The Food and Drug Administration on Tuesday authorized a Pfizer booster dose for children ages 5 through 11 years old at least five months after they complete their two-dose primary series. Dr. Peter Marks, head of the FDA division responsible for vaccines, said data increasingly shows that the protection provided by two shots wanes off over time. The FDA determined…
The Food and Drug Administration on Tuesday authorized a Pfizer booster dose for children ages 5 through 11 years old at least five months after they complete their two-dose primary series.
Dr. Peter Marks, head of the FDA division responsible for vaccines, said data increasingly shows that the protection provided by two shots wanes off over time. The FDA determined that a third shot can help boost protection for children in this age group and the benefits outweigh the risks, Marks said.
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. The drug regulator did not identify any new safety concerns and found that children 5 to 11 experience the same mild side effects that other people do after receiving a booster.
FDA Commissioner Robert Califf said although Covid tends to be less severe in children, more kids have been getting sick and hospitalized with virus since the omicron variant became dominant in the U.S. over the winter.
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