FDA OKS 1st COVID-19 shots for kids under 5
U.S. regulators on Friday authorized the first COVID19 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 U.S. kids under 5 — roughly 18 million youngsters — are eligible for the shots, about 1½ years after the vaccines first became available in the country for adults.
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 Friday and will make its recommendation Saturday.
A final signoff is expected soon after 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.
The FDA also authorized Moderna’s vaccines for school-aged children and teens; the CDC will review those next week. Pfizer’s shots had been the only option for those ages.
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 side effects, including fever and fatigue, were mostly minor.