U.S. regulators on Friday approved the first COVID-19 shots for infants and preschoolers, paving the way for immunizations to begin next week.
The Food and Drug Administration’s action follows the unanimous recommendation of its advisory panel on the Moderna and Pfizer inclusions. That means US children under the age of 5 – approximately 18 million youth – are eligible for the vaccines, about 1 1/2 years after vaccines first became available in the US for adults who have been hardest hit during the pandemic.
The FDA also approved Moderna’s vaccine for school-age children and adolescents. Pfizer’s shots were previously the only ones available for these age groups.
There’s one step left: The Centers for Disease Control and Prevention recommends vaccine use, and their immunization advisors will discuss vaccinations for the youngest children on Friday and vote on Saturday. Final approval would be given by CDC Director Dr. Rochelle Walensky coming.
At a Senate hearing on Thursday, Walensky said her staff was working over the June 16 holiday weekend “because we understand the urgency for American parents.”
She said pediatric deaths from COVID-19 were higher than what’s seen with the flu across the board each year.
“So actually I think we need to protect young children, as well as protect everyone with the vaccine, and especially protect the elderly,” she said.
The Biden administration has been preparing for the introduction of the vaccines for weeks. States, tribes, community health centers and pharmacies have pre-ordered millions of doses. The FDA’s emergency use authorization allows manufacturers to begin shipping the vaccine across the country. Vaccination could start as early as Monday or Tuesday.
The FDA has yet to decide whether to follow the recommendations and approve the COVID-19 vaccine for children between the ages of six months and five years.
Some parents have longed for the chance to protect their little ones.
While young children generally don’t get as sick from COVID-19 as older children and adults, their hospitalizations spiked during the Omicron wave, and FDA advisors determined that the benefits of vaccination outweighed the minimal risks. Studies by Moderna and Pfizer showed side effects, including fever and fatigue, were mostly minor.
The two brands use the same technology, but there are differences.
Pfizer’s vaccine for children under the age of 5 is one-tenth the adult dose. Three shots are required: the first two three weeks apart and the last at least two months later.
International travelers entering the United States no longer require a Covid-19 test.
Moderna’s are two shots, each a quarter of the adult dose, given to children under 6 about four weeks apart.
The vaccinations are for children from 6 months. Next, Moderna plans to investigate its immunizations for babies as young as 3 months old. Pfizer has not yet finalized plans for vaccinations in younger infants. A dozen countries, including China, are already vaccinating children under the age of 5.
dr Beth Ebel, a professor of pediatrics at the University of Washington in Seattle, said the tot-size vaccines are being particularly welcomed by US parents with children in daycare, where outbreaks could put parents off work and increase the financial burden.
“A lot of people will be happy and a lot of grandparents will be happy too because we missed the babies who grew up when you couldn’t see them,” said Ebel.
AP Medical writers Laura Ungar and Carla K. Johnson contributed.