COVID vaccine update: FDA approves Pfizer booster for some children under five
The US Food and Drug Administration (FDA) has approved a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for children six months to four years of age.
At least two months before receiving this booster, children should complete their primary three doses. Vaccination series.
Children this age who received only the first two doses of the Pfizer COVID-19 vaccine are not currently eligible for this booster. The FDA recommends that they complete a three-dose series.
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The FDA said in its announcement that the Pfizer-BioNTech COVID-19 vaccine, Bivalent, contains an mRNA component that produces a “broadly protective” immune response against COVID-19 as well as omicron variants BA.4 and BA.5. provides.
“Today’s authorization provides parents and caregivers of children 6 months to 4 years of age who have received a three-dose primary series with the monovalent Pfizer-BioNTech COVID-19 vaccine, with Pfizer- “BioNTech provides an opportunity to update your child’s protection by receiving a booster dose. BioNTech COVID-19 Vaccine, Bivalent,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. said in a press release announcing the approval.
“Currently available data show that vaccination is the best defense against it. Acute morbidity, hospitalization and death All age groups are affected by COVID-19,” he added.
He also said, “We encourage all eligible individuals to ensure their vaccinations are up to date with a bivalent COVID-19 vaccine.”
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Before approving the booster, the FDA analyzed immune response data from 60 children in this age range who had completed a three-dose vaccine series in addition to the booster dose.
The FDA also cited a clinical study that evaluated children six months to 11 years of age who completed a three-dose primary vaccine series with a booster dose from Pfizer-BioNTech. The Covid-19 vaccinetwo way.
The FDA noted that the most common side effects in children between six months and 23 months of age were drowsiness, irritability, pain and swelling, redness at the injection site, loss of appetite, fatigue, and fever.
For children aged two to four years, the most common side effects were vomiting, headache, fatigue, pain at the injection site, diarrhoea, redness and swelling, joint pain and chills.
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For people five to 11 years of age, the most common side effects are muscle aches, joint pain, fatigue, headache, fever, chills, diarrhea, vomiting, injection site pain, swelling and redness, and lymph nodes. were swollen.
The FDA also cited several other studies that support the safety of the recommended booster dose.
These studies were reviewed. Persons above 55 years of age who received a booster, children six months of age and older who received the initial vaccine series, and people five years of age and older who received a booster vaccination with the monovalent Pfizer-BioNTech COVID-19 vaccine, Which was authorized before but not anymore.
“Just because a vaccine is approved doesn’t mean it should automatically be used.”
Mark Siegel, MD, professor of medicine and medical director of Dr. Radio NYU Langone Medical CenterAlso, a Fox News medical contributor pointed out that just because a vaccine is approved doesn’t mean it should automatically be used.
“This should be a discussion between the parent and the pediatrician and the child,” he told Fox News Digital in an email.
“This should be based on factors such as the child’s previous response to vaccines.”
He added that the effectiveness of the vaccine decreases with time.
FDA noted that fact sheets provided to vaccine recipients, caregivers, and health care providers warn of the risk of myocarditis and pericarditis.
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In February, the Centers for Disease Control and Prevention (CDC) updated it. Official Child and Adolescent Immunization Schedule To include the COVID-19 vaccine.
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The schedule, which is posted on the CDC’s website, recommends that children ages six months to 18 years should receive two doses of the primary series four to eight weeks apart — followed by at least A booster dose should be given after eight weeks.