The Pfizer-BioNTech alliance announced positive results on Thursday for its clinical trials for a booster of its anti-COVID vaccine in children aged 5 to 11, and said it plans to file for authorization “in the coming days. in the United States, then elsewhere in the world.
The trials notably analyzed the blood of children who received this booster dose about six months after the second. After injection, levels of neutralizing antibodies against the Omicron variant increased 36-fold compared to levels seen after the second dose.
Omicron is now the dominant variant in the world.
The two initial doses for children aged 5 to 11 have been authorized by the United States Medicines Agency (FDA) since the end of October.
The dosage used for this age group is 10 micrograms, both for the initial injections and for the booster dose (compared to 30 micrograms for ages 12 and older).
Pfizer and BioNTech “plan to submit an application for emergency use authorization for a booster in children ages 5-11 in the United States in the coming days,” according to a joint statement.
“The companies also plan to share this data with the European Medicines Agency (EMA) and other regulatory agencies around the world as soon as possible,” the statement added.
For children under 5, the results of clinical trials of this vaccine are still awaited, after the companies announced that they wanted to test an initial series of three doses for them.
Indeed, for these very young children, a dosage of only 3 micrograms per injection was chosen, but the immune response triggered after only two doses was then not sufficient.
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