A third dose of Pfizer Inc. and BioNTech’s COVID-19 vaccine produced significant protection against the Omicron variant in healthy children aged between five and 11 years in a trial, the companies said on Thursday.
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, the drug makers said.
Neutralizing antibodies against SARS-CoV-2 wild-type strain rose six-fold following the booster shot.
The mid-to-late stage study was testing the safety and immunogenicity of a 10 microgram booster dose in 140 healthy children aged five through 11 years.
Pfizer and its German partner said the data reinforces potential function of a third dose of the vaccine in maintaining high levels of protection against the virus in this age group.
The companies plan to apply for Emergency Use Authorization of a booster dose in the five-11 age group in coming days, with additional submissions to global regulatory agencies including the European Medicines Agency to follow.
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Earlier this year, the U.S. Food and Drug Administration authorized a third dose of the vaccine for children ages 12 to 15 and those aged five through 11 years who are immunocompromised.
The agency at the time said it will weigh boosters for five to 11 year olds after more children receive two doses.
Vaccination rates stall for Canadian kids aged 5 to 11 – Jan 13, 2022
According to the Centers for Disease Control & Prevention (CDC), about eight million children aged between five and 11 in the United States are fully vaccinated.
In Canada, more than one million children in that age group are fully vaccinated, government data shows.
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