Healthy children ages 5 to 11 mount a safe, strong immune response to the Pfizer-BioNTech COVID-19 booster, according to a new study from the companies.
Blood samples from 30 children showed a 36-fold increase in antibodies against the omicron variant after receiving the third shot. In 140 children, a third dose also increased antibodies six-fold against the original strain of the virus.
Because the vaccine is already approved in adults, regulators have allowed immune responses to be used as a metric of effectiveness, instead of actual infections. No new safety issues arose among the 400 children in the booster trial.
The positive results “reinforce the potential function of a third dose of the vaccine in maintaining high levels of protection against the virus in this age group,” according to a Pfizer news release.
The companies plan shortly to ask the Food and Drug Administration to authorize booster shots for children ages 5-11.
Children ages 5 to 11 receive a 10-microgram dose of the Pfizer-BioNTech vaccine, one-third the dose given to adults. In the study, they were given a third dose six months after the second.
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No vaccines have been authorized for children under 5, with trials still underway. Pfizer-BioNTech found that two vaccine doses, while safe, provided too few antibodies in children ages 2 to 4 and were not likely to be protective.
The companies are testing the third shot in that age group. The Pfizer-BioNTech vaccine is the only one authorized for use in children.
Pfizer-BioNTech’s studies have included more than 10,000 children under 12 in the United States, Finland, Poland, and Spain.
The Centers for Disease Control and Prevention authorized vaccines for children ages 5 to 11 in early November. There are approximately 28 million American children in that age group and about 10 million have received at least one dose, according to the CDC.
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