Doctors in Omaha will lead two new COVID-19 vaccine trials in children ages 5 to 18, and pregnant women, and their infants. A research partnership between the University of Nebraska Medical Center and Children’s Hospital & Medical Center is part of the global studies sponsored by Pfizer. Dr. Kari Simonsen is chair of the UNMC Department of Pediatrics and pediatrician-in-chief at Children’s, and the principal investigator for the studies and said preliminary COVID-19 vaccines were not tested and authorized for pregnant women and children but the new trials can change that.
"In order to have the necessary information that we need about the effectiveness and the safety of these vaccines for kids and for pregnant women, these studies are essential," she said. "And so we really see this as part of the next step in helping us really to move beyond the pandemic. We need to have our full population protected through vaccination, and so these trials are part of that work."
The first trial is a randomized study in pregnant women and their newborns. After childbirth, all mothers will be vaccinated and will be followed until the baby is 6 months old. Dr. Simonsen said mothers typically pass on antibodies to their newborns, so babies could potentially be protected from COVID-19.
"And somewhere then around six months to a year is when most of that maternal antibody is gone. And in the future, we might expect that as a COVID vaccine becomes part of our routine vaccination plan, that that might be the window when we start thinking about vaccinating babies," she said.
The studies will recruit 4,000 pregnant women and 6,000 kids from around the world. UNMC anticipates about 50 women and 50 children will participate in Nebraska. The research partnership will recruit study participants in late spring or early summer, but children not cared for at the hospitals may also enroll. Dr. Simonsen estimates full results will come out in late summer or early fall.