Children under 12 might finally be able to get a COVID-19 vaccine next month, predicts Anthony Fauci, M.D. This week Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases, said in an interview with MSNBC that he is hopeful the U.S. Food and Drug Administration (FDA) will authorize the first COVID-19 vaccine for emergency use in children ages five to 11 in time to start vaccinating kids “before the end of October.”
Dr. Fauci was responding to Tuesday’s announcement from Pfizer and BioNTech that they have submitted data from the phase 2/3 trial of their two-dose mRNA vaccine in this age group to the FDA for initial review—and plan to formally submit a request for Emergency Use Authorization (EUA) to the FDA in the coming weeks. (According to a press release from the drug companies, data from the trial, which included 2,268 children, indicate a “favorable” safety profile and “robust” antibody response.)
The Pfizer/BioNTech vaccine, which received an EUA for use in kids ages 12 to 15 in May and full approval for use in people over 16 in August, should become available to kids shortly after, Dr. Fauci said. “The FDA, you never want to get ahead of their judgment,” Dr. Fauci told Morning Joe‘s Mika Brzezinski. “But I would imagine in the next few weeks they will examine that data, hopefully, and they’ll give the okay so that we can start vaccinating children,” Dr. Fauci said, “hopefully, before the end of October.”
This timeline is roughly on track with previous reports that the FDA could start granting EUAs to COVID-19 vaccines for use in children younger than 12 by early to midwinter. The FDA has indicated that, upon receiving an EUA request for vaccines in kids under 12, it is ready to conduct its meticulous evaluation of the data relatively swiftly. Earlier this month the agency said it is “prepared to complete its review as quickly as possible, likely in a matter of weeks rather than months.”
Then there is one more major regulatory step in the process of making vaccines available to young kids: After the FDA grants an EUA, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) will convene to evaluate the evidence and formulate its clinical recommendations. (In May, the ACIP offered its recommendations just two days after the FDA authorized the Pfizer/BioNTech COVID-19 vaccine for emergency use in children ages 12 to 15.)
Making safe and effective COVID-19 vaccines available to younger kids in the U.S. is a top priority among public health experts and parents alike. While serious illness and death in children due to the coronavirus remain rare, this population has been hit hard by the rise of the delta variant and remains completely without the protection of vaccines.
In fact, the rate of COVID-19 cases in kids has been on the rise since July. And earlier this month the country hit a record number of new pediatric COVID-19 cases in one week, according to the American Academy of Pediatrics (AAP). Cases among kids still remain high, per the most recent weekly report from the AAP. And, of course, kids can spread the virus to other people. If Dr. Fauci’s prediction is correct, it will be welcome news to parents, teachers, and pediatricians across the U.S.