Rutgers seeks more NJ volunteers under 5 for COVID vaccine trial
When COVID-19 vaccines for children ages 5 through 11 were cleared about a month ago, Dr. Sunanda Gaur of Rutgers Robert Wood Johnson Medical School told New Jersey 101.5 that clinical trials for kids from 6 months through 4 years old were also in progress.
Those efforts continue, and in fact, Gaur said Rutgers had actually met its allotment for participants and paused the program.
"But as it turns out, there is slow enrollment in this age group nationally," Gaur, a professor of pediatrics and director of the Rutgers RWJ Clinical Research Center, said. "So we decided to reopen, just to increase the effort."
Rutgers' call for more young volunteers, then, is not an expansion of its trial, but rather an attempt to contribute to a large enough sample size to satisfy the U.S. Food and Drug Administration.
"We need to reach the number in order to really be confident about the safety and the immunogenicity, which means to see if the antibody response is good," Gaur said. "If we don't reach the numbers, then it will further delay the emergency use authorization for this age group, so that's the appeal I have."
With that in mind, Gaur does not expect an additional expansion if the FDA's target number is hit.
She said that did happen for the 5- to 11-year-old age group because regulators wanted more data on potential side effects, but those officials would need to specifically request a larger sample.
At this time, Rutgers is only collecting information about the Pfizer vaccine, although work continues elsewhere to determine if Moderna's shots will be viable for young children.
The Pfizer dose being tested for this youngest age group is about one-tenth the amount given to adults, according to Gaur.
"It's 3 micrograms," she said. "It was 10 for the 5-to-11 (age group), and 30 for the older age groups and adults."
Anyone who is interested in enrolling their child in the restarted clinical trial is asked to complete an online form. Rutgers hopes to notify those selected for the trial by Dec. 13.