Pfizer to request COVID-19 vaccine emergency approval for kids ages 5-11 by fall


Younger children could become eligible for a COVID-19 vaccine this fall, according to a top executive at Pfizer who noted plans to request emergency approval for use of its vaccine in kids aged 5 to 11 by September or October.

Dr. Alejandra Gurtman, vice president of vaccine clinical research and development at Pfizer, appeared along with representatives from other major drugmakers to talk data and timelines behind pediatric clinical trials Thursday during a Johns Hopkins University-University of Washington virtual symposium. 

Pfizer’s COVID-19 vaccine is currently authorized for use in individuals aged 12 and older.

“With this data, we felt very comfortable to move down in age,” Gurtman said, speaking to the trials involving participants aged 6 months to 11 years.

The trials involved a so-called dose de-escalation strategy to safely determine the appropriate dosage in each age group. The company previously announced it selected lower dosages of vaccine for kids younger than 11 than the volume given to shot recipients ages 12 and older. For children ages 5-11 the vaccine will be given at a 10 microgram (ug) dose level, while those younger than 5 down to 6 months will receive a 3 ug dose level.

Gurtman said Pfizer initiated late-stage trials for all three age groups, with studies taking place in the U.S., Poland, Spain and Finland. She noted plans to vaccinate 4,500 participants with two doses spaced 21 days apart. – READ MORE

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