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Pfizer to Ask FDA Soon for Approval of Its COVID-19 Vaccine for Younger Children

Right now, COVID-19 vaccines are only approved for children 12 years and older

MONDAY, Sept. 27, 2021 (HealthDay News) — Pfizer plans to request approval for use of its COVID-19 vaccine in children younger than 12 years 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 years to the U.S. Food and Drug Administration. Right now, COVID-19 vaccines are only approved for children 12 years 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 percent 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 are 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 children, the challenge will be getting them vaccinated. Less than 50 percent 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 Rochelle Walensky, M.D., told CBS Sunday. “When we don’t use the proper mitigation, they’re more likely to have outbreaks.”

Former FDA Commissioner Scott Gottlieb, M.D., 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.”

CNN Article

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