US regulators on Friday authorized the first Covid-19 shots for infants and preschoolers, paving the way for vaccinations to begin next week.
The Food and Drug Administration’s action follows its advisory panel’s unanimous recommendation for the shots from Moderna and Pfizer.
That means US children under five – roughly 18 million youngsters – are eligible for the shots, about 1.5 years after the vaccines first became available in the US for adults, who have been hit the hardest during the pandemic.
The FDA also authorized Moderna’s vaccine for school-aged children and teens. Pfizer’s shots had previously been the only ones available for those ages.
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 the shots for the youngest children on Friday and vote on Saturday.
A final sign-off would come from the CDC director, Rochelle Walensky.
At a US Senate hearing on Thursday, Walensky said her staff was working over the Juneteenth federal holiday this 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.
For weeks, the Biden administration has been preparing to roll out the vaccines.
States, tribes, community health centers and pharmacies preordered millions of doses. FDA’s emergency use authorization allows manufacturers to begin shipping vaccine across the country. Vaccinations could begin as early as Monday or Tuesday.
Some parents have been anxiously awaiting the chance to protect their young children.
While young children generally don’t get as sick from Covid-19 as older groups, 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.
The two brands use the same technology. But 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.
The vaccines are for children as young as six months.
