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 development at Pfizer, appeared along with representatives from other major drugmakers to talk data 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 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.
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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 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 Finland. She noted plans to vaccinate 4,500 participants with two doses spaced 21 days apart.
“We are planning for emergency use authorization submission for the older age group, that is the 5 to 11, in September, October of this year the younger group to follow soon thereafter,” she said.
Meanwhile, Dr. Sabine Schynder Ghamloush, director of clinical development at Moderna, said the company is in the first part of KidCOVE, Moderna’s pediatric trial involving about 7,000 children between 6 months to 11 years of age. Moderna filed for emergency approval of its COVID-19 vaccine among adolescents earlier this month. Currently, the two-dose vaccine is authorized for use in the U.S. for those 18 years older.
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Ghamloush said Moderna is conducting a dose-ranging study to see if a lower dose could be effective in younger kids.
Johnson & Johnson intends to run four pediatric clinical trials for use of its COVID-19 vaccine, expects to begin a trial among adolescents aged 12-17 in fall 2021, before expanding trials to younger age groups, Dr. Macaya Douoguih, MPH, head of clinical development medical affairs at Janssen, said during the virtual event.
Fox News’ Alexandria Hein contributed to this report.