FDA authorizes Pfizer Covid booster dose for kids ages 5 to 11 years old

A vaccinator draws a Pfizer-BioNTech coronavirus disease (COVID-19) pediatric vaccine in Lansdale, Pennsylvania, U.S., December 5, 2021.

Hannah Beier | Reuters

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. Those side effects include swelling at the injection site, fatigue, headache, muscle or joint pain, and chills and fever.

The FDA did not convene its committee of independent experts to review the data before authorizing the booster dose. Some committee members have grown frustrated that the drug regulator has repeatedly moved ahead on booster decisions without holding an open public discussion.

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. Omicron, which has more than 30 mutations, has proven adept at dodging the protective antibodies induced by two doses of the vaccine. Studies have repeatedly shown that third shots significantly increase protection against both infection and severe illness.

Covid infections are rising again in the U.S. as more transmissible subvariants of omicron spread throughout the nation. The U.S. reported more than 90,000 new infections a day on average as of Sunday, a 30% increase over the week prior, according to data from the Centers for Disease Control and Prevention. New hospital admissions of people with Covid have also increased 8% over the past week, according to the CDC.

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