RWJMS enrolls participants ages 6 months to 4 years old in coronavirus vaccine trial

Rutgers is seeking participants between 6 months to 4 years old for a third clinical trial to test the efficacy of the Pfizer pediatric coronavirus disease (COVID-19) vaccine for this age group, according to a press release.

Co-lead investigator for the clinical trial Simon Li, an associate professor in the Department of Pediatrics at Rutgers Robert Wood Johnson Medical School (RWJMS), said the Pfizer pediatric vaccine is an important milestone as it is the first COVID-19 vaccine for school-aged children.

He said it is crucial that children get vaccinated despite facing a lower risk of severe illness due to many having been hospitalized from COVID-19. In addition, since children may only experience mild symptoms from the virus, they are highly likely to transmit it, he said.

“According to the (Centers for Disease Control and Prevention), about 1,000 kids have died from COVID-19, including 296 deaths of children who were less than 4 years old. This is about 6 percent of the deaths of all people in the (U.S.),” Li said. “It is imperative that we work on reducing transmission and build up societal immunity.”

Li said the effect on children of their parent or caregiver developing COVID-19 is often overlooked but should be considered as well. Studies estimate that approximately 140,000 children in the U.S. and 1.5 million worldwide lost a caregiver in the first year of the pandemic, he said.

Children who are selected for the trial will receive either two doses of the Pfizer pediatric vaccine or a placebo to track infection rates with moderate to severe symptoms between vaccinated people of their age group and those unvaccinated over two years, according to the release. They will be informed which one they received and will have the chance to get vaccinated at that point if they were given the placebo instead.

RWJMS has only conducted one pediatric clinical trial for the COVID-19 vaccine so far, but Li said the team is able to draw upon the prior work of Jeffrey Carson, a provost at Rutgers Biomedical and Health Sciences and distinguished professor in the Department of Medicine, and Sunanda Gaur, director of the Pediatric Clinical Research Center at RWJMS.

Li said this specific trial is different from the last because it combines safety and efficacy testing into one trial, when they are normally separated into two different phases.

“We see this often in (studies) of drugs with high potential or where rapidity and efficiency is important,” he said. “This is a smart design that all of the COVID-19 vaccine trials have utilized.”

The clinical trial will still have a similar number of child participants as studies on recent pediatric vaccines unrelated to COVID-19, Li said.

RWJMS is 1 of 81 clinical trial sites worldwide to be testing the COVID-19 vaccine for this specific age group, Li said. The team has not had any difficulty with finding participants for this trial, with an excess of volunteers during the initial recruitment phase, but they restarted the enrollment process after pausing to reach the emergency use authorization for the 5- to 11-year-old age group, he said.

Parents and physicians who would like their eligible children to be considered for the trial are encouraged to apply online, according to the release. The trial started in June and will continue for approximately two years at the Pediatric Clinical Research Center, Li said.

He said that the vaccine being tested has received thorough examination to ensure safety for the trial participants — maybe more so than many regularly used vaccines.

“More than 9,000 heroic kid volunteers will be involved in the study worldwide, and don't forget that more than 260 million doses of Pfizer-BioNTech vaccine doses have been administered with minimal adverse effects,” he said. “The vaccine has proven to be pretty safe so far with more than 3 million doses already given to the recently authorized 5 (to) 11-year-old age group.”