Roundup: U.S. FDA authorizes Moderna, Pfizer-BioNTech COVID-19 vaccines for kids as young as 6 months


LOS ANGELES, June 17 (Xinhua) -- The U.S. Food and Drug Administration (FDA) on Friday authorized emergency use of the Moderna and Pfizer-BioNTech COVID-19 vaccines for children down to 6 months of age.

For the Moderna vaccine, the FDA amended the emergency use authorization (EUA) to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had previously been authorized for use in adults 18 years of age and older.

For the Pfizer-BioNTech vaccine, the FDA amended the EUA to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had previously been authorized for use in individuals 5 years of age and older.

The FDA said its evaluation and analysis of the safety, effectiveness and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs.

The agency determined that the known and potential benefits of the Moderna and Pfizer-BioNTech COVID-19 vaccines outweigh the known and potential risks in the pediatric populations authorized for use for each vaccine.

The Moderna vaccine is administered as a primary series of two doses, one month apart, to individuals 6 months through 17 years of age.

The Pfizer-BioNTech vaccine is administered as a primary series of three doses in which the initial two doses are administered three weeks apart followed by a third dose administered at least eight weeks after the second dose in individuals 6 months through 4 years of age.

The FDA's decision came after a meeting of its advisors earlier this week, which voted to recommend the Moderna and Pfizer-BioNTech COVID-19 vaccines for children as young as 6 months old.

The advisory committee meeting was part of a transparent process to help the public have a clear understanding of the safety and effectiveness data supporting the authorization of these two vaccines for pediatric populations, said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.

"Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data," said FDA Commissioner Robert Califf in a statement.

The U.S. Centers for Disease Control and Prevention (CDC) is scheduled to convene an advisors' meeting on Saturday to vote on guidelines for pharmacies and doctor's offices to give the shots.

CDC Director Rochelle Walensky then has to sign off on those guidelines before kids can start receiving the shots.

The White House expects vaccinations to begin as soon as Tuesday. Appointments might be limited initially but every parent who wants to get their child vaccinated should be able to do so within weeks, according to Ashish Jha, who oversees the Joe Biden administration's COVID-19 response.

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