Vacciner paints Pfizer-BioNTech pediatric coronavirus vaccine (COVID-19) in Lansdale, Pennsylvania, USA, December 5, 2021.

Hannah Baer 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 complete the initial two-dose series.

Dr Peter Marx, head of the FDA’s department responsible for vaccines, said data increasingly showed that the protection provided by the two injections was weakening over time. The FDA has determined that a third injection could help boost the protection of children in this age group, and the benefits outweigh the risks, Marx said.

The FDA has decided to authorize a third vaccination after analyzing data from the current Pfizer trial, in which a subset of 67 children in this age group had higher antibody levels a month after taking the booster dose. The drug regulator has not identified any new safety concerns and found that children ages 5 to 11 experience the same mild side effects as other people after taking the booster. These side effects include swelling at the injection site, fatigue, headache, muscle or joint pain, and chills and fever.

FDA Commissioner Robert Calif said that while Covid tends to be less severe in children, more children are getting sick and hospitalized with the virus since the omicron variant began to dominate the U.S. during the winter. Omicron, which has more than 30 mutations, has proven to be able to evade protective antibodies caused by two doses of the vaccine. Studies have repeatedly shown that third injections significantly increase protection against both infection and serious illness.

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