Pfizer (PFE + 0.5%) and BioNTech (BNTX + 10.1%) are in talks with the US FDA on how to begin testing their COVID-19 vaccine in children, a group the agency likes to collect data on, Reuters reports, citing an interview with Bill Gruber, Pfizer’s senior vice president -president of vaccine clinical research and development.
Faxes work differently in children than in adults. Such tests generally take place in stages, with older adolescents testing first followed by younger adolescents than children.
There are already signs that younger adults have higher rates of reactions, such as bad arms and fever, to the vaccine than older adults do, Gruber said.
This presents the risk that reactions in younger patients may increase even more. For example, ~ 75% of adults between 18 and 55 in the latest Pfizer studies had fever after receiving the vaccine, most being mild.
‘Younger children – maybe that’s not tolerated. Maybe we’ll have a bad fever, ‘he said. ‘That’s why we take a very thoughtful, graduate approach. Children are not just small adults. ”
The company is sending safety data to the FDA and developing a test plan for children, which Gruber expects to begin soon.
He also told Reuters that about 19% of the 11,000 people enrolled in a 30,000-volunteer U.S. trial for the companies’ COVID-19 vaccine are black as Latino, groups among the hardest hit by the pandemic of coronavirus.
“Between Latinx and black populations like African Americans, we run about 19% or so,” Gruber said. “We’re trying to push even higher than that.”
Pfizer increases 0.4% in the late afternoon trade.
Earlier today, Pfizer and BioNTEch said they could file for regulation as early as October.
