Coronavirus: FDA panel endorses Pfizer-BioNTech COVID-19 vaccines for children 5-11

An influential Food and Drug Administration advisory committee voted Tuesday in favor of endorsing the COVID-19 vaccine developed by Pfizer and BioNTech for use in young children, determining that the benefits of the vaccine outweigh its risks.

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The 17-0 vote by the FDA’s Vaccines and Related Biological Products Advisory Committee brings the vaccine one step closer to becoming the first available for children under 12 in the U.S. The 10-microgram dose endorsed for children aged 5 to 11 is a third of the dose administered to older people.

One member of the committee abstained from Tuesday’s vote.

Earlier this month, Pfizer and BioNTech asked the FDA to approve an amendment to its emergency use authorization, which allows people aged 12 and older to receive the COVID-19 vaccine developed by the companies.

>> Related: Coronavirus: Pfizer, BioNTech ask FDA to authorize COVID-19 vaccine use in children aged 5-11

In the days following Tuesday’s vote, the FDA is expected to issue an emergency use authorization to allow the vaccine to be administered to younger people, Stat News reported. Next, a Centers for Disease Control and Prevention advisory committee will review the data and vote on whether the CDC should recommend the vaccine’s use.

An FDA analysis confirmed results from Pfizer and BioNTech, which found that the vaccine is nearly 91% effective at preventing symptomatic infection in children between the ages of 5 and 11. Side effects reported were comparable to those seen in older people who got vaccinated, officials said.

>> Related: Coronavirus: FDA considers Pfizer vaccines for children ages 5-11 on Tuesday

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said that 1.9 million children between the ages of 5 and 11 have been infected with COVID-19, resulting in 8,300 hospitalizations and more than 2,500 cases of multisystem inflammatory disorder.

“There have also been close to 100 deaths, making it one of the top 10 causes of death in this age range during this time,” he said. “In addition, infections have caused many school closures and have disrupted the education and socialization of school children.”

Children between 5 and 11 have accounted for about 9% of all reported COVID-19 cases nationwide and 40% of all pediatric COVID-19 cases – near the highest of any age group, FDA officials said.

Among the biggest concerns related to vaccinating younger children was the risk of myocarditis, a rare kind of heart inflammation that some have reported after COVID-19 vaccination.

>> Related: FDA to add heart inflammation warning to Moderna, Pfizer vaccine fact sheets

Dr. Matthew Oster, of the CDC’s COVID-19 Vaccine Task Force, said officials have received 1,640 reports of myocarditis in vaccinated people under 30. The cases include 877 that met the CDC’s case definition for the heart condition and 637 that remained under review.

“Myocarditis is a rare but important adverse event following COVID-19 vaccination, and not all myocarditis is the same,” Oster said, noting that people who experienced myocarditis after vaccination tended to recover quickly. He added that more research is needed to determine the long-term effects of the condition.

Officials also noted that several overlapping systems are dedicated to monitoring for adverse effects related to vaccinations.

>> Related: Coronavirus: FDA grants full approval of Pfizer-BioNTech COVID-19 vaccine

The Pfizer-BioNTech vaccine is currently available under an emergency use authorization to children aged 12 and older. It has also been fully approved as Comirnaty for use in people aged 16 and older.

Two other COVID-19 vaccines are also available for people aged 18 and older in the U.S.: one developed by Moderna and a second developed by Johnson & Johnson.