The U.S. Food and Drug Administration (FDA) has licensed a single booster dose of the Pfizer-BioNTech COVID-19 vaccine bivalent for youngsters six months outdated by way of 4 years of age.
At least two months previous to getting this booster, kids should have accomplished their three-dose main vaccination sequence.
Children in that age vary who solely obtained the primary two doses of the Pfizer COVID-19 vaccine should not at present eligible for this booster. The FDA recommends that they full the three-dose sequence.
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The FDA mentioned in its announcement that the Pfizer-BioNTech COVID-19 Vaccine, Bivalent consists of an mRNA part that gives a “broadly protecting” immune response in opposition to COVID-19, in addition to in opposition to the omicron variants BA.4 and BA.5.
“Today’s authorization gives mother and father and caregivers of kids 6 months by way of 4 years of age who obtained the three-dose main sequence with the monovalent Pfizer-BioNTech COVID-19 vaccine a possibility to replace their kids’s safety by receiving a booster dose with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent,” mentioned Peter Marks, M.D., PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a press launch saying the authorization.
“Currently obtainable information present that vaccination stays the most effective protection in opposition to extreme illness, hospitalization and dying attributable to COVID-19 throughout all age teams,” he added.
“We encourage all eligible people to ensure that their vaccinations are up-to-date with a bivalent COVID-19 vaccine,” he additionally mentioned.
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Before authorizing the booster, the FDA analyzed immune response information for 60 kids on this age vary who had accomplished the three-dose vaccine sequence along with a booster dose.
The FDA additionally cited a medical examine that evaluated kids six months by way of 11 years of age who accomplished the three-dose main vaccine sequence together with the booster dose of Pfizer-BioNTech COVID 19 Vaccine, Bivalent.
The commonest facet impact amongst kids between six months and 23 months had been drowsiness, irritability, ache and swelling, injection website redness, decreased urge for food, fatigue and fever, the FDA famous.
For kids between two years and 4 years outdated, the commonest unwanted side effects had been vomiting, headache, fatigue, injection website ache, diarrhea, redness and swelling, joint ache and chills.
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For these ages 5 by way of 11, the commonest unwanted side effects had been muscle ache, joint ache, fatigue, headache, fever, chills, diarrhea, vomiting, injection website ache, swelling and redness, and swelling of the lymph nodes.
The FDA additionally cited a number of different research that help the protection of the really useful booster dose.
These research evaluated people older than age 55 who obtained the booster, kids six months and older who obtained the first vaccine sequence, and folks 5 years and older who obtained booster vaccination with the monovalent Pfizer-BioNTech COVID-19 vaccine, which was beforehand licensed however is not.
“Just as a result of a vaccine is authorized doesn’t imply it ought to mechanically be used.”
Marc Siegel, M.D., professor of drugs and medical director of Doctor Radio at NYU Langone Medical Center, in addition to a Fox News medical contributor, identified that simply because a vaccine is authorized doesn’t imply it ought to mechanically be used.
“That ought to be a dialogue between the father or mother and pediatrician — and baby,” he instructed Fox News Digital in an electronic mail.
“It ought to be based mostly on elements such because the baby’s earlier response to the vaccine.”
He added that the effectiveness of the vaccines wanes over time.
Fact sheets offered to vaccine recipients, caregivers and well being care suppliers warn of the chance of myocarditis and pericarditis, the FDA famous.
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In February, the Centers for Disease Control and Prevention (CDC) up to date its official baby and adolescent immunization schedule to incorporate COVID-19 vaccines.
The schedule, which is posted on the CDC’s web site, recommends that kids between six months of age and 18 years outdated ought to obtain two doses of the first sequence between 4 and eight weeks aside — adopted by a booster dose at the very least eight weeks later.
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