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A third dose of the Pfizer/BioNTech vaccine against covid-19 increased antibodies that fight the omicron variant 36-fold in children aged 5 to 11, the two companies reported in a press release Thursday.
The companies plan to apply for an emergency use authorization from the US Food and Drug Administration (FDA) for a booster dose in this age group.
The new data comes from a small study in which 140 children, ages 5 to 11, received a 10-microgram booster of the Pfizer/BioNTech COVID-19 vaccine at least six months after their second dose.
The researchers analyzed the levels of antibodies in the hematic serum ––the clear part of the blood–– of a subset of 30 children from this group one month after the third dose. As a result, they found that antibodies against the omicron variant were 36 times higher than after the second dose of the vaccine.
In an analysis of 140 children with no evidence of prior covid-19 infection, antibody levels against the original strain of the SARS-CoV-2 virus were six times higher one month after the booster than one month after the second dose of vaccine.
The companies said there were no safety concerns associated with a booster dose of the vaccine in these small groups of children.
Pfizer and BioNTech say they will apply to the FDA for an emergency use authorization (EUA) for a booster dose for children in this age group “in the next few days.” They will also share the data with the European Medicines Agency and other regulatory agencies.
Studies by the New York State Department of Health and the US Centers for Disease Control and Prevention found that the efficacy of Pfizer’s vaccine in children ages 5 to 12 dropped substantially during the increase in cases generated by the omicron variant, falling from 68% to around 12% against the spread of covid-19. However, two doses of the vaccine continued to provide protection against severe illness resulting in emergency care or hospitalizations.
The FDA authorized the two-dose primary series for emergency use in this age group last October.
Booster doses of the Pfizer covid-19 vaccine are already authorized for people over 12 years of age.
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