Pfizer booster dose can protect against Omicron in children in 5-11 group
Premium- Blood serum analysis of a few pediatric participants who received a booster dose in the study showed a 36-fold increase in Omicron neutralizing antibodies, Pfizer said
Pfizer Inc and BioNTech on Thursday announced that its third dose of COVID-19 vaccine can protect against severe Omicron infection in healthy children between 5 and 11 years in a trial.
“Blood serum analysis of a few pediatric participants who received a booster dose in the study showed a 36-fold increase in Omicron neutralizing antibodies," Pfizer said adding, “Neutralizing antibodies against SARS-CoV-2 wild-type strain rose six-fold following the booster shot."
During the study, the safety and immunogenicity of 10 microgram booster doses were tested in 140 healthy children in this age group.
A primary series of two 10 microgram doses of the Pfizer-BioNTech COVID-19 Vaccine was previously authorized under EUA for this age group in October 2021. The 10 microgram dose level was carefully selected based on safety, tolerability and immunogenicity data.
Now, the companies plan to apply for Emergency Use Authorization of a booster dose in the 5-11 age group, with additional submissions to global regulatory agencies including the European Medicines Agency to follow.
Earlier this year, the U.S. Food & Drug Administration authorized a third dose of the vaccine for children ages 12 to 15 and those aged 5 through 11 years who are immunocompromised. The agency at the time said it will weigh boosters for 5 to 11 year olds after more children receive two doses.
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According to the Centers for Disease Control & Prevention (CDC), about 8 million children aged between 5 and 11 in the United States are fully vaccinated.