FDA Authorizes Pfizer’s Covid Booster Dose for Kids This Age

The Food & Drug Administration (FDA) has authorized Pfizer’s Covid booster dose for kids aged 5 to 11 years old, at least five months after their two-dose primary series.

The FDA determined that a third Pfizer shot can boost protection for children in this age group and the benefits outweigh the risks, according to Dr. Peter Marks, who heads the drug regulator’s vaccine division.

FDA Commissioner Robert Califf has highlighted that even though Covid tends to be less severe in children, more kids have been getting sick and hospitalized with virus since the omicron variant became dominant. Califf encouraged parents to get their kids vaccinated to protect them against the virus.

The FDA did not convene its committee of independent experts before authorizing the booster dose. It 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 FDA did not identify any new safety concerns and found the children experienced the same mild side effects that other people do after receiving a booster. Those side effects include injection site swelling, fatigue, headache, muscle or joint pain, chills and fever.

Marks said data increasingly shows that the protection provided by two shots wanes over time.

Only about 28% of children ages 5 to 11 had received their primary series of two doses as of April, according to data from the Centers for Disease Control and Prevention.

The FDA’s advisory committee is scheduled to meet next month to review Moderna’s and Pfizer’s requests for the drug regulator to authorize their vaccines for kids under age 5.

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