Testing continues for child COVID Vaccines: Fauci says late spring or summer authorization is possible
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The government’s top infectious disease expert said Friday he hopes to see some kids starting to get vaccinated for COVID-19 in the next few months.
Vaccines do not yet have emergency use authorization for all children, but testing already is underway, including in the Twin Cities.
"Over the next couple of months, we’ll be doing trials–in an age de-escalation manner –so that hopefully by the time we get to the late spring and early summer we’ll have children being able to be vaccinated according to the FDA’s guidance," said Dr. Anthony S. Fauci, Presidential COVID-19 Advisor.
"This is a tremendous honor just to be asked by Moderna to do this study," said Dr. Gary Berman of the Clinical Research Institute based in the Twin Cities.
Dr. Berman said they are one of about 10 Moderna COVID-19 vaccine testing locations in the country whose data could be used for FDA emergency use authorization for use of the COVID-19 vaccine by 12-17 years-olds.
Currently, the Moderna vaccine has only been federally authorized for people 18 and older.
In this Jan. 22, 2021, file photo, Tina Killebrew, a certified medical assistant, prepares doses of the Pfizer-BioNTech COVID-19 vaccine at a vaccination center at the University of Nevada, Las Vegas in Las Vegas. A racial gap has opened up in the nation's COVID-19 vaccination drive, with Black Americans in many places lagging behind whites in receiving shots, an Associated Press analysis shows.[AP Photo/John Locher, File]
"You’ve got to do it a little slower, little more careful, explain it to parents, you’ve got to explain it to the kids," said Dr. Berman. "A lot of kids have anxiety about blood work, the nasopharyngeal swab, they’ve got to know what’s going on."
Dr. Berman said kids and their parents spend around 2-3 hours at the clinic, discussing the risks and benefits of taking part, health screenings, and finally a shot, before returning in 4 weeks.
"It’s a process, and then they get their vaccine –they have to stay here an hour after the vaccine," Dr. Berman said "They need to learn how to use a diary of symptoms, we’re collecting information if they have a fever or a swollen arm."
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But to keep the study up to standards, neither the doctor, nor the patient knows if the syringe holds vaccine or placebo.
Pfizer’s clinical trial for children 12 to 15 is fully enrolled, and the drugmaker could seek emergency authorization from the Food and Drug Administration for children 12 and up sometime in the first half of this year.
Pfizer’s vaccine has received FDA emergency use authorization for those 16-years of age and older.
Minnesota Department of Health data shows 590 16-17 year-olds have been vaccinated.
Since the initial tests to validate the safety and effectiveness of the Pfizer and Moderna vaccines involved tens of thousands of people, the age-related testing on children can be done using smaller groups.
"You don’t want to have to … go through an efficacy trial, where you’re involving tens of thousands of children," Fauci explained. "What you can do, is in a much smaller trial, measured in hundreds to a couple of thousands … what we call safety and … immunogenicity." That’s a term for whether the vaccine successfully triggers an immune system response.
Berman said at their Twin Cities location they are about half-way through their testing with about one month to go for the current age group.
The Associated Press contributed to the reporting on this story.