Vaccinated 5- to 11-year-olds may soon receive a booster shot. The Pfizer-BioNTech alliance is preparing to submit a regulatory filing for its anti-Covid vaccine for children “in the coming days” in the United States and then elsewhere around the world.
The studies conducted by Pfizer-BioNTech specifically analyzed the blood of children who received this booster dose approximately six months after the second. Following injection, levels of neutralizing antibodies against the current world-dominant variant of Omicron increased 36-fold compared to levels observed after the second dose.
Clinical trials for children under the age of 5 are pending
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).
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.
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.