The U.S. Food and Drug Administration (FDA) has authorized a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for children from six months up to five years old.
Children must complete their three-dose primary vaccination series at least two months before getting the booster.
However, children in that age range who only received the first two doses of the Pfizer COVID-19 vaccine are not eligible for this booster.
The FDA recommends children complete the three-dose series.
In a recent announcement, the FDA said the Pfizer-BioNTech COVID-19 Vaccine, Bivalent includes an mRNA component that provides a “broadly protective” immune response against COVID-19 and also against micron variants BA.4 and BA.5.
In a press release announcing the authorization, Peter Marks, M.D., PhD, director of the FDA’s Center for Biologics Evaluation and Research, said:
“Today’s authorization provides parents and caregivers of children 6 months through 4 years of age who received the three-dose primary series with the monovalent Pfizer-BioNTech COVID-19 vaccine an opportunity to update their children’s protection by receiving a booster dose with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.”
“Currently available data show that vaccination remains the best defense against severe disease, hospitalization, and death caused by COVID-19 across all age groups,” he added.
“We encourage all eligible individuals to make sure that their vaccinations are up-to-date with a bivalent COVID-19 vaccine,” he continued..
Before authorizing the booster for young children, the FDA analyzed immune response data for 60 children who had completed the three-dose vaccine series and the booster dose.
The FDA also cited a clinical study that evaluated children from six months old to 11 years of age who completed the three-dose primary vaccine series along with the booster dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent.
The FDA noted the most common side effect were drowsiness, irritability, pain and swelling, injection site redness, decreased appetite, fatigue, and fever, the FDA stated.
The most common side effects for children between two and four years old were vomiting, headache, fatigue, injection site pain, diarrhea, redness and swelling, joint pain, and chills.
For those ages five through 11, side effects included muscle pain, joint pain, fatigue, headache, fever, chills, diarrhea, vomiting, injection site pain, swelling and redness, and swelling of the lymph nodes.
The FDA also cited several other studies supporting the booster’s safety.
As Fox News reported:
These studies evaluated individuals older than 55 who received the booster, children six months and older who received the primary vaccine series, and people five years and older who received booster vaccination with the monovalent Pfizer-BioNTech COVID-19 vaccine, which was previously authorized but is no longer.
Marc Siegel, M.D., professor of medicine and medical director of Doctor Radio at NYU Langone Medical Center, as well as a Fox News medical contributor, pointed out that just because a vaccine is approved doesn’t mean it should automatically be used.
“That should be a discussion between the parent and pediatrician — and child,” he told Fox News.
“It should be based on factors such as the child’s previous reaction to the vaccine.”
He added that the effectiveness of the vaccines becomes less over time.
The FDA also noted that fact sheets provided to vaccine recipients, caregivers, and healthcare providers warned of pericarditis and myocarditis.
In February, the Centers for Disease Control and Prevention (CDC) updated its immunization schedule for children and adolescents to include COVID-19 vaccines.
The schedule recommends that children between six months of age and 18 should receive two doses of the primary vaccine series between four and eight weeks apart, followed by a booster dose eight weeks later.