Pfizer to Ask FDA Soon for Approval of Its COVID Vaccine for Younger Children

MONDAY, Sept. 27, 2021 (HealthDay News) -- Pfizer plans to request approval for use of its COVID-19 vaccine in children under 12 soon.

"It is a question of days, not weeks," Pfizer chairman and CEO Albert Bourla told ABC News on Sunday when asked about when the company will submit vaccine data on children aged 5 to 11 to the U.S. Food and Drug Administration.

Right now, COVID-19 vaccines are only approved for children 12 and older, which is concerning as more younger children are getting sick as the highly contagious Delta variant dominates across the United States, CNN said.

Nearly 26% of all COVID-19 cases nationwide are reported in children, according to recent data published by the American Academy of Pediatrics. And an average of 266 children were hospitalized with COVID-19 every day last week, according to Sunday's data from the U.S. Centers for Disease Control and Prevention.

Once the data from Pfizer is presented, expert panels from the FDA and the CDC will analyze the information and decide whether to recommend the vaccine, CNN reported.

Once the vaccine is available to younger kids, the challenge will be getting them vaccinated. Less than 50% of eligible U.S. adolescents are fully vaccinated against COVID-19, according to a CNN analysis of CDC data.

In the meantime, the CDC recommends that children and school staff wear masks and maintain physical distancing while inside school buildings.

"We know how to keep them safe," CDC Director Dr. Rochelle Walensky told CBS Sunday. "When we don't use the proper mitigation, they're more likely to have outbreaks."

Former FDA Commissioner Dr. Scott Gottlieb encouraged parents to vaccinate their children when they can.

"This is a dangerous pathogen," Gottlieb told CNN. "I wouldn't be so cavalier about this virus, we know that this virus has long-term consequences in a lot of people who contract it, including children."

More information

Visit the U.S. Centers for Disease Control and Prevention for more on COVID vaccines.


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