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A Pfizer-BioNTech COVID-19 vaccine booster in children ages 5-11 years significantly increased neutralizing antibody titers against the omicron variant with no new safety concerns, according to new data from the manufacturers.
“These data reinforce the potential function of a third dose of the vaccine in maintaining high levels of protection against the virus in this age group,” the companies said in a news release.
The data have not been formally peer reviewed or published in a journal. They are based on clinical trials with 140 children who received a 10-microgram booster six months after their two-dose primary series. The dose is one-third of the adolescent and adult dose.
In the trials, there was a six-fold increase in SARS-CoV-2 wild-type strain-neutralizing geometric mean titers one month after a booster compared to one month after the second dose. An analysis with 30 of the children showed a 36-fold increase in neutralizing antibody titers against the omicron variant compared to the level after the second dose.
The third doses were well-tolerated and did not generate new safety concerns, according to the manufacturers.
Pfizer and BioNTech plan to request emergency use authorization from the Food and Drug Administration in the next few days. The Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices is scheduled to meet April 20 to discuss boosters, although it hasn’t announced which brand or age group it will discuss.
Children ages 5-11 years became eligible for COVID-19 vaccines in early November 2021. About 28% of this age group has been fully vaccinated, according to CDC data.