The U.S. Food and Drug Administration (FDA) on Friday authorized the first COVID-19 vaccinations for infants and preschoolers, paving the way for vaccinations to begin next week in the United States.
The FDA accepted its advisory panel's unanimous recommendation for the pediatric shots from Moderna and Pfizer-BioNTech. That means U.S. kids between six months and four years of age — roughly 18 million children — are eligible for the shots, about a year and a half after COVID-19 vaccines first became available in the U.S. for adults.
There's one step left: the Centers for Disease Control and Prevention (CDC) recommends how to use vaccines, and its vaccine advisers are set to discuss both Pfizer and Moderna pediatric vaccines on Friday and vote on Saturday. A final sign-off would come from CDC director Dr. Rochelle Walensky.
At a Senate hearing Thursday, Walensky said her staff will work over the Juneteenth federal holiday weekend "because we understand the urgency of this for American parents."
WATCH | FDA advisers vote to authorize 2 COVID-19 vaccines for kids under 5 in U.S.:
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 in the U.S.
Health Canada still reviewing vaccine for youngest children
No COVID-19 vaccine for Canada's youngest children has been approved yet. Health Canada is still reviewing an application from Moderna for its vaccine for kids between six months and five years of age.
At a media briefing on Friday, Dr. Howard Njoo, Canada's deputy chief public health officer, confirmed that Health Canada had received an application from Moderna but not from Pfizer-BioNTech for the under-five age group. Although he doesn't speak for Health Canada, Njoo said authorization for the Moderna pediatric vaccine could happen "in the coming weeks."
Older Canadian children have been able to get a COVID-19 vaccine for months — Pfizer's for kids age five and up and Moderna's for children age six and up.
U.S. government ready to roll out shots
For weeks, U.S. President Joe Biden's administration has been preparing to roll out the vaccines for little kids, with states, Indigenous communities, pharmacies and community health centres allowed to preorder millions of doses. The FDA's emergency use authorization allows manufacturers to begin shipping vaccines 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 the FDA's advisers determined that benefits from vaccination outweighed the minimal risks. Studies from Moderna and Pfizer showed that possible vaccine 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.
Vaccine doses for kids are smaller
Both Pfizer and Moderna use the same messenger RNA (mRNA) technology, but there are differences.
Pfizer's vaccine for kids younger than five 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 six.
Dr. Beth Ebel, professor of pediatrics at the 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.
