first two given three weeks apart and
the last at least two months later.
Moderna’s is two shots, each a quarter of its adult dose,
given about four weeks apart for kids under 6. The FDA also authorized a third
dose, at least a month after the second shot, for children who have immune
conditions that make them more vulnerable to serious illness.
Both vaccines are for children as young as 6 months. Moderna
next plans to study its shots for babies as young as 3 months. Pfizer has not
finalized plans for shots in younger infants. A dozen countries, including
China, already vaccinate kids under 5, with other brands.
In the U.S., it remains uncertain how many parents want
their youngest vaccinated. By some estimates, three-quarters of all children
have already been infected. And only about 30% of children aged 5 to 11 have
been vaccinated since Pfizer’s shots opened to them last November.
Dr. Beth Ebel, professor of pediatrics at University of
Washington in Seattle, said the tot-sized vaccines would be especially welcomed
by U.S. parents with children in daycare where outbreaks can sideline parents
from jobs, adding to financial strain.
“A lot of people are going to be happy and a lot of
grandparents are going to be happy, too, because we’ve missed those babies who
grew up when you weren’t able to see them,” Ebel said.