FDA authorizes COVID-19 shots for babies and toddlers

U.S. regulators on Friday approved the first COVID-19 injections for infants and toddlers, paving the way for vaccinations starting next week.

The Food and Drug Administration’s action follows the unanimous recommendation of the advisory panel for the Moderna and Pfizer shots. That means U.S. children under 5 — about 18 million young people — are eligible for the injections, about 1 1/2 years after the vaccines first became available in the U.S. for adults, who have been hit hardest during the pandemic. .

The FDA has also approved Moderna’s vaccine for school-age children and teens. Pfizer’s shots were previously the only ones available for those ages.

There’s one more step left: The Centers for Disease Control and Prevention recommends the use of vaccines, and their vaccine advisers are ready to discuss injections for the youngest children on Friday and vote on Saturday. A final endorsement would come from CDC director Dr. Rochelle Walensky.

During a Senate hearing Thursday, Walensky said her staff worked over the June federal holiday weekend “because we understand the urgency of this for American parents.”

She said the infant mortality rate due to COVID-19 is higher than what is generally seen with flu per year.

“So I actually think we need to protect young children, as well as everyone with the vaccine and especially the elderly,” she said.

The Biden administration has been preparing to roll out the vaccines for weeks. States, tribes, health centers and pharmacies ordered millions of doses. FDA’s emergency use authorization allows manufacturers to ship vaccines nationwide. Vaccinations can start as early as Monday or Tuesday.

Some parents have been anxiously waiting for the chance to protect their little ones.

While young children generally don’t get as sick of COVID-19 as older children and adults, their hospitalizations increased during the Omicron wave and FDA advisers determined that the benefits of vaccination outweigh the minimal risks. Studies by Moderna and Pfizer showed that side effects, including fever and fatigue, were usually minor.

The two brands use the same technology, but there are differences.

Pfizer’s vaccine for children under 5 years of age is one-tenth the adult dose. Three injections 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 the dose for adults, about four weeks apart for children under six.

The vaccines are for children from 6 months of age. Moderna plans to study the photos for babies as young as 3 months old. Pfizer has no definite plans for injections in younger babies yet. 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 vaccines on a large scale would be especially welcome among American parents with children in daycare, where outbreaks could put parents out of jobs, adding to financial pressures.

“A lot of people will be happy and a lot of grandparents will be happy too, because we missed those babies growing up when you couldn’t see them,” Ebel said.

AP Medical writers Laura Ungar and Carla K. Johnson contributed.

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