Fauci: Vaccines for Kids as Young as First Graders Could Be Authorized by September

For this to happen by the start of the next school year, trials need to prove the vaccine is safe and effective in children.

(AP Photo/Bernat Armangue)
(AP Photo/Bernat Armangue) (Copyright 2020 The Associated Press. All rights reserved.)

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Children as young as first graders may be able to get the coronavirus vaccine by the time school starts in September, presuming trials are successful in those age groups, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in an interview with ProPublica.

“We’re in the process of starting clinical trials in what we call age de-escalation, where you do a clinical trial with people 16 to 12, then 12 to 9, then 9 to 6,” Fauci said. When asked what was the youngest age group that might be authorized for the vaccine by September, he said, “I would think by the time we get to school opening, we likely will be able to get people who come into the first grade.”

As optimistic as Fauci is, several pediatricians and infectious disease experts said they wish the pediatric trials would move more quickly. In addition to restoring stability to the education system and parents’ work schedules and keeping kids and those around them safe, vaccinating children is essential to helping the country, as a whole, reach herd immunity and decrease the threat of new variants.

Otherwise, “we’re going to have tens of millions of individuals in our communities that are able to maintain the virus. And when that happens, what that allows is for these unusual variants to emerge that may have the ability to evade our immunity,” said Dr. Buddy Creech, associate professor of pediatrics and director of the Vanderbilt Vaccine Research Program.

Despite the need, Pfizer is the only manufacturer whose pediatric vaccine trials are far enough along to potentially have data on elementary-school age children by the end of the summer.

Pfizer has finished enrolling participants in its study of 12- to 15-year-olds and anticipates having data in “the early part of 2021,” according to a spokeswoman. “From there, we will plan to finalize our study in 5-11 year olds,” she added. As Pfizer completes its trials in adolescents, then 5- to 11-year-olds, it’ll need to submit the data to the U.S. Food and Drug Administration for review and get authorization for the vaccine’s use in those age groups before it’s available; currently in the U.S., the vaccine is indicated only for those ages 16 and up.

Moderna is still enrolling participants in its trial for adolescents ages 12 to 18, and it is “on track to provide updated data around mid-year 2021,” the company said in an emailed statement. Stéphane Bancel, Moderna’s chief executive officer, has said that the company’s goal is to have data from the adolescent study in advance of the 2021 school year. Moderna said it’ll begin an age de-escalation study in children ages 11 years to 6 months this year, but Bancel has said that the company doesn’t expect clinical data until 2022.