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FDA approves Pfizer Covid booster dose for children ages 5 to 11

A vaccinator retrieves Pfizer-BioNTech’s pediatric coronavirus disease (COVID-19) vaccine in Lansdale, Pennsylvania, USA December 5, 2021.

Hanna Beyer | Reuters

The Food and Drug Administration on Tuesday authorized a booster dose of Pfizer for children ages 5 to 11 at least five months after they completed their primary two-dose series.

Dr. Peter Marks, head of the FDA’s vaccine division, said evidence is increasingly showing that the protection provided by two shots wanes over time. The FDA has determined that a third shot may help increase protection for children in this age group, and the benefits outweigh the risks, Marks said.

The FDA decided to authorize the third shot after reviewing data from an ongoing Pfizer study in which a subgroup of 67 children in this age group had higher antibody levels one month after receiving a booster dose. The regulatory body did not identify any new safety concerns and found that children between the ages of 5 and 11 experience the same mild side effects as other people after receiving a booster dose. These 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 discuss the data before authorizing the booster dose. Some members of the committee were frustrated that the drug regulator repeatedly pushed booster decisions without open public discussion.

FDA Commissioner Robert Kaliff said that while Covid tends to be less severe in children, more children are getting sick and hospitalized with the virus as the omicron variant became dominant in the US during the winter. Omicron, which has over 30 mutations, has proven to be able to evade protective antibodies elicited by two doses of the vaccine. Studies have repeatedly shown that third shots significantly increase protection against both infections and serious illness.

Covid infections are on the rise again in the US as more transmissible omicron subvariants spread across the country. The US was reporting more than 90,000 new infections per day on average as of Sunday, up 30% from a week earlier, according to data from the Centers for Disease Control and Prevention. The number of new hospitalizations for people with Covid also increased by 8% over the past week, according to the CDC.

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