Doctors say trial data could be released next month that could soon pave the way for emergency use authorization of COVID vaccines in kids under the age of 12.
A doctor supervising the Moderna clinical trial at Chicago's Lurie Children’s Hospital said he expects authorization could come this fall for kids age 5 to 11, and by the end of the year for younger children.
Juliana Gometz, 11, and her brother Gabriel, 8, are part of the Moderna clinical trial for kids ages 5 to 11 at Lurie Children’s Hospital.
“Overwhelmingly we have received a lot of positive support, a lot of feedback from parents saying thank you so much for being part of this,” their dad, Dr. Edward Gometz, said.
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Both Moderna and Pfizer have clinical trials underway for their coronavirus vaccines for kids under the age of 12 that have been going on for months. According to a Pfizer spokesperson, Phases 2 and 3 of their clinical studies were launched in June, testing the vaccine on children between the ages of 6 months and 11 years old.
The results of studies on both vaccines were pushed back when the Food and Drug Administration asked both manufacturers to enroll more children. The request came after reports of myocarditis in some vaccine recipients under the age of 30.
“That really caused the pediatric studies to just slow down a little bit and say 'okay what do we have to do to make sure that this is not going to be a problem,'" Dr. Bill Muller, an associate professor of pediatrics at Lurie, said. "And I think that really was disappointing for a lot of people who are hoping to have a vaccine in time for school."
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When it comes to the current timeline, Muller says Pfizer is likely to seek an emergency use authorization first, as they’ve been ahead of Moderna by several weeks.
Kit Longley, Senior Manager of Science Media Relations for Pfizer, provided NBC Chicago with this timeline:
- In June 2021, Pfizer and BioNTech initiated a Phase 2/3 study to further evaluate the safety, tolerability and immunogenicity of the COVID-19 vaccine in preventing COVID-19 in healthy children between the ages of 6 months to 11 years old.
- We anticipate a potential pivotal readout for children between the ages of 5 and 11 sometime in September and pending the data demonstrating safety and immunogenicity and in agreement with regulators, we could potentially submit for a US Emergency Use Authorization (EUA) shortly after that.
- Data for kids 2 and under 5 could arrive soon after that.
- For children between 6 months and 2 years, we could potentially have a safety and immunogenicity readout that would provide the data sometime in October/November, followed by a potential submission to the US FDA for an EUA once agreed upon with regulators shortly thereafter.
As far as when shots could go into kids’ arms, Muller said that shots could begin this fall.
“Sometime in the fall is reasonable to expect for the 6- to 12-year-old age group and then the younger kids, hopefully by the end of the year," Muller said.
Dr. Scott Gottlieb, a Pfizer board member, also told CNBC late las month that he expects U.S. drug regulators to clear the Pfizer-BioNTech COVID-19 vaccine for emergency use in children ages 5 to 11 by late fall or early winter.
Lurie has about 60 kids enrolled in the trial for kids ages 6 through 12. The hospital says it is already looking ahead to enroll children in the younger age groups, with enrollment for kids ages two up to age 6 happening next.
The Gometz family from Bronezville said they’re proud of their kids for taking part.
“The fact that they were excited about it, and then afterwards they were talking about it with their friends at school and saying this is what I'm doing to help,” Gometz said.
