UNMC taking part in vaccine study for children

UNMC and Children’s Hospital & Medical Center researchers, with the help of the Child Health Research Institute, are testing a vaccine for COVID-19 in the youngest population to date.

The researchers have been involved in the first trials testing a vaccine in younger children — the Pfizer-BioNTech COVID-19 vaccine candidate for children ages 6 months through 11 years (IRB#240-21-CB). In late October, the U.S. Food and Drug Administration authorized the emergency use of the vaccine for the prevention of COVID-19 in the older patients in the study, those in the 5- to 11-year-old age group.

"We are now in the process of vaccinating the 5- to 11-year-old age group in the community since the FDA and CDC just approved Emergency Use Authorization for that age group," said Kari Simonsen, MD, Carol Remmer Angle, MD, Presidential Chair of Pediatrics and UNMC and Children’s professor of pediatric infectious diseases. "So those study participants who did not receive the vaccine initially now have the opportunity to do so."

The Nebraska group — part of a global study with 90 clinical sites — now is continuing to follow all the participants, including children age 6 months to 4 years who do not yet have formal FDA/CDC EUA approvals, and the 5- to 11-year-olds. Participants are monitored for any potential COVID-19 infection symptoms and tested using PCR if they are symptomatic.

"Families we’ve worked with have been amazing," Dr. Simonsen said. "Families are very engaged, and the kids are so brave as they come in to see us for study visits. There is a high level of interest from families with children at all age groups to participate and contribute to this important and historic effort."

She said all 50 children needed and recruited for the ongoing study will be followed for 24 months from date of enrollment.

"We anticipate that initially the vaccine will be part of an expanded emergency use authorization to include these younger age groups and that over time, just as the adult recommendations moved forward to full FDA approval, the pediatric approval will be formalized in the same way.

"We were proud to serve as a site for this important study. This research is an opportunity and an example of what we can realize with the partnership between UNMC, Children's and the Child Health Research Institute," Dr. Simonsen said.