An advisory committee for the Food and Drug Administration is convening Thursday morning to discuss what data the agency would need in order to consider the potential use of the COVID-19 vaccine on children younger than 12, according to the draft agenda.
The committee will consider what data would be needed to support the emergency use authorization or licensure for COVID-19 vaccines on pediatric populations.
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According to CNN, the FDA has said in briefing documents that it would accept data from blood tests to see if vaccines “generated an immune response” in the children, rather than waiting to see if any get infected.
Pfizer started testing its vaccine for children between 6 months and 11 years old in March 2021. Its vaccine was approved for emergency use on children as young as 12 in May. The company announced Tuesday it was entering the second phase of the trial.
Today begins the Phase 2/3 part of our continuous study of the Pfizer - @BioNTech #COVID19 vaccine in healthy children. This is the next step allowing us to gather data to understand the safety and immunogenicity of the vaccine in this group aged 5–11 years.
— Pfizer Inc. (@pfizer) June 8, 2021
According to the company’s website, the three-phased trial will enroll 4,500 children in the United States, Finland, Poland and Spain. The company is evaluating the vaccine use on children in three age groups:
- 5 to 11 years old
- 2 to 5 years old
- 6 months to 2 years old
“What I think we’re going to do with that meeting is we’re going to decide what the parameters are for approval, either through emergency use authorization or for licensure, for much younger age groups,” Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told CNN.
Moderna has also started testing its vaccine on younger children and plans to submit data on vaccine use for children as young as 12.
Dr. Anthony Fauci, the nation’s top infectious disease expert, hinted at the possible timeline for vaccine use on those younger than 12.
“It is likely and almost certain that by the time we get to the end of this calendar year and first quarter of 2022 that we will have enough information regarding safety and immunogenicity to be able to vaccinate children of any age,” Fauci said.
Pfizer said if the benefits of its vaccine on children younger than 12 outweigh the risks, the company hopes to receive potential emergency use authorization in September or October for children 5 to 11 years old.
For more information on what the FDA advisory committee is considering, click here.