FDA authorizes emergency use of COVID-19 vaccines for children 6 months and older

Coronavirus. Courtesy of the Centers for Disease Control
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The U.S. Food and Drug Administration announced it authorized emergency use of COVID-19 vaccines for children 6 months and older to help minimize the potential impacts of coronavirus for young children. 

On Friday morning, Robert Califf, FDA commissioner, and Peter Marks, FDA’s center for biologics evaluation and research director, hosted a virtual press conference dedicated to answering the public questions regarding authorized emergency use of Moderna and Pfizer-BioNTech COVID-19 vaccines. 

“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age,” Califf said during a press conference. “As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death.” 

The FDA amended its emergency use authorization to include use of the Moderna COVID-19 vaccine for individuals 6 months through 17 years of age. The agency also amended its emergency use authorization to include Pfizer-BioNTech COVID-19 for individuals 6 months through 4 years old.  

The Moderna vaccine will be administered as a primary series of two doses, one month apart, to individuals 6 months through 17 years of age. Individuals can get their third primary shot at least one month following the second dose for those in the age group who are immunocompromised, according to the agency. 

The Pfizer vaccine will be administered as a primary series of three doses with the first two doses given three weeks apart followed by the third dose after at least eight weeks.  

Califf reassured viewers the agency was thorough in its evaluation of the data. 

“As with all vaccines for any population, when authorizing COVID-19 vaccines intended for pediatric age groups, the FDA ensures that our evaluation and analysis of the data is rigorous and through,” Marks said during the press conference.  

In addition to the agency’s reviewing of data, the convening of an advisory committee was included for greater transparency, Marks added.  

The committee’s purpose is “to help the public have a clear understanding of the safety and effectiveness data supporting the authorization of these two vaccines for pediatric populations,” Marks said during the press conference. 

According to Barbara Ferrer, director of Los Angeles County Department of Public Health, the doses of Moderna vaccines for children ages 11 and younger are lower than vaccines available for teenagers and adults.  

Ferrer addressed the possibility of the FDA’s authorized emergency use of COVID-19 vaccines in her weekly press briefing on Thursday.  

“The [Centers for Disease and Control] Advisory Committee on vaccines will meet to review the vaccines recommendations from the FDA on Friday or Saturday this week,” Ferrer said. “They [may] go ahead and issue those final approvals.” 

Ferrer said pending the CDC issues those final approvals, COVID-19 vaccines for children 6 months and older will become available as soon as June 21.  

“Once the vaccines are approved, L.A. County will have more than 900 locations prepared to begin administering vaccines to our youngest residents,” Ferrer said. 

Visit vaccinatelacounty.com to learn more about locations and FDA’s authorized emergency vaccinations. For those who have questions about vaccine safety and effectiveness, you can reach out to your pediatricians or clinicians, or call the DPH staff at 833-540-0473. 

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