Clinical studies have observed a 36-fold increase in antibodies against the Omicron variant in children who received a third dose.
The Pfizer-BioNTech alliance on Thursday announced positive results for its clinical trials for a booster dose of its anti-Covid vaccine in children ages 5 to 11 and plans to submit an application for approval “in the coming days” in the United States states, then elsewhere in the world. Specifically, the studies analyzed the blood of children who received this booster dose about six months after the second. After the injection, the levels of neutralizing antibodies against the Omicron variant increased 36-fold compared to the levels after the second dose. Omicron is the dominant variant worldwide today.
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The two starting doses for children ages 5 to 11 have been approved by the United States Medicines Agency (FDA) since late October. The dose used for this age group is 10 micrograms for both the primary and booster injections (compared to 30 micrograms for those 12 years and older).
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Pfizer and BioNTech “plan to file an emergency use authorization application for a booster vaccine in children ages 5 to 11 in the United States in the coming days,” they said in a joint statement. “The companies also plan to share this data with the European Medicines Agency (EMA) and other regulatory authorities around the world as soon as possible,” the statement added.
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Clinical trial results of the vaccine are still awaited for children under the age of 5 after the companies announced they would test a first series of three doses for them. Although a dosage of only 3 micrograms per bite was chosen for these very young children, the immune response triggered after only two doses was then insufficient.
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