Pfizer-BioNTech announced on March 31 that its COVID-19 vaccine is safe and effective for children aged 12 to 15.
The companies reported that a clinical trial involving 2,260 volunteers aged 12 and 15 in the United States showed no cases of the virus among those who received the vaccine, compared to 18 in the group that received placebo shots.
The vaccine “demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years old, and was well tolerated,” the companies said in a statement.
“Across the globe, we are longing for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination,” BioNTech CEO Ugur Sahin stated.
“It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones,” Sahin further stated.
The companies also said that the side effects “were generally consistent with those observed in participants 16 to 25 years of age,” without further elaboration.
Those in the adult trial generally experienced pain, fatigue, and headache, among others, as side effects of the vaccination.
The study, which has not yet been published, will continue to monitor all participants for an additional two years after the second dose to gather more information on “long-term protection and safety.”
The companies said they plan to request for emergency approval from the U.S. Food and Drug Administration, as well as from European regulators, in the coming weeks to expand the use of the vaccine for the age group.
Pfizer CEO Albert Bourla said they hope to start vaccinating the age group before the beginning of the next school year.
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