The Pfizer booster dose can be given to children at least five months after completing their two-dose primary series.
Data shows that the protection provided by two shots fades over time, according to Dr. Peter Marks, head of the FDA division responsible for vaccines. Marks said that a third shot can help boost protection for children in this age group and the benefits outweigh the risks.
The FDA decided to authorize a third shot after analyzing data from an ongoing Pfizer trial in which a subset of 67 children in this age group had higher antibody levels one month after receiving a booster dose. There were no new safety concerns found by the drug regulators and children between the ages of 5 and 11 experience the same side effects after receiving a booster. Swelling at the injection site is one of the side effects.
Robert Califf said that since the omicron variant became dominant in the U.S., more kids have been getting sick and hospitalized with virus. Omicron has been able to dodge the protective antibodies caused by two doses of the vaccine. Studies show that third shots increase protection against infections.
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