The Food and Drug Administration (FDA) on Friday authorized the first COVID-19 shots for infants and preschoolers, paving the way for vaccinations to begin next week, The Associated Press reported.
The move follows the FDA advisory panel's unanimous recommendation for the shots from Moderna and Pfizer. The move means US kids under 5 - roughly 18 million youngsters - are now eligible for the shots.
The Centers for Disease Control and Prevention (CDC), which recommends how to use vaccines, will need to make its recommendation on the shots for toddlers before CDC Director Dr. Rochelle Walensky signs off on them.
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."
For weeks, the Biden administration has been preparing to roll out the vaccines for little kids, with states, tribes, community health centers and pharmacies preordering millions of doses. With FDA's emergency use authorization, manufacturers can begin shipping vaccine across the country. Vaccinations are expected to start early next week.
Without protection for their tots, some families had put off birthday parties, vacations and visits with grandparents.
"Today is a day of huge relief for parents and families across America," President Joe Biden said in a statement on Frida, according to AP.
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 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.
"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 on Friday.
In testing, the littlest children developed high levels of virus-fighting antibodies, comparable to what is seen in young adults, the FDA said. Moderna's vaccine was about 40% to 50% effective at preventing infections but there were too few cases during Pfizer's study to give a reliable, exact estimate of effectiveness, the agency said.
Pfizer originally announced in February it had begun submitting data to US regulators seeking emergency use authorization (EUA) of their COVID-19 vaccine for children under age 5. A week later, however, it postponed the application.
(Israel National News' North American desk is keeping you updated until the start of Shabbat in New York. The time posted automatically on all Israel National News articles, however, is Israeli time.)