Pfizer (PFE +0.5%) and BioNTech (BNTX +10.1%) are in talks with the U.S. FDA on how to start testing their COVID-19 vaccine in children, a group that the agency is eager to gather data on, Reuters reports, citing an interview with Bill Gruber, Pfizer’s senior vice president of vaccine clinical research and development.
Vaccines work differently in children than they do in adults. Such tests generally progress in stages, with older adolescents tested first followed by younger adolescents then children.
There are already signs that younger adults have higher rates of reactions, such as sore arms and fevers, to the vaccine than older adults do, Gruber said.
That presents the risk that reactions could increase even more in younger patients. For example, ~75% of adults between 18 and 55 in Pfizer’s most recent trials had fevers after getting the vaccine, most of them mild.
“Younger children — maybe that’s not going to be tolerated. Maybe we’re going to have severe fevers,” he said. “That’s why we’re adopting a very thoughtful, graduated approach. Children are not just small adults.”
The company is submitting safety data to the FDA and developing a testing plan for children, which Gruber expects to start soon.
He also told Reuters that about 19% of the 11,000 people enrolled so far in a 30,000-volunteer U.S. trial for the companies’ COVID-19 vaccine are black or Latino, groups among the hardest by the coronavirus pandemic.
“Between Latinx and Black or African American populations, we’re running at about 19% or so,” Gruber said. “We’re trying to push even higher than that.”
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