Pfizer Says COVID-19 Vaccine for 5- to 11-year-olds is Safe
The vaccine shows 'robust' antibody response
In a highly anticipated announcement, Pfizer said on Monday a Phase 2/3 trial showed its COVID-19 vaccine was safe and generated a "robust" antibody response in children ages 5 to 11.
These are the first such results released for this age group for a U.S. COVID-19 vaccine, and the data has not yet been peer-reviewed or published. Pfizer said it plans to submit to the U.S. Food and Drug Administration (FDA) for emergency use authorization soon. FDA officials have said that once data is submitted, the agency could authorize a vaccine for younger children in a matter of weeks.
The trial included 2,268 participants ages 5 to 11 and used a two-dose regimen of the vaccine administered 21 days apart. This trial used a 10-microgram dose -- smaller than the 30-microgram dose that has been used for those 12 and older.
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