The Pfizer-BioNTech coronavirus vaccine has been shown to be safe and effective for children ages 5 to 11, the companies said Monday.
"Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population," Albert Bourla, Pfizer's chairman and CEO, said in a release addressing the results of its recent trial with children under 12 years old.
The trial included 2,268 children, with two-thirds of them receiving two doses of the Pfizer vaccine three weeks apart. The others received a saltwater placebo. The trial used a lesser dose than that given to people aged 12 and up.
Pfizer and BioNTech plan to share its findings with the US Food and Drug Administration, the European Medicines Agency and other regulatory agencies soon. The companies also plan to apply for emergency use authorization in the US for the younger age group. The vaccine was previously approved for people aged 12 years and older.
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